Chipotle sued over its allegedly deceptive non-GM advertising campaign.

  • As covered on our blog earlier this year, Chipotle Mexican Grill launched a nationwide advertising campaign premised on the chain’s pledge to serve food made only with non-genetically modified (GM) ingredients.  The company included caveats on its website to indicate that meat and dairy products may come from animals that consume GM grain and that many beverages (e.g., soda) contain GM ingredients (e.g., corn syrup, virtually always sourced from GM corn).
  • On August 31, 2015, a class action lawsuit was filed against Chipotle in the “Food Court” (Northern District of California), based on allegations that the chain’s non-GM advertising campaign violates California consumer protection, false advertising, and unfair competition laws.  The complaint alleges that Chipotle makes false and misleading representations to consumers in claiming that its food products do not contain GMOs.  The complaint acknowledges the existence of the website “carve-outs” for animal products and beverages, but dismisses such disclaimers as contrary to the overall “G-M-Over It” message of the campaign and alleges that consumers are “highly unlikely” to seek out such qualifying language when deciding whether or not to patronize the chain.
  • The current lawsuit highlights the continuing controversy over the presence of GM ingredients in the food supply, as well as the risks that companies face in developing truthful, non-misleading statements about the “GM” or “non-GM” content of their products.

To help combat outbreaks, FDA wants food companies to send in samples of pathogens detected in plants.

  • For the past few years, FDA has been investigating and deploying the use of whole genome sequencing to track outbreaks of foodborne illness.  The Agency is working to build a network of state and federal labs with the ability to map exact DNA sequences for strains of Listeria, Salmonella, and other foodborne pathogens detected in sick individuals.  These sequences are uploaded to a public database hosted by the National Institutes of Health (NIH).  In parallel, FDA has started to sequence pathogens that inspectors find during routine food facility inspections and is adding those data to the database.  The Agency hopes that developing these parallel databases will help expedite the matching of patients within an outbreak and will facilitate early detection of an outbreak’s source, thus reducing the amount of time it takes to respond to the problem.
  • According to a Reuters report, FDA now wants food manufacturers to send in samples of pathogens found during their own plant inspections.  By expanding the database of possible “matches,” FDA hopes to speed the process of connecting pathogens found in ill patients to those swabbed from specific facilities.  FDA scientists cite success in tracking a 2014 Salmonella outbreak where the DNA sequences of the pathogens taken from two sick patients were “almost indistinguishable” from Salmonella that FDA had found at a specific food facility during an inspection.
  • Naturally, even where companies may agree with FDA’s approach in principle, the food industry may be hesitant to turn over concrete evidence of microbial contamination in specific facilities.  To alleviate concerns about “self-incrimination,” FDA reportedly is working with its partners to develop means of allowing companies to provide blind samples through third parties, thus enabling growth of the database while protecting the identity of individual contributing companies unless and until specific identification becomes necessary.

FDA issues Warning Letters to three tobacco manufacturers regarding “additive-free” and “natural” claims.

  • FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act).  Section 911(b)(1) of the FD&C Act defines a “modified risk tobacco product” as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.”  “Modified risk” status may be established where a product’s label, labeling, or advertising suggest that the product lacks harmful substances, presents a lower risk of disease, or is somehow less harmful than other commercially marketed tobacco products.  The marketing of “modified risk” products is not per se unlawful.  Rather, companies seeking to market tobacco products with claims of modified risk must obtain FDA authorization for such claims through the Section 911 Modified Risk Tobacco Product Application process.
  • On August 27, 2015, FDA issued Warning Letters to three companies marketing tobacco products with claims that they are “natural” and/or “additive free.”  Specifically, the Agency warned:  (1) ITG Brands LLC, maker of “Additive Free” Winston cigarettes; (2) Santa Fe Natural Tobacco Company, Inc., maker of “Natural” and “Additive Free” Natural American Spirit cigarettes; and (3) Sherman’s 1400 Broadway N.Y.C. Ltd., maker of “Natural” Nat Sherman cigarettes.  In two of the Warning Letters, FDA acknowledged the existence of a consent order between certain companies and the Federal Trade Commission (FTC) regarding the use of “additive free” claims in conjunction with certain required disclosures (e.g., “No additives in our tobacco does NOT mean safer”).  Although the consent order predates the Tobacco Control Act, FDA has taken the position that it now has jurisdiction over the promotion of tobacco products, including authority over “modified risk” claims.
  • FDA’s action marks the first time that the Agency has used its authority under the Tobacco Control Act to curtail the use of “additive free” or “natural” claims on tobacco product labeling.  These Warning Letters are a shot across the bow of the tobacco industry, suggesting that general claims (or even historically permitted claims) that imply “modified risk” status may incur regulatory scrutiny and enforcement action.

Keller and Heckman LLP has an active tobacco & e-vapor regulatory practice and will be hosting a pre-conference seminar on these topics in conjunction with our upcoming Food Packaging Law Seminar.  For more information and to RSVP to these events, click here.

For more information about our tobacco & e-vapor regulatory practice in general, click here.

FDA responds to Congressional inquiry regarding the Agency’s policies on Untitled Letters.

  • As previously covered on this blog, the U.S. House Committee on Energy and Commerce requested information from FDA regarding the Agency’s policies on the issuance and publication of Untitled Letters.  Congress seemed concerned that FDA may be using Untitled Letters to advance new policies or interpretations without giving adequate notice to industry.  Congress also questioned FDA’s decision to post a specific Untitled Letter under circumstances where the timing and nature of the posting adversely affected the recipient’s stock price.
  • FDA now has issued a written response to the Congressional inquiry.  In the response, FDA’s Associate Commissioner for Legislation:
    • clarifies the differences between Untitled Letters and Warning Letters;
    • notes the Agency’s policy of having the Office of Chief Counsel (OCC) review certain letters prior to their issuance (Specific to food and supplements, OCC reviews Untitled Letters that involve novel, controversial, or sensitive legal issues and those that allege violations of the dietary supplement good manufacturing practice regulations);
    • explains that FDA’s policies regarding the posting of Untitled Letters are specific to individual Centers within the Agency, but reiterates that there also is an Agency-wide proactive approach to posting records that are the subject of three or more requests under the Freedom of Information Act (FOIA) or that are expected to generate multiple FOIA requests;
    • asserts that the Agency uses Untitled Letters to communicate with regulated industry about FDA’s assessment of violations that do not meet the regulatory threshold for a Warning Letter; and
    • expressly denies that FDA uses Untitled Letters as a way to announce new regulatory approaches or policies.
  • FDA’s response does not provide novel or controversial information about the Agency’s policies on the issuance or posting of Untitled Letters.  As a result, this letter does not signal any greater predictability for regulated industry in terms of the timing or nature of a particular Untitled Letter’s release.

FDA cites “Just Mayo” products for non-compliance with the standard of identity for mayonnaise, among other issues.

  • Startup company Hampton Creek previously has faced criticism and legal challenges related to its decision to market an eggless mayonnaise substitute under the name, “Just Mayo.”  Critics have argued that the labeling and marketing are likely to result in consumers believing the product is standard “mayonnaise” despite its failure to comply with FDA’s standard of identity for such food.
  • On August 12, 2015, FDA issued a Warning Letter to Hampton Creek, alleging that the “Just Mayo” product lines are misbranded under the Federal Food, Drug, and Cosmetic Act because they are represented as standardized mayonnaise even though they fail to comply with the applicable standard.  Specifically, the products lack a requisite ingredient for mayonnaise — eggs — and contain ingredients not permitted by the standard of identity, such as modified food starch, pea protein, and beta-carotene.  In the Warning Letter, FDA also alleges that Hampton Creek makes unauthorized and misleading claims about the “cholesterol-free” and heart-healthy characteristics of its products.
  • Particularly in light of the previous challenges to Hampton Creek in this area, FDA’s Warning Letter is likely to generate significant publicity and could serve as the trigger for new consumer class action lawsuits premised on the company’s allegedly deceptive marketing claims.  FDA’s action in this case serves as a reminder of the Agency’s authority to enforce standards of identity for foods and of its power to publicize issues of interest of plaintiffs’ lawyers nationwide.

New England Journal of Medicine op-ed raises concerns about the link between GMOs and herbicide use.

  • The cultivation and consumption of genetically modified (GM) crops and the labeling of foods containing GM ingredients remain subjects of debate and discussion at the global level.  As previously covered on this blog, Congress remains poised to act on legislative efforts to prohibit states from mandating the labeling of GM foods.  One central tenet of arguments that GM labeling is unnecessary is the lack of any scientific consensus that GM foods are any less safe than their “conventional” counterparts.
  • An op-ed published in the New England Journal of Medicine raises questions about the scientific evidence supporting the safety of GM crops.  Specifically, the article asserts that the biotechnology industry’s focus on herbicide resistance has resulted in an overreliance on herbicides, and especially on glyphosate.  In light of the Environmental Protection Agency’s (EPA) 2014 approval of a combination herbicide that will be marketed in conjunction with GM seeds, coupled with the International Agency for Research on Cancer’s (IARC) 2015 determination that the components of the new herbicide (glyphosate/2,4-D) are probable/possible human carcinogens (respectively), this article urges a re-evaluation of the hazards that the link between GM foods and herbicides may pose to human health.  The article concludes by suggesting that the “time has come to revisit the United States’ reluctance to label GM foods.”
  • While many arguments about the alleged hazards associated with GM foods focus on the mere use of genetic engineering, the current article takes a more nuanced approach.  However, since the article postulates theoretical hazards and does not cite empirical data showing increased harm associated with the link between GM foods and herbicides, it remains to be seen whether science will support speculation in this case.

DNA bar coding used to detect mislabeled meat.

  • “DNA bar coding” made headlines earlier this year when the New York Attorney General’s office launched a probe into major retailers and alleged that herbal supplements sold in their stores did not contain the ingredients represented on the product labels.  Many discussed and debated the utility of DNA bar coding as a means of detecting the authenticity of food ingredients.
  • In two recently published studies, researchers have demonstrated the utility of DNA bar coding in identifying potentially mislabeled meat in the marketplace.  Based on tests of consumer commercial products, researchers found that 10 out of 54 game meat products were mislabeled and 10 out of 48 ground meat products were mislabeled.  Horse meat was detected in two of the ground meat products.  Mislabeling could be attributed either to intentional mixing of cheaper meats into the finished product (i.e., “food fraud“) or unintentional cross-contamination during processing.
  • Particularly in light of the increasing prevalence of food fraud and the food industry’s preparation for compliance with the requirements of the FDA Food Safety Modernization Act (FSMA), we suspect this will not be the last we hear of DNA bar coding and its potential utility in the food industry.

Food fraud abounds in the global marketplace.

  • The concept of “food fraud” or “economic adulteration” refers to the whole or partial replacement of genuine foods and food ingredients with cheaper substances without informing the customer or consumer of the substitution.  Fraud cases may relate to specific qualities or the origin of a product (e.g., selling a cut as “certified Angus” when it is not) or they may relate to the fundamental identity and safety of a product (e.g., adding melamine to milk-based products to artificially inflate protein values).
  • At a recent meeting of the International Association for Food Protection (IAFP), experts discussed the increasing prevalence of food fraud in the global marketplace, both in terms of frequency and the range of products and ingredients affected.  They also noted that recent years have ushered in more cases involving deadly adulterants.
  • Food authenticity affects ingredient suppliers, food processors, and consumers alike.  Although FSMA implementation likely will improve supply chain monitoring and verification generally, its direct impact on economic adulteration remains to be seen.

Keller and Heckman is hosting an intensive one-day seminar in New York City on September 24, 2015 to discuss food authenticity issues, particularly with respect to Extra Virgin Olive Oil.  Event details and registration information are available here.

California federal judge finds plausible state law cause of action, but stays trans fat lawsuit pending FDA’s consideration of PHO petition. (subscription to Law360 required)

  • As previously covered on this blog, class action lawsuits have been filed in the wake of FDA’s determination (tentative in 2013, final as of June 2015) that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) under any conditions of use in food.  The Grocery Manufacturers Association (GMA) has submitted a food additive petition to FDA seeking the Agency’s approval of specific low-level uses of PHOs.
  • In a case filed against General Mills, a federal judge in California has decided to stay the litigation pending FDA’s determination regarding the lawful use of PHOs.  The judge first found that the plaintiff plausibly alleged a state law violation (by plausibly alleging that PHOs are injurious to health and that food containing PHOs may be adulterated under California’s Sherman Act, supporting an “unlawful” claim under the state’s unfair competition law).  However, the judge went on to explain:  “Whether small amounts of trans fats can lawfully be used as a food additive is a complicated question requiring agency expertise, and one that the FDA will be reviewing before June of 2018.”  The “primary jurisdiction doctrine” is a prudential doctrine under which courts may determine that the initial decision-making responsibility should be performed by the relevant agency, rather than the courts.  Finding FDA’s determination to be “central” to the plaintiff’s claims in the case, the judge cited the primary jurisdiction doctrine as the rationale for staying further litigation.
  • It remains to be seen whether other judges will accept and apply the reasoning in this case, particularly as this will result in plaintiffs’ lawsuits being stayed for multiple years pending FDA’s review of the food additive petition.  If other courts apply the primary jurisdiction doctrine, this could signal a slowdown in trans fat cases filed between now and 2018.  Nevertheless, the “legal status” of PHOs in the food supply in the interim time period remains a subject of much debate.

Supplement company ordered to cease production and marketing after repeat violations.

  • FDA has the authority to regulate dietary supplements.  The Agency enforces legal and regulatory provisions applicable to supplements in various ways, including through facility inspections and Warning Letters.  Violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may have criminal consequences; FDA may work through the Department of Justice (DOJ) to seek judicial remedies (seizure, injunction) against companies that violate the law.
  • On August 17, 2015, a federal district court in Iowa imposed a consent decree on a dietary supplement company in the state, effectively shutting down operations unless and until a host of legal violations have been remedied.  According to the complaint, the company was aware that FDA alleged numerous violations of the FD&C Act over the past two years.  FDA alleged that the company was distributing unapproved new drugs and misbranded drugs, as well as adulterated and misbranded dietary supplements.  More specifically, the Agency found evidence of:
    • failure to comply with current good manufacturing practices (GMPs) in 21 CFR Part 111;
    • promotional statements indicating that dietary supplement products could be used to cure, mitigate, or prevent diseases such as cancer, malaria, and heart disease
    • product labeling violations
  • The company will cease all production and distribution of adulterated, unapproved, and misbranded products.  Further, the company has agreed that it will not resume operations without FDA approval.  Although FDA enforcement in the dietary supplement area is relatively infrequent, this consent decree serves as a reminder of FDA’s authority and the potentially serious consequences of repeat violations related to the production and marketing of supplements.