FDA Issues Gluten Free Labeling Compliance Guide

Nearly a year ago on August 5, 2013, we reported on the blog that the Food and Drug Administration (FDA) had published a final rule establishing a regulatory definition of the term “gluten-free” for voluntary use in the labeling of foods. The final rule is intended to provide a uniform definition of the term “gluten-free” so that consumers, particularly those who have celiac disease, will know what it means when they see it on the labeling of food.

The rule became binding and effective on September 4, 2013, but August 5, 2014 is the date when FDA-regulated foods labeled “gluten-free” must comply with all requirements established by the final rule. In preparation of the upcoming compliance date, FDA prepared a Small Entity Compliance Guide which restates in plain language the requirements concerning use of the term “gluten-free” in the labeling of foods.

Specifically, the guidance states that any label claiming that a food is “gluten-free” must not contain any of the following ingredients:

  • An ingredient that is a gluten-containing grain (such as wheat, rye, or barley or any of their crossbreeds); or
  • An ingredient that is made from a gluten-containing grain and that has not been processed to remove gluten. For example, “wheat flour” is an ingredient made from wheat that has not been processed to remove the naturally occurring gluten in wheat. Therefore, wheat flour cannot be used as an ingredient to make a food labeled “gluten-free;” or
  • An ingredient that is made from a gluten-containing grain and that has been processed to remove gluten, if the use of that ingredient contains 20 parts per million (ppm) or more gluten.

The claim can also appear on the labels of foods that inherently do not contain gluten, such as fresh vegetables or juices.

Another important bit of information is that, unlike other required label components, there are no requirements for color, type size or placement of the “gluten- free” claim.

Although the rule does not expressly require manufacturers to test for the presence of gluten in the raw ingredients or finished foods labeled “gluten-free,” it might be wise to do so. Failing to ensure that the food item bearing a “gluten-free” claim meets the requirements of the rule could cause the product to be deemed misbranded and thus subject to FDA regulatory action. In its guidance, the agency encourages companies to use effective measures to ensure that any foods labeled as “gluten-free” comply with the requirements including:

  • testing the ingredients to determine their gluten content;
  • requesting certificates of gluten analysis from ingredient suppliers; or
  • participating in a third-party gluten-free certification program.

However, as with all agency guidance, FDA’s compliance guidance for gluten-free labeling does not establish legally enforceable responsibilities. Instead, this guidance describes the agency’s current thinking on a topic and should be viewed only as a recommendation. If you have any questions about gluten-free labeling or other food label claims, contact Stoel Rives label compliance experts Claire Mitchell and Anne Glazer.

FDA Makes Preliminary Determination That Trans Fats Are Not GRAS

Last week, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice that it has made a preliminary determination that partially hydrogenated oils (PHOs), a major source of artificial trans fat in processed foods, are not generally recognized as safe (GRAS) for use in food. The November 7, 2013 notice includes the opening of a 60-day public comment period.

Under section 409 of the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is a food additive subject to premarket approval and review by FDA, with some exceptions. The exceptions include substances “generally recognized as safe,” or GRAS, because they are generally recognized by experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. PHOs, which are the primary dietary source of industrially-produced trans fat have a history of use as food ingredients and have long been considered GRAS ingredients by the food industry.

However, according to the FDA, GRAS status of a specific use of a particular substance in food is time-dependent. In its Federal Register notice the agency points out that:

as new scientific data and information develop about a substance or the understanding of the consequences of consumption of a substance evolves, expert opinion regarding the safety of a substance for a particular use may change such that there is no longer a consensus that the specific use is safe. The fact that the status of a substance . . . may evolve over time is the underlying basis for FDA’s regulation at § 170.38, which provides in part that FDA may, on its own initiative, propose to determine that a substance is not GRAS.

. . .

Further, as stated previously, history of the safe use of a substance in food prior to 1958 is not sufficient to support continued GRAS status if new evidence demonstrates that there is no longer expert consensus that an ingredient is safe.

Essentially, this means that the FDA can take action when it believes an ingredient is, in fact, not GRAS. And that is exactly what is happening here.

For some, this announcement may not come as a surprise. More than a decade ago, in 1999, the FDA proposed that manufacturers be required to declare the amount of trans fat on Nutrition Facts labels because of public health concerns. The agency issued a final rule in July 2003  amending nutrition labeling regulations to require declaration of the trans fatty acid content of food in the nutrition label of conventional foods and dietary supplements (21 CFR 101.9(c)(2)(ii)). That requirement became effective in 2006. Since then, trends have shown that U.S. consumers are making a conscious decision to avoid foods with trans fat and companies are responding by reducing the amount of trans fat in their products.

So if the FDA’s preliminary determination is finalized and PHOs are deemed not GRAS, what will this mean for the food industry? If FDA makes a final determination that PHOs are not GRAS, PHOs would become food additives subject to premarket approval by FDA. Foods containing unapproved food additives are considered adulterated under U.S. law, meaning they cannot legally be sold. Accordingly, the agency and food industry would have to figure out a way to phase out the use of PHOs over time.

Interested persons may submit either electronic comments and scientific data and information to http://www.regulations.gov or written comments and scientific data and information to the Division of Dockets Management. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Federal Judge Orders FDA to Address "All Natural" Labeling on GMO Foods

Coauthored by Claire Mitchell and Thomas Woods:

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.

A "Surprise" for Your Sweet Tooth: FDA Revisits Inedible Objects in Candy

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.

Register Today for FDA's Public Meetings on Two Major FSMA Proposed Rules

Earlier this year, the Food and Drug Administration (FDA) made some progress toward implementing the Food Safety Modernization Act (FSMA) by issuing two new proposed food safety rules. Specifically, the agency published proposed rules to establish standards for (1) growing, harvesting, packing, and holding of produce for human consumption (the “Produce Safety Rule”) and for (2) current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the “Preventive Controls for Human Food Rule”).

These two proposed rules are just the first step for establishing the framework for the modern food safety system called for by FSMA. Eventually, the FDA intends to release additional proposed rules addressing importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors. A helpful overview of the proposed Produce Safety Rule and the Preventive Controls for Human Food Rule can be found here.

The FDA is currently in the process of soliciting comments on the proposed rules from industry stakeholders. The public may offer comments to the proposed rules over the course of the next several weeks. To facilitate that process FDA is planning to host two additional public meetings in Chicago, IL and Portland, OR in March. These meetings are the second and third in a series of public meetings announced in the January 31, 2013 Federal Register Notice and on FDA’s FSMA website. The first public meeting will be held February 28-March 1, 2013, at the U.S. Department of Agriculture in Washington, DC.

Stakeholders will be permitted to submit oral comments during the public meetings. In addition, the meetings aim to inform the public about the FDA rulemaking process (including how to submit comments, data and other information to the rulemaking dockets), and respond to questions about the proposed rules. 

In Chicago, the forum will be held on March 11-12, 2013 at The Westin on Michigan Avenue. The meeting in Portland will take place on March 27-28, 2013 at Crown Plaza Portland Downtown Convention Center. To register for either event visit FDA’s registration page: http://ppleventreg.com/FDA-FoodSafety-IL-OR/.

FDA Releases Two New Proposed Food Safety Rules

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
  • Recordkeeping. 

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.

Egg Safety Rule Now Effective for Midsized Facilities

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.       

Raw Milk Redux (and Ken Redux for an Instant)

Our former colleague and still good friend Ken Odza was in our offices last week; I was in a meeting and just had the chance to say hello. 

By pure coincidence, one of Ken's favorite topics was in the news this week. Ken had written two big pieces on raw milk for this blog, which can be found here and here.  Tyler wrote about another development here

What happened in Oregon is sad:  20 people were apparently sickened in a single outbreak, including four children, and two of the victims may have long-term complications.  E.Coli O157:H7 is not fun for anyone. 

The real issue, as the article points out, is what the right level of regulation would be.  It's not easy to answer.  Drinking raw milk is simply dangerous; it's like playing Russian roulette without knowing how many chambers are in the gun or how many are filled.  Ban it and the users go underground.  Legalize it and yes, some bad batches will not be caught by inspectors (this happens with a lot of other foods, too, in case you hadn't noticed).  You can try to educate people about it, but if there's anything we know now it is that official education on almost any topic will lead to dissent.  There's no perfect solution in a free society. 

FSIS' New Rule on Poultry Inspection Remains Open for Comment

Earlier this year, the U.S. Department of Agriculture (USDA) issued a press release indicating that the agency’s Food Safety and Inspection Service (FSIS) was proposing a new rule to modernize young chicken and turkey slaughter inspection.

Specifically, the rule intends to expand the use of the flexible, more efficient, fully integrated meat and poultry inspection system originally developed by FSIS in the late 1990s known as the HACCP Based Inspection Models Project, or HIMP. According to Alfred Almanza, Administrator of USDA’s FSIS, there have been 20 broiler plants under a HIMP pilot program since 1999. He explained that this 13-year-old study was undertaken to determine how best to modernize poultry inspection on a large scale. By expanding HIMP, FSIS aims to focus its inspection resources on the areas of the poultry production system that pose the greatest risk to food safety: the unseen threat of Salmonella and Campylobacter.

Some of the key elements of that new system include:

(1) Requiring establishment personnel to conduct carcass sorting activities before FSIS conducts online carcass inspection so that only carcasses that the establishment deems likely to pass inspection are presented to the carcass inspector; (2) reducing the number of online FSIS carcass inspectors to one per line; and (3) permitting faster line speeds than are permitted under the current inspection systems it replaces.

In the USDA’s January news release, Secretary of Agriculture Tom Vilsack supported implementation of the new rule by stating that “[t]he modernization plan will protect public health, improve the efficiency of poultry inspections in the U.S., and reduce spending.” He added, “The new inspection system will reduce the risk of foodborne illness by focusing FSIS inspection activities on those tasks that advance our core mission of food safety. By revising current procedures and removing outdated regulatory requirements that do not help combat foodborne illness, the result will be a more efficient and effective use of taxpayer dollars.” Significantly, FSIS representatives pointed out that the new rule would prevent 5,200 foodborne illnesses annually, would save taxpayers approximately $90 million over three years, and save the poultry industry more than $250 million annually.

Yet, despite noting the positive impact that the proposed expansion of the HIMP poultry inspection system would have on both food safety and taxpayers’ wallets, the USDA received a great deal of criticism from consumers, food safety advocacy groups, the media, and FSIS inspectors themselves.

In particular, critics argued that the HIMP model relinquishes most of the physical poultry inspection duties to the companies that produce the birds for ultimate retail sale. Company employees, rather than FSIS inspectors, will be tasked with sorting defective chickens and examining other quality assurance issues. Inspectors will be responsible for reviewing each bird for fecal contamination. Inevitably, the reduced role of the FSIS inspector will eventually result in the elimination of between 800 and 1,000 FSIS inspectors jobs.

In addition, many are concerned that, under the new rule, poultry plants will be allowed to speed up their lines from an inspection rate of 140 birds per minute to 175 birds per minute. Some inspectors urge that raising the line speed would result in an increased number of unsafe and unwholesome poultry products winding up on the consumer’s dinner table.

However, both Almanza and Undersecretary for Food Safety at USDA Elisabeth Hagen maintain that the proposed rule is a step in the right direction for protecting public health. In response to the argument that the new rules places too much inspection authority in the hands of the poultry company, Almanza explained:  

Right now, we focus on visual inspections of birds, carcass by carcass, and we look for bumps and blemishes. Do these blemishes put Americans’ health at risk? No. But the unseen threats, salmonella and campylobacter, do. Today, we inspect poultry much the same way as we have since the Eisenhower administration, evaluating the quality of each carcass and doing industry's quality assurance work for them. Once upon a time, there was a good explanation for this: when FSIS first started inspecting poultry, quality assurance was thought to be the best way of keeping the public safe and holding industry accountable. But now that our scientific knowledge has advanced and helped us better identify true food safety threats, we cannot do the same thing we’ve been doing since the 1950s.

Further, Almanza said that the HIMP facilities have been permitted to use a line speed of 175 birds per minute since 1999. “In other words, we have more than a decade of experience slaughter running at 175 bpm, the proposed maximum line speed in the rule,” he added.

Hagen underscored that, even with those increased line speeds, when it comes to contamination, the HIMP pilot plants have performed far better than non-HIMP plants. Data collected from the HIMP plants over the last several years support FSIS’ proposition to expand the HIMP program to additional poultry slaughter facilities. 

Due to the negative response to the proposed rule, though, Undersecretary Hagen announced that the rule will remain open for public comment until April 26, 2012. Comments may be submitted electronically by visiting http://www.regulations.gov or by mailing them to Docket Clerk, U.S. Department of Agriculture (USDA), FSIS, Docket Clerk, Patriots Plaza 3, 355 E. Street SW., 8-163A, Mailstop 3782, Washington, DC 20250-3700.

Green Chemistry Is Back

The Department of Toxic Substances Control (DTSC) released new informal draft regulations whose stated purpose is:  "to make safer consumer products ....widespread in California...[and].... provide more protection against toxic chemicals in products on store shelves, while creating market opportunities for industry." 

 

The draft released on October 31, 2011, creates regulations identifying consumer products that contain toxic chemicals. The DTSC claims it will use a science-based process that requires the identification of toxic ingredients and the analysis of alternatives to that ingredient. Based on the results of the analysis, removal of the toxic ingredient and/or posting product information may take place. 

 

The DTSC’s draft regulations encompassed the following:

 

1)  The regulations establish a list of Chemicals of Concern (~3,000) based on the work already done by other authoritative organizations. The rules also allow DTSC to identify additional chemicals as Chemicals of Concern.

2)  The regulations require DTSC to develop a list of “Priority Products” that contain  Chemicals of Concern for which an alternative assessment must be conducted.

3) The regulations require responsible entities (manufacturers, importers, and retailers) to notify DTSC when their product is listed as a Priority Product.  DTSC will post this information on its website. Manufacturers (or other responsible entities) for a product listed as a Priority Product must perform an alternatives assessment (AA) for the product and the Chemicals of Concern in the product to determine how to limit potential exposures or the level of potential adverse public health and environmental impacts posed by the Chemical of Concern in the product.

4)  The regulations require DTSC to identify and impose regulatory responses to effectively limit potential adverse public health and/or environmental impacts posed by the Priority Product/Chemical of Concern (if the manufacturer decides to retain the Priority Product), or the potential adverse impacts posed by the alternative chemical/product selected to replace the Priority Product.

 

A prior  proposed set of regulations were introduced in 2010, but additional time was required to refine the concepts.  The version released in October greatly shortens timeframes, immediately establishes a list of chemicals of concern, and is intended to stimulate a change in the way products are created by incorporating impacts to health and the environment into the design phase. The regulations will be discussed by DTSC’s Green Ribbon Science Panel on November 14-15 in Sacramento.

Facts Alleged in CSPI Sodium Suit Incongruent with Claims Asserted

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.

Obama Administration Focuses on Food Safety

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.