• 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  • On April 3, 2024, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.”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 The draft guidance was published as a response to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary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recommendations in the guidance expand upon and replace the recommendations concerning Master Files in FDA’s revised draft guidance “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues“.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.
  • Gerber filed a memorandum (Law360 subscription required) in support of its motion to dismiss a proposed class action that claimed the company had falsely advertised its baby food snack products as containing “no preservatives” even though they contained vitamin C. According to the lawsuit filed in November of 2023, the products were marketed in a misleading manner by bearing a label claim that they do not contain preservatives and listing the ingredient as “Vitamin C (Ascorbic Acid).” The plaintiffs allege that vitamin C is a preservative regardless of whether it is added to preserve the food or for some other purpose.
  • Ascorbic acid is generally recognized as safe for use in human food as both a chemical preservative and a nutrient. According to Gerber, the complaint is preempted because it conflicts with FDA’s regulatory scheme, “which does not require an ingredient to be labeled as a preservative unless it serves a preservative function.” Gerber claimed that vitamin C is used to fortify the products nutritionally, which are preserved through freeze drying, eliminating the need for further preservatives.
  • Gerber stated that consumers could not have been deceived by the “no preservatives” label since there is no ingredient in the products functioning as a preservative. It argued that it is “fanciful, illogical, and insufficient” to support a deception claim based on the theory that “no preservatives” should be interpreted to mean that there are no ingredients that could possibly function as a preservative, even if that is not their intended use.
  • This is one more case in a string of recent lawsuits challenging “no preservative” claims on products that contain ingredients that could function as a preservative. Keller and Heckman has previously blogged on and will continue to monitor these lawsuits.
  • On March 18, 2024, Pennsylvania became the latest state to propose a ban of several food additives, citing alleged safety.
  • Pennsylvania’s HB 2116 proposes to ban the use of the following color additives: red 3, red 40, yellow 5, yellow 6, blue 1, and blue 2.  As a companion bill, HB 2117 would prohibit the use of potassium bromate, brominated vegetable oil, and butylated hydroxyanisole.
  • As we have previously reported, California passed AB 418 in 2023, which bans the use of brominated vegetable oil, potassium bromate, propylparaben, and red 3 in any food product and goes into effect in 2027.  AB 418 originally proposed to ban titanium dioxide as well, but it was removed from the scope of this legislation by the state Senate on September 1, 2023 before reaching the Governor’s desk.   Other states have followed suit in proposing to ban these AB 418 substances (see Illinois’ SB 2637, New York’s S60551A, and New Jersey’s A5436, though California’s AB 418 is the only one yet to pass).  Titanium dioxide is also included in New York’s and New Jersey’s bills. 
  • Recently, California also proposed AB 2316, which would prohibit all public schools from offering, selling, or otherwise providing any food containing the following color additives: blue 1, blue 2, green 3, red 40, yellow 5, yellow 6, and titanium dioxide. 
  • In response to Pennsylvania’s legislation, the National Confectioners Association (NCA) has emphasized that the substances in question are cleared by the U.S. Food and Drug Administration (FDA).  NCA recently called on FDA to push back on state-by-state food safety policy and “assert its authority as the rightful national regulatory decision maker and leader in food safety.”
  • Keller and Heckman will continue to monitor and relay any developments in the food additive space.
  • On March 19, 2024, FDA issued Import Alert 99-49 (“Detention without Physical Examination of Foods Due to Chemical Contamination”), which recommends that FDA field personnel detain without physical examination products offered for import that have previously been found to be contaminated with harmful levels of chemicals, including PFAS.
  • FDA is authorized to refuse admission to food products if the articles appear to violate the Federal Food, Drug, and Cosmetic Act (the “Act”); physical examination is not necessary (21 USC § 381).
  • Companies which have been found to offer violative products for import will have their products added to the import alert’s “Red List,” subjecting future imports of those products to detention without physical examination. Once a product is subject to an import alert, the burden is on the importer to demonstrate to FDA that the product does not violate the Act.
  • It is not clear to what extent FDA will be testing imported food products for chemical contamination, including whether it will focus on particular product types.
  • Keller and Heckman is tracking the regulation of PFAS in various jurisdictions around the world and can assist companies in responding to concerns about PFAS in food and food packaging.
  • On March 15, 2024, the Consumer Brands Association (CBA) filed an amicus brief (Law360 subscription required) urging the 9th Circuit to keep a federal labeling rule allowing digital disclosure of genetic modifications to foods. The brief, which follows two similar briefs filed earlier in March by the federal government and sugar industry groups, tells the court that it “should not disturb” a 2022 ruling that left the National Bioengineered Food Disclosure Standard regulations largely intact after the rule was challenged by organic food organizations.
  • CBA’s SmartLabel tool is one program that is used widely on packaged goods to provide access to supplemental product information through a QR code. According to the amicus brief, vacating the digital disclosure provision of the regulations would instantly render millions of packages of food non-compliant, disrupt the manufacturing process, and delay the release of products while labels are revised. In addition, “any such instant change would threaten consumers’ access to safe, nutritious, and affordable foods and risk confusing consumers who . . . have increasingly begun to rely on digital disclosures.”
  • In the original lawsuit, filed in 2020, food advocacy groups claimed USDA’s rule was arbitrary and capricious because it did not deliver on the aims of the National Bioengineered Food Disclosure Act and that portions of the rule violated the First, Fifth, and Tenth amendments by limiting allowed disclosures and preempting state laws requiring additional disclosures.
  • CBA argued that the advocacy groups’ position that consumers would have difficulty accessing digital disclosures is incorrect since consumers have increased internet access and technological literacy, a telephone disclosure is also required, and the digital option reduces “the impact of over-warning on products.” According to CBA, vacating the rule could, in fact, further reduce consumer access to the information required by the disclosure rule while USDA amends the regulations. CBA also refuted the contention that there would be minimal industry disruption, claiming that an immediate change would leave food companies scrambling to interpret the court’s decision and that it would be impossible to make immediate packaging changes.