• 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.
  • The new guidance reiterates the FTC’s position that unqualified “Made in the USA” claims require “all or virtually all” U.S. content and processing. In determining whether this standard is met, the FTC considers the percentage of a product’s total costs that come from domestic parts and processing, “how far removed any foreign content is from the finished product,” and “the importance of the foreign content to the product’s form or function.”
  • The Labeling Rule, which is specific to unqualified “Made in the USA” claims, never actually discusses “the importance of the foreign content.” However, that concept has long been part of enforcement and closing letters. This new addition to the guidance, thus, should be a welcome reminder to companies, making compliance a little easier.
  • As the new guidance reiterates, qualified claims like “Made in USA of U.S. and imported parts” may also be used as long as a few requirements are met. First, the product’s “last substantial transformation,” as defined by U.S. Customs standards, must have occurred in the U.S. Second, any U.S.-claimed parts or processing must meet the “all or virtually all” standard. Finally, and this is where it gets a little tough, U.S.-claimed parts or processing must be at a level that is either more than “negligible” or, possibly, “significant.” A longstanding example from prior guidance discusses the parts of a treadmill to demonstrate that the U.S. content must be more than “negligible” – with negligible in that instance being “only three percent of the total cost of all the parts.” The new guidance substantially repeats the same example, but with introductory language suggesting the example means that there must be a “significant amount of U.S. content or U.S. processing.” No further information is given on what “significant” might mean.
  • As with many guidance documents that the FTC has released in recent years, companies are well-advised to be aware of where the FTC appears to be increasing pressure, even if new, stricter stances do not always align well with case law or, as in this case, even the FTC’s own prior guidance. Examples of guidance documents with similar new stances include the 2023 updated Endorsement Guides, with new stances on “clear and conspicuous,” and the 2022 Health Products Compliance Guidance. Keller and Heckman will continue to monitor developments on FTC guidance, including “Made in USA” standards.
  • Last month the U.S. District Court for the Western District of Oklahoma dismissed for lack of standing an amended complaint filed by the Plant Based Foods Association (PBFA) and the Tofurky Company challenging the “Oklahoma Meat Consumer Protection Act” (the “Act”). The Court had previously dismissed an earlier iteration of the lawsuit.
  • The Act prohibits any person “advertising, offering for sale or selling meat” from “misrepresenting a product as meat that is not derived from harvested production livestock,” but indicates that plant-based meat products do not violate the Act so long as their packaging bears a disclosure that the product is derived from plants. “Meat” is defined as “any edible portion of livestock or part thereof.”
  • The Court recited the well-known tenants of Article III standing. Namely, a plaintiff must demonstrate (1) injury in fact, (2) causation between the injury and the challenged conduct, and (3) that a favorable decision would be likely to redress the injury.
  • The Court held that Defendants could not demonstrate injury because the Act’s text literally only applied to persons “advertising, offering for sale or selling meat,” the definition of “meat” did not encompass plant-based meat products, and Defendants (including PBFA’s members) could not show that they sold meat. Although the Court recognized that this construction was clearly inconsistent with the Act’s intent to prevent misleading marketing of plant-based meat products, it stated that the task of re-writing the statute was for the legislature.
  • The Court also held that causation could not be established because neither of the Defendants (the OK Governor and the OK Commissioner of Agriculture) had the authority to enforce the Act. The State Board of Agriculture was charged with enforcing the law and the Commissioner was only one member of the Board. Furthermore, the Court held that OK does not have a unitary executive and the governor of OK is not charged with enforcement (unlike many other states). Finally, the redressability element was not met where there was no power to enforce the Act. 
  • Health Canada is proposing to permit the sale of foods derived from somatic cell nuclear transfer (SCNT) cloned cattle and swine and their offspring without pre-market notification (other species such as goats, sheep, etc., will continue to be subject to mandatory pre-market safety assessment). Currently, SCNT animal clones and their offspring are considered novel foods and are subject to pre-manufacture and import assessment requirements under the New Substances Notification Regulations (Organisms).
  • SCNT is a reproductive animal cloning technique that involves replacing the nucleus of an unfertilized egg cell with the nucleus of a somatic cell from another animal to form an embryo. The embryo is transferred to a surrogate to develop until birth, and the animal will have the same genetic makeup as the genetic donor animal. The technique is used to create copies of animals with desirable traits, such as disease resistance and meat or milk quality.
  • Health Canada created an interim policy on SCNT clones in 2003 when the technology was still in the research and development stage. Since then, Health Canada has worked with other agencies to evaluate the scientific evidence regarding the safety of SCNT cattle and swine clones, resulting in the development of the Scientific Opinion on the Impact of Somatic Cell Nuclear Transfer (SCNT) Cloning of Cattle and Swine on Food and Feed Safety, Animal Health and the Environment (2023). The scientific opinion concluded that food from SCNT clones and their offspring is as safe as food from traditionally bred animals. Therefore, Health Canada determined these foods should be regulated in the same manner as those from traditionally bred animals.
  • Recently, Health Canada accepted comments on the revised policy proposal, and the Agency will consider all science-based comments received before publishing a final report, which is expected in Fall of 2024.
  • Keller and Heckman will continue to monitor this proposal and other developments related to food from cloned animals.
  • Last month Chobani petitioned FDA to amend the standard of identity (SOI) for yogurt (21 CFR 131.200) to include ultrafiltered nonfat milk as a basic dairy ingredient. Currently, ultrafiltered milk is only permitted for more limited use as an optional dairy ingredient pursuant to the paragraph (c) provision allowing for other “safe and suitable milk-derived ingredients.”
  • Although the yogurt SOI has been modified in a number of ways over the past few years, FDA previously rejected Chobani’s request regarding the addition of ultrafiltered milk as a basic dairy ingredient, citing an absence of supporting data. However, the agency indicated a willingness to consider the request in future and granted Chobani a temporary marketing permit (TMP) to collect additional data. Chobani’s new petition is supported by data and information obtained during its TMP period. 
  • Chobani’s petition aims to address the previously identified data gaps and argues that the use of ultrafiltered nonfat milk as a basic ingredient:
    • Does not alter the basic nature and essential characteristics of yogurt.Modernizes the SOI and allows manufacturers additional flexibility and efficiency.Benefits consumers by providing them with a high protein, low-sugar and lactose-free option.
    • Is consistent with international standards and FDA policy with other dairy products (e.g., standardized cheeses) and would advance FDA’s nutrition policy which seeks to reduce the population’s sugar intake.  
  • We will continue to monitor and report on this petition and other efforts to modernize SOIs.
  • FDA will publish a rule revoking the existing food additive authorization for brominated vegetable oil (BVO) on July 3, 2024. BVO is a mixture of vegetable oils (generally corn, cottonseed, olive, and soybean) that has been modified with bromine. It has been used as a flavoring oil stabilizer and emulsifier since the 1920s and is primarily used in citrus-flavored soft drinks. We previously blogged about the proposed rule, which was published November 2, 2023.
  • In 1970, FDA removed BVO from the codified list of generally recognized as safe (GRAS) substances and established an interim food additive regulation, later codified at 21 CFR 180.30. The initial authorization was for a 3-year basis and then expanded indefinitely to allow completion of subsequent safety studies. In 2014, FDA determined the existing data on BVO did not provide evidence of a health threat but that there were deficiencies in the existing studies and many studies did not clearly establish safe levels of chronic use. In 2022, the National Center for Toxicological Research published new rodent safety studies that confirmed dietary exposure to BVO results in bioaccumulation of bromine and toxic effects on the thyroid, a gland that produces hormones that play a key role in regulating blood pressure, body temperature, heart rate, metabolism, and the reaction of the body to other hormones.
  • FDA received more than 40 comments to the proposed rule, all of which supported revoking the authorization for BVO, with some urging the Agency to take action against other potentially harmful substances. The rule will become effective 30 days after it is published in the Federal Register. To allow sufficient time for companies to reformulate, relabel, and deplete the inventory of BVO-containing products, the compliance date will be 1 year after the effective date.  
  • This rule follows California’s AB 418, which was passed in October 2023 to prohibit BVO and other chemicals in food. However, the BVO revocation has been on FDA’s regulatory agenda since the spring of 2023.
  • Keller and Heckman will continue to monitor and provide updates on FDA’s review of food additives.