• On September 25, 2024, FDA will hold a public meeting on the development of an enhanced systematic process for post-market assessment of chemicals in food. The Agency intends to share its plans and hear stakeholder perspectives on the proposal to help inform its thinking and further development of the process.
  • The post-market assessment process will include ingredients considered generally recognized as safe, food additives, color additives, food contact substances, and contaminants. The process is intended to be transparent in identifying and prioritizing safety reviews of food chemicals currently in the market.
  • This project is part of a larger enhanced approach for food chemical safety, which involves three key areas with corresponding objectives that complement existing food chemical safety monitoring programs, including:
    • Expanding tools and methods used when conducting safety reviews and assessments to keep pace with scientific advances and technological innovations;
    • Updating process to identify, evaluate, prioritize, and communicate new and evolving information to determine if reassessment of a chemical is warranted; and
    • Continuing to monitor the food supply to ensure chemicals in food are present at levels that are not a risk to public health.
  • The public meeting will have limited in-person attendance and virtual attendance. Information about how to register will be available later in August on the meeting page. Keller and Heckman will provide updates on the meeting and future FDA activity related to the assessment of chemicals in food.
  • The EU has seen a record number of potential fraud, safety, and mislabeling cases involving olive oil so far this year as demand increases for what is considered a kitchen staple. 
  • Cost of olive oil has more than doubled since 2018, according to the Office for National Statistics, following seasons of massive heat spikes and other factors impacting industry.  Along with prices, the number of cross-border EU notifications has increased, addressing mislabeling, potential fraud, and safety cases involving contaminated oil.
  • In the first quarter of 2018, 15 cases were recorded by the EU.  This year, 50 such cases were recorded in the first three months of the year, more than a threefold increase, according to data released to The Guardian.
  • There were many cases where extra virgin olive oil was found to be adulterated by mixing poorer quality oils, cases where virgin olive oil was labeled extra virgin (a more premium, unrefined oil with lower acidity), and cases of misleading or false origin labeling.
  • In 2022, the EU introduced new regulations addressing conformity checks of marketing standards for olive oil, as well as methods for analyzing the product.
  • Keller and Heckman will continue to monitor and relay any developments in these types of cases.
  • For additional discussion and background on food fraud, we have also published a new K&H Food & Chemicals Unpacked podcast, featuring our attorneys discussing the history and global scale of food fraud and economic adulteration (available on Spotify and Apple Podcasts).
  • On July 8, 2024, the U.S. District Court for the Central District of California granted partial summary judgment in favor of the Plaintiffs and held that a “Manufactured in the USA 100%” claim on Defendant Bigelow’s tea bag products was materially false. See Order (Law360 subscription required). The issue of material falsity was common to the class-certified claims Plaintiffs brought under California law (fraud, misrepresentation, breach of express warranty, and violation of the CA Consumer Legal Remedies Act).
  • The tea bag products at issue were blended and packaged in the United States, but the tea leaves were imported from abroad. Furthermore, the tea leaves were processed abroad “in order to be consumable and suitable for use in commercial tea products.” The Defendants argued that the claim was true because it referred to the tea bags (mixed and packaged in the United States) and not the tea leaves.
  • The Court rejected this argument because consumers purchase tea bags for the tea leaves, and it was not disputed that the tea leaves were processed abroad. For reasons not clear in the opinion, Plaintiffs did not pursue a claim under CA Bus. & Prof. Code Section 17533.7, which makes unlawful a “made in the USA” or similar claim where an “article, unit, or part thereof, has been entirely or substantially made, manufactured, or produced outside of the United States.” However, the Court found it appropriate to rely on that section because there was “no substantive difference between the terms ‘made’ and ‘manufactured’” for the purpose of its legal analysis.
  • The Court also held that the claim was material as a matter of law because it was proscribed by the legislature.
  • On July 29, 2024, USDA issued a proposed rule and determination to more effectively reduce Salmonella contamination in raw poultry products. This follows a final determination to declare Salmonella an adulterant when it is present at more than 1 colony forming unit (CFU) per gram that was published in May 2024.
  • The proposed rule would establish standards to prevent raw poultry products that contain any type of Salmonella at or above 10 CFU and certain serotypes of Salmonella at any detectable level from entering commerce. The proposed Salmonella serotypes of public health significance identified for raw chicken include Enteritidis, Typhimurium, and I 4,[5],12:i:- ; and for raw turkey include Hadar, Typhimurium, and Muenchen. According to the proposal, these are the most highly virulent Salmonella serotypes associated with these products identified in FSIS chicken and turkey risk assessments. FSIS expects that the serotypes of public health significance will likely change over time.
  • The proposal would also require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination throughout the slaughter system. FSIS is proposing to amend recordkeeping requirements so that sampling results may be submitted electronically, and the Agency is developing a web portal and templates to aid establishments in recording and submitting monthly results.
  • FSIS has been working to gather data and develop the Salmonella framework since 2021. The proposed rule has not yet been published in the Federal Register, but comments will be accepted for 60 days following publication.
  • Keller and Heckman will continue to monitor and report on this proposed rule.
  • On July 24, 2024, the U.S. Food and Drug Administration (FDA) published its new web page that discusses microplastics and nanoplastics in food.  The new page includes information on what is known about the health effects of microplastics and nanoplastics in foods and presents information about the FDA’s efforts to monitor the research on microplastics and nanoplastics in the food supply while working to advance the science through analysis of testing methodologies and other related work.
  • FDA notes that “some evidence suggests microplastics and nanoplastics are entering the food supply, primarily through the environment… current scientific evidence does not demonstrate that levels of microplastics or nanoplastics detected in foods pose a risk to human health.”  Notably, the page also states that “the presence of environmentally derived microplastics and nanoplastics in food alone does not indicate a risk and does not violate FDA regulations unless it creates a health concern.”
  • The web page includes drop-down menus that discuss health, scientific, and regulatory information surrounding macroplastics and nanoplastics.  FDA will continue to update the page as more research is conducted. 
  • FDA states that if it determines that macroplastics and nanoplastics in food do in fact adversely affect human health, regulatory action will be taken.
  • Keller and Heckman will continue to relay regulatory updates in this area.
  • Last month the U.S. Circuit Court of Appeals for the 9th Circuit reversed a lower court decision and held that claims based on the California Sherman Law, the CA equivalent of the federal Food, Drug, and Cosmetic Act (FDCA), were not preempted, even where the relevant provision in the Sherman Law merely incorporated federal labeling standards.
  • The products at issue were marketed to children under two and contained nutrient content claims in violation of federal regulations which were incorporated into the Sherman law. The relevant federal regulation (21 CFR 101.13(b)(3)) prohibits most nutrient content claims on food products intended for children under the age of two. This and all other federal labeling regulations are incorporated into California law by California Health & Safety Code Section 110100(a). 
  • There is no private right of action to enforce the FDCA and it is enforced by the federal government except in certain delineated instances in which states (but not private parties) are authorized to enforce it (21 USC 337). The lower court had held that this provision impliedly preempted private enforcement of state law claims which were identical to claims alleging that the FDCA had been violated.
  • The 9th Circuit reversed this decision, reasoning that while the FDCA prohibits states from establishing nutrition labeling requirements that are “not identical” to the federal standards (21 USC 343-1) and does not permit private enforcement of the FDCA, it nowhere prohibits private enforcement of identical state laws. Although the Court found that it was unambiguous that 21 USC 337 permits private enforcement of identical state laws, it noted that even if there had been “some doubt” as to this interpretation, it would have come to same conclusion based on the presumption that “the historic police powers of the States are not preempted unless that was the clear and manifest purpose of Congress.”
  • USDA’s Food Safety and Inspection Service (FSIS) will begin testing products for the presence of allergens in its new allergen verification sampling program. The sampling will occur at establishments that produce ready-to-eat products with labeling that claims the absence of at least one of 14 food allergens, including soy, crustacean shellfish, eggs, peanuts, milk, almond, Brazil nut, cashew, coconut, hazelnut, macadamia, pine nut, pistachio, and walnut. FSIS will also test for gluten and intends to expand the program to include sesame.
  • According to the FSIS website, unreported allergens make up 37% of recalls of FSIS-inspected products, with 12 recalls for unreported allergens so far in 2024. FSIS is implementing this program to expand its industry compliance verification by significantly expanding and replacing the current soy testing program, broadening the scope to include multiple allergens. FSIS aims to ensure the accuracy of labeling claims in ready-to-eat products, which will enhance consumer safety.
  • FSIS intends to issue instructions to inspection program personnel by July 26, 2024. In addition to the new sampling program, USDA is working to increase allergen awareness with food safety and allergen tips for parents and caregivers.
  • Keller and Heckman will continue to monitor and provide updates on the allergen verification sampling program and other allergen awareness initiatives from USDA and FDA.
  • Last month, the U.S. Food and Drug Administration released the findings of a groundbreaking study confirming that pasteurization is effective in killing the bird flu virus in milk and other dairy products.  The study was conducted as part of ongoing efforts to ensure the safety of milk amid growing concerns about the expanding outbreak of H5N1 Highly Pathogenic Avian Influenza (HPAI).
  • The study simulated, for the first time, the exact time and temperature used in commercial milk pasteurization and demonstrated that conditions for pasteurization widely used by producers effectively inactivated the HPAI virus, even in raw milk samples that contained higher than usual concentrations of the virus.  In all 297 samples of milk and dairy products collected for the study, HPAI was inactivated after pasteurization.
  • Currently, federal law states that all milk and milk products in final package form intended for direct human consumption must be pasteurized, though there has been recent state action that would allow unpasteurized milk in the marketplace.  As we previously reported, Michigan (HB 5603) and West Virginia (HB 4911) have proposed allowing the sale of unpasteurized, raw milk within their respective states.  Delaware has also passed legislation (SB 273), since our last reporting, that would legalize the sale of unpasteurized, unprocessed milk directly from dairy producers to consumers.
  • Keller and Heckman will continue to monitor and relay any industry developments.
  • Earlier this month, the White House’s Office of Information and Regulatory Affairs (OIRA) announced the release of the 2024 Spring Unified Regulatory Agenda. The unified agenda, which is published twice a year, summarizes agencies’ proposed timelines for anticipated regulatory actions, although the timelines are subject to change and are frequently inaccurate, particularly in election years.
  • FDA’s proposed regulatory actions in the spring agenda include a proposed rule which, “if finalized, would provide by regulation that an ingredient is not excluded from the dietary supplement definition” (0910-AI91).  Although the ingredient is not referenced in the regulatory agenda, it is widely believed that the referenced ingredient is N-acetyl-L-cysteine. As we previously reported, FDA previously concluded N-acetyl-L-cysteine was excluded from the definition of a dietary supplement based on its use as a drug but would be subject to enforcement discretion pending a decision on whether to allow for its use through the issuance of a regulation.
  • Among FDA’s many other proposed actions are a proposed rule regarding front of pack nutrition labeling (0910-AI80); changes to standards of identity (SOI), including a proposed rule to modernize the SOI for maple syrup (0910-AI96) and a proposed rule to modernize the way in which changes to SOIs are considered (0910-AI79); a proposed rule to change certain written assurance provisions in the HARPC rules (0910-AH77); a final rule for the definition of “healthy” (0910-AI13); and a final rule regarding soy protein and coronary heart disease health claims (0910-AH43).
  • Notable actions on USDA’s regulatory agenda include a proposed rule to establish requirements for labeling of meat or poultry products made using animal cell-culture technology (0583-AD89) and a proposed rule to establish a new framework to reduce Salmonella illness associated with poultry products (0583-AD96).
  • The Second Circuit vacated a New York federal court dismissal of a complaint regarding a misleading cracker box label (Law360 subscription required).  According to the Second Circuit, the district court erred in dismissing Venticinque v. Back to Nature Foods Company, LLC because the plaintiff “has pleaded sufficient factual allegations to state a plausible claim” under the New York General Business Law.
  • The proposed class action was initially filed in November 2022, alleging that consumers were “duped into purchasing” Back to Nature Food Co.’s organic stoneground wheat crackers. Advertising of the crackers emphasized organic whole wheat flour, although the primary ingredient in the crackers is unbleached enriched white flour. According to the plaintiff, she paid a premium for the product compared to a similar cracker that did not advertise organic whole wheat flour.
  • The Second Circuit relied on Mantikas v. Kellogg, a similar dispute over a box of Cheez-It crackers that were advertised as “made with whole grain” even though the primary ingredient was “enriched white flour.” According to that decision, a reasonable consumer could plausibly understand a label with “large, bold-faced claims of ‘WHOLE GRAIN’” to mean that whole grain is the predominant ingredient because consumers likely understand that crackers are typically made with grain, whereas a claim of “made with real vegetables” on a cracker box would not likely lead the same consumer to believe the cracker is made predominantly of vegetables. Context is crucial in determining whether advertising may be misleading, according to the court.
  • Because the Back to Nature cracker package implies that whole grain is the primary ingredient in a similar way to the package in Mantikas, the court determined that the allegations were sufficient to state a claim and remanded to the district court for further proceedings.
  • Keller and Heckman will continue to monitor and provide updates on this case and other food litigation developments.