• FDA updated its infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The program comprehensively outlines the agency’s approach towards inspections, sample collection, sample analysis, and compliance activities to help ensure infant formula products in the US are safe and nutritious.
  • As our readers know, in September 2022, FDA published its internal evaluation of the infant formula response which identified five major areas of need to ensure the safety of the food supply. Specifically, the evaluation found that FDA’s infant formula compliance program lacked specificity regarding Cranobacter and is limited by scientific gaps related to this pathogen. The evaluation recommended that FDA review and update its compliance program and associated Compliance Policy Guide for infant formula manufacturers to ensure it reflects current science, provides consistent industry oversight, and provides better tools for investigators and compliance officers.
  • In line with these recommendations, the updated compliance program includes instructions for annual environmental sampling of Cranobacter and Salmonella at powdered infant formula facilities. It also provides instruction for FDA notification if a sample tests positive for Cranobacter or Salmonella, or if a sample is found to have nutrients that are above or below required levels per the FDA’s infant formula regulation. The program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated, and also provides additional background information on the risks associated with Cranobacter and Salmonella in infant formula products.
  • This past weekend California governor Gavin Newsom signed Assembly Bill (AB) 418 into law. This bill will prohibit the use of brominated vegetable oil, potassium bromate, propylparaben, and Red No. 3 in food manufactured, sold, delivered, distributed, held, or offered for sale in California after January 1, 2027.  
  • A previous version of this bill would have also banned titanium dioxide, but that was dropped for lack of support. FDA has received a petition by non-profit advocacy groups seeking to revoke the clearances for titanium dioxide in food, but the agency has also recently reaffirmed that it continues to view the use of titanium dioxide in foods as safe. 
  • The safety of the remaining four food additives included in AB 418 has been questioned, and they are not permitted in some parts of the world; indeed, FDA terminated the provisional listings of Red No. 3 for use in cosmetics and externally applied drugs and for all uses of the lakes of Red No. 3 in 1990, but never revoked the permanent clearances for the use of the straight dye, Red No. 3, in food (21 CFR 74.303) or its use in ingested drug products (21 CFR 74.1303). Nevertheless, the bill raises serious questions about the ability of a state to ban food additives with federal regulatory clearances (i.e., preemption issues).
  • We will continue to monitor and report on AB 418 and developments regarding state regulation of food additives.
  • On September 29, 2023, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced that it would be placing restrictions on the importation of poultry from France, as well as live ducks, duck eggs, and unmitigated/untreated duck products from the European Poultry Trade Region (EPTR)), as well as Switzerland, Liechtenstein, and Norway.  The restrictions are due to an increased risk of introducing Highly Pathogenic Avian Influenza (HPAI) into the U.S. and became effective October 1, 2023.
  • The U.S. does not currently allow the import of poultry from countries affected with HPAI or from flocks that have received HPAI vaccinations. Vaccinated birds may not show signs of HPAI infection, which could lead to the export of infected live animals or virus-contaminated products to the U.S.  These restrictions follow France’s recent decision to vaccinate commercial meat ducks against HPAI. 
  • European countries did not consider vaccination against HPAI at the time the EPTR was established.  Given the way poultry moves through the EPTR, APHIS has concluded that there is no assurance currently that countries trading in the European common market can reliably certify that exports do not originate from European countries that vaccinate for HPAI.  APHIS intends for these restrictions to address the risk of open trade within Europe, while accounting for the higher risk with imports from France.
  • APHIS is engaged in ongoing discussions with the European Commission regarding HPAI vaccination programs in the EU.  Keller and Heckman will continue to monitor and relay any developments in this area.
  • A proposed putative class action lawsuit has been brought against the dietary supplement manufacturer, Nordic Naturals, Inc., and claims that the defendant has made false, misleading, and deceptive representations on product packaging (subscription to Law360 required). Specifically, the plaintiff claims declaration of the company name “Nordic Naturals” and its prominent appearance at the top of all packaging constitutes false advertising because the product contains synthetic ingredients, such as gelatin, soy lecithin, maltodextrin, ascorbic acid, beta-carotene, riboflavin, niacin, thiamine mononitrate, microcrystalline cellulose, citric acid, pectin, sodium citrate, folic acid, silica, potassium, chloride, stearic acid, and silicon dioxide, among others.
  • In a motion to dismiss, Nordic Naturals argued that it never labeled the products as “all natural” or “100% natural” and therefore no reasonable consumer would be deceived based on the presence of synthetic ingredients. However, on September 28, a New York federal judge denied the motion to dismiss stating that the defendant’s argument relies on too fine a distinction to succeed at this stage of the suit. Judge Nina R. Morrison said “Here, the court agrees with the numerous other courts that have found this distinction unpersuasive at the motion to dismiss stage. Defendants have failed to show, as a matter of law, that while a reasonable consumer would be deceived by an ‘all natural’ or ‘100% natural’ representation, she would not be deceived by a prominent representation of ‘Naturals’ on the label.
  • Judge Morrison also disagreed with Nordic Naturals that the plaintiff could not have been misled because the back panel declares the full ingredient list. Judge Morrison referenced the Second Circuit’s 2018 ruling in Mantikas v. Kellogg Co., stating that reasonable consumers do not anticipate that the ingredients will contradict representations made on the front panel. Rather, consumers expect the ingredient list to contain more detailed information about the product that confirms other label representations.
  • Keller and Heckman will continue to monitor any developments in this case.
  • Last week, FDA released a video that provides a high-level overview of the requirements for importing food into the United States along with recommendations on how to find out more information on each subject.
  • The video covers facility registration requirements, food safety standards and the foreign supplier verification (FSVP) program, labeling requirements, prior notice (to FDA), shipment declaration (to Customs), FDA admissibility determinations, among other topics.
  • Many additional videos, guidance documents, summary pages, and other tools are available on FDA’s website. Keller and Heckman can assist with any questions or issues that arise with importing foods.
  • The Food and Drug Administration (FDA) has published a draft guidance document titled “Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals.” The guidance document is part of an ongoing effort to promote the judicious use of medically important antimicrobial drugs in animals. It is intended to give animal drug sponsors specific recommendations to revise product use conditions of certain antimicrobial drugs to provide continued effective use in or on animal feed while minimizing antimicrobial resistance.
  • The scope of the guidance document includes “all medically important antimicrobial drugs that are approved for use in or on medicated feed” with at least one indication that does not adequately provide a duration of use on current labeling. The information regarding feeding duration on the label should ensure the drug is only used when necessary for the animal’s health and provide veterinarians with flexibility to use the drug in a variety of scenarios. Sponsors should provide both expected and maximum duration of use statements. Affected products are listed on FDA’s website, and the list will be reassessed and updated periodically.
  • Compliance with the guidance is voluntary, but FDA will monitor progress for three years. If FDA determines adequate progress has not been made in that time, it will consider whether further action under the Federal Food, Drug, and Cosmetic Act is appropriate. FDA is seeking public comments on the draft guidance document until December 26, 2023.
  • As we reported previously, on September 26, 2023, the U.S. Food and Drug Administration (FDA) announced an updated draft guidance designed to assist food facilities with the requirements for current good manufacturing practices (CGMPs) and preventive controls for human food.  Specifically, the new chapter on food allergens (Chapter 11) outlines ways to ensure protection of food from major food allergens cross-contact and to ensure that the finished food is properly labeled with respect to the major food allergens.
  • Earlier this year, sesame was added as the ninth major food allergen when the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act became effective on January 1st.  Sesame is now required to be disclosed on food labels when it is present in a  food and businesses should implement controls to significantly minimize or prevent sesame allergen cross-contact.  FDA believes some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence, rather than take measures to minimize or prevent cross-contact.  FDA is encouraging industry to follow the draft guidance on ways to significantly minimize or prevent allergen cross-contact and undeclared allergens and review the examples provided, rather than intentionally adding sesame to comply with the law.
  • Chapter 11 (Food Allergen Program) and Chapter 16 (Acidified Foods) are among the chapters added since the draft guidance (Hazard Analysis and Risk-Based Preventative Controls for Human Food) was first issued in 2016.  Chapter 11 explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and that the finished food is properly labeled with respect to the major food allergens, and includes many examples.  Chapter 16 explains how manufacturers of acidified foods (with an overall pH of 4.6 or below) can use procedures, practices and processes that they have established to meet requirements in the acidified foods regulations to satisfy requirements under the preventive controls for human foods rule.
  • On September 26, FDA announced the availability of two new chapters of the Draft Guidance for Industry: Hazard Analysis and Rick-Based Preventive Controls for Human Food. The two new chapters – Chapter 11: Food Allergen Program and Chapter 16: Acidified Foods – have been designed to help food facilities comply with the requirements for current good manufacturing practices (CGMPs) and preventive controls for human food.
  • Chapter 11: Food Allergen Program explains how to establish and implement a food allergen program that protects against cross-contact and ensures finished food is properly labeled with respect to the nine major food allergens. The chapter includes examples of how CGMPs and preventive controls can significantly minimize or prevent allergen cross-contact and the presence of undeclared allergens. It also discusses instances where cross-contact cannot be avoided despite adherence to CGMPS and preventive controls, and what options firms can consider, including the use of a voluntary allergen advisory statement when appropriate. Per FDA, the chapter complements the recently released Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact, which reflects the agency’s approach for the evaluation of potential allergen violations.
  • Chapter 16: Acidified Foods explains how manufacturers of acidified foods can use their established procedures and processes to meet the requirements of the acidified foods regulations and the requirements under the preventive controls for human foods rule.
  • Stakeholders may submit comments on the two new chapters, or the draft guidance in general. All submissions must include the Docket No. FDA-2016-D-2343 and should be submitted within 180 days to ensure the FDA receives comments before it works on the final versions of the guidance.
  • Last month FDA published a response to 25 recommended changes to the Food Code that were made by the Conference for Food Protection (CFP) following its 2023 biennial meeting. See Response Letter.
  • The Food Code is published by the FDA every four years (along with yearly supplements) and serves as a model to ensure safe handling of food in a retail setting. See Most recent 2022 edition. Some version of the Food Code has been adopted by every state except California.
  • When updating the code, FDA works in cooperation with CFP, a voluntary national organization that is devoted to bringing together members of industry, regulatory, academia, consumer, and professional organizations to develop modern food safety standards, including those at the retail level. See Memorandum of Understanding (MOU) 225-93-4006 between FDA and CFP; see also CFP Conference.
  • FDA’s response indicates that it “conceptually agrees” with 17 of the recommendations, “partially concurs” with 5 of the recommendations, and “either non-concurs or will consider the recommendation before deciding whether a Food Code modification is warranted” with 3 of the recommendations. Notably, CFP requested that FDA acknowledge the practice of intentionally adding sesame to bread and similar products to work around sesame allergen labeling issues. (For more background on the issue, see our prior post). FDA noted that it had already acknowledged the practice and was working with industry to find alternative solutions. 
  • Kraft Heinz is recalling about 83,000 cases of its individually wrapped Kraft Singles American cheese, as they might be considered a choking hazard.  The company stated that a “temporary issue” with one of its wrapping machines means that a “thin strip of the individual film may remain on the slice after the wrapper has been removed.”  If not removed, it could be “unpleasant and potentially cause gagging or choking hazard.”
  • The recall comes after several customer complaints of finding the piece of plastic on the cheese.  No injuries or health issues have been reported and the faulty machine has since been fixed.
  • The issue affects two types of packing, including 16-ounce “Kraft Singles American Pasteurized Prepared Cheese Product” with a “Best When Used By” date between January 10, 2024, and January 27, 2024.  Individual packages in this recall contain an “S” and “72” in the manufacturing code on the packaging.  Also affected are the 3-pound multipacks of “Kraft Singles American Pasteurized Prepared Cheese Product” with a UPC code of 0-2100060491-3 and a “Best When Used By” of January 9, 2024 and January 16, 2024.
  • The recall comes after Kraft announced earlier this year that it was changing the packaging on its individually wrapped cheese to make them easier to open.