• On April 26, 2024, USDA’s Food Safety and Inspection Service (FSIS) announced its final determination to declare Salmonella an adulterant in raw breaded stuffed chicken products. We blogged about the proposed determination when it was released in April 2023.
  • Under the determination, raw breaded stuffed chicken products will be deemed adulterated if they test positive for 1 colony forming unit (CFU) of Salmonella. FSIS will complete sampling and testing of raw chicken components prior to stuffing and breading to ensure establishments control Salmonella in the products. The determination and associated sampling and verification testing will become effective 12 months after publication in the Federal Register.
  • FSIS’s final determination is nearly identical to the proposal, with the exception of modifying the proposed sampling location to provide flexibility and lower costs for industry. In developing the proposal, FSIS considered data from outbreak investigations and consumer behavior research studies and determined that “the appropriate response to protect public health is to ensure that [raw] breaded stuffed chicken products contaminated with Salmonella at levels more likely to cause human illness are excluded from commerce.”
  • The final determination is scheduled to be published in the Federal Register on May 1, 2024. Keller and Heckman will continue to monitor this issue.
  • On April 25, 2024, the U.S. Department of Agriculture (USDA) published a final rule updating the long-term school nutrition requirements, based on the goals of the Dietary Guidelines for Americans, 2020-2025.  The final rule institutes the first cap on added sugar in school meals, but pulled back on proposed restrictions for sodium, milk, and refined grains that some public comments had claimed were unrealistic.
  • Starting in the 2025-2026 academic year, USDA will require schools to reduce the amount of added sugar in breakfast cereal to no more than 6 grams per dry ounce, in yogurt to no more than 2 grams per ounce, and in flavored milk to no more than 10 grams per 8 ounces or, when sold as a competitive food in middle and high schools, no more than 15 grams per 12 ounces.  Foods sold in schools outside of the school meal program are considered competitive foods.  Limits on added sugar in school meals will shift further during the 2027-2028 academic year to account for less than 10% of calories in one week.
  • The final rule does not limit grain-based desserts at breakfast as proposed last year.  However, USDA has stated that it “expects that schools will select grains with less added sugars to meet the weekly added sugars limit at breakfast.”
  • The final rule allows schools to continue to serve flavored milk.  In the proposed regulation, USDA proposed banning flavored milk for children in kindergarten through fifth grade, but stakeholders voiced fears that some children would not drink unflavored milk, leading to food waste and a decline in milk consumption.
  • Additionally, in its final rule, USDA decided to scale back and delay proposed sodium reduction targets in school meals.  Schools now have until the 2027-2028 school year to reduce sodium by 15% in lunches and by 10% in breakfasts from current levels, which vary in amount by grade level and meal.  Originally, USDA suggested schools reduce sodium by 10% year by year, beginning in the 2025-2026 through 2029-2030 school years.  USDA explained that it intended to give schools more time to meet the reduction target because it normally takes around three years for manufacturers to reformulate products.
  • Finally, USDA dropped its previous proposal which would require all grains served at schools to be whole grains except for one serving per week.  Instead, the final rule keeps the current standard requiring 80% of weekly grains offered in school meals be whole-grain rich, which is defined as “the grain content of a product is between 50 and 100% whole grain with any remaining grains being enriched.”
  • Last month, the U.S. District Court for the Southern District of New York dismissed a class-action lawsuit alleging that Snapple beverage products (e.g., Snapple Apple) were falsely and misleadingly labeled as “all natural” because they contained (1) vegetable and fruit juice concentrates added for color and (2) citric acid, which Plaintiffs alleged is commercially made by fermentation of Aspergillus niger and “recovered through numerous chemical reactions with synthetic mineral salts and reagents.”
  • In regard to the vegetable and fruit juice concentrates, Plaintiffs had conceded that they came from natural sources, but argued that an “all natural” claim was nevertheless misleading because FDA’s informal natural policy considers “natural” to preclude the inclusion of any color additive, regardless of source. The Court held that FDA’s regulations, and in particular its informal views, “are irrelevant or at least not dispositive when it comes to determining whether a reasonable consumer would be misled.” It also found it implausible that a reasonable consumer would distinguish fruit and vegetable concentrates added for color from similar concentrates not added for color. Finally, the Court held that “all natural” was an ambiguous phrase, that a reasonable consumer would “seek clarification elsewhere on the package,” and that the ingredient list dispelled any ambiguity.
  • In regard to the citric acid allegations, the Court held that generalized claims about the method of production were insufficient, and even if the claims were true, it would be not be dispositive because there were no claims that the finished citric acid product contained synthetic ingredients or differed from citric acid found in nature.
  • The case is one of many food litigation lawsuits filed by attorney Spencer Sheehan. 
  • A Greener World (AGW) submitted comments asking FSIS to issue an Advanced Notice of Proposed Rulemaking (ANPR) regarding a petition to define “free range” and “pasture-raised” claims on meat and poultry products. An ANPR would allow a broader range of stakeholder input on changes to the claims, which are currently confusing and often misused, according to AGW.
  • Perdue Farms submitted the petition in March 2023 requesting that FSIS promulgate regulations to separately define “free range” and “pasture-raised” claims for poultry products, as well as amend guidance on claims related to living and raising conditions to ensure they align with consumer expectations.
  • AGW stated in its comments that “pasture-raised” claims do not clearly inform consumers about production systems or living conditions and provide “no assurance of high-welfare or environmentally sustainable practices.” AGW says these claims should be clearly defined and third-party verified to ensure transparency and consistency. Further, “free range” is not synonymous with or equal to “pasture-raised,” and clarity is required for both claims. AGW advocated for USDA to pursue this clarity to meet consumer expectations for transparency and animal welfare “conducted in an open and deliberate process with robust public engagement and stakeholder consultation.”
  • In February 2024, five members of Congress also commented on the need for stakeholder engagement in defining these terms. Keller and Heckman will continue to monitor any updates regarding “free range” and “pasture-raised” claims on meat and poultry products.
  • The Supreme Court declined to review (Law360 subscription required) a First Circuit decision affirming dismissal of false advertising and consumer protection claims alleging that McNeil Nutritionals LLC misbranded Lactaid drug products as a dietary supplement. The lower court found that the FDA’s sole authority to enforce the Food, Drug, and Cosmetic Act (FDCA) preempts the state law claims.
  • Petitioners in the proposed class action claimed that Lactaid was labeled as a treatment for lactose intolerance in violation of federal regulations for labeling dietary supplements. According to the petition, the circuit court decision has “upset the delicate balance of federalism by failing to follow controlling Supreme Court precedents.” The petition referenced Medtronic, Inc. v. Lohr and Buckman Co. v. Plaintiffs’ Legal Comm., stating that those cases articulate that “’somewhat delicate balance’ between state sovereignty and the federal statutory scheme that Congress and this Court have so carefully established.”
  • The circuit decision employed a test in which a “complaint is preempted unless the conduct it pleads: (1) violates FDCA labeling requirements and (2) would also violate [state law claims] even if the FDCA did not exist.” The petition challenged this test as “illogical” and said that the case “presents this court with an opportunity to return the law of implied FDCA preemption to the land of sanity and certainty.”
  • The First Circuit held that “[b]ecause the FDCA doesn’t provide a private right of action, state law claims hinging on a theory that the targeted products violate the act are preempted.”
  • FDA is in the process of updating its regulatory definition of the term “healthy” when it appears as an implied nutrient content claim on food labels. See FDA’s proposed rule published in September 2022. The current criteria for healthy claims (21 CFR 317.363) include limits for amounts of fat, saturated fat, cholesterol, and sodium, and also require foods to contain at least 10% of the daily value (DV) of one or more of vitamin A, vitamin C, calcium, protein, or fiber. The proposed criteria would establish a more complicated framework in which foods would be required to (1) contain at least one of the food groups or subgroups recommended by the 2020-2024 Dietary Guidelines for Americans (food group equivalents) and (2) would set limits for added sugars, saturated fats, and sodium. The required food group equivalents and the nutrient limitations would depend on product category.
  • The 2024 Consolidated Appropriations Act, which was signed into law in March 2024, includes provisions dealing with the effective date of any final rule FDA issues in connection with this proposal. Specifically, the Appropriations Act states that (1) food manufacturers may continue to comply with FDA’s current requirements regarding the term “healthy” on food labels throughout the compliance date FDA provides in the final rule establishing new criteria, and (2) any food products manufactured and labeled as “healthy” during the compliance period FDA provides in that final rule shall not be directly or indirectly subject to any state-law requirements that are not identical to either the current or updated FDA requirements. See Section 745. We read this language, particularly the words “directly or indirectly,” as being intended to preempt any lawsuits that might target “healthy” claims under state consumer protection laws.
  • We will continue to monitor and report on the updated healthy rule.  
  • On April 8, 2024, the U.S. Food and Drug Administration (FDA) released data from a 2022-2023 sampling assignment to test imported honey for economically motivated adulteration (EMA).  The sampling was designed to identify products with undeclared sweeteners that are less expensive than honey, such as cane and corn syrups.
  • EMA occurs when a valuable ingredient or part of a food is intentionally let out, taken out, or substituted, or when a substance is added to a food to make it appear better or of greater value.  EMA is known by FDA to occur in other products as well, such as olive oil, seafood, juice, and spices.
  • The assignment was conducted between April 2022 and July 2023.  The Agency collected 107 samples of imported honey and found three samples (3%) to be violative.  This was a reduction from the 10% violative samples found in imported honey in the previous 2021-2022 study.
  • When FDA finds a violative sample, the product is refused entry into the US and the associated company and product are put on Import Alert (IA).  The Agency states that it continues to develop methods to further improve the detection of undeclared sweeteners in honey.
  • On April 3, 2024, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.”  See 89 Fed. Reg. 23599 (Apr. 4, 2024). The draft guidance was published as a response to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications (NDINS).  The recommendations in the guidance expand upon and replace the recommendations concerning Master Files in FDA’s revised draft guidance “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues“.
  • Although NDIN Master Files are not required by statute or regulation, they can be used to facilitate the submission of NDI-related identity, manufacturing, and/or safety information to FDA for use in evaluating a potential future NDIN.  The intent of the guidance is to help industry comply more easily with the NDIN requirement by providing recommendations on the content, submission, and use of Master Files.
  • Although some or all of the data in an NDIN Master File may be trade secret information6 or confidential commercial information (CCI) (and generally exempt from public disclosure), there is no presumption that any particular information in the Master File is trade secret information or CCI.  A determination of whether specific data and information in an NDIN Master File is exempt from public disclosure is based on the status of the data and information under the Freedom of Information Act (FOIA) and FDA disclosure regulations at 21 CFR part 20, rather than on the type of file in which the data and information is stored.
  • Comments may be submitted by June 4, 2024. Keller and Heckman LLP will continue to monitor any developments in the dietary supplement space.
  • Last month FDA issued a final rule revoking the standard of identity (SOI) for frozen (and unbaked) cherry pie in 21 CFR 152.126. The final rule comes more than three years after FDA issued a proposed rule revoking the SOI in response to a citizen petition filed by the American Bakers Association.  
  • FDA’s authority to issue and/or revoke SOIs stems from Section 401 of the Federal Food, Drug, and Cosmetic Act (codified at 21 USC 341) which directs FDA to issue SOIs whenever “such action will promote honest and fair dealing.”
  • FDA determined that the SOI for frozen cherry pie was no longer necessary to promote honest and fair dealing and that its revocation would provide flexibility to manufacturers. FDA also reasoned that frozen cherry pie was the only standardized pie, and there was no reason to single it out. Indeed, even non-frozen cherry pies and baked, frozen cherry pies are not subject to any SOI. It also noted that the SOI does not allow for the use of artificial sweeteners and that this restriction was inconsistent with consumer interest in reduced-sugar products.
  • This action is part of FDA’s broader goal of updating SOIs to support innovation and production, including of healthier foods. Other current and proposed updates to SOIs can be found at FDA’s SOI webpage.
  • In March 2024, USDA’s Food Safety Inspection Service (FSIS) issued a revised guidance document to help establishments determine whether their labels must be submitted for approval. The revised guidance includes information about voluntary U.S.-origin labeling claims based on a final rule defining the conditions under which FSIS-regulated products may bear these claims.
  • On March 18, 2024, FSIS published the final rule “Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims.” The final rule amends FSIS labeling regulations at 9 CFR Parts 317, 381, and 412 by specifically defining the claims “Product of USA” and “Made in the USA.” These two claims will be generically approved for use on single ingredient FSIS-regulated products derived from animals born, raised, slaughtered, and processed in the U.S., as well as on multi-ingredient products if all FSIS-regulated products are (1) derived from animals meeting the U.S. origin requirement, (2) all other ingredients other than spices or flavorings originate in the U.S., and (3) the preparation and processing steps occur in the U.S. In addition, other label claims that indicate a preparation or processing step of a FSIS-regulated product occurred in the U.S. will be generically approved for use as long as they indicate the steps upon which the claim is made. Use of the U.S. flag or a U.S. State or Territory flag will be deemed to be a claim indicating the product’s origin and must meet the same requirements.
  • The revised guidance document includes a new section that explains the requirements for voluntary use of the defined claims, as well as other U.S.-origin label claims related to the product’s preparation and processing.
  • In addition to U.S.-origin labeling guidance, the document includes new label examples with special statements and claims that require FSIS approval before they can be used on labels of products in commerce, such as claims about verification programs, animal production methods, and breed claims, as well as factual statements that do not require approval, such as “authentic,” “gluten free,” and certain negative claims.