Last week U.S. Representatives Mike Pompeo (R-KS) and G.K. Butterfield (D-NC) introduced a bipartisan bill that would amend the Federal Food, Drug, and Cosmetic Act with respect to foods produced from, containing, or consisting of a bioengineered organism. The result has been either applause or outrage depending on which side of the GMO labeling debate you find yourself on.
Titled the “Safe and Accurate Food Labeling Act of 2014,” the bill, if passed, would establish a federal labeling standard for foods with genetically modified ingredients and give sole authority to the Food and Drug Administration (FDA) to require mandatory labeling on such foods if they are found to be unsafe or materially different from foods produced without genetically modified ingredients.
Specifically, the bill provides that biotechnology companies developing genetically modified ingredients for use in food products must submit a premarket approval notification to the FDA at least 210 days before the bioengineered organism is first introduced into interstate commerce. The premarket approval process outlined by the bill looks quite similar to the GRAS Notice Program currently in place for food additives.
The bill states that:
[a] bioengineered organism shall not be introduced or delivered for introduction into interstate commerce for a food use or application unless (1) the use or application of the bioengineered organism in food has been addressed by the developer of the bioengineered organism in a premarket biotechnology notification, to which the Secretary has responded…by stating no objections.
Within 30 days of receipt of the premarket notification, the FDA must deliver a preliminary where it will either:
- inform the notifier that the notification is complete and has been filed; or
- inform the notifier of any missing elements that prevents further review of the notification.
Once the notification is complete and filed, the FDA then has an additional 180 days to substantively respond by informing the notifier that the agency has no objections or that the notifier’s safety determination is inadequate.
If the FDA does indeed determine that the notifier’s safety determination does not pass muster there is a material difference between a food produced from, containing, or consisting of a bioengineered organism and its comparable marketed food and that disclosure of such difference is necessary to protect health and safety or to prevent the label or labeling of such food from being false or misleading, the agency may specify labeling that would adequately inform consumers of such material difference. The bill is clear that the use of bioengineering does not, by itself, constitute a material difference.
The part of bill that has caused the biggest uproar can be found in Section 104 on Preemption. The Section states that:
no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement for the labeling of a food by virtue of its having been developed using bioengineering, including any requirements for claims that a food is or contains an ingredient that was developed using bioengineering.
The bill would block states from implementing their own labeling laws pertaining to food containing genetically engineered ingredients. The rationale behind the ban according to Rep. Pompeo is that this legislation would eliminate a 50-state patchwork of GMO labeling laws that could mislead consumers and raise the price of groceries. According to a recent article by James Andrews at Food Safety News, [e]fforts to label genetically modified organisms (GMOs) have sprouted across more than two dozen states, including two successful bills in Maine and Connecticut, along with measures that came up short at the ballot box in California and Washington.”
It is unclear whether the bill will pass, but Stoel Rives attorneys will be tracking its progress in the legislature and reporting on any developments.
The Nutrition Facts panel found on many food packages, that most of us have been scanning in grocery aisles for the past 20 years, is expected to undergo some significant changes starting this week. According to a recent press release from the U.S. Food and Drug Administration (FDA), the agency is planning to update the Nutrition Facts label based on the latest science-based nutrition recommendations.
Sources indicate that the changes may be announced as soon as this Thursday, when First Lady Michelle Obama is scheduled to speak at the fourth anniversary celebration of the “Let’s Move!” campaign. Bookmark this site for our report once the proposed Nutrition Facts changes are announced.
By way of background, the Nutrition Facts panel has allowed consumers to have consistent nutritional information and to make healthier choices, since passage of the Nutrition Labeling and Education Act of 1990 mandated nutrition labeling. In addition, throughout the years, mandatory nutrition labeling has encouraged many companies to change their ingredients to make the foods more healthful and thus more appealing to many consumers.
However, in light of new knowledge about nutrition and more evidence that people actually consult the labels of food packages, FDA officials believe it is time for an overhaul. Paula Trumbo, Ph.D., acting director of FDA’s nutrition programs staff explains that “updates are currently being assessed to address such factors as current nutrient recommendations, public health concerns based on recent data on food consumption, and the agency’s desire to make this information as clear and useful as possible.”
Based on preliminary results from Tuesday’s election, it appears that Washington State’s hotly debated Initiative 522 (I-522) concerning the labeling of genetically-engineered foods has gone the way of California’s Proposition 37. Washington officials reported on Wednesday, November 6, 2013 that voters had rejected the measure, 54% to 46%. California’s similar labeling measure, Proposition 37, was rejected by California voters in November 2012.
County by county results show that certain counties in Washington including, King, Whatcom, and Jefferson, were largely in favor of passing I-522. However, the measure lost heavily in the southwest, central and eastern regions of the state.
If it had passed, I-522 would have required that any food offered for retail sale in Washington that was or may have been entirely or partly produced with genetic engineering to be labeled as follows:
- In the case of a raw agricultural commodity, the package offered for retail sale must clearly and conspicuously display the words “genetically engineered” on the front of the package, or where such a commodity is not separately packaged or labeled, the label appearing on the retail store shelf or bin where such a commodity is displayed for sale must display the words “genetically engineered;”
- In the case of any processed food, the front of the package of such food must clearly and conspicuously bear the words “partially produced with genetic engineering” or “may be partially produced with genetic engineering;” and
- In the case of any seed or seed stock, the seed or seed stock container, sales receipt or any other reference to identification, ownership, or possession, must state clearly and conspicuously that the seed is “genetically engineered” or “produced with genetic engineering.”
In addition to the labeling requirements, I-522 would have also created a new private right of action for consumers to sue food companies alleging that they are not meeting the labeling standards set forth in the measure. Throughout the I-522 campaign, opponents argued that these so-called “bounty-hunter” lawsuits would impose significant defense costs and force settlements on food processors that may have inadvertently violated the measure’s requirements.
Despite I-522’s failure, the issue of GMO labeling appears to be here to stay. Earlier this year, Connecticut became the first state to enact legislation requiring the labeling of genetically engineered foods. According to Connecticut’s law, however, the labeling requirement will not take effect until four other states, including one state sharing a border with Connecticut, enact similar legislation. In addition, the requirements of the law will not take effect until a combination of Northeastern states with a cumulative population of over 20 million residents enacts similar legislation. Maine enacted similar legislation this summer, but the law also requires other states to enact GMO food labeling laws before the mandate takes effect.
Several other states currently have pending GMO labeling legislation that will be addressed during the next legislative session for those respective states. Stoel Rives attorneys will continue to track these state GMO labeling measure as developments occur. Check back here for updates.
The FDA's final rule on gluten-free labeling was published in the Federal Register on August 5, 2013, with a mandatory date for compliance of one year thereafter, or August 5, 2014. But the FDA makes clear that this is an outside date. "However, as stated, FDA anticipates that manufacturers are likely to follow the requirements of the final rule as soon as possible." (emphasis supplied).
Imagine you're a consumer who suffers from the travails of celiac disease. Indeed, let's not imagine one, let's take a real one, a paralegal in my office who always orders the gluten-free option at our monthly lunches. Here's what she says is important about the rule:
As a celiac grocery shopper for the last three years, I was limited to the outside aisles. But now that food manufacturers are producing more gluten free products, I can once again shop in the once barren inner aisles. Clear, uniform rules on gluten free labeling are important. It means less time spent reading labels and less risk of a gluten reaction (usually lasting about 10 days). I can spend more time with family and friends and don’t have to worry about my reading glasses.
When she talks about "outside aisles", she means the meat, dairy and produce departments. The inner aisles are prepared and packaged foods. She's looking forward to shopping in the inner aisles again like everyone else.
Here's the deal: as the FDA knows, most of the goods that comply with the new rule (i.e., do not have wheat, rye or barley as an ingredient and contain less than 20 parts per million of gluten) are already known to be gluten-free to manufacturers. But right now, a "gluten-free" label does not need to be one that complies with the rule, yet a consumer like my paralegal has no way of knowing this until next August.
Why make her wait?
And wouldn't a manufacturer get serious bang for the buck by putting out, as soon as it can, a label that says, in essence, "Gluten-Free: Complies with new FDA Rule"?
And do it in big type, so she doesn't need her reading glasses. To quote a very wise man, "Make It So".
We'll have plenty more about the FDA gluten-free labeling rule that came out Friday.
While I'm still digesting the 95 pages of the release, I wanted to point out something in the FDA's update that echoed what was in my last entry. In describing why the FDA chose 20 ppm as the level below which an item would be deemed "gluten-free", the FDA said,
This is the lowest level that can be consistently detected in foods using valid scientific analytical tools.
Well, exactly. We can't measure what we can't measure.
California federal courts now appear positioned to lead the way nationally on the issue of whether food products containing genetically modified ingredients, commonly referred to as “GMOs” can be labeled “All Natural.” Just last week a federal judge in Colorado stayed the case of Nicole Van Atta v. General Mills, Inc. (Case No. 12-cv-02815-MSK-MJW) (PDF), pending the Food and Drug Administration’s (FDA) input on this very issue recently sought from the agency by a California judge in the case of Cox v. Gruma Corp. (Case No. 12-CV-6502 YGR) (PDF).
California, a hotbed of consumer litigation activity due to the state’s expansive consumer protection laws, has become a particularly common venue for consumer class actions alleging misbranding and false advertising regarding the use of “All Natural” claims. In particular, many cases have been filed challenging a manufacturer or retailer’s use of “All Natural” labels on products containing GMOs. These lawsuits are typically brought under California’s unfair competition and false advertising laws (referred to as the “UCL” and “FAL” or §§ 17200 and 17500 of the California Business and Professions Code).
Cox v. Gruma Corp. (“Cox”), the case that lead to the Colorado court’s stay, is a class action lawsuit filed in December 2012 in U.S. District Court for the Northern District of California against Gruma Corporation, the manufacturer of Mission® Tortilla chips. The complaint in Cox alleges that the product’s labeling is false and misleading because it claims to be “All Natural” when it is not in fact natural due to the involvement of genetically modified corn seed in the product’s manufacture.
In Cox, U.S. District Judge Yvonne Gonzalez Rogers issued a final order dated July 11, 2013 (PDF) that stayed the class action for six months and referred to the FDA for an administrative determination the precise question of whether a food product containing GMO ingredients may be labeled “All Natural.” In making her decision, Judge Rogers agreed with plaintiffs’ argument that “a gaping hole in the current regulatory landscape for ‘natural’ claims and GMOs” exists. Accordingly, relying on the primary jurisdiction doctrine, Judge Rogers explained that a court may stay proceedings or even dismiss a complaint without prejudice where the claims involve “an issue of first impression or a particularly complicated issue Congress has committed to a regulatory agency.” Clark v. Time Warner Cable, 523 F. 3d 1110, 1114 (9th Cir. 2008). Based on the nature of the claims in this lawsuit, Judge Rogers concluded that “[u]nder these circumstances, deference to the FDA’s regulatory authority is the appropriate course.”
Many, including the plaintiffs, were surprised by this order based on the fact that, more recently, judges handling similar cases in California have refused to apply the primary jurisdiction doctrine to dismiss or stay matters. The plaintiffs object to the stay order. They argue that FDA has repeatedly declined to define the term “natural” when asked to do so, and there is no reason to suspect it should address the issue now differently now. Specifically, in 2010, a New Jersey federal court judge stayed a food-labeling suit against Hornell Brewing Co. Inc. and ordered FDA to address whether products that contain high-fructose corn syrup may be labeled “natural.” In a September 2010 letter responding to the court (PDF), Michael Landa, Acting Director of Center for Food Safety and Applied Nutrition (CFSAN) at the time, wrote that FDA was declining to provide such a determination.
It is unclear how FDA will respond to the recent order issued in Cox v. Gruma Corp., however, it is undeniable that there is mounting pressure on the agency to act. Although the Cox plaintiffs are correct that FDA has declined to issue formal rules concerning what is and is not “natural,” courts appear to recognize that something this time “feels” different. Perhaps this is because FDA and courts are undeniably more cognizant of the need for resolution of this issue in the context of GMO-containing products given voter interest on the issue throughout 2012, recent Congressional pressure in the form of letters to the agency requesting action on GMO labeling, and several court orders now staying litigation specifically on the issue of whether GMO-containing foods can be labeled “All Natural.”
While it is not expected that the FDA will issue a formal rule in response to recent court orders, it is expected that FDA will respond in some form six months from now in a manner that will tell us whether it will, or will not, issue formal rules or updated guidance on this issue in the reasonably near future. For certain, it will be interesting to see how the Court in Cox formally deals with this issue six months from now and how that case impacts litigation throughout the country.
Stoel Rives attorneys will continue to track this case and other similar “All Natural” cases as developments occur. Check back here for updates.
Many of you may be familiar with the famous confection known as the Kinder Surprise or Kinder Egg, a toy-filled chocolate that is touted as the single largest children’s candy category in the world. The treat is manufactured by the Italian company Ferrero and has risen to nearly cult status in certain countries. Kinder Eggs are sold worldwide; however, U.S. consumers have likely only tried the confection while traveling abroad or through some other surreptitious means. The candy has been banned in the United States for decades.
This Spring, though, U.S. consumers might see something similar to the Kinder Egg in their Easter baskets. Kevin Gass, one of the founders of Candy Treasure LLC located in New Jersey, has developed a safe alternative to the Kinder Egg that meets the approval of both the U.S. Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC).
The FDA has long viewed the practice of intermingling confectionaries with trinkets with apprehension because of the potential choking hazard it presents. In fact, Section 402(d)(1) of the Federal Food, Drug, and Cosmetic Act expressly states that a confectionery is deemed to be adulterated “if it…has partially or completely imbedded therein any nonnutritive object,” unless the nonnutritive object has a functional value and would not be injurious to health.
It is clear that the agency’s thinking on this subject has not changed. Most recently, in April 2012, the FDA reissued its import alert against Kinder Eggs and other similar products containing imbedded, non-nutritive objects, being offered for sale in the U.S. In the alert, FDA explained that “[t]he imbedded non-nutritive objects in these confectionary products may pose a public health risk as the consumer may unknowingly choke on the object.” Individuals attempting to smuggle Kinder Eggs across the border are subject to refusal of admission and a could face a potential fine of $2500 per egg.
Despite these restrictions, Gass announced earlier this month that his company’s product has been approved for sale in the U.S. Candy Treasure makes a confection called the Choco Treasure, which, like the Kinder Egg, is a chocolate egg that contains kid-friendly toys, such as figurines, full decks of mini playing cards, 3D puzzles and spinning tops. So how did this New Jersey company circumvent the country’s longstanding ban on the sale of confectionery that has a partially or completely imbedded non-nutritive object?
Gass explains that the Choco Treasure candy egg has a specially designed yellow egg-shaped capsule that contains each toy. There is a plastic ridge around the capsule which physically separates the two halves of the chocolate egg. It also alerts children that there is something hidden inside the chocolate. The capsule has a button that must be pushed in order to break it apart. In addition, the inedible toys contained inside the capsule are larger than those typically found inside the European equivalent. You can see how the concept works at the company’s website here: http://www.chocotreasure.com/how-it-works/.
This modification to the traditional Ferrero Kinder Egg is considered acceptable and is permitted for sale in the U.S. Ferrero's similar confection remains illegal, on the hand. FDA explained in a Compliance Policy Guide that if the trinkets are physically separated from candy item by some form of wrapping, this would be a sufficient safety precaution.
So this weekend you can enjoy your confection with nonnutritive objects legally. Or, if you are so inclined, you can sign the petition currently pending to lift the ban on Kinder Eggs.
Social media has become a critical component of a company’s product marketing and promotion. However, based on FDA’s increased enforcement action around social media activity, it is a risk to be carefully considered.
The Food and Drug Administration (FDA) recently published a December 11, 2012 warning letter on its website that cited a dietary supplement company for its improper social media activity, among other things. Specifically, the warning letter explained that the supplement company’s “liking” of a consumer testimonial posted to its product Facebook page was a violative claim in that it established the product as a drug intended to cure, mitigate, treat, or prevent a disease. The FDA noted in its warning letter that the liking of the following March 10, 2011 Facebook post by the company constituted an impermissible disease claim:
“[Product]has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation.”
The company has since removed this content from its Facebook page.
This is not the first time that FDA has scrutinized a company’s use of social media. In the past two years, over a dozen companies have been cited by FDA for making improper claims on the company or product Facebook page or Twitter account. However, this is the first time FDA has interpreted that a “like” implies endorsement of an unapproved claim.
There is some speculation that a crackdown on similar social media activities, such as “retweeting” a post on Twitter or “+1” on Google+, might be next on FDA’s agenda. In light of this regulatory risk, companies should ensure consider drafting formal social media policies and thoroughly vetting all social media marketing strategies to avoid enforcement action.
On January 4, 2013, exactly two years after the Food Safety Modernization Act (FSMA) was signed into law by President Obama, the Food and Drug Administration (FDA) published two new proposed food safety rules that will be available for public comment for the next 120 days.
The first rule on “Preventive Controls for Human Food” sets safety requirements for facilities that process, package or store food to be sold in the United States, whether produced at a foreign or domestic-based facility, for human consumption. A separate rule will be issued for animal food in the near future. The rule will require that food facilities implement “preventive controls,” a science-based set of measures intended to prevent foodborne illness similar to Hazard Analysis and Critical Control Points (HACCP) systems that are already required by FDA for juice and seafood processors. Each covered facility would be tasked with preparing and implementing a written food safety plan, which would include the following:
- Hazard analysis;
- Risk based preventive controls;
- Monitoring procedures;
- Corrective actions; verification; and
The FDA is also seeking public comment on a second proposed rule, which proposes enforceable safety standards for the production and harvesting of produce on farms.
This proposed “Standards for Produce Safety” rule proposes science- and risk-based standards that would address the major areas of concern for the fruit and vegetable industry including:
- Irrigation and other agricultural water;
- Farm worker hygiene;
- Manure and other additions to the soil;
- Intrusion of animals in the growing fields;
- Sanitation conditions affecting buildings, equipment and tools.
FDA indicated that the effective date of both proposed rules would be 60 days after the final rule is published. However, in order to allow all businesses, particularly small and very small facilities, adequate time to comply with the new requirements of the rule, FDA plans to adjust the compliance dates based on the facility’s size.
Although many in the food industry believe these rules are long overdue, FDA notes that it conducted extensive outreach to the produce industry, the consumer community, other government agencies and the international community. Since January 2011, FDA staff have toured farms and facilities of all sizes nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community. The goal was to develop proposed rules that could be applied to small and large food facilities alike.
FDA intends to release additional proposed rules addressing importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors.
The attorneys at Stoel Rives will be providing more details about the proposed rules implementing FSMA here at the Food Liability Law Blog in the coming weeks. Stay tuned.
The Food and Drug Administration (FDA) has extended the deadline for food facilities to submit their registration until January 31, 2013.
Under the FDA Food Safety Modernization Act (FSMA), domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to renew their facility registration by December 31, 2012, and every two years after that. FSMA directed that the food facility registration portal would be available starting on October 1, 2012.
However, FDA experienced a delay in implementing the biennial registration renewal for the 2012 cycle. As a result, the registration renewal portal did not become available until October 22, 2012. Food industry members requested that FDA extend the time to register in order to allow companies a full three-month window to complete the renewal requirement. In a new guidance document issued on December 12, 2012, FDA noted that it would exercise its enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.
Failure to register a facility, renew the facility registration, or update required registration information can have serious consequences. For instance, the U.S. can bring a civil or criminal action in federal court against a company that handles food without a proper facility registration. In addition, if food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted, the food could be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food until the foreign facility is registered with FDA.
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that bisphenol A (BPA) is now formally banned from use in baby bottles and sippy cups. The announcement came as a surprise to some as the FDA had only just recently, on March 30, 2012, issued a decision to deny a petition by the Natural Resources Defense Council (NRDC) to ban the use of Bisphenol A (BPA) in all food and beverage packaging materials (see previous blog post on FDA’s denial here). The FDA explained in its denial letter that it appreciated the NRDC’s concern for consumer safety, and that it planned to continue to study the effects of BPA on human health.
Although the FDA is prohibiting the controversial chemical from baby bottles and sippy cups, the agency will continue to allow the presence of BPA in the packaging of other consumer goods. According to a statement by FDA spokesman Allen Curtis, “The agency continues to support the safety of BPA for use in products that hold food.” Rather than being based on safety, the FDA maintained that the ban is in response to the baby bottle industry’s voluntary phase out of the chemical over the last several years.
In related news, Washington State’s ban on the use of BPA in plastic sports bottles became effective last week. The ban is the result of a law passed in 2010 (RCW 70.280) prohibiting the sale of certain products containing BPA. Beginning in July 2011, manufacturers were banned from using BPA in bottles, cups and other containers for children under the age of 3. Now the law has been officially extended to prohibit the presence of BPA in sports bottles. A statement from the Washington State Department of Ecology explains that “[n]o sports bottles containing the chemical BPA can be made, sold or distributed in Washington as of July 1, 2012.” The ban will apply to all sports bottles up to 64 ounces. However, metals cans designed to hold or pack food will still be allowed to contain BPA.
Egg-associated illness caused by Salmonella has long been recognized as a serious public health problem. Specifically, Salmonella Enteritidis, a bacterium commonly found inside shell eggs that appear normal, continues to be one of the leading bacterial causes of foodborne illness in the United States. These eggs primarily become contaminated on the farm because of infection in the laying hens.
During the 1990s, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture implemented a series of post-egg production safety efforts such as refrigeration requirements designed to inhibit the growth of bacteria that may be in an egg. Those efforts, as well as egg quality assurance programs (EQAPs) and consumer and retailer education, contributed to a decrease in Salmonella Enteritidis illness during the mid-1990s. However, while these steps limited the growth of bacteria, they did not prevent the initial contamination from occurring. FDA and USDA officials became aware that further reductions in Salmonella Enteritidis illness could not be accomplished without additional federal measures addressing the contamination of shell eggs.
Just over three years ago, in July 2009, the FDA, in collaboration with the USDA’s Food Safety and Inspection Service (FSIS), announced a new food safety regulation that it expected would prevent approximately 79,000 cases of foodborne illness and 30 deaths caused by consumption of eggs contaminated with the bacterium Salmonella Enteritidis each year.
In July 2010, the rule become effective for egg producers having 50,000 or more laying hens. Most recently, as of this past Monday, July 9, 2012, egg producers with fewer than 50,000 but at least 3,000 laying hens whose shell eggs are not processed with a treatment, such as pasteurization, are required to comply with the egg safety regulation as well.
Some of the highlights under the rule include that egg producers whose shell eggs are not processed with a treatment, such as pasteurization must:
- Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria
- Establish rodent, pest control, and biosecurity measures to prevent spread of bacteria throughout the farm by people and equipment
- Conduct testing in the poultry house for Salmonella Enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an eight-week time period (four tests at two-week intervals); if any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use
- Clean and disinfect poultry houses that have tested positive for Salmonella Enteritidis
- Refrigerate eggs at 45 degrees F during storage and transportation no later than 36 hours after the eggs are laid (this requirement also applies to egg producers whose eggs receive a treatment, such as pasteurization).
To ensure compliance, egg producers must also maintain a written Salmonella Enteritidis prevention plan along with records documenting their compliance. Egg producers covered by this rule must also register with the FDA. The FDA will develop guidance and enforcement plans to help egg producers comply with the rule and will also begin inspecting medium-sized facilities with fewer than 50,000 but at least 3,000 laying hens in the final quarter of this year.
This week, the Food and Drug Administration (FDA) updated the Reportable Food Registry (RFR) to include a Rational Questionnaire incorporating additional data elements as part of an effort to improve the RFR’s information gathering capability.
- The reason the food has been determined to be reportable (agent);
- A description of the root cause of the reportable food (if applicable);
- A brief justification of the process used to determine which product(s), lot(s), or batch(es) were affected;
- Whether or not the submitter believes all of the reportable food has been removed from commerce;
- A brief description of the corrective actions taken to avoid repeating the reportable event;
- The commodity type of the reportable food;
- The dates that the product was manufactured;
- Whether or not the reportable food underwent treatment to reduce microorganisms;
- A brief description of the microbial reduction treatment;
- Whether or not a bacterial isolate is available for FDA collection;
- For reportable foods intended for animal consumption, the animal species that the reportable food was intended to be consumed by;
- For reportable foods intended for animal consumption, the life stage of the animal that the reportable food was intended to be consumed by;
- Whether the responsible party has notified all of its immediate previous sources (suppliers) of the reportable food (if applicable); and
- Whether the responsible party has notified all of its immediate subsequent recipients (customers) for the reportable food (if applicable).
The RFR, created by Congress as part of the FDA Amendments Act of 2007, is an electronic portal for industry to report when there is "reasonable probability" that an article of food will cause "serious adverse health consequences." It covers all human and animal food/feed regulated by FDA except infant formula and dietary supplements for which FDA has other mandatory reporting systems.
In addition, the RFR does not accept submissions regarding drugs or other medical products, reports about products under the U.S. Department of Agriculture’s jurisdiction, or reports from consumers. Registered food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States under section 415(a) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 350(d)) are required to submit an electronic report to the FDA within 24 hours of discovering reportable adulterated food.
When a reportable food report is submitted to the Safety Reporting Portal, it is sent to the FDA Risk Control Review (RCR) team for review. The team includes representatives from the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Office of Emergency Operations (OEO), and the Office of Regulatory Affairs (ORA). In addition, the FDA District Office for the geographic area from which the report originated receives a copy and participates in the review. Each report is then reviewed by the RCR team to assess whether the subject food or feed meets the definition of a reportable food, and to identify appropriate follow-up actions.
For reports that FDA considers to meet the definition of reportable food, an FDA District Office investigator is assigned to contact the firm or individual submitting the report to obtain additional information. The District Office investigator may visit the firm to conduct a follow-up investigation. When necessary, District Offices will advise the firm to alerts its supplier and/or its customers of the reportable food.
It is important to point out that submitting a report to the portal can have serious implications for food companies. As Ken Odza, a former Stoel Rives attorney and continued friend of the firm, wrote in a previous post, “Even if a recall has not yet been issued, an RFR report often has the consequences of a Class I recall. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell almost never can be unrung.”
For more information about the RFR and its impact on industry, check out some of our other Food Liability Law blog posts on here.
In following up from a previous Food Liability Law blog post that was recently published on Law360, the U.S. Food and Drug Administration (FDA) announced on Friday, March 30, 2012, that is was denying a petition by the Natural Resources Defense Council (NRDC) to ban the use of Bisphenol A (BPA) in food and beverage packaging materials.
The NRDC had filed a petition with the FDA in October 2008. The petition challenged the FDA’s position that exposure to BPA in low levels is safe, and accordingly, requested that the FDA ban the use of BPA as a food additive or in any substance that may become a component of a food product, as defined by the Federal Food, Drug and Cosmetic Act (FFDCA). Pursuant to a court order issued in December 2011, the FDA had until Saturday March 31, 2012 to issue a response to the NRDC’s petition.
The FDA explained in its denial letter that it appreciates the NRDC’s concern for consumer safety, and it will continue to broadly and comprehensively review scientific data regarding the effects of BPA on human health. In addition, the FDA plans to complete studies already in progress at the agency’s National Center for Toxicological Research (NCTR). The letter concluded:
FDA has determined, as a matter of science and regulatory policy, that the best course of action at this time is to continue our review and study of emerging data on BPA. . . . FDA is performing, monitoring, and reviewing new studies and data as they become available, and depending on the results, any of these studies or data could influence FDA's assessment and future regulatory decisions about BPA.
Douglas Karas, a spokesman for the FDA, stated, “I cannot stress enough that this is not a final safety determination on BPA.” He added, “This is a decision on the NRDC petition. The FDA denied the NRDC petition because it did not have the scientific data needed for the FDA to change current regulations, which allows the use of BPA in food packaging.”
Yet, despite the FDA’s decision to deny the NRDC’s petition, many major food companies have already begun using alternative packaging methods thereby eliminating BPA in order to quell public concern over the potential risks associated with the chemical.
Recently, on March 12, 2012, 55 Members of Congress sent a letter to the U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg calling on the agency to require the labeling of genetically engineered (GE) foods.
The bicameral, bipartisan letter led by Senator Barbara Boxer (D-CA) and Congressman Peter DeFazio (D-OR) was written in support of a legal petition filed by the Center for Food Safety (CFS) on behalf of the Just Label It campaign and its nearly 400 partner organizations and businesses; many health, consumer, environmental, and farming organizations, as well as food companies, are also signatories. Since CFS filed the labeling petition in October 2011, the public has submitted over 850,000 comments in support of labeling.
The letter comes as the most recent move in the longstanding and familiar debate over whether the U.S. should require labeling of GE foods. For years, proponents of labeling have emphasized that consumers have a right to know what is in their food and have expressed concern over the potential unintended consequences of consuming GE food products. On the other hand, opponents have maintained that the expense and difficulty of labeling GE food products would be prohibitive.
As background information, GE or genetically modified (GM) foods are those whose genetic makeup has been altered using laboratory techniques in order to achieve certain desirable traits such as pesticide resistance, drought tolerance, or improved nutrient content. This process involves the introduction of foreign or synthetic DNA material into the organism’s cells. The technology used to produce genetically modified organisms (GMOs) is fairly new, having only been developed in the early 1970s. However, today, the use of that technology in commercial food production is widespread.
Nearly two decades ago, in May 1992, the FDA issued a Statement of Policy where it addressed the labeling of foods derived from new plant varieties, including plants developed by genetic engineering. The agency concluded that those GE foods do not differ from other foods in any meaningful or uniform way, and, as such, are not subject to special labeling requirements. This decision caused a stir among consumer advocacy groups who believed that GE foods should be labeled so that consumers can make fully informed choices. However, the FDA’s policy on GE food labeling has remained unchanged.
Congress’ letter from earlier this month urges the FDA to change that position. The letter notes that “[a]t issue is the fundamental right consumers have to make informed choices about the food they eat.” The Center for Food Safety has asked the FDA to respond to its petition within a “reasonable time.” It is unclear where the FDA will fall on this issue.
Yet despite the fact that there is currently no federal regulation mandating the labeling of GE foods, several states have begun to consider bills that would require labeling of GE foods or would prohibit them entirely. Among those states are California, Maryland, New York, North Carolina, Oregon, Tennessee, Vermont, and Washington. In addition, nearly 50 countries including the European Union member states, Japan and other important United States trading partners, have laws requiring companies to disclose the presence of GE ingredients on their food product labels.
It will be crucial for the food industry to pay careful attention to the changing state of the law surrounding GE food labeling to ensure that their product labels are in full compliance.
Effective March 1, 2012, the FDA implemented an Interim Final Rule on the “Establishment, Maintenance, and Availability of Records” under the Food Safety Modernization Act, “FSMA”.
The FSMA statute among other new provisions, expanded the FDA’s authority to access and demand records from relating to the specific suspect article of food records, to include those relating to any other article of food that the FDA “reasonably believes is likely to be affected in a similar manner.” Although they are already in effect, the comment period for these rules is May 23, 2012. . These rules were not subject to the normal public review procedure because the FDA found that it was contrary to the public interest to delay them as the FSMA statute called for that access from its inception. The FDA has always indicated that” reasonable belief” determinations are made on a case by case basis because such decisions are fact-specific.
The expanded rule continues to reflect the requirement that records “must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee only designated by the Secretary of Health and Human services who presents appropriate credentials and a written notice.”
Also issued in February was a “Draft Guidance for Industry: FDA Records Access Directly Under Sections 414 and 704 of the Federal Food, Drug & Cosmetic Ad.”
The guidance makes clear that records request may:
- Apply to either human and animal food;
- Apply to both domestic and foreign persons;
- The scope of records are those that are “needed to assist FDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to human or animals,” and they may access records needed to assist in determining whether there is a reasonable probably that the use of or exposure to the food will cause serious adverse health consequences or death to human or animals.
There is also a listing of what FDA believes are examples of the circumstances under which they would access documents for related food articles. They include:
- Salmonella outbreaks with multiple foods implicated;
- Multiple articles of food on an identical processing line;
- Articles of food in shared use equipment;
- Articles of food prepared, packed or held under similar conditions.
They also list examples of the type of records they could/would access:
- Manufacturing records;
- Raw materials (ingredients and packing) receipt records;
- Product distribution records;
- Product inventory records;
- Test records;
- Recall records;
- Reportable food records;
- Customer distribution lists;
- Complaint and adverse event records.
The FDA also lists the types of records the FDA cannot access:
- Records from farms;
- Records from restaurants;
- Financial data;
- Pricing data;
- Personnel data;
- Research data;
- Sales data other than shipment data researching sales.
In the document they also address actions they make take for refusal to provide records, including civil administration actions, suspension of registration, administrative detention, seizure of the food, issuance of a recall and injunction against the firm.
Finally, the FDA also issued a 52-page guidance for Industry, Edition 5, for Questions and Answers Regarding Establishment and Maintenance of Records by Persons who Maintain, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food. This document contains numerous scenarios to provide industry with a better understanding of how the rules play out in practice.
In follow up to previous articles, we note that a consumer group last week released a report that alleged that caramel colored sodas (Coke,Diet-Coke, Pepsi and Diet Pepsi) contain levels of 4-methylimidazole (4-MEI) that reached a level of 7 in a million cancer risk. The Center for Science in the Public Interest, claims that the carcinogen forms when ammonia or ammonia and sulfites are used to manufacture the caramel coloring that gives those sodas brown colors. In conjunction with their report the group requested that the Food and Drug Administration revoke its authorization for caramel colorings that contain 4-MEI, and in the interim to change the name of the additive to ammonia-sulfite process caramel coloring or chemically modified caramel coloring for labeling purposes.
Although according to industry experts the amount of soda that would trigger these effects is excessive, Coca Cola and Pepsi recently announced that they were changing their formulas, because of California's Prop 65 law that would require labeling if, as alleged, these products exceed the 1 in 100,000 risk that triggers labeling requirements.
As we noted earlier a sixty day notice has already been served on certain grocers with respect to similar products. The sixty day notice is the first step in the Prop 65 private enforcement process.
Attorneys Lee N. Smith and Melissa A. Jones participated in the GMA 2012 Food Claims and Litigation Conference in Dana Point. Mr. Smith (his real name) spoke on the effect of the New Food Safety Modernization Act and its potential impact on litigation, and Ms. Jones (her real name) and Mr. Smith also presented an overview of Proposition 65 and recent developments with particular regard to food products.
How FSMA May effect Litigation
It was our premise that FSMA will affect litigation in two main areas. One related to the threshold standards under the statute, which have yet to be defined in detail by law or regulation and two, related to the potential increase in government actions under those standards and the commensurate increase in related plaintiff litigation.
The areas under FSMA that have similar thresholds are those that trigger recalls (Sec. 206) , reporting to the food registry (Sec. 211), deregistration (Sec 102), additional record review (Sec.101) and finally those that may trigger administrative detentions (Sec. 207). The first four sections are triggered by the reasonable probability standard, which is usually taken to be mean more than 50% or more probable than not; which is a low standard to trigger recalls or reporting. The other standard for detention is “A reason to believe” food is “adulterated or misbranded.” for administrative detentions." We believe that these standards will trigger litigation similar to the Del Monte Fresh litigation where industry challenged the FDA's lack of evidence available to require a detention and recall.
With respect to Prop 65 we discussed the Prop 65 listing process, and recent case law California Chamber of Commerce v. Schwarzenegger et al., 196 Cal. App 4th, 233 (2011) that supports listing that comes directly from listing made under the labor code.
We identified a recent preemption case that found that the regulation of poultry did not in fact pre-empt prop 65 (see Physicians Comm. for Responsible Med. v. McDonald’s Corp., 187 Cal. App. 4th 554 (2010) (federal Poultry Products Inspection Act did not preempt Prop 65 warnings) and discussed the naturally occurring defense under Prop 65 which is difficult and can costly to prove.
We also noted a recent sixty day notice for MEI; which was just listed last year. The chemical 4-MEI is a fermentation byproduct in certain food products including caramel coloring, soy sauce, Worcestershire sauce, wine and ammoniated molasses, as well as ammoniated livestock feed. The chemical is used in the manufacture of pharmaceuticals, photographic chemicals, dyes and pigments, cleaning and agricultural chemicals, and rubber. First Sixty Notice to grocers in Feb. 2012 as to carbonate soft drinks with caramel coloring.
We mentioned the recent listing of Sulphur Dioxide and the current dispute over safe levels. SO2 is a colorless, nonflammable gas with a pungent odor. As a component of ambient air pollution, SO2 is found in combination with sulfuric acid, sulfur trioxide, ozone, nitrogen dioxide, and particulates, and its presence in ambient air occurs primarily as a result of fossil fuel consumption at power generation and other industrial facilities
• Used in many food products as a preservative including on Cherries and Raisins.
• Should have been listed as an inhalant hazard only.
Please contact us if you have any questions.
On December 8, 2011 I participated in a webinar organized by the Strafford Publication Group. In conjunction with Jonathan Cohen from the Gilbert firm and Joseph Bottiglieri with Bonner Kiernan Trebach & Crociata LLP, we presented Food Safety Claims: Products Liability Issues on the new requirements under the Food Safety Modernization Act.
Nicole Hancock of our Boise office and I will be presenting on Tuesday, January 10, 2012 a webinar on The FDA Food Safety Modernization Act – Part I on related topics including the relation of FSMA to feed and pet products. This webinar will be managed by the University of Idaho farm extension. David Atchison of the Leavitt Partners firm will also be presenting.
Amy Edwards and I will be speaking on January 16, 2012 at the Northwestern Food Processors Association Expo on protecting the attorney-client privilege and how that interaction relates to the new FSMA requirements.
Melissa Jones from our Sacramento office, and I will make a presentation on Proposition 65 and Food Safety litigation at the 2012 Food Claims & Litigation GMA Conference at Dana Point California in February 21-23, 2012.
FDA Creates The Food Safety Preventive Controls Alliance (FSPCA) To Develop Training Courses And Materials For Prevention Of Contamination
The U.S. Food and Drug Administration (FDA) in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) created the Food Safety Preventive Controls Alliance (FSPCA) to develop materials to will help the industry comply with the new preventive control rules.
The Alliance is composed of members from the FDA, loca and state food protection agencies, the food industry and academia.
Under the FSMA, facilities are required to develop food safety plans that evaluate food safety hazards and identify the preventive measures to guard against those hazards. Facilities must also monitor preventive measures and manufacturers must also develop a plan of action to correct any problems that are discovered.
The Alliance will develop training modules, to train the trainer, develop industry specific measures, assess the need for future research, and prioritize the need for specific controls.
In its latest step to increase the safety of the American food supply, the U.S. Food and Drug Administration (FDA) announced a Retail Food Safety Action Plan that includes several measures to help assure the safety of food sold in stores, restaurants, schools, and other foodservice operations. In support of the Action Plan, FDA also unveiled a cooperative agreement with the National Association of County and City Health Officials . FDA and the Association will promote the use of best practices by local authorities and attempt to increase retail food safety oversight as well as encourage the implementation of FDA’s Voluntary National Retail Food Regulatory Program Standards for retail food programs.
FDA today also released a Supplement to the 2009 FDA Food Code. The Food Code contains model food-safety regulations for retail and food-service operations including restaurants, schools and food stores. Local, authorities use the Food Code to develop food safety rules consistent with national regulatory policy.
Key changes contained in the new Supplement include:
- Requiring that food establishments have a certified food protection manager with the following additional requirements:
- that all operating procedures required by the Food Code are developed and implemented;
- that it can be verified that all employees are informed about their obligation to report certain health conditions that relate to transmission of food borne illness; and
- that any food the establishment receives after operating hours is delivered in a manner that does not create a food safety hazard;
- Requiring that food establishments have a plan for responding to and properly cleaning-up after an employee or other becomes physically ill in areas where food may be prepared, stored or served;
- Clarifying appropriate exceptions to the prohibition of bare hand contact with ready-to-eat foods prepared in the establishment;
- Clarifying the requirements for the safe storage and display of ground and whole-muscle meat and poultry;
- New requirements for devices used to generate chemical sanitizers on- site in the food establishment;
- Establishing clearer guidelines for the amount time a food establishment should be given to correct violations of different types of provisions in the Food Code.
It's the battle of the network talking heads, M.D. division. In this corner, Dr. Mehmet Oz, host of the Dr. Oz Show on FOX, and former Oprah Winfrey contributor. In the other corner, Dr. Richard Besser, former head of the Centers for Disease Control and now chief health and medical director of ABC News. The issue: is there too much arsenic in apple juice marketed to consumers, including kids?
Click on the links above to see the positions of the two sides. Basically, Dr. Oz did a study of apple juice and found elevated levels of arsenic in excess of the amounts the FDA approves for simple bottled water. Weighing in on the side of Dr. Besser (or perhaps vice versa), though, is the FDA itself, which rather loudly is proclaiming "tosh." Or, rather, "Apple Juice is Safe to Drink."
It's hard to wade through the rhetoric here to figure out who's "right", particularly when even Dr. Oz is not recommending anyone give up apple juice because of the risk of arsenic. The FDA and the manufacturers all dispute both Dr. Oz's test results--they both tested juice from the same batches and came up with significantly lower levels of total arsenic--and criticize him for testing only for total arsenic, instead of distinguishing between inorganic arsenic, which is really bad, and organic arsenic, which the FDA says is generally safe and is ordinarily the kind of arsenic found in apple juice (but not in bottled water). Dr. Oz's response doesn't seem to be all that persuasive; if the juice doesn't test for too much inorganic arsenic (or too much total arsenic), does it matter that it comes from countries that use arsenic as pesticides? And arguments about whether apple juice is better for you than eating raw apples are neither made stronger nor weaker if the level of arsenic is insignificant.
Although known to the ancients as a poison, arsenic has many benign uses, including being used in the first effective treatment of syphillis. Along with other poisonous chemicals, it was used for centuries in makeup. The plot of Dorothy L. Sayers novel Strong Poison centers on a murder by arsenic poisoning, where the murderer (SPOILER ALERT!) developed a resistance to arsenic over time, and thus survived while eating the exact meal as his victim. The story was suggested by the tale of King Mithridates, as A.E. Housman wrote in "A Shropshire Lad,"
They put arsenic in his meat And stared aghast to watch him eat;
Today, arsenic is used in semiconductors and light-emitting diodes.
It is not for this blog, of course, to weigh in on the actual merits of the controversy. But we note that comments in the popular media about the safety of food can have a really strong, negative impact on purveyors of food items, whether they are true or not. A strong debate about food safety is always welcome, but the use of sensationalist headlines and a failure to meet scientific arguments head on can leave misleading impressions that can have really significant impacts on real people. Stay tuned.
In the wake of recent recalls the progress of implementation of the Food Safety Modernization Act (FSMA) has become more significant. The Pilot Traceability Project was announced as of last week. This project is intended to provide a structure for tracing ingredients back to their source in the event of a recall. Section 204 of FSMA requires the FDA to “establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a food borne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated …or misbranded."
The Pilot projects will be carried out by the Institute of Food Technologists (IFT) at the direction of FDA.
A product tracing system involves documenting the production and distribution chain so that a product can be traced back to a common source or forward through distribution channels if there’s evidence of contaminated food. The actions that follow may include removing the product from the marketplace and alerting the public if it has already been distributed.
The FDA indicated that: “What we’re looking for is a system that is practical, feasible, and rapid,” says Sherri McGarry, senior advisor in FDA’s Office of Foods. “Our No. 1 priority is protecting public health.”
McGarry explained that IFT will work with the key groups that have a stake in this endeavor—food industry, state and federal government agencies, and consumers—in developing the pilot programs. The goal is to include industries that represent the food supply chain, including farms, restaurants, and grocery stores.
The pilot programs will evaluate the types of data that are most needed for tracing, ways to connect the points in the food supply chain, and how quickly data can be made available to FDA. A key goal in the pilot projects will be to explore methods to track food and identify a common source or supplier starting at multiple points of sale. “We’re looking for a system that will allow FDA to quickly connect the dots along the food supply chain,” says McGarry.
Business should keep an on eye on this process as the resulting programs may impose similar requirements on FSMA registrants in the future.
On Monday, September 19, 2011, I will be speaking at The DEMATIC Material Handling and Logistics Conference in Salt Lake City , Utah and presenting, "Field to Fork: How the new Food Safety Modernization Act Will Affect You."
I attended the American Cheese Society conference in Montreal earlier in the month. The conference was attended by cheese producers and suppliers from around the world. At the conference I presented a PowerPoint on Food Safety Modernization Act (FSMA) . There were several talks on Food Safety and clearly, the industry is concerned about the new provisions where cheese in particular has been identified as one of the high-risk foods that will be subject to some of the more stringent new regulations.
Because of the conferences’ location, FSMA’s features related to import and export certifications and foreign inspections were of particular interest (see below). It is clear that imported food will garner additional attention under FSMA. This is particularly true given accounts of food safety issues in China involving vinegar, meat and bread.
FSMA IMPORT REQUIREMENTS
1. The FDA has a stepped up their foreign facility inspection program to be carried out in a manner to be negotiated with the relevant foreign authority. If inspections are not allowed within 24 hours of the request, a ban on the importation from that facility is authorized.
2. FSMA contains a new section (sec. 808) that requires the FDA to create a system for the accreditation of third party auditors for certification of eligible foreign facilities. The certification in turn will be used for the Foreign Voluntary Qualified Importer Program (see below) to provide assurance for food imports and to target foreign inspection resources. There are express requirements for auditors and certifications set out in this statute.
3. The Foreign Supplier Verification Program (sec. 805) requires every United States importer to perform risk-based reviews of foreign suppliers to verify that the food they import is produced in compliance with the Food and Drug Administration (FDA) standards (produce and hazard analysis and preventive controls) and is not altered or misbranded. In January 2012, the FDA is required to issue regulations specifying the contents of the specific verification programs. Each importer is required to perform foreign supply verification activities which may include monitoring records, inspections or annual on site inspections. It may also require reviewing the hazard prevention programs for foreign suppliers, periodic sampling and testing of shipments.
4. The law has clarified the definition of inspection to include: An “importer,” for this program, is defined as the United States owner or consignee of the article of food at the time of entry of such articles into the United States, or, if there is no United States owner or consignee, the importer is defined as the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry into the United States. (Note that FDA seafood and juice facilities subject to Hazard Analysis and Critical Control Points (HACCP) or low-acid canned food requirements are exempt.)
5. In January 2012, the FDA is required to issue a guidance document to assist importers in developing their foreign verification program.
6. Each importer is required to maintain records related to the Foreign Supplier Verification program for at least two years.
7. The FDA is required to maintain on its website a current list of the names, locations and other information deemed necessary by the importers in compliance with Section 2805 exemptions.
8. There is also a Foreign Voluntary Qualified Importer Program (FVQIP) (sec. 806) which requires the FDA to establish in consultation with the Department of Homeland Security a “voluntary” program to expedite movement of materials through the process. Under this program, an “importer” is defined as the person that brings food, or causes the food to be brought from a foreign country into the United States. This is an important distinction from the definition under FSVP because it could mean that foreign manufacturers may be allowed to participate in this program. The deciding factors will not be known until the final regulations are issued. FVQIP regulations are not required to be finalized by the U.S. FDA until July 2013. In July 2012, the FDA is required to issue a guidance document regarding participation, revocation, reinstatement compliance of the qualified importer program. To be eligible the importer must be importing food from its facility that has been certified by a third party auditor that year.
9. The FDA is authorized to require as a condition to granting admission to an article of food imported or offered for export to certification or such other assurances FDA deems appropriate.
In short, the following is the relevant time table:
|January 2011||Authority to require import certification.|
|July 2011||Require importers to notify the FDAof any country tot which food was denied access.|
|January 2012||FDA to publish guidance AND regulations for the Foreign Supplier Verification Program.|
|July 2012||Establish program for Voluntary Qualified Importer Program.|
|January 2013||Effective date for Foreign Supplier Verification Program.|
Fred Degnan, from King & Spalding, led a very insightful presentation on "Responding to Government Investigations and Warning Letters" at the recent ACI food regulatory summit. His presentation led to an interesting discussion about FDA's close out of investigations.
It was generally agreed that the FDA, in essence, is not notifying parties when it has decided to close out an investigation or take no further action. But, as another conference attendee pointed out, reinspection fees under FSMA section 107 may provide an opportunity to determine whether FDA has completed its investigation. If a facility is required to pay the FDA reinspection fees, it seems logical that FDA will have to inform the facility when it has closed the file and is no longer assessing fees. Whether this becomes reality has yet to be seen.
The FDA asserts in its inspection manual its right to photograph in your plant. Yet the FDA does not have statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States v. Acri Wholesale Grocery Co., 409 F. Supp. 529 (S.D. Iowa 1976). But these cases rely on the theory of implied consent or a minimal expectation of privacy. These cases do not hold that FDA has the right to photograph the interior of a food facility when the facility has a strict policy against photography and does not consent to the photography.
So, should you resist FDA's request to photograph?
The first thing you need to do is to ask yourself the following two questions:
- Do you have a policy against photography in your plant?
- If you do, is the policy strictly enforced?
If the answer to either question is no, then you're on shaky footing in resisting the FDA's request. By not having a policy or by not strictly enforcing the policy, FDA's legal authority based on implied consent is that much stronger.
Assuming your plant does have a no-photography policy that is strictly enforced, you need to assess whether the photography is worth the fight. It may be. Resisting the request for photos may be worthwhile to protect potential disclosure of trade secrets and to prevent out-of-context photographs from being used adversely by FDA. The problem is that the harder you push against FDA, the more likely that it will seek more information and the more likely that it will seek enforcement action.
In a future entry, we'll explore what legal remedies might be available to prevent the FDA from photographing the inside of your plant.
Next Wednesday at the ACI Food Regulatory Summit in Chicago I'll be presenting a talk entitled "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should Government Come Knocking." My slide-deck can be linked here.
Topics that I plan to cover include:
- FDA's plan to increase frequency of inspections and how it plans to do it
- How to be prepared for FDA's greatly expanded records access authority
- How to avoid new fees that will be imposed by FDA
- Developing an appropriate strategy to deal with FDA
- Preparing a privileged FDA inspection plan and training
More information about the ACI conference and registration can be found here.
The Food Safety Modernization Act ("FSMA") significantly expands the FDA's ability to access a food company’s records.
The expanded authority is found in three places in the statute:
- FSMA § 101 amends 31 USC § 350c(a) and allows the FDA to obtain records related not only to a product that the FDA believes "will cause serious adverse health consequences or death to humans or animals" but also those related to "any other article of food" that the FDA believes is "likely to be affected in a similar manner."
This statute may allow FDA to "access and copy" all records in any format and at any location of products that are not known to be contaminated but that might share similar ingredients or be produced in a shared facility or that could otherwise be affected in a "similar manner" as products thought to be contaminated.
Section 101 was effective immediately on FSMA becoming law in January 2011.
- FSMA § 103 requires that FDA facilities (with certain exceptions) implement "Hazard Analysis and Risk-Based Preventative Controls." As part of this section, Congress requires the affected FDA facilities to keep "records documenting the monitoring of the preventative controls" and to keep a "written plan that documents and describes the procedures used by the facility to comply with the requirements of this section." Congress requires that these records "be made promptly available" to the FDA upon "oral or written request." The statute also requires that records be kept for at least two years.
Note that unlike in section 101, Congress did not use the term "copy" in section 103. This section instead says that records must "be made promptly available."
The question remains open whether the FDA interprets "be made promptly available" to mean copy and whether such a broad interpretation will be held up by the courts. Section 103 is effective in July 2012.
- FSMA § 202 requires the FDA by January 2013 to create a "program for the testing of food by accredited laboratories." By July 2013, section 202 will require testing by an "owner or consignee (i) in response to a specific testing requirement under this Act or implementing regulations, when applied to address an identified or suspected food safety problem; and (ii) as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem.“
Test results from the FDA-accredited lab "shall be sent directly to the [FDA]" unless exempted by regulation.
The big questions under section 202 are whether:
a. Routine product and environmental testing accomplished for the purpose of a food safety plan under section 103 will be considered "in response to a specific testing requirement . . . when applied to address an identified or suspected food safety problem" and
b. The FDA will exempt certain testing records under this provision.
So, what should you do to prepare for the FDA's considerable expansion of its ability to access your records?
Here are five things that a food company should consider:
- Understand what records the FDA does not have the right to access (recipes, financial, pricing, research, personnel or certain sales data), and maintain these separate from records the FDA can access.
- Create and enforce a document destruction policy that conforms with FSMA.
- Create a standard FOIA letter to present to the FDA when it requests letters explaining that it considers information provided to be trade secrets, confidential and proprietary.
- Create and train employees on a confidential FDA inspection policy that involves legal counsel and therefore can be cloaked in the attorney-client privilege.
- Understand what finished product and environmental testing is needed and not needed for a section 103 food safety plan.
I authored the following article that appeared in the April 29, 2011 issue of Food Chemical News:
As the clock ticks on the FDA’s 24-hour deadline to report to the FDA’s Reportable Food Registry, a food retailer, manufacturer or supplier is forced to make snap decisions that can profoundly impact business and litigation.
Once a report is submitted, the FDA promptly alerts customers and suppliers of the "reasonable probability" that the product will result in "adverse health consequences or death." Even if a recall has not yet been issued, an RFR report often has the consequences of a Class I recall. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell almost never can be unrung, food companies are now painfully aware.
But some burning questions regarding FDA’s RFR remain for the food industry, including if and how the agency will:
(1) use the RFR as an enforcement tool;
(2) move toward the concept of "control" and away from "possession" in interpreting one of the key exceptions to the RFR;
(3) address what it perceives as "out of control" undeclared allergen problems; and
(4) use the information obtained through the RFR to shape coming regulations on required preventive controls.
Let’s take a stab at answering some of these questions and a few others.
Will FDA Use RFR as an Enforcement Tool?
The RFR was created by Congress as part of the Food and Drug Administration Amendments Act of 2007 and is codified at 21 U.S.C. §350f. The RFR requires that "as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall  (A) submit a report to [FDA] ... and (B) investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party." 21 U.S.C. §350f(d)(1).
The reporting includes a "one step up and one step back" requirement. Food companies must identify their suppliers and customers to FDA through the web portal.
The FDA Food Safety Modernization Act (FSMA) tweaks the RFR and requires the FDA to promulgate new regulations requiring submission of "consumer-orientated information," including a description, product ID codes, contact information and anything else FDA deems necessary to enable consumers to accurately identify whether they are in possession of the reportable food.
The congressional intent behind the RFR is to provide the FDA with a mechanism to track patterns of adulterated product, essentially as an information gathering tool. Many in the industry fear that the FDA also will use the RFR as an enforcement tool. Even an unintentional failure to report in compliance with 21 U.S.C. §350f constitutes a criminal violation of the Food, Drug, and Cosmetic Act (FD&C Act).
It’s not clear if the FDA has initiated any enforcement action based on the RFR yet, but this should be monitored closely by the food industry.
Can You Take Advantage of Intra-Company Transfer Exception to Reporting Obligation?
21 U.S.C. § 350f(d)(2) provides an exception to the reporting obligation if:
The challenge with interpreting this exception centers on the term "transfer." The FDA's current draft guidance says: "A transfer to another person occurs when the responsible person releases the food to another person. 'Person' is defined in section 201(e) of the FD&C Act as including individuals, partnerships, corporations and associations. FDA does not consider an intra-company transfer in a vertically integrated company to be a 'transfer to another person,' where the company maintains continuous possession of the article of food."
The rub is that if the product is shipped to a third-party warehouse, but the responsible party maintains ownership and direct control over distribution, the product is reportable. The FDA’s draft guidance rationalizes that "'[p]erson is defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)) as including individuals, partnerships, corporations, and associations," and a "warehouse operator is a distinct legal person."
Another scenario under the 21 U.S.C. § 350f(d)(2) exception that is not addressed by the FDA's draft guidance arises if the product is subject to an intra-company transfer but the company uses a common carrier to transport the product. Under the FDA's rationale that use of a third-party warehouse takes a company out of the exception, a common carrier also could be considered a "distinct legal person" to which the product is transferred, eliminating the exception and requiring the company to report.
Many believe that the FDA (and the statute) could not intend that an otherwise unreportable food under 21 U.S.C. §350f(d)(2) become reportable for no reason other than that a company uses a third-party trucking company in an intra-company transfer. Many also question whether the FDA's current position on third-party warehouses is correct if the food company retains complete control over the product.
Neither of these policies reflects the reality of how many food companies operate. From a food safety policy perspective, many believe that food companies should not be forced into the business of trucking and warehousing.
Some believe that the FDA might be moving away from interpreting "transfer" through the lens of possession and broadening its view toward an interpretation based on issues of control. Control might reflect more accurately the reality of food production and promote more effectively food safety and the intent of the RFR. Whether the FDA will move toward a notion of control should be revealed in the FDA's expected amendments to its draft guidance and should be monitored closely by the industry.
In January 2011, the FDA issued its first annual report on the RFR, which provides statistics on the first full year of the RFR (2,240 entries, 229 "primary reports," a breakdown by hazards, etc.) (see FCN Jan. 28, Page 8). Beyond the statistics, companies should take particular note of the FDA’s focus on both allergen controls and creation of food safety plans.
The FDA reported that undeclared allergens/intolerances accounted for 34.9% of its primary reports. Industry experts assert that the FDA believes that the industry does not have good control over the issue of undeclared allergens. These experts believe that the FDA will give special attention to this issue in promulgating regulations under the FSMA's requirements for hazard analysis and preventive controls. In anticipation, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue.
Do You Have A Food Safety Plan? If So, Will It Be Sufficient Under FSMA?
In FDA’s report on its RFR results , FDA Deputy Commissioner for Foods Michael Taylor says “[s]everal key U.S. industries are already re-evaluating their hazard and preventive controls, core principles of the Food Safety Modernization Act recently passed by Congress. We also anticipate improved reporting as we continue our vigorous outreach to food facilities through federal, state, local and foreign agencies, to help us expand the positive effect of the RFR on the safety of the U.S. food supply.”
The RFR will be a guide for the FDA in risk assessment and writing regulations for preventive controls and what companies must include in their food safety plans. The new hazard analysis and preventive controls requirements in FSMA are not required to go into effect until July 4, 2012, 18 months from the date of enactment.
Deputy Commissioner Taylor's comments suggest that industry standards already might be moving in the same direction. To mitigate the risk of FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers should anticipate the FDA's eventual rule making, and update or create food safety plans that address the hazard analysis and preventive controls prescribed by the FSMA. One way to anticipate FDA's direction is to mine the information FDA has collected (and continues to collect) as part of the RFR.
(A) the adulteration originated with the responsible party;
(B) the responsible party detected the adulteration prior to any transfer to another person of such article of food; and
(C) the responsible party –
(i) corrected such adulteration; or
(ii) destroyed or caused the destruction of such article of food.
Here is a link to my article, "FDA's Reportable Food Registry Profoundly Impacts Litigation and the Food Industry," posted this week by the American Bar Association's Litigation Section (Products Liability). The article is a follow-on to lively discussions over the litigation impacts of the federal Reportable Food Registry ("RFR") at the ABA’s recent Food & Supplements CLE at Coca-Cola World Headquarters in Atlanta. The RFR was created by Congress as part of the Food and Drug Administration ("FDA") Amendments Act of 2007 and requires that a company submit a report to the FDA within 24 hours of discovering reportable adulterated food.
Two hot-button issues discussed at the ABA CLE (and in the ABA article) were whether the FDA (1) intends to use the RFR as an enforcement as well as an informational tool, and (2) will move toward the concept of "control" and away from "possession" in interpreting one of the key exceptions to the reporting requirement.
Stoel Rives food liability attorney Ken Odza discussed with NutraIngredients-USA.com the significance of a rise in activism from consumer lobby groups combined with food manufacturers pushing the envelope with more aggressive health claims. General Mills recently lost its bid to invalidate class action certification at the Eleventh Circuit of Appeals in a Florida lawsuit involving digestive claims for Yo-Plus, a probiotic yoghurt product.
Odza said that plaintiff attorneys who have made fortunes out of asbestos and pharmaceutical lawsuits are now turning their attention to the food industry, and predicted that “these kind of [health claims] are going to explode.” He added that the Yo-Plus case was “pretty unusual” in that it wasn’t prompted by an investigation by the FDA (Food and Drug Administration) or the FTC (Federal Trade Commission). “Usually you see a warning letter rapidly followed by a class action piggy-backing off of that.”
“Class Action Lawsuits Set to Explode in Health Claims Arena” was published by NutraIngredients-USA.com, April 1, 2011.
If you're in the Seattle area March 22, please join me at Parker, Smith & Feek's offices in Bellevue for a discussion of the new Food Safety Modernization Act, the Reportable Food Registry, and how to survive a food product recall. Here is the full announcement of the event, including a link to registration (no charge). Hope to see you there.
On February 24, 2011, Lee Smith and I presented "How Regulatory Changes Affect Litigation Risks" to the Grocery Manufacturers Association's food litigation conference. A link to the slide-deck can be found here.
We discussed ways that the Reportable Food Registry (RFR) and the Food Safety Modernization Act (FSMA) are affecting litigation now and can be expected to affect litigation in the near term.
In particular, we discussed:
- Ongoing and pending changes to the RFR
- FSMA’s grant of records access to FDA
- Mandatory recall authority and how this may delay certain recalls
- Suspension of FDA registration
- Hazard analysis and preventative controls: What are they? How do they differ from HAACP? How they will be effective with or without FDA rulemaking
- Regulation of chemicals under FSMA (and under proposed changes to TSCA and Proposition 65 in California)
- Specific things that food sellers should consider now to reduce risk
Let me know if your business is interested in an in-house, customized presentation or training on the RFR and FSMA.
One of the few pleasures of my current road trip is the chance to eat at Burgerville, a fast food chain based in Vancouver, WA, but with more stores in Oregon and none north of Centralia. Their motto is Fresh►Local►Sustainable; we’re proud to have them as a client.
Their attitude toward food may be a little different from what is ordinarily thought of as a fast food.
Healthful food choices are a natural for us. We use local, vegetarian-fed and antibiotic-free beef in our burgers, cage-free eggs in our breakfast items and our salads feature mixed greens with sustainable, local ingredients such as smoked salmon and Oregon hazelnuts.
As I entered their Kelso, Washington store last week, after being greeted by literally every member of the staff, I ordered my Rosemary Chicken Sandwich and Cherry Chocolate Shake, paid and was handed my receipt This is quite different “fast” food, as both items were individually prepared, and I had time to look down at my bill (pictured). Because I am wired that way, the bill immediately brought to mind the restaurant food labeling provisions of the Patient Protection and Affordable Care Act, about which I blogged last year.
The PPACA contains a requirement that retail food establishments with 20 or more locations doing business under the same name (even if under different ownership, such as a franchise) post certain basic nutrition information for their “standard menu items.” While the FDA has recently withdrawn guidance on how to conform to the statute, it claims it will propose regulations by the March 23, 2011, statutory deadline.
Burgerville appears to have made a virtue out of necessity. As you examine the bill, you will see two things. First, my food order is compared to two different daily caloric intake amounts, 2000 and 2500 calories. Second, Burgerville notes on the bill that I have the option of ordering my shake with yogurt instead of ice cream, which would cut the calories by about 45% and the fat intake by 90%. With this information, I can make choices, both on this trip to the restaurant and next time. This time, I rode my bike after dinner for eight hard miles. Next time, I’m ordering the yogurt shake.
Note: next time was the very next day, as I stopped at the Centralia, Washington store and indeed asked for my shake to be made with yogurt. Not only did I save the calories and fat, but the extra tang of the yogurt worked really well with the chocolate and cherries.
I suppose that makes me a bit of an anecdotal counterexample to the study published last month in the American Journal of Preventive Medicine, which indicated that ordering patterns were no different at Taco Time restaurants in King County, Washington, where caloric labeling is mandatory, and their stores in other jurisdictions.
Yesterday (while taking a break from the Sustainable Food Summit in San Francisco), I traveled to Modesto, California to speak to the Manufacturer's Council of the Central Valley. I spoke about the new Food Safety Modernization Act (FSMA).
The focus of my talk was how the FSMA changes the status quo for food businesses. And when I mean changes the status quo, I mean not only what a food company needs to do to comply with the FSMA, but also how the FSMA is likely to affect exposure from recalls and product liability. I also discussed in some detail the dilemmas faced by food businesses and the FDA by the Reportable Food Registry (RFR) and its fallout. Here is a link to my slide deck.
I'm willing to tailor this talk to your company or trade association; just let me know.
Please also consider attending the ABA's Food and Supplements CLE at Coke World Headquarters in Atlanta on February 17. I'll be moderating with Ricardo Carvajal a panel of experts on the FSMA including Robert Brackett (formerly head of CFSAN), Art Liang from CDC, Miriam Guggenheim and Fred Degnan.
At the upcoming GMA food litigation conference in Scottsdale, Arizona, I'll be speaking with my law partner Lee Smith about specific strategies and action steps to take to reduce the increased risks from FDA compliance, and recalls and product liability exposures created by the FSMA and the RFR. We'll also touch on strategies to deal with some current trends in marketing and labeling putative class claims.
For what it's worth, this is the link to the FDA's own interpretation of what the new food safety bill means.
There are few places in the United States that have less in common than Oroville, Washington and Washington, D.C. Tucked against the Canadian border in the peaceful and beautiful Okanagan Valley, Oroville is easier to reach from Kelowna, B.C. than from Seattle. Yet events in Oroville last Friday combined with the unusual events in the other Washington beginning last Sunday to give an Oroville business an historical significance it undoubtedly would have preferred not to have.
Last Friday, the FDA Food Safety Modernization Act, then known as S. 510, was as dead as Don Van Vliet, a/k/a Captain Beefheart, the legendary musician who passed away that day. Thus, the FDA had no more than the same power it has always had: publicity and the right to shut down a facility, but no power to force a recall. That day, Sally Jackson Cheeses of Oroville, provided evidence that linked its artisanal cheeses to outbreaks of E. Coli O157:H7, agreed to a recall of all of its products.
As we know, on Sunday, the food safety bill was resurrected in an unusual weekend session of the Senate and was passed today by the House and heads to President Obama’s desk for a certain signature. The new act contains a section, effective immediately upon the President’s signature, which gives the FDA mandatory recall authority for the first time in its history. While that section includes a provision (which will become Section 423(a) of the Federal Food, Drug & Cosmetic Act) calling on the FDA to give companies a chance to effect a voluntary recall before using its mandatory powers, the difference between wielding a velvet glove and a velvet fist is significant.
Thus, a tiny cheese manufacturer in an isolated Washington town, through an unexpected chain of events occurring nearly 2700 miles away, may have become the last food manufacturer ever to agree to a voluntary recall without the FDA’s power to order it to do so looming in the background.
On Friday, S. 510, the food safety bill, was declared dead. Last nite (Sunday), the Associated Press reported the bill may finally pass in the final hours of the 111th Congress. The New York Times report can be linked here. The text of what I understand will be headed to a final vote in the House on Tuesday and signed into law by the President can be linked here.
The multinational food company Dannon agreed to a 45 million dollar class action settlement earlier this year based on consumer complaints about advertising claims regarding the health benefits of its probiotic line of dairy products. Now the company has entered into a $21 million dollar settlement with the attorneys general from 39 states. The L.A. Times reports that this is the largest-ever multistate attorney general consumer protection settlement with a food producer. The attorneys general alleged that Dannon made deceptive and unlawful claims in advertising which were not substantiated by competent and reliable scientific evidence at the time the claims were made. According to the allegations, the majority of scientific studies showed improvement in intestinal transit time when an individual consumed three servings of the probiotic products per day for two weeks, and did not support Dannon's advertised claims that one serving per day for two weeks improved digestive health. In addition, the attorneys general alleged that Dannon could not substantiate claims regarding improved immunity against the flu and common cold.
Dannon also agreed with the FTC to drop claims that the probiotic foods help prevent irregularity and offer protection against the flu and common cold. The FTC found no substantiation of these claims. This isn’t the first time Dannon has had to alter its advertising; the March settlement required Dannon to remove specific language about the health benefits of the products from labels and advertising.
Dannon also agreed with the FTC to drop claims that the probiotic foods help prevent irregularity and offer protection against the flu and common cold. The FTC found no substantiation of these claims. This isn’t the first time Dannon has had to alter its advertising; the March settlement required Dannon to remove specific language about the health benefits of the products from labels and advertising.
Between this and the March settlement, Dannon has now agreed to pay $66 million as restitution for the misleading health claims, which comes out to about 1.3% of Dannon reported $5 billion in worldwide net sales of the probiotic line in 2009. This latest settlement should remind companies to keep state governments on the list of watchful eyes monitoring health claims related to food and supplement products.
For years, a debate has raged on the merits of vesting the FDA with mandatory recall powers. Mandatory recall is part of the food safety legislation that may or may not pass in this Congress, so it’s worth discussing. At present, the FDA lacks any power to order a recall. Its only legal authority is administrative detention and seizure.
Many, including some regulators, have argued against mandatory recall because it will result in less and less timely recalls. The argument that mandatory recalls may result in less timely recalls goes as follows:
- Under the current system (where FDA lacks mandatory recall authority), the onus is on the food seller to initiate the recall. If it doesn't issue a recall in the face of an FDA request to issue a recall, the food seller faces the dire consequences of FDA's bully pulpit (press releases from FDA explaining why the food is unsafe) and possibly a seizure order. In the event of foodborne illnesses, ignoring an FDA request may also be grounds for punitive damages under the laws of some states;
- Because the onus under the current system is on the food seller (and not the FDA), the FDA frequently defers to the food seller's judgment when the facts surrounding a potential recall remain murky and uncertain. The FDA is not required to make a judgment about a recall and, for political reasons, often refrains from or delays making a decision as to whether to request a recall;
- Mandatory recall may reverse the dynamic and remove much of the onus from the food seller and put it on FDA. Mandatory recall may give the food seller cover if it chooses to delay or not issue a recall. If a food seller believes that its product is unlikely to be a threat to human or animal health, it might choose to wait until the FDA orders a recall. Under the current system, most food sellers will err on the side of caution when deciding whether or not to issue a recall. If the facts surrounding a recall are murky or uncertain, a mandatory recall regime may make it more prudent for a seller to wait for the FDA to decide. If the FDA is worried about being too trigger happy or quick to order recalls, a recall that may have been issued routinely under the current system may (ironically) never happen if FDA is vested with mandatory recall authority.
Mandatory recall authority, as its currently written in S. 510, may also change the threshold of when recalls are initiated. The threshold for a recall under sec. 206 of S.510 is described as when "there is a reasonable probability that an article of food . . . is adulterated . . . or misbranded . . . and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals."
The language of the statute closely follows what the FDA currently defines as a class I recall. But what about situations defined under the current scheme as class II or class III recalls? FDA's definition of a Class II recall is "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." A Class III recall is "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences." Query whether the statute lets foodd sellers off the hook for issuing recalls in Class II or Class III situations?
Note that FDA appears to retain some power even if there is not "reasonable probability" that the product will "cause serious adverse health consequences or death." S. 510 appears to lower the threshold for administrative detention by FDA by removing the condition that the food presents a risk of serious adverse health consequences. And, under S. 510, FDA would continue to have seizure power. The standard for seizure is simply if the food is adulterated or misbranded. One has to wonder whether FDA would use its limited resources on a seizure action in a class II or class III food recall where the chances of serious adverse health consequences are remote or not likely.
Today, the United States Senate passed the food safety bill, S. 510. If this were to become law (and according to the New York Times , this is a big if), the legislation would impose the most sweeping changes to food regulation in decades.
Among many other things, the bill would allow the FDA to order mandatory recalls, impose new record keeping requirements on businesses and establish stricter import standards. As a consequence, virtually every FDA regulated food manufacturer would have to adjust its approach to food safety, record keeping, supply-chain contracting and government relations. If this legislation becomes law, stay tuned here for in-depth analysis.
In an update to an earlier blog post, the FDA issued warning letters today to four manufacturers of caffeinated alcoholic beverages. The FDA stated in the letters that caffeine added to malt alcoholic beverages was an “unsafe food additive ” and thus, such products are in violation of the Federal Food, Drug, and Cosmetic Act (“FFDCA”).
Recipients of the letters, which included Charge Beverages Corp.; New Century Brewing Co., LLC; Phusion Projects, LLC (d/b/a Drink Four Brewing Co.); and United Brands Company Inc., have 15 days from receipt of the letter to respond to the FDA with their respective mitigation measures. Those companies may also challenge the ruling that their particular products are in violation. Failure to comply could result in enforcement actions by the FDA, including seizure of merchandize.
The FDA’s move was considered an almost certainty given the myriad of recent actions taken by a number of states to curb or ban the sale of caffeinated alcoholic beverages.
Amidst rising incidences of hospitalizations in college and teenage drinkers linked to consumption of alcoholic energy drinks, the Washington State Liquor Control Board banned their sale effective tomorrow, November 18, 2010. The move came on the heels of a request by Washington Governor Christine Gregoire, whose office stated in a November 10 press release that they were “…particularly concerned that these drinks tend to target young people.”
The Liquor Control Board placed the ban in an emergency ruling which will last for 120 days. During that time, the Liquor Control Board will move to make the ban permanent. Liquor Control Board Chairperson Sharon Foster stated, “[t]he Board is acting in the public safety…the Board is acting now to ensure these products do not contribute to a tragedy before the Food and Drug Administration or Legislature can act.” Earlier this year, the Liquor Control Board had lobbied for State legislative action to ban the sale of caffeinated malt beverages in Washington but those efforts were unsuccessful. A list of particular products affected by the Liquor Control Board’s ruling can be seen here.
Washington’s ban is merely the most recent action in an ever increasing movement by states to control the sale of caffeinated alcoholic beverages. The Oregon Liquor Control Commission Chairman stated in an October press release that, “…alcoholic energy drinks should be removed from the market until further research isdone.” The OLCC also stated that it is currently looking into possible regulatory efforts with the state legislature and is reaching out to community organizations to warn them of the dangers of the beverages.
While California’s Department of Alcoholic Beverage Control has not yet made a statement regarding the drinks, Connecticut announced Monday that it had reached agreements with state distributors to voluntarily stop shipments of caffeinated alcoholic beverages starting December 10, 2010. Michigan has banned one particular brand of caffeinated alcoholic beverage, Four Loko. New York has reached an agreement with Phusion Projects LLC, the manufacturer of Four Loko, to stop sales in the state until “…emerging science, regulatory developments or other relevant changes in circumstances arise." Utah and Oklahoma have followed Washington’s lead in banning the sale of any brands altogether. Massachusetts’ Alcoholic Beverage Control Commission stated that it will file an emergency ruling, similar to Washington’s, on Monday, November 22, 2010.
At the federal level, the Food and Drug Administration (“FDA”) is currently reviewing whether caffeine is a safe additive to alcoholic beverages. A negative finding would essentially ban the sale of caffeinated alcoholic beverages nationwide. It is widely assumed the FDA will, in fact, reach a negative finding. NY Senator Chuck Schumer, who has been lobbying for a ban on the drinks, stated that the FDA decision “…should be the nail in the coffin of these dangerous and toxic drinks.” The FDA decision is expected within the week.
Here's a link to an article that appeared recently in Inside Washington's FDA Week concerning the issue of front-of-package labeling (FOP). The article takes aim at the debate about state vs. federal regulation of FOP labeling. Here's a link to a recent post in this blog on the FOP issue.
Cheesemakers have endured a string of bad publicity recently over food safety. Cheesemakers, especially raw milk cheesemakers, are in the cross hairs of the FDA, the media, retailers and plaintiffs’ lawyers such as Bill Marler. I was interviewed last week on FDA seizure issues by the Pacific Northwest Cheese Project. Click here for the PowerPoint slides from my presentation to the American Cheese Society's annual meeting last August entitled "Product Liability - Protect Yourself and Protect Your Business."
The FDA recently took the relatively unusual step of obtaining a court-issued warrant to seize all cheese products at Estrella Family Creamery, a small, family-owned artisan cheese maker in Washington State. According to the United States Attorney's Office for the Western District of Washington, "the FDA asked Estrella to recall all cheese products. The company refused." The FDA requested the recall after both products and the manufacturing environment at Estrella tested positive for Listeria. A copy of the FDA form 483 report immediately pre-dating the recall request is here.
As the Estrella situation illustrates, the FDA is not just focused on large-scale manufacturing. As the FDA and USDA move to more risk-based allocation of resources, they are increasingly concerned about smaller operations and retail. Below are issues any food manufacturer must tackle when it comes to Listeria (much of this also applies to other food-borne pathogens).
What is Listeria?
Listeria monocytogenes is a bacterium that causes listeriosis, which primarily affects persons of advanced age, pregnant women, newborns, and adults with weakened immune systems. Though it affects only a small portion of the population, Listeria is the most deadly food-borne pathogen in the United States, killing 20-30% of all those who become seriously ill.
What should you do if your product tests positive for Listeria?
Assemble your well-rehearsed crisis management team immediately if a product tests positive (or if a regulator believes that your product may be contaminated). Members of the crisis management team; food safety personnel; company executives; and representatives from accounting, legal, supply chain, sales and customer service all are essential in the decision making process below.
Can you trace back and isolate contamination?
Quality assurance and food safety personnel need to answer trace-back issues as soon as possible. Can you determine the source of the contamination? Is it limited to one lot or a single day of production? How often are production facilities sanitized? How often are production surfaces swabbed for Listeria? Does the production facility re-use contaminated product from shift to shift?
Will you have to issue a recall?
Both the FDA and USDA lack mandatory recall authority. Though, as Estrella learned, the agencies do have the bully pulpit and the ability to get a court order to seize products. Because of the high mortality rate, regulators (federal and state) take any positive Listeria test result in food products extremely seriously.
If the food is considered a ready-to-eat product (RTE), a positive Listeria test will almost invariably lead to the FDA or USDA requesting a class I recall.
Even for a non-RTE food, a positive Listeria test will lead to a requested recall. If the agencies believe that the cooking instructions are clear, are easily followed by consumers and, if followed, will kill the bacterium, then the recall may be considered class II.
A primary difference between class I and II is that the class I recall will result in much greater publicity. For FDA-regulated facilities, a class I recall also triggers reporting and notification requirements under the Reportable Food Registry (RFR).
What does the Reportable Food Registry require?
RFR requires FDA-registered facilities to report to the FDA portal within 24 hours when there is a "reasonable probability that an article of food will cause serious adverse health consequences." As part of the report, information must be submitted "one step back and one step forward" in the supply chain. Once a report is submitted, the FDA will promptly alert your customers of the "reasonable probability" that your product will result in "adverse health consequences or death." If suppliers and customers are also FDA facilities, the FDA will also pressure those companies to report to the portal.
The ticking of the RFR's 24-hour reporting deadline forces a company to make snap decisions that might affect its entire business. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell can almost never be unrung. A more lengthy discussion of the RFR can be found here.
How do you marshal your case with the regulators?
Assuming that you have information showing that contamination is limited (or non-existent), how do you convince the regulators? The FDA and USDA’s concern is public health (and politics). The regulators’ concern is not for your business.
Providing information to the regulators in a manner they perceive as credible, prompt and transparent is critical. Once the regulators lose confidence in your company's credibility and competence, the game may be over. In most cases, the most effective way to marshal your evidence is a well-prepared and credentialed crisis management team (e.g., food safety, quality assurance, supply chain, accounting, sales, legal, media, etc.).
A recent decision held that Front of Package (”FOP”) labeling claims may not (yet) be subject to federal preemption. The decision in a putative class action, Chacanaca v. The Quaker Oats Company, involves what has become a common fact pattern: The FDA says an issue is complex and subject to industry guidance and possibly rule-making (for example, use of the terms “natural,” “wholesome,” and “smart choices”), while a court says the issue may not be complex and may be perfectly within the expertise of the judiciary and jury system.
Federal District Court Judge Richard Seeborg of the Northern District of California dismissed plaintiffs’ state law claims targeting the “0 grams trans fat,” “good source,” “made with whole grain oats,” and “no high fructose corn syrup” declarations on preemption grounds. Yet, insofar as Quaker Oats "seeks a favorable judgment at this juncture on all state claims that focus on the term 'wholesome'; on images of children, nuts, or oats; or the 'smart choices made easy' language or decal," the court denied the motion to dismiss.
The plaintiffs’ challenges to Quaker Oats’ use of the term ”wholesome” and images of the children seem targeted exactly at the claims that were preempted: the trans-fat issue. The court concedes that the FDA has recently indicated its intent to explore rule-making in the area of FOP labeling claims and that the FDA already “has extensively regulated food labeling in the context of a labyrinthine regulatory scheme.” “Nonetheless,” according to the court, ”plaintiffs advance a relatively straightforward claim: they assert that defendant has violated FDA regulations and marketed a product that could mislead a reasonable consumer. As courts faced with state-law challenges in the food labeling arena have reasoned, this is a question ’courts are well-equipped to handle.’”
Are the plaintiffs’ claims really that straightforward? How is a court "well-equipped" to determine the meaning of ”wholesome,” ”natural,” or other FOP claims? Is a court able to fully consider comments and information from all corners of the food manufacturing world? Isn’t this really in the wheelhouse of the regulators (or possibly the legislators)? Can the food business in the United States function effectively with individual courts and states determining their own common law (or even statutory) rules for product labeling?
Over the last several weeks, the Federal Trade Commission (the “FTC”) and POM Wonderful LLC (“POM”), the makers of POM Wonderful 100% Pomegranate Juice and POMx supplements, have been engaged in a battle over the scope of the FTC’s authority to regulate advertisements and the propriety of claims POM has made in marketing its products.
After initially being placed on the defensive by a warning letter from the Food and Drug Administration (the “FDA”) in February, POM has taken an offensive approach by suing the FTC for declaratory relief, asking that the FTC’s standard for non-deceptive advertising be held invalid. Further, POM has asked the Washington D.C. District Court to find that the FTC overstepped its authority in defining what constitutes “substantiation” of health-related claims in recent consent agreements with Nestle Healthcare Nutrition, Inc. and Iovate Health Sciences, Inc. In those cases, the FTC alleged that Nestle and Iovate had engaged in deceptive trade practices in contravention of the FTC Act by falsely advertising the health benefits of their various products. As we have blogged previously (here and here), POM has been fairly active in the past year in pursuing its legal remedies, the two prior instances being Lanham Act claims.
On September 27, the FTC responded, alleging in its suit against POM that the advertisements for the company’s 100% Pomegranate Juice and POMx supplements contain false and unsubstantiated claims regarding the ability of the products to treat or prevent heart disease, prostate cancer, and erectile dysfunction. Interestingly, the FTC has proposed a settlement to POM, with one of the conditions being that POM receive FDA approval for any advertisements that claim its product “cures, prevents, treats, or reduces the risk of any disease.” Thus far, POM has stood by its research behind its health claims, making this an interesting set of cases to follow moving forward.
The Corn Refiners Association (the “CRA”), a trade organization representing the US corn refining industry, recently petitioned the Food and Drug Administration (the “FDA”) to allow the term “corn sugar” as an alternative label declaration for high fructose corn syrup (“HFCS”). The the FDA’s decision on whether to approve the renaming is expected to take up to two years.
The CRA is advocating the renaming, stressing that HFCS, despite the name, is not actually high in fructose. There are three different types of HFCS one that is 55 percent fructose and 42 percent glucose (HFCS 55, most commonly found in soft drinks) - one that is 42 percent fructose and 58 percent glucose (HFCS 42, usually used in food products), and one used for specialty applications that is 90 percent fructose and 10 percent glucose (HFCS 90, typically used to blend with HFCS 42 to make HFCS 55). Buttressing the CRA’s claim is an American Dietetic Association study that also reached the conclusion that HFCS contains proportions of fructose and glucose that are similar to sugar.
While the CRA’s stated objective in pursuing the alternative label declaration for HFCS is achieving greater clarity for consumers, this change may also yield economic benefits for companies that use HFCS in their products. According to a recent report by market research organization Mintel, a majority of consumers surveyed claim to avoid products in which HFCS is listed as one of the first ingredients. This preference is strongest among more affluent and better educated consumers. HFCS has faced significant levels of negative publicity in recent years, reaching a crescendo with the 2004 publication of a study in the American Journal of Clinical Nutrition highlighting the parallel between obesity and the rise in high fructose corn syrup consumption, and hypothesizing that the two could be related. The study’s authors have since said they were wrong in their speculation, and the American Medical Association has concluded that HFCS “does not appear to contribute more to obesity than other caloric sweeteners”, but as the results of consumer surveys and sales data indicate, the backlash against HFCS has continued. There is precedent for this type of rebranding, as in November of 2009 Ajinomoto rebranded its aspartame sweetener as “AminoSweet” based on many of the same issues at play in the current discussion of HFCS.
SAVE THE DATE FOR THE ABA'S FOOD & SUPPLEMENTS FIRST ANNUAL WORKSHOP AT COCA-COLA IN ATLANTA THIS WINTER
Thursday, February 17, 2011 - Hosted by The Coca-Cola Company.
Please save the date for this first annual one-day CLE workshop sponsored by ABA’s Food and Supplements subcommittee that will include panels on the impact of federal statutory and regulatory reform on the food industry, state consumer laws and consumer class actions related to food packaging, labeling, and marketing, the evolving science of food safety and technology, ethical considerations in the labeling of bioactive foods, and in-house counsel's top predictions for the future of food regulation and litigation. Leslie M. Turner, General Counsel for Coca-Cola North America, will speak on "Protecting the Brand in the Food Industry" at our networking luncheon and a networking reception will follow the workshop.
Ricardo Carvajal from Hyman Phelps & McNamara and I will be moderating the panel on the impact of federal statutory and regulatory reform on the food industry.
More information and a full program agenda to come. Stay tuned.
This article was first published on August 27, 2010 in Food Chemical News as part of its "On the Front Burner" series.
In its first year, the FDA’s Reportable Food Registry has proven itself to be a high-stakes game changer. The ticking of the RFR's 24-hour reporting deadline forces a company to make snap decisions that might affect its entire business (not to mention the health of its customers). Once a report is submitted, FDA will promptly alert your customers of the "reasonable probability" that your product will result in "adverse health consequences or death." While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell can almost never be unrung.
On the other hand, the civil and criminal consequences of failing to report when obligated to do so can be devastating. Companies that fail to comply with RFR requirements (even without intention not to comply) can be charged with felonies, and subject to fines and jail time for their executives. Those violating the RFR with intent are subject to greater penalties.
Assuming your company is a "responsible party" (meaning an "owner, operator, or agent in charge of a domestic or foreign facility" required to register under 415(a) of the FD&C Act) and already follows a HACCP plan, a GMP, GAPs, etc., what else can it do to prepare for and, if possible, prevent an RFR report? The answer is a lot. At minimum, here's what should be in any food company's RFR toolkit/standard operating procedures (SOPs):
1. Identify the right personnel authorized to report before the event occurs
The first thing a food company that is a "responsible party" needs to do is to identify the personnel responsible for reporting under the RFR. FDA permits a responsible party to authorize an employee or agent "to report an instance of reportable food on their behalf through the Reportable Food electronic portal."
Best practices dictate that personnel authorized should be:
- Trained food scientists and/or epidemiologists. All food companies should have competent and experienced food scientists in house or consultants on retainer who are food safety experts. Without proper food safety staff, compliance with a HACCP, a GMP or GAPs is impossible. Without the right staff, problems from food-borne illness, foreign objects and allergens are inevitable rather than avoidable. Without the right staff, unavoidable food-borne illness and other problems may easily destroy a company.
- Intimately familiar with the company, its products and its quality and with supply chain personnel and practices. More than well-trained and competent, food safety personnel authorized to report should be as familiar as possible with the company, its products, personnel, SOPs, suppliers, etc. Food products are often complex, involving multiple ingredients, suppliers, customers, formulations, etc. As with any crisis concerning the company’s products, no one can fully grasp the scope of the problem, formulate a response or provide regulators with required information without all the information. The time of crisis is not the time to familiarize your experts with your company and your products.
For companies with multiple facilities required to register under the FD&C Act, clear identification of personnel responsible for reporting is critical to avoid multiple and inconsistent reports concerning the same product.
2. Train personnel to understand the RFR, the portal and legal requirements
The web-based RFR Portal is relatively straightforward and user friendly. The easy part is learning to use the software. More challenging is understanding when a report is required.
For example, personnel must be able to determine what constitutes a "reportable food" under the law and what does not. Section 417 of the FD&C Act defines "reportable food" as "an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals." FDA in its guidance documents says that "reportable food" includes "those foods that would meet the definition of a Class I recall situation. A Class I recall situation is one in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death."
But what would FDA consider a "reasonable probability"? What if one lot of product tests positive for a food-borne illness but other lots do not? The nuances are significant.
Another example of a nuance-laced provision of the RFR that personnel need to understand in advance of a crisis relates to product transfer. The RFR might not require your company to report if your product is still in the field or in the possession of a third party. On the other hand, product not yet owned by your company but located on your company's premises might be reportable.
An exception in the RFR states that a responsible party is not required to submit a report for a reportable food if all of the following conditions apply:
- The adulteration “originated” within the responsible party;
- The responsible party detected the “adulteration” prior to any “transfer” to another person of such article of food; and
- The responsible party either corrected such adulteration, or destroyed or caused the destruction of such article of food.
3. Revamp recordkeeping policies
In addition to the reporting provision itself, the RFR imposes new recordkeeping requirements and FDA inspection authority. FDA instructs that "the responsible party shall maintain records related to each report received, notification made, and report submitted to the FDA under section 417 of the FD&C Act for two years."
In addition to revamping document destruction/retention, companies should consider SOPs that define and segregate documents "related to" an RFR report. Both the document maintenance provision and the FDA's current authority to demand documents are limited to those "related to" an RFR report.
For those documents that are provided to FDA, companies should take precautions to prevent disclosure of confidential and proprietary business information and trade secrets. Documents turned over to the FDA will be subject to Freedom of Information Act (FOIA). However, a FOIA exception exists for "certain information, including but not limited to trade secrets and confidential commercial or financial information." One SOP a food company should consider is including a standard cover letter with any documents provided to FDA explaining that the company considers some or all of the information exempt from FOIA disclosure.
4. Revisit supply contracts and reconsider timing/location of product testing
As discussed above, in the context of the RFR, possession is more than 9/10, it is everything when it comes to reporting responsibilities. A supply contract that does not transfer ownership of the product until after sampling does not relieve the purchaser from reporting if the product is held in a truck on the purchaser's premises. A company may be required to report product owned by another party if the product happens to be located at the non-owner's facility.
FDA describes this scenario in a Q and A format in its draft industry guidance:
QUESTION: Our manufacturing facility receives bulk trailer shipments of ingredients from our suppliers. A truck driver brings a trailer full of bulk ingredients onto our property, drops off the trailer, and drives away. However, as company policy, we do not off-load the trailers that are delivered to our facility or take ownership of the food in the trailers until after we test a sample of the food and determine that the food is acceptable. If we “reject” a shipment, i.e., return the food to the supplier, because the sample results indicate that the food is a reportable food, are we required to submit a reportable food report?
FDA’s ANSWER: Yes, provided that you are a facility required to register with FDA under section 415(a) of the FD&C Act, you must submit a report for the food you determined to be a reportable food, even though you returned the food to your supplier. FDA considers that your facility “held” the reportable food because the trailers were no longer in transit once they were dropped off on your property. Thus, you are a responsible party with regard to the reportable food. Provided that the adulteration did not originate with you, you do not meet the criteria for the exemption from reporting in section 417(d)(2).
One solution to prevent the potentially awkward situation of having to report product not yet purchased is to require product testing prior to arrival on premises. Aside from requiring test results before shipment or arrival, supplier agreements should be amended to require at minimum that the supplier provide its food safety SOPs, plant inspection reports and, if possible, identities of other parties supplied. Personnel authorized or involved with the RFR reporting should make regular inspections and be familiar with the supplier’s facilities.
5. Know what to do when FDA inspectors arrive
A report submitted to the registry will likely result in a visit and inspection from the FDA. While FDA's current statutory inspection powers are technically limited under current law, the reality is that companies should almost always cooperate with FDA's request. The more difficult a company makes it for the FDA, the more difficult FDA will make it for the company. FDA has both the bully-pulpit and enforcement powers available if it feels that it’s not getting the cooperation it needs and public health is at risk.
Any FDA inspection should be shadowed by company personnel. Photos taken by FDA officials also should be taken by company personnel. The company should request from the FDA split samples if it decides to swab the plant or test product. As discussed above, the company should segregate in advance records related to the reportable food and those unrelated. Records unrelated to the reportable food need not be provided for inspection. The company also should provide a letter to the FDA indicating that all photos and documents are confidential and proprietary, and should be exempted from FOIA disclosure.
6. Appreciate that attorney-client privilege will not protect plant records from disclosure
The company's records and communications (including emails) do not necessarily become privileged (and therefore protected from disclosure to FDA or other parties) because they are transmitted to or "through" the company's lawyer. Company personnel should not assume that emails to counsel will be shielded unless they clearly relate directly to the provision of confidential legal advice provided to the company. Even when provided for the explicit purpose of legal advice, "facts" or "business records" will still not be shielded from discovery. Many courts appreciate that in-house counsel provide both legal and business advice and presume that communications are not privileged unless it is very clear that the communication was strictly in the nature of legal counsel.
The quote, "Watch what we do, not what we say," is attributed to John Mitchell, Nixon's first attorney general. It can apply, however, to the behavior of consumers with respect to shrimp from the Gulf of Mexico, and that will be watched carefully everyone from shrimp fishers to the owners of your local fish market. The FDA says flatly, about Gulf shrimp, "the public should not be concerned about the safety of seafood in stores at this time." Not surprisingly, a coalition led by the Natural Resources Defense Council, while not going so far as to advise anyone not to eat Gulf shrimp, thinks higher standards and more testing is appropriate, and has so advised both the FDA and NOAA.
Shrimpers themselves are of course worried about the backlash if any tainted shrimp are consumed. Similar to the dialogue I had with Jim Prevor a few months ago, there is often a difference between what we might think of as rational behavior and how consumers in fact react. Every year, a certain percentage of shrimp turn bad for reasons unrelated to oil spills; in 2010, it's likely a consumer who gets a bad shrimp will first blame it on the oil spill.
According to an AP article reprinted in today's Wall Street Journal, however, the reality on the ground in fish stores is less grim. It quotes the supplier to Hapuku Fish Shop, an upscale store in the Rockridge District of Oakland, as saying, "the shrimp has been nothing less than spectacular lately." The shop itself is selling about as much of the shrimp as it did before the spill.
President Obama also has put his stomach where his mouth is, serving Gulf shrimp at his birthday party.
As with any seafood, consumers of Gulf shrimp should handle it properly and apply their own smell test before cooking and before eating.
You have probably heard about the great egg recall of 2010, which has required Wright County Eggs of Galt, Iowa to recall an ever-growing number of shell eggs because of fears of salmonella enteriditis.
An interesting issue here is the non-overlapping jurisdiction of USDA and FDA over eggs in the shell. According to the FDA:
Generally, USDA is responsible for egg safety at what are called breaker plants or egg products processing facilities. In these facilities eggs are broken and pasteurized. FDA is responsible for shell egg safety and egg products once they leave the breaking facility.
The FoodSafety.gov page about safely handling and dealing with eggs is a good place to start for consumers worried about their own eggs.
We also repeat the advice we have collected from previous outbreaks:
- Have a crisis management plan in place.
- Know what you will do when the investigators knock.
- Double check the language in your insurance policy to ensure that it covers the particular facts of a recall. In 2008, Ken blogged about this issue after the tomato outbreak and in 2009 after the peanut recall.
- If you know your products are not affected by the outbreak, publicize this appropriately and ask your trade organization to help with that as well.
- If your products are involved, consider getting criminal law advice as well as advice about civil law responsibilities.
- Reconsider how you choose your suppliers, and what you do to qualify them.
- Publicize whatever is happening on your web page; consumers who hear about your product being recalled may check your web page and don't want to see a sales pitch for the very product subject to recall.
- Review your supply contracts to ensure that you have recourse against someone selling you tainted product, but remember that such entities are unlikely to have adequate resources to make you whole; that is what insurance is for, and also what prevention is for.
- Consider how to publicize the situation to consumers who use different languages.
American Conference Institute (“ACI”) will hold its 4th National Conference on Food-Borne Illness Claims in Chicago, October 27 to 28. Highlights of this year's conference will include:
• Appearances by a number of current and former high-level regulators such as Dr. Arthur Liang from CDC, Dr. David Goldman from USDA, Dr. David Acheson formerly of FDA, Dr. Bob Brackett formerly of CFSAN, Jack Guzewich from FDA, Dr. Bill Keene from Oregon Public Health Division and Benjamin Miller from Minnesota Department of Agriculture
• Mock witness examination of a testifying epidemiologist
• Insights from of the nation's top in-house and outside food-borne illness counsel
The complete conference brochure can be linked here.
Unfortunately, my schedule won't allow me to join the conference this year (I've spoken at the first three ACI national conferences on food-borne illness). But I can arrange for a conference discount. Just give me a call (206-386-7595) or send me an email.
In an opinion issued on July 21, 2010, Judge John Gleason of the United States District Court for the Eastern District of New York largely denied the defendant’s motion for dismissal and held that 10 of the 13 claims in a class action suit brought against Coca-Cola for alleged unlawful health claims on its Vitaminwater drinks could proceed. The claims that still must be examined in court include allegations of misleading advertising, fraudulent business acts, and unfair methods of competition.
The plaintiffs in the class action, which include the health advocacy group Center for Science in the Public Interest (“CSPI”) as co-counsel, contended that Vitaminwater’s labeling and marketing is misleading because it (1) communicates a number of purported health benefits (including healthy joints, optimal immune function, and reduced risk of chronic disease), drawing consumer attention away from the significant amount of sugar (33 grams per bottle) in the product; (2) portrays Vitaminwater as healthy when it is essentially a snack food that provides nutritional benefits because it has been specifically fortified to do so; and (3) suggests that Vitaminwater contains nothing but vitamins and water.
While the court concluded, citing applicable Food and Drug Administration (“FDA”) rules and commentary, that sugar was not a “disqualifying nutrient” under applicable FDA regulations, the plaintiffs’ latter two claims were found to accurately describe violations of FDA regulations, and accordingly may serve as a non-preempted basis of state law liability.
The FDA regulations restricting health claims or implied claims of healthiness related to foods that meet certain minimum nutrient levels, colloquially termed “the jelly bean rule,” were developed in an effort to prevent food producers from encouraging the consumption by consumers of junk food by fortifying the food in question with nutrients. The “jelly bean rule” is applicable only to (1) health claims, and (2) nutrient content claims that use the word “healthy” to suggest that a food may help consumers maintain healthy dietary practices because of its nutrient content. Finding that Vitaminwater’s labeling contains claims in each of these two categories, the court ruled the plaintiffs could proceed with this claim.
The plaintiffs alleged Vitaminwater’s labeling is misleading because it uses a product name that includes two of the product’s ingredients (vitamins and water), but fails to mention another notable ingredient (sugar). FDA regulations on this subject recognize that such product names have the potential to mislead consumers. Thus, the court held that the plaintiffs were allowed to pursue this claim. In the aftermath of this ruling, Coca-Cola released a statement expressing their confidence that the plaintiffs’ claims are without merit and will ultimately be rejected. Given that the implications this case could carry into the growing functional food and beverage segments of the market, we will continue to track it closely.
Click on the image below to view the slide-deck from the presentation that I recently gave with Scott Rickman from Del Monte at ACI’s summit on Food Safety and Regulatory Compliance in Chicago. The ACI summit was a nice introduction to food regulation byFDA, USDA, FTC, EPA and DHS. Our presentation was intended to start from the premise that the job of a food lawyer (whether inside or outside counsel) does not end at ensuring regulatory compliance. Products that are regulatory-compliant may still be subject to putative class claims.
At its recent annual meeting, the American Medical Association (“AMA”) agreed to urge the Food and Drug Administration (“FDA”) to adopt more accurate labeling standards regarding trans fats and saturated fats used in food products.
Current FDA rules allow nutrition labels to list saturated and trans fats as zero, so long as the product contains less than 0.5 grams of fat per serving. However, the AMA claims that this is misleading to consumers, who could potentially consume more than a quarter of the American Heart Association’s recommended limit of two grams of trans fat per day in a single serving, unaware that the product contains trans fats.
The AMA’s position that consumers are being misled by current FDA rules does have some support in the marketplace. In a consumer survey conducted by market researchers Greenfield Online, 72 percent of U.S. respondents said they read nutrition labels and fact panels in an effort to make healthy purchasing decisions when shopping, and 61 percent said they considered zero grams of trans fat per serving to be the most important heart health related claim for a product.
FDA recently released updates to its Draft Industry Guidance for the Reportable Food Registry (“RFR”). The RFR, not rolled out until the fall of 2009, is still new to many companies. FDA, overwhelmed by the information coming through the RFR, is still trying to determine how to use the information submitted to the RFR and how to advise industry.
Among the more interesting clarifications in the May updates is the importance FDA puts on the possession of reportable food as a trigger for obligations under the RFR. For example, if produce is still in the field (contracted but not owned by a food seller) and tests positive for a pathogen, no reporting obligation accrues.
[F]ood facility that contracted with the farmer and tested the produce in the field is not required to submit a reportable food report, provided that the facility did not manufacture, process, pack, or hold the produce and therefore never became a responsible party with respect to the produce. However, if the field had been harvested and the contaminated produce had been moved to the food facility, the facility would have become a responsible party because it “held” the food and would be required to submit a reportable food report.
On the other hand, if the same contaminated produce is received on a company’s premises, stays in the trailer, tests positive and is rejected, a reporting obligation is triggered (even though the company did not take ownership of the product).
FDA’s description of this scenario in a Q and A format:
Q: Our manufacturing facility receives bulk trailer shipments of ingredients from our suppliers. A truck driver brings a trailer full of bulk ingredients onto our property, drops off the trailer, and drives away. However, as company policy, we do not off-load the trailers that are delivered to our facility or take ownership of the food in the trailers until after we test a sample of the food and determine that the food is acceptable. If we “reject” a shipment, i.e., return the food to the supplier, because the sample results indicate that the food is a reportable food, are we required to submit a reportable food report?
A: Yes, provided that you are a facility required to register with FDA under section 415(a) of the FD&C Act, you must submit a report for the food you determined to be a reportable food, even though you returned the food to your supplier. FDA considers that your facility “held” the reportable food because the trailers were no longer in transit once they were dropped off on your property. Thus, you are a responsible party with regard to the reportable food. Provided that the adulteration did not originate with you, you do not meet the criteria for the exemption from reporting in section 417(d)(2) (see Question E.3).
TAKE AWAY: If a company can set up a system to do its micro-biological testing before the product arrives on its premises or at its warehouse (public or private), it should. If faced with a reportable event, the reporting requires notification to FDA of one step forward and one step back in the supply chain even if the product is never distributed. Once a report is submitted to the RFR, a company should expect that the FDA will notify the company’s customers of the reportable event despite the fact that the customer never received product. FDA notification means the customer will be told that its vendor had contaminated product that rises to the level of class I recall though this may not actually be true. Food sellers and manufacturers, therefore, would be wise to take steps to avoid being “stuck” with RFR obligations for contaminated product it does not own.
“Got Milk?” The answer to that question may not be as cut and dried as you might believe, at least in Wisconsin. In a May 19 letter to the state Senate, Wisconsin Governor Jim Doyle explained his rationale behind his veto of Senate Bill 434, which would have authorized dairy farmers with a Grade A dairy farm permit to sell unpasteurized milk, buttermilk, butter, and cream directly to consumers. Sellers would have been required to post a warning sign at the site of sale stating that raw milk does not provide the protection of pasteurization and is not recommended for certain categories of consumers – including children, seniors, pregnant or nursing women, diabetics, or those with compromised immune systems.
Citing widespread opposition from the public health community (including the Wisconsin Public Health Association and the Food and Drug Administration, which has previously issued releases on the health issues related to unpasteurized milk) and numerous industry stakeholders, Governor Doyle explained that, in his view, the lack of rigor in the testing standards for pathogens, risks to public health and the state’s economic interests should an outbreak of disease linked to consumption of unpasteurized milk occur, and the ongoing work of the Wisconsin Department of Agriculture, Trade and Consumer Protection’s recently created Raw Milk Policy Working Group, which has been charged with reviewing the legal and regulatory framework surrounding the sale of unpasteurized milk to consumers in an attempt to strike a balance between market demand and public health, warranted a veto of the bill. An aide to Majority Leader Russ Decker stated that the Senate is not likely to attempt to override Governor Doyle’s veto.
This issue of the sale of unpasteurized milk to consumers is not limited to Wisconsin. In his letter to the Senate, Governor Doyle mentioned the comprehensive testing approach required for raw milk products under California law. In order for raw milk to be legally sold in California, it must meet the standards provided in the Milk and Milk Products Act of 1947. Under California Administrative Code, raw milk and raw milk products must bear a detailed warning to consumers on the principal display panel of the label. Washington State Administrative Code also requires raw milk containers to bear a warning label. As more consumers express preferences for unprocessed, “natural” foods, issues related to the sale and consumption of unpasteurized milk could find a more prominent place in the judicial system and industry marketplace.
By Guest Blogger Jonathan Stagg
This post also appears on the Essential Nutrition Law Blog
One major complaint of companies marketing nutritional supplements is that the FDA severely limits their use of scientific findings in promoting the health benefits of their products. Under current FDA regulations, use of a scientific study to advertise the health benefits of a given product can convert the product from a nutritional supplement into a drug, and therefore impose the vast array of regulations applied to drugs. As a result, nutritional supplement manufacturers have to be very careful about claiming health benefits or citing to scientific research, whether on their product labeling or even on their websites.
In response to these concerns, Congressmen Jason Chaffetz (R-UT) and Jared Polis (D-CO), introduced what they are calling the “Free Speech About Sciences Act.” This proposed legislation seeks to soften the application of these FDA regulations to nutritional supplements. If the law were to pass, companies would be allowed to reference “legitimate scientific research” in support of claims about the health benefits of their products. In order to fall within the definition of “legitimate scientific research,” the study must have been conducted and reviewed according to certain standards, and must appear in a peer-reviewed scientific publication. Companies must also follow certain guidelines in presenting the findings, such as including an accurate and balanced summary of the research, providing consumers a citation to the study, and providing information about the entities who funded the research.
Jim Prevor has an intriguing story in one of his latest Perishable Pundits, updated here and here, that frankly has me wondering. According to Jim, Freshway Foods discovered E.Coil 0145 in some romaine and, using tracking numbers, was able to trace it to a specific lot supplied by a grower in Yuma, Arizona. It then issued a recall limited to that specific lot.
But the FDA decided to be more cautious and to advise Freshways to recall all the romaine from Yuma, not just the identified lot. And the buyers of the product decided to pull anything they had on their shelves from Freshways, whether it was from Arizona, and whether, apparently, it was romaine or not.
This raises a number of questions and I am not going to purport to answer them. Rather, I'd really like to solicit comments from our very knowledgeable and resourceful readership. This is the age of Web 2.0 and beyond. We'd love to hear from you.
- Is the implication of Jim's article right, that spending money on good tracing systems may be futile because consumers and regulators will never trust the system?
- What kind of public education might work to improve the acceptance of traceability?
- As a legal matter, it's unlikely that the buyer of the non-recalled products has any recourse against the seller; in the real world, however, is the seller likely to make good in order to assure future sales?
- Ken recently wrote about a similar insurance issue; is there any kind of insurance for something taken off the shelves because of an abundance of caution when the supplier says only to recall specific items?
- In his updates, Jim suggests that the real issue is that perhaps we are providing more traceability than the market demands and others suggest that the issue is that upon discovery of an outbreak, the FDA doesn't either adequately communicate the perceived cause of the outbreak or ever issue an "all clear" after it is over. Is either step either (a) practical when things are moving in real time, or (b) really the FDA's responsiblity or even power under current laws and regulations?
By Guest Blogger Jay Eckhardt
In a dispute over product labeling and marketing, the Coca-Cola Company avoids liability as a result of its careful compliance with FDA rules. (Also, see Rick's post from last week, regarding Coca-Cola's victory in a dispute over its original formula label found on Coke® Classic.) But pomegranate champion POM Wonderful can still pursue a Lanham Act deceptive advertising claim against the company.
On May 5 the U.S. District Court for the Central District of California issued summary judgment orders that cut out two of POM's claims against Coca-Cola's "Minute Maid Enhanced Pomegranate Blueberry Flavored 100% Juice Blend." (Download a copy of the Central District of California's Order here.)
The court acknowledged that consumers have griped about the emphasis on pomegranate and blueberry in the Minute Maid product labeling and advertising. (See Ken's post about a consumer class action concerning Tropicana's pomegranate blueberry juice blend here.) Still, the court agreed with Coca-Cola that POM could not bring a Lanham Act claim challenging the product name, because the company complied with FDA labeling requirements. The Minute Maid product contains less than one-half of one percent (0.5%) pomegranate and blueberry juice, but the court determined that the name is compliant with FDA rules, which allow for product names that prominently cite ingredients that are less than prominent in volume. Because the label clearly notes that the juice is "flavored" with pomegranate and blueberry juice and that the juice is a "blend" of several juices, the court held that the name complies with applicable FDA regulations (21 C.F.R. §§ 102.33(c) and 101.22(i)(1)(i)).
A second claim raised by POM was thrown out by the court. POM sought restitution under California Business & Professions Code section 17200, which provides a cause of action for "Unfair Competition." The court dismissed this claim because "restitution" has been narrowly interpreted by the California Supreme Court, thus barring POM's claim for recovery of a "lost business opportunity." Among authorities cited for the decision to dismiss this claim, the court reported that POM's similar claims under California's Unfair Competition law, brought against Tropicana and Welch's, have recently been dismissed in separate actions.
A third claim survived Coca-Cola's summary judgment attack. POM may proceed under the Lanham Act to challenge the marketing and advertising for the "blueberry pomegranate" product. The court held that POM may attempt to prove at trial that advertising and marketing actually deceived customers, or that Coca-Cola willfully and intentionally misled customers with the marketing of its product.
As noted from the court's order, Coca-Cola is not the only target of POM's litigation strategy. Other juice makers, Tropicana and Welch's, have been the focus of POM's efforts to defend its niche. Ken reported on POM's challenge to Ocean Spray's pomegranate cranberry juice blend last August, when POM survived Ocean Spray's initial motion to dismiss all claims.
An inspired marketing campaign for POM's products, and its essential ingredient, helped build the pomegranate franchise. It's hard to say whether litigation against advertising and labeling practices of POM's pomegranate competitors will be effective. At the same time, there's no doubt that POM is well aware of the burdens of FDA labeling regulations – the company was one among 17 companies notified by the FDA last February that its product labeling and advertising did not pass muster. The FDA warned POM that its advertising was suspect, based on the health claims made on its web site about the benefits of pomegranate juice.
This post also appears on the Essential Nutrition Law Blog.
In an April 28 release, the Food and Drug Administration (the “FDA”) asked for comments and information from the public and other interested parties about front-of-pack (“FOP”) nutrition labeling and shelf tags in retail stores. The FOP is the part of the package label that is most likely to be examined under customary conditions of display for retail sale.
According to the FDA release, the FOP nutrition labeling effort aims to “maximize the number of consumers who readily notice, understand, and use point-of-purchase information to make nutritious choices for themselves and their families.” Specifically, the agency is seeking to learn more about:
• the extent to which consumers notice, use, and understand nutrition symbols on FOP labeling of food packages or on shelf tags in retail stores
• research that assesses and compares the effectiveness of particular approaches to FOP labeling
• graphic design, marketing, and advertising data and information that can help develop better point-of-purchase nutrition information
• how point-of-purchase information may affect decisions by food manufacturers to reformulate products
The FDA is accepting comments on this issue until July 28, 2010. Further information is available in a notice from the FDA and the Department of Health and Human Services announcing the establishment of a docket to obtain the data and other information that will be utilized in the FDA’s deliberations.
These recent developments did not appear out of thin air. As noted by our colleagues at the FDA Law Blog, in a March 3 letter to industry, the FDA said it is working to devise a front-of-pack labeling system that consumers can understand and use. In the meantime, the FDA announced plans to issue new draft guidance relating to front-of-pack calorie and nutrient labeling. The agency is also planning to issue draft guidance that would recommend nutritional criteria for foods that make “dietary guidance” statements (such as “Eat 2 cups of fruit a day for good health”) in their labeling. Dating back even further, in an October 2009 letter to the industry, the FDA said it was working on developing a regulation that would define the nutritional criteria that would have to be met by manufacturers making broad FOP or shelf label claims concerning the nutritional quality of a food.
Dr. Hamburg also noted that the FDA is in the process of notifying numerous manufacturers that their current labels are in violation of the law and subject to proceedings that will remove their misbranded products from the marketplace. Thus it appears the FDA is willing to back up this position with action. Given the increasing number of headlines such as this one regarding the ability of the armed forces to find able-bodied servicemen and women, the issue of how manufacturers communicate to consumers with respect to nutritional content is likely to be a subject of FDA scrutiny for the foreseeable future.
You've heard the phrase "buried in the bill," of course. Section 4205 of the "Patient Protection and Affordable Care Act," the health care reform bill President Obama signed on March 23, 2010, is contained on pages 1206-1214 of a 2407 page bill. It could hardly be more buried than that.
In very technical terms, Section 4205 inserts a new subclause (H) into Section 403(q)(5) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 343(q)(5), and adds a proviso (referring to the new subclause (H)) in Section 403(q)(5)(A). Section 403 is entitled "Misbranded Food" and clause (q) is entitled "Nutrition Information." Previously, subclause (5)(A) has exempted both restaurant food or takeout food from federal nutritional labeling requirements.
The new statute creates a new regime for labeling, in essence only requiring caloric and other information to be provided by restaurants covered by the act, by vending machines owned by persons covered by the act, and by those who opt in to the act.
The covered restaurants are those "part of a chain of 20 or more locations doing business under the same name (regardless of the type of ownership of the locations).and offering for sale substantially the same items." This appears to be intended to cover chain restaurants even if they are franchised, or held in separate subsidiaries.
The substance required to be disclosed is actually quite discrete. It must be:
- In a clear and conspicuous manner
- Adjacent to the name of the standard menu item
- Clearly associated with the standard menu item
- Of the number of calories contained in the standard menu item as usually prepared and offered for sale
In addition, there must be posted prominently on the menu "designed to enable the public to understand, in the context of a total daily diet, the significance of the caloric information provided on the menu." This would include information about a recommended daily calorie intake.
Finally, all of the standard information required under clause (q)(1)(C) and (D), meaning the standard information on calories derived from fat, plus total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber and total protein, must be provided somewhere in the restaurant and a prominent, clear and conspicuous sign stating this fact must be on the menu or menu board.
The caloric disclosure also applies to a salad bar, buffet line, cafeteria line, or similar self-service line, "adjacent to each food offered," on the basis of per displayed food item or per serving.
Food establishments are required to have a reasonable basis for their nutrient content disclosures.
There will be regulations on how to deal with different flavors or combinations (such as soft drinks from a fountain with many choices or pizza with different toppings). Regulations can also add to the list of nutrients required to be disclosed.
Exceptions to the disclosure requirements include items not listed on the menu, such as condiments, daily specials not on the menu for less than 60 days per calendar year, and food that is part of a customary marketing test but for a period of less than 90 days.
Food from vending machines where the machine does not allow the nutrition facts panel to be seen prior to purchase is required to have "in close proximity to each article of food or the selection button" a clear and conspicuous statement of calories in the article. Vending machines are covered if they are operated by a person who is in the busienss of owning or operating 20 or more vending machines.
The Secretary of Health and Human Services has one year to propose regulations.
An important aspect of the law is its preemption of inconsistent state laws. This applies to the establishments required to be included, and any others that choose to opt into the program. Thus, a smaller chain that crosses state lines where the two states have differing disclosure rules can choose to follow the federal rule and thus be able to print and display consistent menus,as well as train their personnel on only one set of rules. The preemption does not apply to labeling requirements in the nature of warnings concerning the safety of food, presumably including the California warnings about alcohol during pregnancy.
Until the rules come out, of course, the devil will remain in the details.
As Ken noted last week, there has been a widespread recall of products containing hydrolized vegetable protein (HVP), a flavor enhancer, after salmonella Tennessee was discovered in product manufactured by Basic Food Flavors of North Las Vegas, Nevada. Consumers, who may have been unaware of the existence of HVP, are starting to learn how pervasive an ingredient it is in packaged and processed foods. The FDA has a handy list of products so far affected by the recall. There's a widget, too.
So far, no one has been reported to have been made sick or died as a result of this outbreak.
The FDA warns consumers "Remember to follow cooking instructions on all foods", except that many of the foods that contain HVP are not ones consumers cook. Included are salad dressings, ready to eat meal products, sauce and marinade mixes and snacks. I don't think there's a way for a consumer to cook a pretzel.
This outbreak is a good excuse to reiterate some of our advice from prior outbreaks, like the 2008 tomato outbreak and the 2009 peanut and pistachio outbreaks.
- Have a crisis management plan in place.
- Know what you will do when the investigators knock.
- Double check the language in your insurance policy to ensure that it covers the particular facts of a recall. In 2008, Ken blogged about this issue after the tomato outbreak and in 2009 after the peanut recall.
- If you know your products are not affected by the outbreak, publicize this appropriately and ask your trade organization to help with that as well.
- If your products are involved, consider getting criminal law advice as well as advice about civil law responsibilities.
- Reconsider how you choose your suppliers, and what you do to qualify them.
- Publicize whatever is happening on your web page; consumers who hear about your product being recalled may check your web page and don't want to see a sales pitch for the very product subject to recall.
- Review your supply contracts to ensure that you have recourse against someone selling you tainted product, but remember that such entities are unlikely to have adequate resources to make you whole; that is what insurance is for, and also what prevention is for.
- Consider how to publicize the situation to consumers who use different languages.
As Professor Moody would say, "Constant vigilance."
As we have discussed in recent postings (here and here), issues regarding the certification of food ingredients as generally recognized as safe (“GRAS”) by the Food and Drug Administration (the “FDA”) have been a hot topic in industry circles. Now, the Government Accountability Office (the “GAO”) has released a report encouraging the FDA to improve its oversight of GRAS food ingredients. Our colleagues from Hyman, Phelps & McNamara’s FDA Law Blog released an excellent post on this subject, so we will discuss the general findings and recommendations of the report here.
The GAO report includes findings that (1) the FDA’s oversight process does not help ensure the safety of all new GRAS determinations, (2) the FDA is not systematically ensuring the continued safety of current GRAS substances, and (3) the FDA’s regulatory approach allows engineered nanomaterials to enter the food supply without its knowledge. The report contains six specific recommendations for FDA action, encouraging the FDA to develop a strategy to:
- require any company that conducts a GRAS determination to provide the FDA with basic information about that determination;
- minimize the potential for conflicts of interest in companies’ GRAS determinations;
- monitor the appropriateness of companies’ GRAS determinations through random audits or some other means;
- finalize the rule that governs the voluntary notification program;
- conduct reconsiderations of the safety of GRAS substances in a more systematic manner; and
- help ensure the safety of engineered nanomaterials that companies market as GRAS substances without its knowledge.
Further, the report contains a general directive that if the FDA determines it does not have the authority to implement one or more of these recommendations, the agency should seek the authority from Congress. In its response to the report, the FDA, while not indicating any definitive posture on the GAO’s recommendations, was generally receptive to the findings and recommendations of the GAO. Given the prominence of the issue of GRAS certification as it pertains to a number of food and beverage products in the marketplace, we will continue to closely monitor this subject.
Difficult Week for the Food Industry (Good Week for the Plaintiffs' Bar): HVP Salmonella and FDA Warning Letters
The week of March 1 saw a double whammy hit food manufacturers.
I. Open Letter to Industry on Marketing Claims
First, on March 3, FDA sent warning letters to 16 food manufacturers concerning their labeling practices. FDA also issued an Open Letter to Industry warning against certain practices. For example, FDA warned that:
o Nutrient content claims that FDA has authorized for use on foods for adults are not permitted on foods for children under two. Such claims are highly inappropriate when they appear on food for infants and toddlers because it is well known that the nutritional needs of the very young are different than those of adults.
o Claims that a product is free of trans fats, which imply that the product is a better choice than products without the claim, can be misleading when a product is high in saturated fat, and especially so when the claim is not accompanied by the required statement referring consumers to the more complete information on the Nutrition Facts panel.
o Products that claim to treat or mitigate disease are considered to be drugs and must meet the regulatory requirements for drugs, including the requirement to prove that the product is safe and effective for its intended use.
o Misleading “healthy” claims continue to appear on foods that do not meet the long- and well-established definition for use of that term.
o Juice products that mislead consumers into believing they consist entirely of a single juice are still on the market. Despite numerous admonitions from FDA over the years, we continue to see juice blends being inaccurately labeled as single-juice products.
II. HVP Recall
A day later, on March 4, FDA announced a recall of hydrolyzed vegetable protein (HVP). As of noon on March 4, 56 products containing HVP have been recalled. Some have suggested that HVP is the "Next Peanut Butter.”
III. What Food Companies Can Do in the Wake of FDA's Warning Letters and HVP Recall
What do last week's FDA warning letters and HVP recall have in common? The answer is, of course, litigation and exposure of brand value.
The first thing any affected food seller should do is engage its crisis management team. While lawyers and public relations staff are critical in crisis response, management of the crisis should not be left solely in the hands of either. Decisions should be made holistically, examining legal, public relations, business, financial and public health implications.
As discussed previously in this blog, companies faced with putative class claims filed as a result of the FDA warning letters on labeling should develop strategies to challenge the merits of the claims and class certification at the earliest possible stage. The end game for the plaintiffs' class action law firms is to obtain class certification and use that "litigation blackmail" to enter into a settlement with a handsome payout of attorneys’ fees.
For those companies with products that include recalled HVP, the good news is that there are few, if any, reported illnesses. The bad news is that recalls are very expensive and, for some companies without recall coverage or sufficient resources, financially devastating. Many food manufacturers were driven out of business in 2009 after being overwhelmed with the expenses of recalling products that included ingredients manufactured by Peanut Corporation of America (PCA).
For those affected companies with recall coverage or financial means, proactive measures can pay dividends. For example, offering refunds to consumers mitigates against putative class claims. Setting up consumer hotlines and payment of medical expenses for persons with illnesses linked to recalled products mitigates against personal injury suits.
Coauthored by Susan Johnson
As we have blogged about previously, the Food and Drug Administration (the “FDA”) has been closely monitoring the appropriateness of additives to alcoholic beverages, with a particular emphasis on caffeinated alcoholic beverages. A recent release from the Alcohol and Tobacco Tax and Trade Bureau (the “TTB”) indicates that the two agencies could be working together to address this increasingly prominent issue.
The TTB release emphasizes that (1) the issue of whether or not an ingredient added to an alcoholic beverage is generally recognized as safe (“GRAS”) is within the jurisdiction of the FDA; (2) due to uncertainty as to how FDA regulations would apply to such products and the need for the TTB to provide clear guidance to the industry, the TTB believes it is appropriate to partner with the FDA on this matter so forthcoming TTB guidance will be clear and correct; and (3) as a result of the current uncertainty in the field, the TTB has temporarily suspended consideration of requests from industry members seeking guidance about the addition of vitamins and other nutrients, whether directly or indirectly through a flavor, to alcoholic beverages.
While each added ingredient will be analyzed individually by the FDA to determine whether or not it is GRAS, the agency’s action in November 2009 with respect to caffeinated alcoholic beverages could be an indication of its future posture. As we noted in our discussion of that issue, the agency explained in letters to manufacturers of caffeinated alcoholic beverages and a press release detailing the rationale for its action that under the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is deemed unsafe and is unlawful unless its specific use has been approved by an FDA regulation, the substance is subject to a prior sanction, or the substance is listed as GRAS. While caffeinated alcoholic beverages carry with them a number of specific health and public policy concerns, this recent action indicates that manufacturers of alcoholic beverages with added ingredients should be prepared to justify their rationale for inclusion.
Stoel Rives was a sponsor of this year's GMA food litigation conference in Austin from February 22 to 25. The slide deck from Ken Odza's presentation on consumer fraud class claims can be viewed by clicking on the image to the left.
Some of the takeaways from my presentation and those by others at the conference include:
- Assure Marketing Is in Sync with R&D (to Avoid Exposure from Consumer Fraud Class Claims) (Ken Odza, Paul Benson, Richard Fama)
The point was underscored in several presentations that exposure on consumer fraud class claims often comes from unsupported marketing claims (health claims in particular). Marketing departments should make sure not only that claims are supported but that the supporting research is not contradicted by other credible internal or external research.
Iqbal/Twombly Makes FRCP 12(b)(6) Motions More Attractive (Ken Odza, Richard Famas)
The Supreme Court has overruled the Conley standard on Rule 8 notice pleading. "Plausibility" is the new pleading standard on a Rule 12(b)(6) motion to dismiss. If the operative allegations are not factually specific and the complained-of-conduct can be explained by another obvious reason, the complaint may be dismissed.
Class Certification in Consumer Fraud Cases Not Likely If Individualized Reliance/Causation Need to Be Proven (Ken Odza)
A court should deny class certification in a consumer fraud case under the FRCP 23(b) "predominance" standard (1) when the proposed class includes multiple states with materially different statutes or (2) where the applicable state law requires an individualized showing of reliance/causation for each class member.
- Inexorable Pursuit of Zero, and the EPA Asserting Itself in Food Safety (Scott Rickman, Bob Brackett)
As technology improves and chemicals can be detected at lower and lower levels, regulators are looking at stricter standards and lower thresholds. EPA, for example, has a renewed emphasis on risk assessments that will inevitably affect food regulation.
- FALCPA Does Not Apply to Restaurants, but "Allergen-Free" and "Gluten-Free" Claims Must Be Supported (Joseph Bottiglieri)
- Pros and Cons Of MDLs (Paul LaScala)
Paul La Scala provided a thorough and thoughtful analysis of the pros and cons of Multi-District Litigation (MDL) from a defendant's perspective.
- FDA Recall Procedures Manual Is a Great Resource and Can Be Found Online (Tom Mazziotti)
The FDA's regulatory procedures manual (or at least the chapters related to recalls) should be mandatory reading as part of any company’s recall preparedness program.
- Class Actions and Mass Torts on the Rise Internationally with More Countries Passing Plaintiff-Friendly Laws (Greg Fowler)
American companies selling products abroad need to be aware of and prepared for litigation abroad with rules that are increasingly unfriendly to business.
In just a couple of weeks (Feb. 23-25), I’ll be in Austin for the GMA Food Claims & Litigation Conference. Let me know if you plan to attend. I’ll be presenting with Scott Rickman from Del Monte Foods on consumer fraud class claims arising from food product labeling and marketing. Anyone in the business of selling branded food products should be tracking the trends in consumer fraud class claims. Thanks to the erosion of preemption defenses and increased FDA enforcement action, we’re see many more of these claims, and more result in protracted litigation.
If you’re interested in a preview of the consumer fraud issues that we’ll cover, look at the related posts here. If you can’t be in Austin, let me know and I’ll be happy to share the PowerPoint slide deck and supplemental materials.
Also, if there’s something related to consumer fraud claims or food liability that we haven’t covered in the blog or that you’d like to see more coverage on, please let me know. We at foodliabilitylaw.com would love to hear your feedback. Thanks!
Court's Decision on CR 12(b)(6) Motion In Zupnik: FFDCA Preemption Under Further Attack and Twombly Ignored
We previously cited the motion to dismiss in Zupnik, et al. v. Tropicana Products, Inc. as an example of good pleading practice in a putative consumer fraud class case. United States District Judge Dale S. Fischer apparently disagreed with our assessment, this week issuing an order denying the motion.
Tropicana’s lead argument was a failure of pleading. Tropicana attacked the complaint both on the basis of Rule 9(b), and under the Supreme Court’s recent decision in Twombly. The Twombly decision requires the federal court on a Rule 12(b)(6) motion to determine whether operative factual allegations are “plausible” and more than simply “conclusory.”
Judge Fischer rejected summarily Rule 9(b) arguments. She completely disregarded Tropicana’s Twombly arguments, failing even to mention the Supreme Court’s decision.
Tropicana also moved to dismiss based on federal preemption. Most of Judge Fischer’s decision is devoted to the preemption argument. She ruled that since California’s Sherman Law is substantively identical to 21 U.S.C. § 343(a) of the FFDCA, the preemption argument fails.
Judge Fischer theorized that even though plaintiffs could not point to anything on Tropicana’s label that violated any FDA regulation, the FDA could bring an enforcement action “to target specific false or misleading labels.” If the FDA can bring that kind of action under 21 U.S.C. § 343(a), plaintiffs, according to Judge Fischer, should also be able to bring a private right of action under the identical California law. Query whether Judge Fischer’s reasoning negates any FFDCA preemption defense to a claim brought under California’s Sherman Act?
A recent headline in the Huffington Post breathlessly importuned:
If you only read the headline, you might think this was some important information that might change your eating habits. If you read the article, you would discover a balanced set of conclusions from a fairly limited study.
First, the limitations. The study tested a total of 29 dishes at 10 chain restaurants, plus some frozen supermarket meals from nationally-distributed brands. That's hardly a study of "restaurant food" in general.
Now the facts from the actual article:
- The only item that came up at 200% over the published calorie count was Denny's "grits and butter." Denny's responded to the study by pointing out the serving size for its calorie count was a four-ounce serving and the one used in the study was a 9.5 ounce serving. So you can pretty much discount the headline already.
- The average variation in calorie counts was nowhere near 200%; it was 18%. Or, according to my calculation, 1111.11% overstated.
- The Food and Drug Administration permits a variation of 20%, so even with the Denny's grits and butter (which was, to repeat, apparently not an appropriate comparison), the food in the aggregate met the government standard.
- Reasonable minds--in the person of two professors of nutrition--can differ about whether the calorie numbers on restaurant menus should be relied on.
- Some of the variation can easily be explained by such simple things as the fact that a different amount of mayonnaise may come off the spatula on different sandwiches.
One thing I know is that the reporter, who in this case appears to have done a careful and balanced job, is not the headline writer, whose job is to grab attention. And grab attention the headline did. If you read the article, you learned a lot. If you only read the headline, you learned nothing and might have been misled.
For the record, when my name is on the byline, I wrote the headline, too.
We’re in the “crystal-ball” season—time to look forward and assess what’s coming in 2010 and beyond. The most likely scenario: more of the same and landmark change.
More of the Same
The last few years have seen growth in both the number of food-borne illnesses detected and the variety of foods affected. This is because more resources are being put into detection (though the CDC recently reported an overall decline in epidemiological capacity by the states) and technology is continuing to advance (think Next Generation Sequencing). There’s little reason to believe these trends will abate in 2010. Expect more outbreaks. Expect to hear about recalls of products not previously implicated in food-borne illness.
Nobody doubts that we’re in the midst of the most significant legislative and regulatory changes in food safety in generations. Most believe that Congress will pass some form of food safety legislation (e.g., S 510 or HR 2749) in the new year. It will likely include the most comprehensive food safety reform in decades. Among other things, this legislation is likely to give FDA mandatory recall power and great authority for risk-based inspections, and require FDA to create a traceability program.
FDA and USDA are already pushing the boundaries of their current authority to become more aggressive on food safety and labeling enforcement. Examples include USDA moving toward classification of Salmonella as an adulterant, more aggressive rules on ground beef safety, and increased retail enforcement. FDA is already studying how traceability could work, being more aggressive in identifying products and retailers in the event of recalls, reexamining the effectiveness of current nutritional labeling requirements, and investigating whether front of pack nutrition labeling (FOP) practices need to be regulated.
And on the heels of legislative reform and increased regulatory enforcement come the lawyers. Action by the government creates new avenues for the plaintiffs’ bar. Food litigation will likely increase in prevalence both in product liability claims (i.e., food contamination) and in putative consumer fraud class claims into 2010 and beyond.
On November 13, the FDA notified nearly 30 manufacturers of caffeinated alcoholic beverages that the agency intends to look into the safety and legality of their products. As the FDA explained in a news release announcing this action, under the Federal Food, Drug, and Cosmetic Act any substance intentionally added to food, in this case caffeine in alcoholic beverages, is deemed unsafe and is unlawful unless its specific use has been approved by an FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized as Safe (GRAS). To date, the FDA has only listed caffeine as GRAS as an ingredient for use in cola-type beverages in concentrations specified by the agency.
The FDA noted in its release that it is not aware of any basis on which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS sanctioned. Consequently, in its letters to notified companies, including City Brewing, Gaamm Imports, Inc., and United Brands Company, Inc., the agency asked that within 30 days the notified companies “produce evidence of their rationale, with supporting data and information” for their conclusion that the use of caffeine in their products is GRAS or prior sanctioned. If the FDA determines that the use of caffeine in the alcoholic beverages is not GRAS or prior sanctioned, the agency stated it would take “appropriate action to ensure that the products are removed from the marketplace.”
This issue has been fermenting (pun intended) for some time. In the past year, alcoholic beverage industry leaders Anheuser-Busch and MillerCoors agreed to discontinue their popular caffeinated alcoholic beverages Tilt, Bud Extra, and Sparks, and further agreed not to produce any caffeinated alcoholic beverages in the future. In late September 2009, the FDA received letters from eighteen attorneys general and one city attorney and five scientists expressing concerns about caffeinated alcoholic beverages. Among the chief policy concerns cited by these stakeholders was the increasing popularity and consumption of caffeinated alcoholic beverages by college students, coupled with general health risks associated with excess consumption of both alcohol and caffeine.
Manufacturers of alcoholic beverages had been operating under the TTB guideline that caffeine was a permitted but restricted ingredient, and had been warned by TTB and FTC about prohibited and/or deceptive advertising practices related to the effects of combining caffeine and alcohol. If the FDA takes the strong position that caffeine is an illegal additive, these advertising concerns related to caffeine and alcohol will disappear. The TTB and FTC will likely continue to focus scrutiny on other less common alcoholic beverage additives that have been treated like caffeine, such as ginseng, guarana and taurine.
And consumers will turn back to the original Red Bull and vodka for their caffeinated alcoholic beverage.
Hurdles Faced By Plaintiffs In Class Action Lawsuit for Sale and Marketing of Cold and Flu Medications Containing Vitamin C
By Guest Blogger Tyler Anderson
On November 2, we blogged about the FDA warning letter issued to Procter and Gamble for its unlawful marketing of Vicks cold and flu medications containing Vitamin C. On November 4, 2009, a putative class action lawsuit was filed against Procter and Gamble in the U.S. District Court for the Southern District of Ohio (Sixth Circuit) alleging Procter and Gamble violated federal and state consumer protection laws through false and misleading advertising practices regarding the two Vicks products mentioned in the FDA warning letter.
Regardless of the merits of their case, the plaintiffs in this action may have a hard time obtaining their desired relief. In Count 1 of the complaint, the plaintiffs allege Proctor and Gamble violated the consumer protection laws of 43 separate states. The Seventh Circuit’s holding in its Bridgestone/Firestone decision (J. Easterbrook) and its progeny, suggests that under FRCP 23(b)(3), such a class action is unmanageable. Courts point to the impracticability of one court applying the divergent laws of differing jurisdictions in circumstances such as those at bar.
“Plausibility” pleading standards (see recent discussion of Wright v. General Mills) present additional hurdles. Applying Twombly as the court did in the Wright case, to survive a motion to dismiss the plaintiffs would need to make plausible, non-conclusory allegations that the plaintiffs purchased the Vicks products because they contained Vitamin C and the cost of the product with the Vitamin C was greater than it would have been without. No such allegations exist here, so applying the holdings of Twombly and Wright to this claim indicates that it may be subject to dismissal.
“Reliance” may be yet another avenue to dismiss the action (at least in part). Many state consumer fraud statutes require reliance. This means that the plaintiffs would be required to show that each plaintiff in the action bought the product in reliance on the purported fraudulent statement. Because purchasing decisions are individual decisions, proving reliance on a class-wide basis would be an individual inquiry that would predominate over issues of fact common to the class, which would negate class treatment.
Take-Aways from November 3 Webinar: Making Good Marketing Claims: Product Labeling Pitfalls, Third-Party Certification and "Green Washing"
Tuesday, November 3, we held our second webinar in a three-part series on bringing sustainable food products to market. Thanks again to our presenters and attendees. The recorded webcast was archived and is accessible at this link. Click here to access a PDF copy of the presentation slides.
Take-aways from the second webinar include:
• With the exception of the FDA’s policy on “natural” claims, it has been silent on “green claims.”
• “Natural” could be hottest claim on the market but is becoming controversial. Food companies should continually monitor the marketplace to see which claims are drawing challenges.
• Food companies should pay attention to consumers union findings regarding eco-label credibility.
• While third-party certification may not help every food business, certification is a tool that supports your brand and your marketing/sales strategy.
• Retail leaders in sustainability, such as Burgerville, aspire for continuity of sustainability in each link in its supply chain.
• To understand the FTC green guidelines companies need to appreciate three key points: substantiation, specificity and qualification.
• To avoid “green washing” issues, food companies need to understand the complex matrix of federal, state, local and foreign statutes, regulations and guidelines governing “green” advertising.
I hope you can join me, Steve Marinkovich from Propel Insurance, my colleague at Stoel Rives, Anne Glazer, and Peter Truitt from Truitt Bros., Inc. on November 17, at 9 am PST, noon EST, (live Twitter feed at #sustainlaw) for the last webinar in the series as we discuss the following:
• Preventing and Dealing with Consumer Fraud, Unfair Trade and False Advertising Claims from Consumers and Competitors
• Real-Life Businesses Approaches to Sustainability, Product Labeling and Marketing
• Coping with Increased Risks of Food-Borne Illness from Local or Small Farm Products
• Insurance Coverage You Need, Think You May Have but Don’t Have or Think You May Want but Shouldn’t Get
Melinda Beck has a terrific article in today's Wall Street Journal about home remedies for the H1N1 virus and (as we have previously blogged) the FDA's efforts to reign in those making unsupported marketing claims for their remedies.
One remedy sweeping the blogosphere like wildfire is the use of onions to soak up flu bugs. I did a Google search on the topic "onion flu remedy" and while a couple of articles came up debunking the idea (including Ms. Beck's), far more were articles claiming that the home remedy was in fact effective.
I turned then to Snopes.com, the great arbiter of urban legends, and it's verdict was unequivocal: false. The article did a nice job of tracing the history of onion/flu fetishism well into the nineteenth century, though I suspect one can go further, perhaps to ancient Rome and Greece.
Unlike most quack claims made for flu remedies, the onion cure at least has the advantage of being inexpensive and, particuiarly if you're using raw, unpeeled onion, completely benign.
Ms. Beck was, however, quite positive on my own family's way of dealing with any form of illness, chicken soup. Her article even includes a chicken soup recipe, which is not too far from the recipe my family has used for generations (although the key to ours is a kosher chicken). Chicken soup may not cure anything (though the title of an abstract listed at the bottom of recipe suggests it might), but it sure feels good on a sore throat.
Marketing Missive: FDA Issues Warning Letter to Procter and Gamble for Unlawfully Marketing Cold and Flu Medications Containing Vitamin C
By Guest Blogger Tyler Anderson
On October 29, 2009, the FDA issued a warning letter to Procter and Gamble notifying the company that its “Vicks DayQuil Plus Vitamin C” and “Vicks NyQuil Plus Vitamin C” are illegally marketed combinations of drug ingredients and a dietary ingredient. Both of the over-the-counter (OTC) medicines, which contain Vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA issued the warning letter (1) to clarify that these single dosage form combinations of drug ingredients and dietary ingredients cannot legally be marketed because they have not been proven safe and effective, and (2) because the agency has previously determined that there is not sufficient data to show that Vitamin C is safe and effective in preventing or treating the common cold.
Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. The FDA found the two Vicks products did not comply with the applicable FDA monograph, and therefore the products must first be evaluated and approved under the agency’s new drug approval process before they can be legally marketed.
American Conference Institute (ACI) recently held its latest conference on food-borne illness litigation. The conference has been a fairly intimate gathering of the nation’s lawyers, insurers and experts involved with food-borne illness litigation.
This year, I had the privilege of moderating an in-house counsel “think tank.” The panel was composed of lawyers from a nice cross-section of food businesses: Yum Brands, Hormel, Fresh Express and SUPERVALU (though for each, food-borne illness litigation is a rare event) A slide-deck from the panel can be found here.
Also among the presenters at this year’s conference were Center for Disease Control’s (CDC) Dr. Arthur Liang and USDA/FSIS representative Dr. Dan Engeljohn. Both presentations provided fascinating insight into changes afoot in food safety enforcement and policy at the federal level. Here are some of the take-aways:
• “Outbreaks Waiting to Be Discovered” – Dr. Liang opined that, based on surveilled illnesses, most food-borne illness outbreaks are not presently discovered. He believes that recent data shows that there are perhaps 2-3 times more outbreaks nationally than what’s been uncovered over the last few years.
• Food Safety Progress Being Undone by Retail Deli Operations – FSIS says there has been a “steady increase in risky behavior at the retail level.” According to Dr. Engeljohn, budget authority is being sought to intervene with retailers, particularly smaller supermarket deli operations.
• Negative Tested Product Can Be Considered Adulterated - FSIS will be issuing a policy soon that for the first time will consider a “negative tested product to be determined adulterated” under circumstances where an associated product tested positive for pathogens.
• Non-0157 STECs - FSIS will be finalizing methodology to detect non-0157 Shiga Toxin-Producing Escherichia coli (STEC).
Learn About Who Is Setting Sustainability Standards and How to Make Good Sustainability Claims: Register for the 11/3 Sustainable Foods Webinar
If you haven’t already, register here for the second in a three-part webinar series on environmentally friendly sustainable food products, to be held at 9 am PT, Tuesday, November 3. This installment of the series will focus on sustainability standards, third-party certification and avoidance of “green-washing.”
The webinar will feature:
- FDA regulatory lawyer Ricardo Carvajal from Hyman, Phelps & McNamara;
- Roberta Anderson from Food Alliance, the nation’s leader in setting third-party sustainability standards for food production;
- Alison Dennis from Burgerville, a traditional quick-service restaurant on the cutting edge of sustainability; and
- Advertising lawyer Jere Webb from Stoel Rives.
The webinar is interactive, and those listening live will be able to submit questions. We will strive to answer all questions either during the broadcast or off-line directly with listeners.
If you missed the first installment, you can read about the take-aways and replay the webinar on demand here. The slide deck can be downloaded here.
By Guest Blogger Troy Hutchinson
In response to recent consumer complaints and state attorney general investigations that the use of the Smart Choices label is misleading and deceptive, food companies now face the threat of consumer class action litigation under state fraud and deceptive practices statutes.
Adding to the uproar, the Food and Drug Administration (FDA) announced that it will consider using its regulatory tools if front of pack nutrition labeling is not used in a common, credible way, it said in a letter to industry on October 20, 2009.
In a conference call with journalists, Margaret Hamburg of the FDA said that the FDA wants to work with industry, but that over time it “will take enforcement action for egregious examples.” Hamburg did not pinpoint specific products, but mentioned claims of “zero trans fats” on the front of packaging for products that have high levels of saturated fat, and said: “There are products that have got the Smart Choices check mark that are almost 50 percent sugar.”
At least one member of Congress has also weighed in on the issue. U.S. Rep. Rosa DeLauro announced that she is “very encouraged by FDA’s commitment to proceed with enforcement actions” against unauthorized claims. She went on to state that “[c]learly something is wrong when foods such as Froot Loops cereal, Cookie Crisp cereal, and Uncle Ben’s Instant Rice are designated as ‘healthy’ by these labeling systems.”
Responding to the FDA’s letter, president of the Grocery Manufacturers Association Pamela Bailey said in a statement that the organization is looking forward to working with the FDA “to determine what nutrition information is most useful in providing consumers with the tools they need to help them build a healthful diet.”
While companies who are using the Smart Choices program to promote legitimately healthy options should encourage FDA enforcement, that enforcement brings with it the risk of class action litigation. Whenever there are attorney general investigations or other regulatory enforcement action taken, class action litigation often follows. Food companies using the Smart Choices labeling should be strategizing on how best to defend these actions. Some private litigation may be preempted if the FDA has used its rule making authority. Where companies are legitimately using the Smart Choices label to promote healthier food options, those companies should encourage the FDA to use its rule making function to give clear rules on how companies can use the Smart Choices label.
Products Liability Law360 ran a piece this week entitled “Suits Over Deceptive Food Marketing Likely To Increase” (unfortunately, this is a subscription-only site) authored by Liz McKenzie. The article discusses rightly how increased FDA enforcement action may lead plaintiffs attorneys to file “piggy-back” putative class actions. For example, it took just 13 days following the FDA’s warning letter to General Mills concerning Cheerios for the first putative class suit to be filed.
Compounding increased FDA enforcement, recent rulings from the Supreme Court and the Third Circuit, like the Snapple Decision, have made it more difficult to assert a preemption defense in food cases in the absence of formal FDA rulemaking.
But, what one hand giveth the other taketh away. The hope for food companies is that that the Supreme Court’s recent decisions in Twombly and Iqbal will negate the preemption decisions and effectively heighten the bar for consumer fraud claims related to product marketing. Dismissal for failure to meet the new “plausibility” pleading standard and not preemption is exactly how the District Court ruled in Wright v. General Mills. Wright involved a putative class complaint involving Nature’s Valley products sold as “100% Natural” “even though the products contained one or more non-natural or artificial ingredients such as high-fructose corn syrup (’HFCS’).”
In Wright, the court found defective, under the Iqbal/Twombly “plausibility” standard, the plaintiffs’ injury-in-fact allegation. The Wright court ruled that the injury-in-fact allegation “conclusory,” “sparse” and “defective.” The plaintiff alleged only that “Defendant caused Plaintiff and other members of the Class to purchase, purchase more of, or pay more for, these Nature Valley products.”
Following the Supreme Court's new standard of notice pleading and its application in the Wright case, query how any putative consumer fraud class complaint can survive a Rule 12 motion without having first completed market surveys or gathering of other evidence of consumer injury.
Ken has previously blogged about liability issues relating to H1N1 flu, also known as swine flu. Today, the FDA has issued a widget to allow employers, consumers and others to browse and search fraudulent H1N1 influenza products and report suspected fraud. The widget can be copied onto any other Web site or blog. The FDA had previously issued a similar widget for the peanut butter recall. Additional information can be obtained from the FDA's swine flu page or flu.gov.
This is the widget:
Environmentally Sustainable Foods: Dispelling Fear and Understanding That Sustainability Must Be Good for Business
Stoel Rives is proud to sponsor an upcoming webinar series on legal and business aspects of bringing sustainable food products to market. Industry representatives will talk among other things about what sustainable food products are, help dispel the fears of traditional food companies, discuss strategies for minimizing business and litigation risks, and underscore the importance of sustainable foods as a profit-making enterprise.
The first session, October 20, will discuss what an environmentally sustainable food product is, how a company may need to rethink research and development and supply chain issues, and financing. Participants include Steve Rowe, Sr. V.P. and General Counsel from Darigold, Inc. and its parent Northwest Dairy Association, food supply chain consultant Monica Gelinas from Karp Resources, and business lawyers Joel Dahlgren and Duff Bryant from Stoel Rives.
The second session, November 3, will look at what the FDA and USDA may do to define sustainability, third-party certification issues and green washing. Participants include Alison Dennis, Director of Supply Chain from Burgerville, Roberta Anderson from third party certifier Food Alliance, FDA lawyer Ricardo Carvajal from Hyman Phelps and trademark lawyer Jere Webb from Stoel Rives.
The third session, November 17, will look at increased risks presented by sustainable food products and strategies to mitigate those risks. This panel will include Peter Truitt, CEO of Truitt Brothers; Steve Marinovich, insurance broker at Propel Insurance; advertising lawyer Anne Glazer from Stoel Rives and me.
Each session will be 60 minutes and feature an interactive, "rapid fire" roundtable format. The panels will also respond in real time to questions submitted by listeners. Registration is free. Contact me if you would like further information.
FDA has a short video "anatomy of a recall" about the investigation of the Salmonella outbreak and recalls associated with Peanut Corporation of America (PCA). Anyone interested in learning how the federal government (with the help of Minnesota's "Team Diarrhea") goes about a food borne illness investigation and recall should take a look.
Thought to be the first putative class action against a restaurant chain related to disclosure of sodium content on menus, Center for Science in the Public Interest (CSPI) has filed what appears to be a test case against Denny’s. Best guess is the case will fail on its merits (though for CSPI, success in litigation may not be the point).
The case, DeBenedetto v. Denny’s Corporation, asserts claims under New Jersey law for consumer fraud, N.J.S.A. 56:8-1, et seq., and breach of the implied warranty of merchantability under the New Jersey U.C.C., N.J.S.A. 12A:2-314(1)-(2). The theory advanced in CSPI’s complaint is that consumers have been “duped” about sodium content and that the “ordinary consumer, unschooled in nutrition and perhaps preoccupied with other matters, would not reasonably expect to encounter these high levels of sodium in one meal.”
Big incongruency in the complaint is that Denny’s does disclose sodium content in its meals. CSPI admits that Denny’s provides this information both online and in store pamphlets, but it complains that the information is “incomprehensible.” A review of Denny’s online disclosures shows a detailed nutritional chart, including sodium levels for every item on its menu. Here's an excerpt of Denny's online disclosures:
But, CSPI's complaint does not really seem to be that disclosures are not clear enough. Indeed, CSPI argues that regardless of such disclosures by restaurants, studies show that “almost no one reads the nutrition information . . . .”
What CSPI is really saying is that sellers of salty foods (not unlike foods contaminated with E. coli) are strictly liable no matter the disclosures. If this were the law (which as of now, it is not), few restaurants (or food manufacturers) would be exempt from paying the medical bills of their customers who develop heart disease. No doubt CSPI's real goal is "regulation through litigation" and the jury is still out whether CSPI's penchant for the court system will affect change.
The Third Circuit ruled this week in Holk v. Snapple Beverage Corp., reversing the district court and reinstating the state law putative class claims for consumer fraud and breach of warranty for use of the term “all natural” despite the inclusion of high fructose corn syrup (HFCS) (though the court noted that the manufacturer no longer uses HFCS in its products).
The case is significant and is getting attention because the Third Circuit concluded that “FDA’s policy statement regarding the term ‘natural’ is not entitled to preemptive effect.” The court was persuaded because “the FDA declined to adopt a formal definition of the term ‘natural’ choosing instead to simply enforce its long standing ‘informal policy’”:
[T]he agency has considered “natural” to mean that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. For example, the addition of beet juice to lemonade to make it pink would preclude the product being called “natural.”
As expected, the court followed its previous ruling in Fellner v. Tri-Union Seafood, LLC (our blog entry about it is here), ruling that neither the FDA’s “informal policy” nor their enforcement letters were entitled to any preemptive weight.
Practice Tip: For the next HFCS case, preemption may not be a dead issue. The Third Circuit did not rule (though it expressed its skepticism) on the “express preemption” argument based on 21 U.S.C. § 343-1(a)(3). The court ducked the issue by concluding that Snapple waived the argument by not “advancing it” in the district court.
On July 31, the FDA issued draft guidance on three categories of produce: tomatoes, leafy greens and melons. Comments on the drafts are due, according to Hyman, Phelps & McNamara P.C.'s FDA Law Blog, by November 3 at www.regulations.gov using docket numbers FDA-2009-D-0346 (tomatoes), FDA-2009-D-0347 (melons), or FDA-2009-0348 (leafy greens). They may also be submitted directly to the FDA at Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, using the same docket numbers to identify comments.
The purpose of the guidance is to provide advice on the FDA's current thinking of the best practices to minimize contamination, comply with legal requirements and identify and stop outbreaks as soon as possible. The guidance is intended to cover all stages of food production and handling up to the final retail sale of either raw or prepared foods.
The tomato guidance is particularly detailed. It covers everything from selecting the field to grow, including assessing the uses of nearby land, to detailed hygienic recommendations for those with access to the fields, to harvesting practices, including documentation to facilitate product tracing, to packing and repacking, storage and transportation, and preparation by food service providers. A special section covers greenhouse production.
The guidance is based on practices developed by the produce industry with the assistance of the FDA, but does not necessarily agree with the practices used in the industry. Consider this discussion of "top icing" of melons. The FDA notes, "Melons are typically top iced after cooling as a means of temperature control during transport and distribution." The first recommendation, though, is to ditch the practice entirely.
- Employing alternative means of keeping melons cool because top icing is not particularly effective in cooling or keeping melons cold.
It will be interesting to see the comments and how the FDA responds to them as the process continues.
False advertising claims under the Lanham Act and corresponding state law claims for food companies can be tough going. Many intersect issues regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA). No private right of enforcement of the FDA regulations exists. Only the FDA is allowed to bring a legal action to enforce its regulations. Lanham Act claims are generally barred where private litigants ask the court to determine preemptively how the FDA will interpret its own regulations.
Now comes the recent decision in POM Wonderful LLC v. Ocean Spray Cranberries, Inc. POM is aggrieved because Ocean Spray markets pomegranate and cranberry blended juices though, according to POM, the juices are “almost entirely comprised of apple and grape juice.” POM is alleging Lanham Act false advertising claims and California state law false advertising and unfair competition claims.
The court denied a Rule 12(b)(6) motion to dismiss. Threading the needle, the Court found that the claims were not seeking FFDCA enforcement. According the Court, POM’s claims are not for “mislabeling,” but for false advertising and promotion. The court determined it would not have to interpret FDA regulations and that “POM’s Lanham Act claim ‘extend beyond the packaging and name . . . to its advertising and marketing including . . . website.” Applying similar logic, the court found that the FFDCA did not preempt POM’s state law claims.
Lesson from the POM court: Whether one food company can bring false advertising claims against another depends in part on whether a court believes that the claims are focused on non-FFDCA-regulated issues such as advertising, websites, social media or other marketing efforts.
U.S. House of Representatives approved HR 2749 moments ago. This action followed some confusion yesterday where it was brought to the floor needing a 2/3 vote and failed. Here’s a link to a report by the Rules Committee including the language of the bill as approved today by the House. Changes to the bill from what was proposed by the Energy and Commerce Committee include amendments aimed at concerns by smaller farmers of the $500 “facility registration fee,” performance standards and record keeping.
The legislation has been the subject of heavy debate inside and outside the beltway. Here’s a link to the Editorial in the New York Times in support of the bill. The Grocery Manufacturer’s Association (GMA) also has expressed support in a June press release for the bill as marked-up by the Energy and Commerce Committee. From some opposed to the bill, here’s a link with an impassioned argument from yesterday.
Note that the registration requirements in the bill as currently written “does not include farms; private residences of individuals, restaurants, other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer.”
The bill further exempts from registration farms that sell food primarily at farmers markets. Also exempts farms that “manufacturer grains or other feed stuffs” grown on those farms and distributed to other farms for “consumption as food by humans or animals on such farm.”
Also note that traceability provisions remain. Section 107(c)(2) recognizes that work remains on the regulatory level for FDA to collect information, and develop technology and systems, and establish pilot programs before traceability becomes a reality.
For lawyers and insurance adjustors, compartmentalizing food-borne illness claims is easy. They often see their jobs solely as minimizing the tort liability and legal fees. In my experience, attorneys and adjustors often fail to appreciate how outbreaks can affect a client’s (or even a whole industry’s) business going forward. Often, the long-term business losses of a food-borne illness outbreak, recall, or government alert are not insured.
There is no better example of how a nationally reported food-borne illness outbreak can affect an entire industry (or even an entire category of food products) than the 2006 E. coli spinach outbreak. Two new studies published by the Agriculture & Applied Economics Association (AAEA) in its Choices magazine analyze consumer information and studies in the wake of the spinach outbreak.
Among the highlights from the first study, “Public Response to Large-Scale Produce Contamination” by Carra Cuite and William K. Hallman, were findings that Americans were more aware of advisories beginning than ending. For example, 87% of spinach consumers knew about the outbreak, but more than six weeks after the FDA had lifted its spinach warnings “almost half (45%) of people who were aware of the spinach recall were not confident that the recall had ended.”
A second study entitled “E. coli Outbreaks Affect Demand for Salad Vegetables” was authored by Faysal Fahs, Ron C. Mittelhammer, and Jill J. McCluskey. It examines the cumulative effects that sequential outbreaks can have on consumer demand and concludes that “the empirical results suggest that the subsequent outbreaks had a greater impact on the consumption of salad vegetables than the first.”
For food companies the lesson is this:
A lawyer’s role in responding to a food product crisis is important. But the roles of others, such as public relations experts, may be as important or more important in preserving the business. Make sure your lawyer (and your insurer) understands that the world may not revolve around simply resolving the tort claims as economically as possible.
As I predicted last week, more and more companies are discovering that they had incorporated products from Plainview Milk Products Cooperative into what they sold. The full FDA database, which is constantly being updated, is here.
While there have now been recalls of products as widely different as frosting and diet mixes, I was most struck by Godiva's recall. As others have noted, as of the time of this post this doesn't appear anywhere in the Godiva website, either.
Godiva's recall related to a special collection that was available only for Valentine's Day and Mother's Day. The "consume by" date for the Valentine's Day candy has passed and the "consume by" date for the Mother's Day collection has nearly passed. Exactly one candy in the box, a praline crunch, included product from Plainview. No one has complained of any symptoms from eating this candy. So, if you, your mom, your grandma, your spouse or your sweetheart (a) got this box for Valentine's Day or Mother's Day, (b) haven't finished it yet, even though it has a short "consume by" window that has more likely passed; and (c) didn't eat that praline crunch, then you are supposed to discard the product and call 1-800-9GODIVA for a refund.
The Godiva recall is being taken as a superabundance of caution, given the unlikelihood anyone meets all those criteria. However, it does indicate that not all Plainview products were shelf-stable. This may go on for awhile.
One of Monty Python's most imitated sketches was "The Four Yorkshiremen." Even if you've never seen it, it will be instantly recognizable to you. It's the one where four men sit around talking about how tough they had it as kids, compared to how kids have it today. One starts by complaining about how small his house was, and another exclaims, "You had a house?" Eventually, the last one claims to have been roused from bed half an hour before he went to bed, worked 27 hours a day and paid for the privilege and then was murdered every night when he got home.
I was thinking about this sketch as I was contemplating how different from the last food recall about which I blogged, involving tuna in New England, was from the painfully slow recalls involving the salmonella finding that has led Plainview Milk Products Cooperative to recall the last two years of its products. As you might recall, the last recall involved fresh tuna steaks sold to three New England supermarket chains over four days before the problems were identified. By this time, most of the food subject to the recall had probably been consumed and the recall required only publicity in a limited area for those who might have frozen the steaks rather than eaten them fresh. Without denying the difficulties that North Coast Sea-Foods might have encountered in that recall, or the suffering of anyone who got scombroid poisoning, as a recall goes, they, in the words of Monty Python, had it easy.
The Plainview Milk Products Cooperative and everyone who bought from them, on the other hand, have it anything but easy, and the fact that almost every day new products are added to the recalled list demonstrates this.
It all started with a package of powdered milk shake mix. A USDA test showed there was salmonella in the powder. Plainview was the supplier of a main ingredient in the powder. Although tests of its products have uncovered no salmonella, there was salmonella found on some equipment in Plainview's plant. This triggered the recall. No persons have been found who have been made ill by any of Plainview's products.
Plainview does not sell products to consumers. However, as the recall has unfolded, the number and scope of products that are sold to consumers that incorporate Plainview's products has been shown to be huge. Included are:
- Instant non-fat dry milk
- Instant oatmeal
- Instant gravy
- Instant cocoa
- Sports drinks
- Instant milk shakes
Because the products are the kind that are shelf-stable, and the recall covers two full years, even after all the recalled foods have been identified, getting consumers to search pantries for them will be difficult. Indeed, a lot of these products were incorporated into emergency kits, the kinds of things you don't open until needed.
Another place where the powder can be found is in Meals-Ready-to-Eat, the famed MREs of the miltary. In other words, U.S. soldiers in Iraq and Afghanistan are having to toss out their vanilla, chocolate, strawberry and stawberry-banana milkshakes, according to Stars and Stripes. MREs are also used by FEMA and by campers.
As Ken noted recently, the two highest priorities on the Obama Administration's list for the FDA are Salmonella and a national traceback and response system. What the Plainview situation indicates is that, to be effective, the tracing system may need to go in both directions. It didn't take the FDA long to find that Plainview's products were incorporated into the milk shake mix, but it is taking a very long time to find all the products into which the same set of ingredients--including nonfat dry milk, fruit stabilizers, whey protein, and gum products--have also been incorporated.
The implications of such a system, however, are huge. Here are just a few:
- There is an identity between food safety information and confidential commercial information in terms of the relations between suppliers, manufacturers, distributors and retailers. How will this be kept confidential? Who will be trusted to keep it confidential?
- Who pays for the system, and who controls its expenses?
- What is the end point on the origination side? Does every farmer have to keep track of all the inputs into its produce?
- Manufacturers may use many sources of fungible goods; will they be required to trace these? Who pays the capital cost of changing from one big hopper to four small ones?
Finally, I would be remiss without mentioning the point made by Kimberly Lord Stewart, editorial director of Functional Ingredients Newsletter. As Ms. Stewart points out, there is no proof that the salmonella found in the milkshake powder came from the Plainview ingredients, and there are nine other ingredients in the powder made by others.
As Ms. Stewart says,
The Plainview situation has hints of the salsa recall, which initially implicated tomato growers, then salsa makers, only to find out the source of contamination was jalapeños. Traceability is a complicated and looming issue for processed foods. Looking for a needle in a haystack is easy compared to tracking down 9 lesser ingredients in DairyShake blends or multiple ingredients in salsa.
Or, as the late Graham Chapman would say, "Luxury."
The Third Circuit may be close to opening the floodgates of claims against food and beverage manufacturers who use high-fructose corn syrup (“HFCS”) in products labeled “all natural.” Shannon Duffy at the Legal Intelligencer reported recently on a “lively hour-long” oral argument in the Third Circuit about reversing a District Court’s dismissal of state consumer claims against Snapple for use of HFSC.
The District Court dismissed the consumer claims in 2007 on the basis of field preemption. The dismissal predated the Third Circuit’s decision in Fellner v. Tri-Union Seafood, LLC. See our previous blog on the Fellner case. Despite the FDA’s position in Fellner that a state law failure-to-warn claim is preempted by federal law, the Third Circuit ruled to the contrary.
In Fellner, a claim by a person who suffered from mercury poisoning after eating canned tuna literally for breakfast, lunch and dinner for five years may have been an outlier. But reversal of the District Court’s decision in the Snapple case will open the floodgates to consumer class action claims against a whole slew of food sellers and manufacturers.
The FDA announced a recall of fresh tuna steaks distributed to Shaw's, Star Market and Big Y grocery stores by North Coast Sea-Foods Corp. of Boston and New Bedford. The alleged problem was increased levels of histamine that might cause scombroid poisoning. The tuna was removed from sale on June 24, but consumers who might have frozen the steaks were told to return them to the stores for a full refund. We again assume that North Coast (and its insurers) will be funding the refunds.
What made me write about this recall was a rather silly poll in DailyKos. The question was whether the increase in recalls was due to the food supply becoming less safe or that the FDA was getting better. Like many online polls, this so oversimplified the situation that I thought I should write about it, and the North Coast tuna recall seemed as good a vehicle as any.
The three reported cases of scombroid poisoning associated with this tuna would presumably have been reported to local public health officials in New England, not the FDA. Or they might have been reported to the markets, which in turn would have easily been able to identify the source of the tuna and reported to North Coast (scombroid poisoning occurs almost immediately, so there isn't the usual problem of figuring out what food might have caused a delayed reaction). Both the markets and North Coast will have significant food safety programs. Some of this will be the result of government action, and some of it the result of simply caring about their customers. There is no indication that this outbreak was the result of anyone's inattention or failure.
It took me awhile to identify that I had the right North Coast Sea-Foods Corp., because their name is spelled differently in the release. In doing my research, I discovered some nice things about them, such as that they had argued strenuously against a Department of Defense initiative to buy cheaper, and potentially more hazardous fish for our troops, on the grounds of food safety. Another thing I learned was that they had installed solar power at their Boston facility, and considered wind power at their New Bedford facility. We at Stoel are not just committed to renewable energy, we literally wrote the book on it. So, similar to the Fat Duck and Nestle, even those committed to doing the right thing can sometimes be the subject of a food recall.
We wrote recently about the food safety legislation coming out of Henry Waxman’s House Committee on Energy and Commerce. That legislation, H.R. 2749, has passed out of committee and been reported to the full House for a vote. When the vote will occur is anybody’s guess. Reuters quotes Chairman Waxman as saying, “I am hopeful that before too long, we can have a comprehensive food safety bill on President Obama’s desk.”
Nestlé is voluntarily recalling all its refrigerated and frozen chocolate chip cookie dough. The FDA and CDC warn of the risk of contamination with E. coli O157:H7. In its release, Nestle says the following:
The CDC has a podcast telling kids the same thing: don't eat raw cookie dough.
We have complimented Nestle for its food safety program in the past. As their release says, "The safety and quality of its products is a non-negotiable priority for Nestlé, and the company apologizes for any inconvenience cause by this voluntary recall. "
But there is good news: the recall doesn't affect any chocolate chips, or any baked cookies.
Last week, members of the U.S. House of Representatives Committee on Energy and Commerce released a discussion draft of the “Food Safety Enhancement Act of 2009.”
The draft proposes beefing up the FDA registry of “all food facilities serving American consumers” and charging every facility $1,000 per year to fund FDA food safety activities. The new legislation would expand the types of facilities that need to register by eliminating certain exemptions from the 2002 Bioterrorism Act, though for now it appears to maintain exemptions for retailers, restaurants, farmers and nonprofits.
The proposal’s most ambitious and controversial proposal may be traceability.
The draft legislation proposes to require FDA to “by regulation establish a tracing system for food that is located in the United States or is for import into the United States.” The legislation gives the FDA few specifics other than to “maintain the full pedigree of the origin and previous distribution history of food,” “link that history with subsequent history,” “establish and maintain a system for tracing food that is interoperable with the systems established and maintained by other such persons” and “use a unique identifier for each facility.” No doubt the devil will be in the details.
Verbatim, here is the Summary of Discussion Draft of The Food Safety Enhancement Act of 2009:
1. Creates an up-to-date registry of all food facilities serving American consumers: Requires all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.
2. Generates resources to support FDA oversight of food safety: Requires registered facilities to pay an annual registration fee of $1,000 in order to generate revenue for food safety activities at the FDA; requires registered facilities to pay for FDA’s costs associated with reinspections and food recalls; allows FDA to charge a fee to domestic firms requesting export certificates for exported food.
3. Prevents food safety problems before they occur: Requires all facilities operating within the U.S. or importing food to the U.S. to implement safety plans that identify and protect against food hazards. FDA would have the authority to specify minimum food safety plan requirements and to audit food safety plans.
4. Requires safety plans for fresh produce: Directs FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.
5. Increases inspections of food facilities: Sets a minimum inspection frequency for all registered facilities. High-risk facilities would be inspected at least once every six to 18 months; low risk facilities would be inspected at least once every 18 months to three years; and warehouses that store food would be inspected at least once every three to four years. Refusing, impeding, or delaying an inspection is prohibited.
6. Improves traceability of food: Enhances FDA’s ability to trace the origin of tainted food in the event of an outbreak of foodborne illness. FDA would be required to issue regulations that require food producers, manufacturers, processors, transporters, or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food; and to establish an interoperable record to ensure fast and efficient traceback (current law permits facilities to hold a record in any format — paper or electronic — making efficient tracing of foods difficult for FDA). Prior to issuing such regulations, FDA would be required to conduct a feasibility study, public meetings, and a pilot project.
7. Enhances the safety of imported food: As an additional layer of protection, FDA can require food to be certified as meeting all U.S. food safety requirements by the government of the country from which the article originated or by certain qualified third parties. Third party certifying entities must meet strict requirements to protect against conflicts of interest with the firm seeking certification.
8. Expands laboratory testing capacity: Requires FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Gives FDA the ability to require laboratories to send test results to FDA.
9. Provides strong, flexible enforcement tools: Provides FDA new authority to issue mandatory recalls of tainted foods. Strengthens criminal penalties and establishes civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.
10. Creates fast-track import process for food meeting security standards: Permits FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.
11. Enhances the safety of infant formula: Enhances FDA’s ability to assure the safety of new infant formulas before they go on the market.
12. Advances the science of food safety: Directs the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the food supply.
13. Enhances FDA’s ability to block unsafe food from entering the food supply: Strengthens FDA’s authority to administratively detain unsafe food products. Grants FDA “quarantine” authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.
14. Directs FDA to assess the use of carbon monoxide in certain foods: Requires FDA to conduct a safety review of the use of carbon monoxide in meat, poultry, and seafood products.
15. Enhances transparency of GRAS program: Requires posting on FDA’s website of documentation submitted to FDA in support of a “generally recognized as safe” (GRAS) notification.
16. Requires country-of-origin labeling and disclosure: Requires all processed food labels to indicate the country in which final processing occurred. Requires food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for all produce.
1. Creates an up-to-date registry of importers: Requires all importers of drugs, devices, and foods to register with the FDA annually and to pay a registration fee.
2. Requires unique identification numbers for facilities and importers: To enhance information about FDA-regulated entities, creates unique identification numbers for all drug, device, and food facilities and importers.
3. Creates a dedicated foreign inspectorate: Requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.
4. Grants FDA new authority to subpoena records related to possible violations.
5. Provides protection for whistleblowers that bring attention to important safety information: Prohibits entities regulated by the FDA from discriminating against an employee in retaliation for assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.
This week the Obama administration announced the launch of a new website for the recently formed food safety working group. Obama announced the formation of this group in March in the wake of the high-profile food safety issues surrounding PCA peanut products.
This website will assist in tracking the efforts of the working group. As discussed previously on this blog, this group is expected to make recommendations aimed at detection, awareness and government reorganization. Possible examples include increasing funding to states to monitor food-borne illness, combining FDA and USDA food safety efforts, reexamining mandatory recall authority, increasing retail enforcement and implementing more aggressive consumer warnings.
What is not clear is whether the working group will look beyond just detection, awareness and reorganization to bolder initiatives that may result in less consumer illness and less legal exposure for food sellers. Bolder initiatives could include funding for irradiation, consumer food safety education, and fast-track development and implementation of technology that can sample food products for whole colonies of microorganisms.
The Senate Health, Education, Labor and Pensions Committee had moved up her confirmation hearings because of the imminent threat of H1N1 influenza, and she sailed through both the heaings and action on the Senate floor with bipartisan accolades.
There are few things that would be better for the country than for those bipartisan accolades to continue to be earned by her during her entire tenure in this incredibly challenging job. We wish her luck.
The U.S. Food and Drug Administration is taking issue with claims that Cheerios cereal can lower cholesterol.
In a letter to General Mills, the FDA says that statements made on Cheerios packaging like the claim that the cereal is “clinically proven to help lower cholesterol” make the product a drug under federal law. The agency suggests that General Mills should file a new drug application with the FDA if it wants to keep making these claims on Cheerios boxes. The FDA also noted concerns with statements made on a General Mills-sponsored website regarding the benefits of eating whole grains.
The Wall Street Journal is reporting that a General Mills spokesperson said the company will work with the FDA to reach a resolution regarding Cheerios labeling.
When the peanut butter recall hit, the American Peanut Butter Council issued a list of the items that were not affected by the recall, which was isolated to the products of now-defunct Peanut Corporation of America.
The similar, though less-publicized, pistachio recall has also been isolated to pistachios from a single company, Setton Farms. And the Western Pistachio Association has developed a website, pistachiorecall.org, dedicated to listing products unaffected by the recall. According to the FAQ on the site, the products listed on the unaffected products list are those that producers and distributors indicated on a signed affidavit did not include pistachios from Setton Farms.
Setton Farms International Inc. and Setton Pistachio of Terra Bella, Inc. did finally put the news of the recall on their website, along with messages to their wholesale customers. The differences between the pistachio and peanut outbreaks come down to two things, which bode well for Setton Farms' future. First, there have not only been no reported deaths from pistachios, there have been no cases of salmonellosis. Second, an inspection of Setton Farms' other plant, in Commack, New York, by New York State authorities, indicated no presence of salmonella.
Finally, the FDA has a pistachio widget, too.
The Food and Drug Administration is seeking to increase its budget for Fiscal Year 2010 by nearly 20 percent more than FY 2009 – to $3.2 billion. The Washington Post reports that the increase is the largest in the agency’s history.
The FDA’s spending request includes $259.3 million to be devoted to the “Protecting America’s Food Supply” initiative. The agency plans to, among other things, strengthen the safety and security of the food supply chain, increase food inspections, and reinspect food facilities that fail to meet FDA’s safety standards. The Associated Press reports that the FDA’s proposed budget would put 222 more food inspectors in the field, for a total of 1,022. A summary of the FDA’s FY 2010 budget is available here.
When the news of salmonella in something as American as peanut butter needs to get out, spreading the word is fairly routine. What happens when salmonella rissen is found in white pepper distributed mainly to Chinese and other Asian restaurants on the west coast?
Union Internatonal Food Company of Union City, California has voluntarily recalled dry spices after 42 cases of salmonella rissen have been reported in California, Oregon, Washington and Nevada. White and black pepper are particularly suspect. The company's products were marketed almost entirely to restaurants in those states and Arizona.
But it is likely that many of the people most likely to using the products do not have English as their first language. Accordingly, the FDA and Union International itself issued some of their material in Chinese, including this complete notice.
Dr. Margaret Hamburg, President Barack Obama’s nominee to oversee the Food and Drug Administration, is appearing before a U.S. Senate committee this afternoon regarding her nomination. The confirmation hearing before the Senate Health, Education, Labor and Pensions Committee began at 2:00 p.m. ET. Streaming video is available here.
The Associated Press is reporting that, if confirmed, one of Hamburg’s first tasks will be overseeing development of a vaccine for the H1N1 influenza virus. In Hamburg’s opening remarks to the Senate committee that were made available to reporters earlier today, she also noted that food safety will be among her top priorities. “Important steps must be taken to better protect the nation’s food supply from farm to form,” Hamburg said.
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are recommending against eating raw alfalfa sprouts because of potential salmonella contamination.
According to the FDA, the salmonella contamination appears to be in seeds for alfalfa sprouts. As of yesterday, 31 cases of illness with Salmonella Saintpaul have been reported to the CDC. The reported cases are in Michigan, Minnesota, Pennsylvania, South Dakota, Utah, and West Virginia. The FDA cautions that the number of infected people may rise because some illnesses have not yet been confirmed with laboratory testing.
The FDA believes this outbreak may be linked to an outbreak from earlier this year. Its initial investigation traces the contaminated raw alfalfa sprouts to multiple sprout growers in multiple states. Additional details are available here.
An update to a case we’ve been following: the U.S. Supreme Court has refused to review a decision by the U.S. Court of Appeals for the Third Circuit involving state-law claims over methylmercury content in canned tuna.
The Supreme Court’s order in Tri-Union Seafoods, LLC v. Fellner leaves in place the Third Circuit’s ruling that allowed the plaintiff to sue the maker of Chicken of the Sea products over methylmercury poisoning she allegedly suffered after consuming canned tuna almost exclusively for five years.
In its petition for a writ of certiorari, Tri-Union Seafoods argued that the Supreme Court should review the case to determine, among other things, whether regulatory actions by the U.S. Food and Drug Administration and the Federal Food, Drug, and Cosmetics Act preempt state-law claims based on a failure to warn of the risks of methylmercury in tuna products. The Supreme Court declined to review the case without comment.
The report links the illnesses to Vibrio parahaemolyticus, which in turn got into the rojak by having raw cuttlefish on an upper shelf of a refrigerator, which dripped into the gravy on the lower shelf of the refrigerator. Needless to say, this is a poor food handling practice. The stall remains closed and prosecution is likely.
The question that has not been answered is why the deaths occurred. According to the FDA, cases linked to vibrio are usually "mild or moderate" and only in rare cases even require hospitalization. Here, there were not only significant numbers of hospitalizations, but two deaths and an apparent miscarriage. The Singapore officials await the coroner's report on the deaths to find out why Ordinarily, vibrio causes death (about 7 a year in the US) only when there are other medical conditions present.
The Food and Drug Administration has announced an effort to explore the intentional adulteration of products to increase a producer’s bottom line. So-called “economically motivated adulteration,” or EMA, is the topic of an FDA-sponsored public meeting to be held on May 1 in College Park, Maryland.
The meeting follows last year’s concerns about products tainted with melamine and other incidents of concern to public health. For purposes of the meeting, the FDA proposes to define EMA as “the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.” The FDA hopes to raise awareness about EMA and receive input regarding how industry and regulators can predict, prevent, and address EMA.
Full details regarding the meeting can be found in the Federal Register.
As pistachio recalls continue to be announced in the wake of salmonella-tainted pistachios from Setton Farms, two California lawmakers this week announced legislation that is expected to strengthen food-safety standards in that state.
The bill to be introduced in the California State Assembly by Assembly Speaker Karen Bass and Assemblyman Mike Feuer is expected to require detailed safety plans from food processors, periodic testing of food at California food processing facilities, and requirements for food processors to report to state authorities any positive tests for a dangerous contaminant within 24 hours.
A video of Assemblyman Mike Feuer’s announcement is available below. Meanwhile, the FDA continues to update its list of recalled products.
The FDA and the California Department of Public Health announced on March 30 the recall of pistachios from Setton Farms, which have been linked to a discovery of salmonella originally identified by Kraft Foods in Back to Nature Trail Mix. The FDA has a list of recalled products, but that may grow.
Obviously, we have been through this drill before. It is interesting to note the reactions of different involved parties.
Kraft notes it as a "Consumer Alert" in the upper right hand corner of their home page. It's not particularly prominent, but it is visible.
Setton Farms, at least as of the time this post was entered, did not note the recall on its home page at all.
Given that information about a nationwide recall of their pistachio products is available on Fox Business, the New York Times, Huffington Post and pretty much any other news outlet, you would think that Setton Farms would have had someone update their website and put this in big red letters.
The Obama administration placed food safety front and center over the weekend. In his weekly radio address, President Obama on Saturday announced new leadership at the Food and Drug Administration and the creation of a panel to toughen food safety laws.
Characterizing outdated food safety laws and the lack of resources at the FDA as “a hazard to public health,” Mr. Obama announced the appointment of Dr. Margaret Hamburg, a former New York City health commissioner, as FDA commissioner, and Baltimore Health Commissioner Dr. Joshua Sharfstein as the FDA principal deputy commissioner. The president also unveiled the Food Safety Working Group – a group that will consist of cabinet secretaries and senior officials to advise the president on how to update and enforce food safety laws.
President Obama also announced two additional food-safety steps on Saturday: closing a loophole in federal regulation that allows some diseased cows to be slaughtered for food, and a billion-dollar investment to modernize labs and increase the number of food inspectors.
Read a transcript of the president’s weekly radio address, download the .mp3 audio, or view the video below.
In the wake of the latest Salmonella recall, Congress is holding well-publicized food safety hearings, and food safety may be rising on the priority list of the Obama administration. One question that arises is whether the perceived crisis in food safety will lead lawmakers and the public to revisit the option of food irradiation. The New York Times recently ran a nice piece on the topic. The article begins:
Before the recent revelation that peanut butter could kill people, even before the spinach scare of three summers ago, the nation’s food industry made a proposal. It asked the government for permission to destroy germs in many processed foods by zapping them with radiation.
That was about nine years ago, in the twilight of the Clinton administration. The government has taken limited action since.
The article quotes Suresh Pillai, director of the National Center for Electron Beam Research at Texas A&M University, as saying “It’s unnecessary for people to be getting sick today with pathogens in spinach or pathogens in peanut butter.” He describes the potential for irradiation of food as “humongous” and says that “[w]e have the technologies to prevent this kind of illness.”
As discussed previously on this blog, irradiation has wide support in the food industry and even has the support of plaintiffs’ lawyers such as Bill Marler, who has written a lengthy three-part series on the topic.
The question may not be whether irradiation is another tool that can prevent food-borne illness, but rather why is irradiation not being used on a wide-scale. Mr. Pillai likened fears of irradiation to “early phobias about the pasteurization of milk.” Aside from lengthy delays in FDA approval, consumer fear may be the problem. The only solutions may lie in (1) a joint effort between industry and lawmakers to educate the public on the benefits and safety of food irradiation, and (2) action by Congress and the FDA to help provide industry with the resources and political cover to begin using irradiation on a wide scale.
The headline in last Friday's Seattle Post-Intelligencer read, "Local Food Banks Go Peanut-Free." A main supplier to food banks in the Puget Sound region, Food Lifeline, has decided to quarantine all peanut products "rather than try to keep up with the flood of U.S. Department of Agriculture or Food and Drug Administration recall alerts."
In a similar story, the Detroit Free Press reports confusion at a Meijer store in Royal Oak, Michigan, where a reporter sought to buy a product containing peanut butter, but the cashier couldn't ring it up. The cashier told the reporter, "Oh, the computer said this one's recalled. It's got that peanut butter in it. I don't know why it's still on the shelf -- shouldn't be, but the computer won't let those through."
As we have previously reported, the FDA has provided some great tools, including a web-widget, and both a list of recalled peanut products and the American Peanut Council has a list of products unaffected by the recall. What the reports out of Seattle and Detroit indicate, however, is that even in a world where information can move at web-speed, there is still wisdom in the old Mark Twain quote, "A lie can travel halfway round the world while the truth is putting on its shoes." When we're talking about what parents are putting in their kids' lunchboxes, the level of certainty required feels very different from any legal standard.
On February 5, Dr. Stephen Sundlof, director of the Center for Food Safety and Applied Nutrition of the FDA, testified before the Senate Agriculture Commmittee. His advice for consumers was cautious in the extreme.
Consumers are urged to check this web page to determine which products have been recalled and to become aware of new recalls as they are announced. Any product that is on the recall list should be disposed of in a safe manner. Consumers are also urged to wash their hands after handling potentially contaminated products. If consumers are unsure whether a peanut-containing product is potentially contaminated, they should avoid consuming it until they obtain more information about the product. Persons who think they may have become ill from eating peanut products are advised to consult their health care providers
(emphasis supplied). When the man in charge of food safety is sending the message to consumers that they should be watching out for themselves, it will be hard for any food bank volunteer or grocery store clerk to do more than what we have seen Food Lifeline and Meijer do.
On a personal note, my wife was a volunteer at the Fremont Public Association food bank (now Solid Ground) for many years. She taught me that peanut butter has always been a critical staple for food banks, providing a good source of protein, particularly to the many food bank customers who don't have cooking facilities, as well as to vegetarians and vegans. There isn't much I can do personally to deal with the problems caused by this crisis, but what I am doing is writing a nice check to Solid Ground.
UPDATE to the Salmonella-driven peanut product recall: as the number of peanut products recalled continues to rise, the U.S. Food and Drug Administration has created a Web widget that allows users to search for peanut-containing product recalls (see below). The FDA updates the list as it receives new information from companies that have recalled products. As discussed in an earlier article, a list of products that are unaffected by the recall is also available.
2008 was a terrible year for makers of ethanol and biodiesel. Huge spikes in the prices of raw materials, natural gas and transportation and drops in the prices they received for their main products have driven many of them to cut back production, shutter plants or even seek bankruptcy protection. In additiion, U.S. biodiesel producers saw themselves faced with an antidumping investigation by the EU that might affect their export market.
If you thought it couldn’t get any worse, hang on.
The National Grain and Feed Association reports that at the International Feed Expo in Atlanta on January 27, Dr. Daniel McChesney of the Food and Drug Administration spoke about studies the agency has reviewed concerning distillers’ grains, the main by-product of ethanol, and glycerin, the main by-product of biodiesel. The information presented by the FDA’s Center for Veterinary Medicine is of concern to anyone in the biofuels industry, as well as anyone who feeds livestock or purchases, processes or consumes meat and poultry.
The FDA has tested 45 samples of distillers’ grains from ethanol plants and in over half of them detected antibiotics, including virginiamycin, erythromycin and tylosin. NGFA later learned that the concentration of those antibiotics exceeded the level (0.5 ppm) from a letter of no objection relating to virginiamycin issued in 1993 to the predecessor of Philbro Animal Health. There are no safe levels established for the other two antibiotics in feed grain. The FDA has 15 more samples to test and intends to make its final report available this summer.
With regard to biodiesel-derived glycerin, Dr. McChesney stated that the FDA does not consider it to be GRAS, or generally recognized as safe, for use as animal feed. Two issues raised concerns:
· Many samples contained more methanol than the 150 ppm level recognized as safe for animal feed; and
· Samples contained salt in concentrations as high as 16,500 ppm.
Accordingly, the FDA will be conducting a safety review of glycerin as a by-product of biodiesel. This will focus on the type of feedstock used, the manufacturing process and how the glycerin is introduced into feed.
Developing markets for by-products has been a significant challenge for the emerging biofuels industry. The latest news of the FDA’s concerns about both distillers’ grains and glycerin will increase those challenges in an already difficult environment.
By guest blogger Per Ramfjord
The FDA’s recent announcement that it is pursuing a criminal investigation of Peanut Corporation of America, arising out of the Salmonella-driven peanut product recall, is sure to raise concerns with executives in food product companies throughout the country. White House Press Secretary Robert Gibbs’s comment that the Obama administration intends to put in place a “stricter regulatory structure” to prevent breakdowns in food safety only heightens that concern.
And looking at the law, there are reasons to be concerned. The Federal Food, Drug, and Cosmetic Act criminalizes under sections 331 and 333 more than two dozen practices, including a host of activities associated with the manufacture or sale of contaminated food products. The potential punishment for such offenses includes corporate fines and the possible imprisonment of executives for up to one year for misdemeanor offenses or up to three years for felony violations. The burden of proof to establish such crimes against corporate executives is very low. For misdemeanor offenses, the government needs to prove only that the violation occurred under the executive’s watch; it need not show that the executive had any actual criminal intent or personal involvement in the violation. For felony violations, the government can prove the required intent simply by showing that a defendant consciously avoided knowledge of the violation or was involved in a prior violation.
So, the question arises, what should companies do to avoid prosecution if they become aware of potential criminal violations? The obvious first step is to stop the offending practice as quickly as possible and to identify and take any available remedial action, up to and potentially including a recall. Although there may be concern that the remedial action or recall may itself draw attention to the problem, the benefits of acting in a manner that the government deems responsible will pay off down the road. The second step is to investigate the violation immediately, with counsel, to develop facts that can help steer the case away from criminal enforcement. The FDA will almost always hold a “Section 305” meeting to allow a company to tell its side of the story before initiating a criminal prosecution. The decision about whether to prosecute will be based on factors such as the nature and seriousness of the offense, the potential deterrent effects of prosecution, and the company’s or individual’s culpability, criminal history, and willingness to cooperate. Uncovering evidence to show that the event in question was isolated in nature, due to unique and excusable circumstances, and not part of a pattern of misconduct or noncompliance is critical to making such a meeting a success and to the company’s overall defense going forward. Finally, an important third step is avoiding pitfalls during the investigation itself that could contribute to the government’s decision to prosecute. The current enforcement atmosphere is one in which the “cover-up” is often deemed worse (and more likely to spark prosecution) than the “crime.” Avoiding any false statements, document destruction, or other actions that the government could construe as constituting obstruction of justice is therefore of vital importance.
In sum, obviously the best way to avoid prosecution is to avoid violations, particularly through adopting policies and procedures that minimize risk. But once a potential violation has been discovered, it is vital to respond quickly and with the benefit of counsel who know and understand the system. While any enforcement proceedings are unfortunate, the prospect of criminal proceedings, with their potential of adverse publicity to the company and incarceration of executives, poses unique problems that require a rapid and focused response.
UPDATE - This panel will address emerging issues related to the recalls and investigations related to the Peanut Corporation of America. The panel includes persons intimately involved with these issues. Anybody with an interest in the peanut recall should register and tune-in.
The American Bar Association is presenting its second Hot Topics in Food Law teleconference on February 10, 2009 at 10am Pacific Time (1pm EST). Anybody connected with the food industry and concerned with risks affecting the industry should consider registering. I have been involved with planning this event. No other use of 60 minutes will give you as much insight into the most current issues in food law. The cost begins at $35 for section of litigation members and ranges to $150 for non-ABA members.
Ricardo Carvajal, Of Counsel, Hyman, Phelps, & McNamara, PC, Washington, DC
Sherry A. Marcouiller, Chief Counsel, Food Law, Kraft Foods Global, Inc., Northfield, IL
UPDATE to "Avoiding the Panic" - The American Peanut Butter Council has a website that lists products it knows are UNAFFECTED by the peanut butter recall associated with the current Salmonella outbreak. The list of unaffected products is lengthy and growing. Lets hope the media is successful at assisting consumers avoid the panic by providing them with the information to consume safely the products they enjoy.
Supreme Court Asked to Hear Preemption Case Involving Methylmercury; FDA Issues Draft Documents Regarding Consuming Commercial Fish
By Guest Blogger Bryan Anderson
The maker of Chicken of the Sea products has asked the U.S. Supreme Court to grant certiorari in a case we reported on involving preemption of state-law tort claims. In August 2008, the Third Circuit in Fellner v. Tri-Union Seafoods, LLC reversed the district court and held that Food and Drug Administration (FDA) actions regarding methylmercury content in tuna did not preempt the plaintiff’s claims under the New Jersey Product Liability Act. Tri-Union Seafoods’ certiorari petition presents two questions for the Supreme Court’s consideration:
1. Whether state-law tort claims based upon failure to warn of the risks of methylmercury in tuna fish products are preempted by the Federal Food, Drug, and Cosmetics Act and regulatory actions of the FDA, including a written determination that state-law warning requirements concerning methylmercury in tuna products are preempted by federal law and denial of a petition to require such warnings; and
2. Whether a “presumption against preemption” applies in conflict preemption cases.
If the Court grants the petition and hears the case, it certainly will have implications concerning local and state labeling requirements vis-à-vis federal agency action. Stay tuned; we will update you on this case as the plaintiff/respondent submits her brief opposing the petition.
Also related to methylmercury, the FDA yesterday published a notice in the Federal Register announcing the availability of two draft documents assessing the benefits and risks of consuming commercial fish.
The first document attempts to quantify the impact of eating commercial fish on three health endpoints: (i) fetal neurodevelopment, (ii) risk of fatal coronary heart disease, and (iii) risk of fatal stroke. The FDA notes that “[e]ach of these health endpoints has been associated in the scientific literature both with adverse effects of methylmercury exposure (including through fish consumption) and beneficial effects of regular fish consumption.”
The second document provides an overview of published scientific literature regarding beneficial effects of fish consumption and Omega-3 fatty acids for neurodevelopmental and cardiovascular endpoints.
Marler Blog and some of the press have been sounding the alarm on all peanut butter products. True the FDA and CDC have been investigating a multi-state Salmonella outbreak and that there may be a connection with certain peanut butter products. But does this mean that consumers, restaurants and food sellers should avoid all peanut butter products? The answer is NO.
For example. the CDC has stated that:
Preliminary analysis of an epidemiologic study conducted by CDC and public health officials in multiple states comparing foods eaten by ill and well persons has suggested peanut butter as a likely source of the bacteria causing the infections. To date, no association has been found with major national brand name jars of peanut butter sold in grocery stores.
One thing that any restaurant or food seller can do is to educate their customers about the safety of their products. CNN has a great article up today in their Consumer Tips section. Based on information available to date, the article provides the following guidance for the consumer:
1. Is it safe to make my child a peanut butter sandwich? The FDA says as of Sunday there is no indication that brand name peanut butter sold in grocery stores is linked to the outbreak.
2. What about the peanut butter served at schools? The peanut butter found to contain salmonella bacteria was made by the Peanut Corporation of America. They make peanut butter for institutional use in places like prisons, schools and nursing homes. As a precaution, the Peanut Corporation of America has recalled all peanut butter and peanut paste made in its Blakely, Georgia, plant. That means institutions should no longer be serving it.
3. What about other food made with peanut butter? Officials say for right now, hold off on eating foods that contain peanut butter or peanut paste. Peanut paste is found in commercially made cakes, candies, crackers, cookies and ice cream. The Kellog Co. announced a voluntary recall of 16 products, including Keebler and Famous Amos peanut butter cookies, because they contain peanut butter that could be connected to the Peanut Corporation of America.
4. How do I know if I have been infected by salmonella? According to the Centers for Disease Control, most people infected by salmonella bacteria develop diarrhea, fever and abdominal cramps 12 to 72 hours after the infection. Most people recover without treatment. However, in some cases salmonellosis, as the infection is called, can be deadly. The infection may spread from the intestines to the blood stream and on to other body parts. Antibiotics need to be administered immediately. The elderly, infants and people with impaired immune systems are more likely to get seriously sick. If you think you may have infected with salmonella, go to the doctor immediately. The doctor can perform lab tests to determine if you have it.
To keep current on the list of products recalled as a result of the recall, sign-up for FDA email alerts and keep in close communication with suppliers.
This week brought news of yet another nationwide Salmonella outbreak from a source not yet identified by government regulators. The last time we had a nationwide Salmonella outbreak for an extended period of time without identification of a definitive source the federal government initially singled out tomatoes imported from Mexico (a huge array of products). In that case, the government was wrong and wreaked financial havoc on many farmers and businesses.
So far, in the current outbreak, nothing more specific than “poultry, eggs and cheese” have been identified as possible sources. Last year’s outbreak involved Salmonella Saintpaul whereas the current outbreak is Salmonella Typhimurium, which is more commonly associated with poultry, eggs and cheese, but could come from almost anything.
That a source has yet to be identified to the media doesn’t mean that state and federal officials aren’t zeroing in on possible sources. Restaurant owners, retailers and food manufacturers should be ready for the regulators when they come knocking.
In the past, I’ve had clients who were worked over aggressively by regulators (especially federal officials) who were investigating a large, nationwide outbreak with an uncertain cause. These officials face enormous pressure from those in Washington and from the public. Federal officials can make demands that threaten an entire business. They can demand credit card receipts, contact information for customers, personal employee information, shutdown of the business and more. Noncompliance might mean the officials will go to the press and advertise that the business is a target of the investigation. Unlike local health officials, who are usually vested in the well-being of local food producers under their jurisdiction, federal officials may care only about the investigation and nothing else.
Any food business should implement its crisis response team the minute it suspects it could be targeted in an investigation like the one that is currently ongoing. Specialists in food safety and foodborne illness investigations, genetic microbiologists, public relations experts, accountants, quality assurance personnel, purchasing personnel and lawyers should be lined up and ready to go. Events may unfold quickly for your business (over the course of a day or even a morning). Everything needs to be done at that moment to assist a business in navigating what may appear to be an impossible crisis.
I just returned from ACI’s Second National Forum on Food-Borne Illness, which included several interesting presentations and discussions. One was by Dan Engeljohn, Deputy Assistant Administrator of the Office of Policy and Program Development at the Food Safety and Inspection Service (“FSIS”). Mr. Engeljohn spoke about FSIS’s priorities for “2009 and beyond.” Takeaways from this presentation include:
FSIS is increasingly concerned with strains of E. coli other than O157:H7. Non-O157:H7 strains such as E.coli O121:H19 and O111 are growing more prevalent in the environment. FSIS is putting additional resources into developing methodology for detection of non-O157 STECs.
As FSIS, CDC, FDA and local health departments develop this methodology, the industry can expect more reported outbreaks and more liability exposure. Most experts believe that many non- O157:H7 outbreaks go undetected. Increased focus on detection of non-O157 E. coli strains is yet another reason to examine the sufficiency of your companies' insurance limits.
Frozen, Not Ready to Eat Meals
According to Mr. Engeljohn, because of recent salmonella scares, FSIS remains concerned about “frozen, not ready to eat” meals and specifically “frozen, not ready to eat” poultry meals. He explained that “evidence is mounting that these products cannot be safely prepared unless salmonella is controlled in the source materials.” In other words, FSIS now believes that no amount of package labeling or consumer education can prevent consumers from undercooking these meals.
FSIS jurisdiction over salmonella in poultry is limited. FSIS attempts restrict the sale of “frozen, not ready to eat” meals or impose more stringent standards against salmonella in poultry may be a reach for the agency. As discussed in Supreme Beef Processors v. USDA Salmonella, "is not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat 'inspected and passed.'" Absent statutory reform, FSIS action in this area may be challenged.
Mr. Engeljohn stated that FSIS is “deeply concerned” about listeria. It believes that gains made in recent years at meatpacking plants may be undone by problems at supermarket deli counters. FSIS believes that little is being done to address critical control points at the retail level, such as proper cleaning and sanitizing of meat slicers. FSIS may be exploring ways to exercise more jurisdiction to regulate supermarket delis.
While largely under the radar in the American press due to the compelling election cycle and historical meltdown in the financial markets, the news out of China concerning melamine has gone from bad to worse. Concern about Chinese dairies has morphed into a global crisis affecting what seems like an infinite number of products tainted with melamine.
Melamine has been intentionally introduced into animal feed, dairy products, pet food and other products because it can make diluted or poor-quality products appear to be higher in protein by elevating the total nitrogen content detected by some simple protein tests. Already, the FDA has identified a wide variety of products affected in the first wave of concerns about Chinese dairy products.
How should a food manufacturer or retailer prepare for a melamine issue? Any food company that imports any food ingredient or product from Asian markets should be concerned, and its first steps should be to update its crisis management plan and rehearse a melamine recall.
Food companies should also review with coverage counsel and their brokers whether they have—or can obtain—insurance coverage for financial exposure from melamine tainted products. Financially, a food company will be affected by a melamine issue in at least three ways: recall costs, loss of business and personal injury/consumer fraud claims. Standard comprehensive general liability (“CGL”) insurance may not cover any of these exposures. Most CGL policies do not cover recall costs. While recall and property insurance policies are available, the coverages offered by these policies also may be problematic.
Even personal injury or consumer fraud claims might be denied by CGL insurers. For example, many CGL policies will only provide coverage for occurances that arise out of events that are “accidental.” “Accident” is commonly defined as “a sudden, unforeseen or unintended event.” Even though a food company may have no knowledge of an upstream supplier’s fraudulent acts, some insurers are sure to argue that claims arising from products intentionally tainted by melamine are not covered.
The insurer's argument denying coverage is not a slam dunk and may not prevail. But, the key is to avoid (or minimize) the dispute with the insurer. To the extent possible, when placing insurance, a food company should obtain a representation or endorsement from its insurer that coverage will be extended to claims arising from melamine-tainted food.
As previously discussed on this blog, the FDA recently approved irradiation for iceberg lettuce and spinach. We pointed out that "irradiation may provide an added level of protection from food-borne illnesses such as salmonella and E. coli. When used in combination with other state-of-the-art food handling practices, irradiation should dramatically reduce the chances of transmitting food-borne illnesses to consumers."
Now, it appears that at least some in the plaintiffs' community agree that irradiation of fresh produce may be a good thing. Bill Marler, one of the leading plaintiffs' attorneys in the food liability area, is running a series of in-depth pieces on his blog on irradiation.
Mr. Marler's conclusion in part II of his series echoes what we've posted in this blog :"In summary, food irradiation is not a 'silver bullet' for food safety. However, the increasing problem of illnesses and deaths associated with consumption of fresh produce, including lettuce and spinach, emphasizes the need for an intervention."
With a fair amount of fanfare , last week the FDA approved irradiation of iceburg lettuce and spinach. For restaurant owners, the question is whether they should invest in this process.
Like pasteurization, irradiation may provide an added level of protection from food-borne illnesses such as salmonella and E. coli. When used in combination with other state-of-the-art food handling practices, irradiation should dramatically reduce the chances of transmitting food-borne illnesses to consumers.
The FDA estimates that irradiated fruits and vegetables will cost two to three cents more per pound than nonirradiated products. Irradiation does not substitute for any other food safety practices or investments. Indeed, without added precautions against cross-contamination or field-to-fork regulation of the supply chain, irradiation provides little benefit.
Perhaps more significant than cost is the question of consumer acceptance. The good news is that the FDA does not require labeling of irradiated foods by restaurants (as it currently does for supermarket products). Yet some organic foods advocates are passionate about what they believe to be harmful effects of irradiation and are already lobbying restaurants and consumers to steer clear of irradiated foods.
At this point, arguments against irradiated foods are similar to those against pasteurization and appear to be grounded more in emotion than in science. In weighing issues of consumer acceptance and lowered risk to human health, businesses should understand that unlike economics and politics, in food safety, perception is not reality. Failure to irradiate will likely result in more personal injury claims and a significant threat to the business and the brand.
By Guest Blogger Richard Goldfarb
Sunday, at a local restaurant, I saw a sign saying that there would be no fresh sliced tomatoes on my burger. Although it is quite clear that there are safe tomatoes available, the FDA has encouraged restaurants simply to cease selling them. This makes a lot of sense: rumors fly so rapidly and irresponsibly. Though, individual restaurants may take different steps; those that pride themselves on knowing the source of their heirloom tomatoes should be advertising that fact.
The problem is salmonella, in particular a strain called “saintpaul.” The FDA identified salmonella in tomatoes as a significant risk a year ago. Thus, they had the infrastructure in place to monitor and deal with the significant number of reported outbreaks this year. So far, no one knows the source of the problem, and all the FDA can do at this point is to list those tomatoes that have not been associated with the outbreaks:
• Cherry tomatoes
• Grape tomatoes
• Tomatoes sold with the stems on
• Homegrown tomatoes
In addition, the FDA lists those tomato-growing areas that have been ruled out in the outbreaks. This doesn’t mean that tomatoes grown in those areas will always be safe, but that they have not been linked to this outbreak. The FDA also reiterates its advice on the safe handling of fresh tomatoes and other fresh fruits, both in restaurants and at home. The CDC website provided a nice summary:
• Refrigerate within 2 hours or discard cut, peeled, or cooked tomatoes.
• Avoid purchasing bruised or damaged tomatoes and discard any that appear spoiled.
• Thoroughly wash all tomatoes under running water.
• Keep tomatoes that will be consumed raw separate from raw meats, raw seafood, and raw produce items.
• Wash cutting boards, dishes, utensils, and counter tops with hot water and soap when switching between types of food products.
The problem isn’t limited to the United States; New Zealand tomatoes have been implicated as well, and banned in Hong Kong. It was nice to know that the tomatoes we had with dinner last night were doubly safe: they were hothouse tomatoes sold with the stems on, and they were from British Columbia, one of the locales ruled out by the FDA.