• On May 5, FDA released a report titled “Resiliency Roadmap for FDA Inspectional Oversight,” explaining how FDA adjusted its inspection program during the COVID-19 pandemic and providing details on its priorities moving forward. In March 2020, FDA responded to COVID-19 by postponing all domestic and foreign routine facility inspections, only resuming prioritized domestic inspections in July 2020.
  • The report explains that as FDA works to make up for lost time during the pandemic, it plans to continue to prioritize routine surveillance inspections for high-risk facilities and conduct inspections over a longer period of time.  As a result, certain lower-risk facilities may have an increased amount of time between inspections. The report proposes several different scenarios for a return to normal inspection schedules, considering best-case and worst-case scenarios.
  • The report also mentions FDA plans to begin a multi-year modernization plan for data enterprise platforms and cross-program interoperability infrastructure to better support innovation related to its regulatory oversight role, including remote approaches. FDA will review its approach to inspections with updated assessment programs and establish an agency-wide FDA Inspectional Affairs Council to plan and coordinate inspectional activities.
  • On May 6, 2021, the European Food Safety Authority (EFSA) updated its 2016 safety assessment of the food additive titanium dioxide (TiO2, E 171) and concluded that it can no longer be considered safe as a food additive despite EFSA’s findings in 2016 that E 171 did not raise a genotoxic concern.  Currently, TiO2 is authorized as a food additive in the European Union according to Annex II of Regulation (EC) No 1333/2008.
  • EFSA’s expert panel on Food Additives and Flavourings (Panel) stated that it reached this conclusion because of the food additive’s genotoxicity concerns when it is absorbed by the body.  The Panel concluded that, although the absorption of TiO2 particles is low, it has the potential to accumulate in the body, as the food additive contains at most 50% of particles in the nano range (i.e., less than 100 nanometers) to which consumers may be exposed.  EFSA noted that although the evidence for general toxic effects was not conclusive, the new data and strengthened methods did not allow the Agency to rule out a concern for genotoxicity.  By way of background, French authorities suspended the marketing of foods containing TiO2 in 2019, as there were gaps and uncertainties in the food additive’s safety data.
  • Based on EFSA’s opinion, the European Commission and the EU member states will meet to consider phasing out TiO2 from the EU legislation on food.  If the EU takes action in response to EFSA’s opinion, the decision would be notified to the World Trade Organization and would subsequently be considered by the Codex Alimentarius Commission.  It remains to be seen whether there will be ripple effects in other countries or on other products.
  • On May 4, the FDA published two Warning Letters for undeclared allergens and the “introduction or delivery for introduction into interstate commerce of any food that is misbranded” which is prohibited by section 301(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 331(a)).
  • In a March 26 letter sent to Hanover Foods Corporation, the FDA stated that its recalled Baked Rice Pudding and Cheddar Flavored Popcorn were misbranded within the meaning of section 403(w) of the FD&C Act because the labels failed to declare the major food allergens of milk and egg (Rice Pudding) and milk (Cheddar Flavored Popcorn). Specifically, the Rice Pudding was manufactured with milk and egg, but the label incorrectly declared an ingredient list for another product that did not contain milk or egg. Similarly, the Cheddar Flavored Popcorn incorrectly declared another product’s ingredient list, which did not contain milk.
  • On March 30, a separate letter was sent to George DeLallo Company Inc. for their recalled Holiday Cookie Platter and Provolini Antipasti products. FDA stated that the products were misbranded within the meaning of section 403(w) of the FD&C Act because the products did not declare the presence of pecans (tree nuts) and milk, respectively.
  • In comments to both Warning Letters, FDA noted that the manufacturing facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule). Thus, both Hanover and DeLallo are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) would be significantly minimized or prevented. In other words, the presence of the undeclared allergens may have been a result of the manufacturers’ inadequate prevention or failure to comply with CGMP and PCs.
  • As our readers know, food or ingredients that contain one of the now nine major allergens must be specifically labeled with the names of the allergen source. The nine major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. These Warning Letters, in addition to the one sent to Whole Foods in December, reconfirm FDA’s attention and efforts to reduce the prevalence of undeclared allergens and allergen recalls.
  • Plaintiffs, on behalf of a proposed class of consumers, have filed a class-action against Baker Mills, Inc. and Kodiak Cakes, LLC, which alleges that the Defendants have deceptively labeled and marketed their Kodiak Cakes by overstating the products’ protein content and quality.
  • First, Plaintiffs allege that the amino acid testing that they conducted indicates that the products contain 17% less protein than the 14 grams of protein that is claimed (or 11.5 grams). Additionally, Plaintiffs allege that the products contain even less biologically available protein because they contain lower value wheat and pea protein. Furthermore, the nutrition panel does not include the percent daily value of protein as required by federal (and parallel state) regulations when a protein claim is made. See 21 CFR § 101.9(c)(7)(i). And, the percent daily value is required to take into account not only the amino acid content, but also its PDCAAS score, which is a method of evaluating protein quality based on human amino acid requirements and amino acid digestibility.
  • Plaintiffs also allege that Defendants’ website and other marketing materials, which make numerous protein claims, “confirm” Defendants’ intent to mislead consumers regarding the protein content of their products. For example, the website states that “Combining the nourishment of whole grains with the benefits of high-quality protein just makes sense” and describes the products as “Protein Packed.”
  • Although not directly at issue here, the case serves as a reminder that internet marketing materials may be considered to be labeling by the FDA, particularly where the marketing materials explain or supplement the product and appear on a company website where the product may be directly purchased by consumers. Keller and Heckman will continue to monitor this case and other food litigation news.
  •  We have reported on FDA’s guidance document, “Inorganic Arsenic in Rice Cereals for Infants: Action Level Guidance for Industry,” which was finalized in August 2020 and sets an action level of 100 parts per billion (ppb) as the threshold for considering whether infant rice cereal may be “adulterated” and enforcement action is warranted.  A February 4, 2021 Congressional report on the finding of heavy metals in baby foods in the U.S. raised questions regarding compliance with FDA’s action level and, among other things, recommended the possibility of “phasing out” ingredients such as rice, that are high in toxic heavy metals.  As discussed here, the “Baby Food Safety Act of 2021,” was later introduced, on March 25, 2021, and would impose a lower action level of 15 ppb for inorganic arsenic in infant and toddler cereal.
  • In an April 29, 2021 press release, New York Attorney General Letitia James announced a new investigation into whether infant rice cereal products that are sold in New York contain arsenic at levels exceeding the legal maximum under the law and whether the advertising and promotion of the products complies with New York’s consumer protection laws.  Gerber Products Co., Beech-Nut Nutrition Co., Nurture Inc., and Hain Celestial Group Inc. were identified as targets of the probe.  This action follows Attorney General James’ February 9 2021 request urging FDA to set federal standards for toxic metals in all baby food categories and require all baby food manufacturers to test their finished products for toxic metals rather than testing just individual ingredients.
  • The recently announced NY investigation and U.S. congressional activity, as well as recent litigation (discussed here), involve complicated and multifaceted issues.  As discussed in Closer to Zero, the new FDA action plan released on April 8, 2021 for reducing exposure to toxic elements from foods eaten by babies and young children to as low as possible, FDA is simultaneously focused on avoiding unintended consequences, such as eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one toxic element while increasing another.
  • On April 23, 2021, the Center for Science in the Public Interest (CSPI) announced that it had worked together with companies, including Sara Lee® and Thomas’®, to ensure that the companies provide additional information quantifying their products’ whole grain content.  CSPI notes that this disclosure will help consumers make informed decisions about the grains they consume and enable them to build a diet that meets the U.S. Department of Agriculture’s (USDA) 50% whole grain recommendation.  USDA’s recently published 2020-2025 Dietary Guidelines for Americans recommend Americans consume half of their grains from whole grain sources and the remainder from enriched grains.
  • CSPI and the companies agreed that “whole grain” claims will be accompanied by a prominent disclosure of the percentage of the grains that are whole grains.  For example, the companies will present their claims along with percentages as follows: “Sara Lee® White Made with Whole Grain Bread (32%),” “Thomas’® Plain Made with Whole Grain Bagels (25%),” and “Thomas’® Made with Whole Grain English Muffins (29%).”  Additionally, CSPI and the companies agreed that the words “made with” be more prominent (i.e., at least 75 percent as large as the words “whole grain”) when “made with whole grain” claims appear on the products.
  • In January 2021, CPSI also worked with Wonder Bread so that the company could provide additional information on its product labels that quantify the product’s whole grain content.
  • On April 29, 2021, the European Commission published a study considering the status of “new genomic techniques” (NGTs) under EU law. The study defined NGTs as techniques  for altering genetic material that have been developed since 2001 and considered the use of NGTs in plants, animals, and microorganisms in food, industrial, and pharmaceutical applications. The report concluded that the EU’s 2001 legislation on genetically modified organisms (GMOs) “is not fit for purpose for these innovative technologies” and that NGTs, such as CRISPR/Cas, have the potential to contribute to sustainable agriculture initiatives like the European Green Deal and the Farm to Fork Strategy.
  • The Council of the European Union commissioned the study following a controversial 2018 Court of Justice of the European Union (CJEU) ruling in Case C-528/16 that found organisms obtained by any technique that induces DNA mutagenesis are GMOs subject to the restrictions in its 2001 legislation. The ruling said that while techniques that have a long safety record can be exempt from the 2001 obligations, individual member states can decide for themselves whether to require these to be compliant with the law. Although the case did not directly address gene editing (which encompasses CRISPR/Cas), a distinct technology from mutagenesis, regulation over gene editing techniques was called into question.
  • The study clarifies that while organisms obtained through NGTs are subject to the 2001 GMO legislation, the current regulatory framework will stymie innovation, inhibit the EU from reaching its goals for a more resilient and sustainable food system, and put the EU at a competitive disadvantage. It explains that NGTs cover a diverse group of techniques and that a targeted regulatory framework considering the safety, risks, and uses of each technique will better serve the EU. While maintaining a cautionary tone, the report shed a more positive outlook on innovation in gene editing than past publications.
  • The Commission outlined its next steps in a letter to the Portuguese Presidency of the EU, which include initiation of a policy action on plants derived from targeted mutagenesis and cisgenesis and an accompanying impact assessment. It also stated that it will begin meeting with the European Parliament and stakeholders in meetings to gather opinions on proposed changes to the current regulatory framework. We will continue to monitor and report on developments.
  • On April 21, the Attorney General of Washington, DC, Karl A. Racine, filed a lawsuit against Beech-Nut Nutrition Company, one of the largest baby food manufacturers for “misleading parent-consumers about the health and safety of its products.” As stated in a press release, the DC Office of the Attorney General (OAG) alleged that Beech-Nut’s advertising violated the District’s consumer protection laws and misled parents that its baby food underwent the most stringent testing and was safe for babies when the food contained high levels of heavy metals. The OAG’s lawsuit seeks to stop Beech-Nut from engaging in these and similar violations, to obtain restitution damages for parent-consumers and their children, and to obtain civil penalties.
  • The OAG alleged that Beech-Nut violated DC’s Consumer Protection Procedures Act and harmed DC consumers by:
    • Misleading parents about the safety of its baby food;
    • Misrepresenting its testing practices; and
    • Falsely claiming to have high internal safety standards
  • As our readers know, the OAG’s lawsuit comes as a result of the congressional investigative report that found high levels of heavy metals in several brands of popular baby foods. Additionally, several baby food manufacturers have been hit with class action lawsuits that alleged consumer deception claims relating to the presence of heavy metals in baby foods. The FDA has responded with a plan, called Closer to Zero, to reduce exposure to toxic elements in baby foods.
  • Keller and Heckman will continue to monitor and report on any developments with the DC OAG lawsuit and other baby food-related lawsuits.
  • By way of background, on January 19, 2021, the Department of Health and Human Services (HHS) issued the final “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) rule which would have amended nearly all of the approximately 18,000 HHS regulations to add self-executing expiration dates.
  • Specifically, the final rule stated that “subject to certain [undefined] exceptions,” all regulations in Titles 21, 42, and 45 of the CFR would expire on the later of the following dates: (1) five years after the effective date of the rule [originally March 22, 2021 and later delayed to March 22, 2022], (2) ten years after the regulation’s promulgation, or (3) ten years after HHS assessed and (if required) reviewed the regulation to determine if the regulation should be rescinded or modified to minimize its impacts on small entities. And, because over 17,000 of HHS’s rules are more than five years old, to avoid expiration, the SUNSET rule would require the vast majority of these rules to be assessed in a time and resource intensive process within five years of the effective date of the rule. The rule was purportedly issued to “enhance the Department’s implementation of section 3(a) the Regulatory Flexibility Act (RFA),” which requires agencies to periodically review rules which have or will have a significant economic impact on a substantial number of small entities.
  • As we have previously blogged about, various entities filed a lawsuit alleging that, among other things, the SUNSET rule violated the RFA and the Administrative Procedure Act (APA).
  • On April 21, 2021, in response to the lawsuit, HHS stated in a stipulation seeking to stay the case (filed jointly with Plaintiffs) that it “anticipates issuing, in the coming months, a notice of proposed rulemaking repealing the SUNSET Rule.” Keller and Heckman will continue to report on any developments in the repeal of the SUNSET rule.
  •  Since the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the label of a food that contains an ingredient that is or contains protein from a “major food allergen” must declare the presence of the allergen in the manner described by the law.  Until last week, there were eight major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, designated by FALCPA in 2004 for special food allergy labeling because they account for over 90 percent of all documented food allergies in the U.S. and represents the foods most likely to result in severe or life-threatening reactions.
  • On April 23, 2021, President Biden signed into law the Food Allergy Safety, Treatment, Education and Research (FASTER) Act, making sesame the ninth allergen that must be declared in specific allergen labeling.  This change will apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023.  The new law (discussed here) also requires that FDA collect data on the prevalence of food allergies and prepare a report to Congress on the development of effective food allergy diagnostics, the prevention of food allergies, and the scientific criteria for defining a food or food ingredient as a “major food allergen.”  In this regard, while FDA has the authority to issue regulations requiring the disclosure of additives, such as spices and flavorings, that are, or contain, allergens other than the major food allergens, and a Citizen Petition was filed in November 2014, requesting that sesame be regulated similarly to other major allergens, by the end of last year, FDA had not yet moved beyond issuing a draft guidance, discussed here, for the voluntary disclosure of sesame as an allergen.
  • Consumer groups hope the FASTER Act of 2021 will lead to quicker expansion of the list of “major food allergens” the next time it becomes clear that an allergy is severe and prevalent in the U.S., and food that contains the allergen would not otherwise be required to disclose it as an ingredient.  According to a response from the Food Allergy Research & Education (FARE) organization, nearly 1.6 million Americans are allergic to sesame and will now be at less risk for death from accidental ingestion of food with sesame that was not listed on the food label.