• 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.
  • In recent proposed legislation, Michigan (HB 5603) and West Virginia (HB 4911) have proposed allowing the sale of unpasteurized, raw milk within their respective states.  The Michigan bill is currently stalled in committee, while the West Virginia bill has been approved without the governor’s signature.
  • Currently, federal law prohibits dairies from distributing raw milk across state lines in final package form, and many states have full or partial bans on its sale within their borders.
  • Michigan’s HB 5603 was first introduced on the House floor March 24, 2024.  Under the proposed legislation, unpasteurized, raw milk may be sold to a final consumer or retail establishment in Michigan if the raw milk and raw dairy products comply with specific criteria.  This includes a warning that must be placed on the labels of covered products: “WARNING: unpasteurized milk and dairy products may contain disease-causing microorganisms. Individuals at the highest risk of disease from these microorganisms include newborns and infants; the elderly; pregnant women; individuals taking corticosteroids, antibiotics, or antacids; and individuals with a chronic illness or another condition that weakens immunity.”
  • West Virginia’s HB 4911 legalizes the sale of raw milk as long as the containers are clearly labeled as “unpasteurized raw milk” along with the seller’s name, address, the date of production, and a warning that “Consuming unpasteurized raw milk may increase your risk of foodborne illness, especially for children, elderly, immunocompromised individuals, and persons with certain medical conditions.”  The final version of the law does not include an originally proposed provision that would have made sellers of raw milk immune to lawsuit and liability for claims related to personal injury for actual or alleged act, error or omission that occurred as long as the act was not intentional.  The bill will become law 90 days after the legislature approved it on March 9, 2024.
  • Earlier this month, the Federal Trade Commission (FTC) released a report which analyzes market factors contributing to the infant formula market disruptions that occurred in 2022 following the recall of infant formula manufactured at Abbot’s Sturgis, Michigan manufacturing facility due to potential bacterial contamination.
  • The report describes how the U.S. infant formula market has been highly concentrated among only a few manufactures for decades; primarily Abbot, Mead Johnson (owned by Reckitt Benckiser), Perrigo (owns PBM Holdings), and Nestle (which sold the U.S. and Canadian rights to Gerber Good Start brand to Perrigo along with its Wisconsin manufacturing facility). The report also discusses two principal factors which have contributed to market concentration.
  • One factor is the single-rebate system used in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program. The WIC program, which is administered by USDA through state agencies, offers assistance, including nutritional assistance, to certain at-risk individuals. In 2018 56% of the infant formula sold in the U.S. was purchased by WIC participants. Infant formula purchased through WIC is heavily discounted because individual states negotiate significant rebates (averaging 92% of the wholesale price of infant formula in 2013) in exchange for market exclusivity within the state’s WIC program. These WIC-exclusivity agreements have spill-over effects in the broader infant formula market and dramatic (≈ 90%) increases or decreases in market share have been seen following the gain or loss of a WIC contract.
  • The report also discusses FDA’s extensive regulation of infant formula as a second factor contributing to market consolidation by acting as a barrier to entry. Infant formula must be of “sufficient biological quality” and must support growth, demonstration of which typically requires a specific 15-week preclinical study. Among the other requirements, new infant formula submissions are also required at least 90 days before marketing the formula.
  • The report is written in a neutral manner which details the primary factors contributing to the consolidation of the infant formula market, but acknowledges that these factors also have positive impacts (e.g., lower infant formula prices for WIC participants), and does not offer any recommendations.