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/.

Oregon to Adopt 2009 FDA Food Code

The Oregon Public Health Division’s (OPHD) Foodborne Illness Prevention Program announced that it is moving forward with the adoption of the 2009 Food and Drug Administration (FDA) Food Code.  The new rules will take effect on September 4, 2012. Oddly, however, the agency noted that it would not be adopting the “No Bare Hand Contact” section of the Food Code.

In creating the “No Bare Hand Contact” rule for food handlers, the FDA pointed out that when hands are heavily contaminated, even effective handwashing practices may not be enough to prevent the transmission of pathogens from the hands to ready-to-eat (RTE) foods, such as sandwiches, salads, and other foods that are eaten without further washing or cooking. Accordingly, the rule requires the use of “suitable utensils such as scoops, spoons, forks, spatulas, tongs, deli tissue, single-use gloves, or dispensing equipment” when handling RTE food items to reduce foodborne illness.

Discussion of implementing the “No Bare Hand Contact” rule in Oregon was met with fierce opposition by restaurateurs who raised concerns over the cost of complying with the rule and whether it would actually increase food safety. In response, OPHD explained that over the next few months it will assemble a workgroup of interested parties (restaurateurs, government inspectors, consumers, etc.) to review and provide recommendations on addressing norovirus and fecal contamination of food, and to identify the best options to reduce illness.

Oregon’s process of adopting the 2009 FDA Food Code began in August 2010 when a Food Code Review Workgroup was established to work with the Oregon Department of Agriculture, food service and retail industry groups and regulators to develop recommendations regarding the new rules. Earlier this year, OPHD also provided training for regulators and industry on the 2009 Food Code in preparation for the September effective date.

The Association of Food and Drug Officials (AFDO), under contract to the FDA, has been gathering data on the progress of FDA Food Code adoptions by States, Territories, Local and Tribal Nation agencies. AFDO reported that 49 of the 50 States adopted codes patterned after the 1993, 1995, 1997, 1999, 2001, 2005, or 2009 versions of the Food Code, representing 96% of the U.S. population. Specifically:

  • Four States adopted the 1993, 1995 or 1997 Food Code, representing 4% of the US population.
  • Ten States adopted the 1999 Food Code, representing 13%of the US population.
  • Eleven States adopted the 2001 Food Code, representing 38% of the US population.
  • Twenty one States adopted the 2005 Food Code, representing 39%of the US population.
  • Three States adopted the 2009 Food Code, representing2% of the US population.

In September, Oregon will join Mississippi, New Hampshire, and Delaware in adopting the 2009 version of the food code. Until the final rules take effect, food industry members can review the Fact Sheets provided by OPHD to ensure compliance and see what other changes may affect their business in the coming weeks.

Arsenic in Apple Juice: Strong Poison or Much Ado About Nothing?

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.

Are FDA Reinspection Fees An Opportunity?

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.

FDA's Right To Photograph In Your Plant

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:

  1. Do you have a policy against photography in your plant?
  2. 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.

FDA's Reportable Food Registry Makes a Profound Impact

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.

What's in a Name? - Trade Organizations Push for HFCS Flexibility

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.

The Show Goes On: USDC Allows Vitaminwater Lawsuit to Proceed

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.

A Traceability Story: Request for Comments

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? 

In case you should come across some romaine tainted with E Coli 0145, the answer is to heat it, not wash it.  Salon.com has a recipe.

The Great HVP Recall of 2010: A Review of Lessons Already Taught

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. 

As Professor Moody would say, "Constant vigilance."

 

On the Horizon: TTB and FDA to Jointly Consider Additives to Alcoholic Beverages

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.

Media Headlines and Food Labels Each Might Be Misleading (Film at 11)

A recent headline in the Huffington Post breathlessly importuned: 

 "Restaurant Food Has Up to 200% More Calories Than Advertised." 

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.

From Onions to Chicken Soup: The Wall Street Journal Weighs in On Home Flu Remedies

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.

FDA's Searchable Widget for Fraudulent H1N1 (Swine) Flu Products

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:

 

FDA Warning to General Mills: Cheerios is a Drug

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.

FDA Seeks Largest Budget Increase in Agency's History

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.

FDA Commissioner Nominee Faces Confirmation Hearing

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.

FDA and CDC Warn of Salmonella in Raw Sprouts

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.

Update: Supreme Court Declines Review of Methylmercury Case With Potential Preemption Implications

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.

FDA Seeks Input on Intentional Adulteration of Products

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.

California Lawmakers Announce Proposed Food-Safety Reforms in Wake of Pistachio Recalls

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 Pistachio Recall: More Salmonella

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.

As the links above show, both the FDA and the Calfiornia Department of Public Health note the recall on their home pages.  I would note that the FDA's message is easier to find, though.

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. 

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.

 

FDA's Searchable Widget for Peanut Product Recall

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.

 FDA Salmonella Typhimurium Outbreak 2009. Flash Player 9 is required.