• 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. 

Feta Maker Puts Greek Font Labeling Suit Out To Pasture (Law360 Subscription Required)

  • A federal judge in New York dismissed a class action lawsuit alleging that a feta cheese package would deceive a reasonable consumer into believing the product had been made in Greece. We commented on this lawsuit when it was filed in August 2022, noting that the plaintiff’s success could depend on whether the package explicitly used the country name.
  • The lawsuit, filed against Lactalis America Group Inc. on August 14, 2022, claimed that the labeling of the company’s President brand feta cheese falsely led consumers to believe that the product is made in Greece based on:
    • Representation that the company is “Europe’s leading cheese expert;”
    • The depiction of a gold olive branch; and
    • The word “feta” stylized in an “ancient-Greek font.”
  • In addition, the back label of the package states the cheese was “created by a family of artisan cheesemakers with over 80 years of French heritage” and “distributed in ‘Buffalo, NY.’”
  • According to the judge, these facts are insufficient to state a claim that consumers would have been misled into believing the product is made in Greece. He stated in his opinion that “while a discerning shopper may associate feta cheese with Greek tradition, it is unreasonable to conclude that reasonable consumers would expect that a mass-produce cheese product was made in Greece based on little more than a font style, and in the absence of any statement that the product was made in Greece.” He also noted that without a statement that the product is made in Greece, “no reasonable consumer” would view the statement that the product is distributed in “Buffalo, NY” and referencing “French heritage” and automatically conclude that the product is made in Greece.
  • The judge further dismissed the plaintiff’s remaining claims of unjust enrichment, negligent misrepresentation, fraud, and violations of express warranty, implied warranty, and the Magnuson-Moss Warranty Act for failure to state a claim, as well as a multistate misrepresentation claim due to lack of standing.
  • In a September 16 opinion, U.S. District Judge John P. Cronan denied the majority of Starbucks’ motion to dismiss a proposed class action lawsuit related to the allegedly misleading names of their “Refreshers” products (subscription to Law360 required). Named plaintiffs Joan Kominis and Jason McAllister alleged that Starbucks advertises its Refreshers beverages as containing fruits like mango, passionfruit, and acai, but that the beverages do not actually contain said fruits. The plaintiffs argued that had they been aware that the Refreshers did not contain the named fruits, they would not have purchased the products or would have paid significantly less for them.
  • In their motion to dismiss, Starbucks argued that consumers understand that the product names refer to flavors, not the ingredients, and that its advertising accurately represents the products’ fruit content. However, Judge Cronan held that, based on the context of the menu and advertising images of drinks with fruit pieces, a significant portion of the general consuming public could reasonably believe that the products contain the named fruits.
  • Out of eleven causes of action, Judge Cronan only granted the dismissal of unjust enrichment and common law fraud. In his opinion, Judge Cronan stated that the plaintiffs adequately alleged that a significant portion of the general public could be misled by the product names. Judge Cronan held that the pleading of unjust enrichment failed because it is duplicative of the New York General Business Law claims and because it cannot be brought under California law in conjunction with an express warranty claim. Further, Judge Cronan held that plaintiffs failed to sufficiently plead scienter to support the fraud claim. The claim of unjust enrichment was dismissed with prejudice, and the claim with respect to fraud was dismissed with leave to amend.