• The Association of American Feed Control Officials (AAFCO) is inviting industry professionals and the public to provide feedback on a new list of food items proposed for inclusion in the Common Food Index (CFI).
  • The CFI serves as a repository of common foods deemed suitable for animal consumption.  It helps streamline the review process for ingredients listed on animal food labels, ensuring consistency and clarity.  According to Austin Therrell, AAFCO’s executive director, the goal of the CFI is to compile a list of historically safe items that can be trusted by both manufacturers and consumers.  However, he emphasized that the CFI does not replace the official process for defining new feed ingredients, which is outlined in AAFCO’s Official Publication.
  • Common foods include commercially available items such as whole seeds, vegetables, and fruits that are safe for animal consumption but not specifically defined by AAFCO.  These can also encompass certain human foods known to be safe for animals.  Manufacturers are responsible for ensuring the safety and suitability of these foods before they are distributed as animal feed.
  • The current list under consideration includes five items: Oyster Mushroom; Lion’s mane mushroom; Almond; Cilantro; and Sunflower seed.  AAFCO encourages veterinarians, animal nutritionists, consumer groups, and the general public to review the proposed items and provide their feedback by December 13, 2024.  To participate in the feedback process, e-mail aafco@aafco.org.
  • The request for feedback and the CFI is an opportunity for companies in the food industry to provide AAFCO with information about common food products that are suitable for use in animal feed applications, with the potential to limit waste and provide nutrition with efficient identification and labeling. 
  • Keller and Heckman will continue to monitor updates to animal feed ingredients and can assist in providing feedback to AAFCO.  
  • On October 11, 2024, Costco issued a recall for nearly 80,000 pounds of its Kirkland Signature butter due to a labeling oversight.  Milk, classified as one of the nine major allergens that the U.S. Food and Drug Administration (FDA) requires to be declared on product packaging, was not included on the ingredient list.  The recall included 46,800 pounds of Kirkland Signature Unsalted Sweet Cream Butter and 32,400 pounds of  Kirkland Signature Salted Sweet Cream Butter.
  • The Food Allergen Labeling and Consumer Protection Act of 20024 (FALCPA) identified eight foods as major allergens: milk, eggs, fish, crustacean, shellfish, tree nuts, peanuts, wheat, and soybeans.  The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 added sesame as the ninth major food allergen.  These laws require all food labels to identify the source names of all major food allergens.
  • The recall has gained attention across social media platforms with consumers commenting that it should be obvious that butter contains milk.  However, the purpose of allergen labeling is to help consumers with allergies avoid consuming products with hidden allergens. For those with Milk allergies, consuming products with undeclared milk ingredients can lead to serious health risks, including allergic reactions that may require medical attention. 
  • Consequently, on November 7, 2024, FDA classified the recall as a Class II recall, indicating that the product may cause temporary or medically reversible adverse health consequences.
  • Social media commentary aside, adhering to allergen labeling requirements is critical in ensuring consumer and product safety.
  • Keller and Heckman will continue to monitor and report any significant recalls.
  • Today, the U.S. Food and Drug Administration (FDA) released guidance with revisions to the FDA Food Safety Modernization Act (FSMA) Voluntary Qualified Importer Program (VQIP).  VQIP offers expedited review and importation of human and animal foods into the US for importers who maintain a high level of control over the safety and security of their supply chains.
  • With these updates, FDA is implementing a revised inspection approach to optimize program efficiency by leveraging other oversight activities, which may reduce user fees. The updates are effective immediately.
  • Participants now have the flexibility to add new foreign suppliers and foods to their existing program throughout the year, allowing them to access more benefits through their program.  To support participants in obtaining a facility certificate from an accredited certification body under the Accredited Third-Party Certification Program (TPP), FDA is also extending the deadline for submitting the notice of intent to participate and application.
  • FDA and NIH will hold a joint nutrition regulatory science workshop on December 17-18, 2024. The goal of the workshop is to highlight how nutrition and science can generate evidence and data to inform food-related policy and regulatory decision making and to foster additional collaboration between NIH and FDA in supporting research that addresses priority nutrition research gaps.
  • Among the topics to be discussed is ultra-processed foods, a topic that has been of particular interest/concern for Jim Jones, the FDA Deputy Commissioner for the Human Foods Program. Earlier this year, the Deputy Commissioner was quoted as saying “we think that there are a lot of studies that show an association between ultra-processed food and a negative health outcome, but causality has not been demonstrated. And it’s important to have causality to define it and then to regulate it. And so, we think that the next thing that we need to do is to get more research to get greater certainty around whether or not ultra-processed foods are causing bad health outcomes.”
  • You can register for the virtual event here. The 17th is a full day program, while the 18th is a half day. We will continue to monitor and report on any updates to the regulation of ultra-processed foods.
  • An Illinois federal judge has granted Danone Waters of America’s request to dismiss a proposed class action lawsuit alleging that Evian spring water is falsely labeled as “natural” even though it contains microplastics because the claims are preempted by federal law (Law360 subscription required). The lawsuit, which was filed in Illinois state court then removed to federal court in March, alleges violations of various consumer protection statutes, common law fraud, and unjust enrichment.
  • According to the complaint, the plaintiffs and class “paid a premium price for premium products, but instead received non-premium products,” because microplastics are not “natural.” However, the judge held that the terms “spring water,” which is federally regulated, and “natural” are intertwined. As long as the water meets FDA’s standard for “spring water,” then it is, by extension, “natural.”
  • FDA defines “spring water” at 21 CFR 165.110(a)(2)(vi) as “water derived from an underground formation from which water flows naturally to the surface of the earth.” The judge explained that the regulation uses the word “natural” seven times to describe the source of the “spring water.” Therefore, any water that comes from a “natural spring” can be labeled as “natural spring water.” Because the regulation does not impose any further requirement for use of the word “natural,” any claim that imposes such a requirement beyond identification of the water’s source is preempted.
  • There have been multiple other consumer fraud claims based on the presence of microplastics in federally regulated bottled water that have been similarly found to be preempted, including one that we discussed on this blog. However, in those cases, the courts based their reasoning on the fact that the bottled water regulations do not mention microplastics. Here, though, the judge found that it is unnecessary to address any requirement regarding microplastics to determine the scope of the term “natural.” According to the judge, “[w]hether the regulation imposes requirements regarding the content of ‘spring water,’ including whether the presence of microplastics might violate those requirements, is irrelevant to this logic.”
  • Keller and Heckman will continue to monitor litigation related to microplastics and food labeling claims.
  • On November 4, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA) announced the registration of the first antimicrobial treatment for pre-harvest agricultural water.  This new treatment, a combination of hydrogen peroxide and Ethaneperoxoic acid, can kill harmful pathogens like Salmonella and E. Coli in the water used to grow crops prior to being harvested.
  • This approval marks a significant step forward in agriculture and food safety practices.  Previously, treatments for pre-harvest agricultural water were limited to managing algae, biofilm formation, or produce rot, with no treatments specifically approved for killing human pathogens.
  • The new registered product aligns with the FDA’s revised rule under the Food Safety Modernization Act (FSMA) on agricultural water.  This rule replaces previous microbial quality criteria and testing requirements with system-based assessments.  Farms must evaluate various factors, including the nature of the water source, water distribution systems, and potential contamination sources from nearby land uses.  The rule also requires farmers to implement appropriate mitigation measures to minimize risks.  Treating water with this new approved antimicrobial treatment aligns with the mitigation requirements under this rule.
  • Products designed to protect humans from disease-causing pathogens are referred to as “public health” pesticide uses, which require a high bar for efficacy data at the EPA, making cross-collaboration between the EPA and the FDA essential in moving this registration forward.  The development and registration of this treatment involved joint collaboration between government agencies, academia and industry, highlighting the importance of joint efforts in advancing food safety.
  • Keller and Heckman will continue to monitor and follow developments in agriculture water safety.
  • Today, the U.S. Food and Drug Administration (FDA) has requested public input regarding its current approach managing FDA certification for the export of human food products. 
  • Companies that export products from the US are often asked by foreign customers and/or governments to supply a certification for products regulated by FDA.  FDA’s export certification provides an official statement concerning a product’s regulatory or marketing status, based on available information at the time of issuance.  To assist US exporters, FDA provides necessary export certification in the form of certificates or export lists.
  • Through FDA’s Request for Information, the agency intends to gather input from all impacted stakeholders to help the Human Food Program (HFP) ensure it is considering the full range of perspectives when planning and resourcing changes and improvements to the export list component of the Export Certification Program.  Specifically, FDA requests comments on the challenges and experiences related to meeting the listing requirements of other countries and FDA’s certification processes for export lists, including suggested approaches for implementing fees to offset the operational costs associated with maintaining a growing number of export lists and potential program enhancements.
  • FDA requests feedback by January 7, 2025.  Keller and Heckman will continue to monitor and relay any updates in the process.
  • We have previously blogged about a lawsuit filed by Upside Foods challenging Florida’s cultivated meat ban. Last month, a district court judge rejected Upside’s request for a preliminary injunction and held that the company had failed to meet its burden to establish that it was substantially likely to succeed on the merits of its express preemption claims.
  • The court addressed the merits of the preemption argument with respect to both the “ingredient requirements” and the “premises, facilities, and operations” provisions in the Poultry Products Inspection Act (21 USC 467e). As to the ingredient requirements provision, the Court found that Plaintiff had identified no statute or regulation which required that cultivated poultry products be permitted and noted that “just because Plaintiff’s product arguably falls within the scope of the PPIA . . . this does not mean that a state is expressly preempted from banning the sale of that particular kind of poultry product.”
  • With respect to the “premises, facilities, and operations” provision, the Court held that (1) Plaintiff did not manufacture cultivated chicken in Florida and so its operations were not directly impacted and (2) that a sales ban did not impose additional or different facilities requirements as compared to federal law.
  • Notably the case is not a final decision on the merits and we will continue to monitor and report on the case.
  • On November 4, 2024, FDA published a Supplement to the 2022 Food Code that incorporates recommendations from regulatory officials, industry, academia, and consumers. The FDA Food Code and its Supplement represent FDA’s best advice to address the safety and protection of food offered at retail and in food service and are intended to be a model for adoption by state, local, tribal, and territorial regulatory bodies.
  • The Food Code and its Supplement are joint projects by FDA, the Centers for Disease Control and Prevention, and USDA’s Food Safety and Inspection Service. The documents provide practical, science-based controls for reducing the risk of foodborne illness.
  • The amendments in the Supplement include:
    • Adding new provisions addressing disinfection of food contact, nonfood-contact, and equipment surfaces;
    • Expanding and clarifying how and when containers can be refilled and reused in a food establishment;
    • Addressing food protection with new provisions that improve awareness of food defense measures;
    • Building on the concept of Food Safety Management Systems and Active Managerial Control by defining the terms, including new provisions that speak to when a Food Safety Management System is required;
    • Updating testing requirements for reinstatement of food employees diagnosed with an illness from STEC, Shigella, or Nontyphoidal Salmonella to include culture-independent diagnostic tests; and
    • Enhancing information regarding sushi rice acidification with a dedicated section in Annex 6 Food Processing Criteria addressing risks and controls.

The Food Code was most recently updated in 2022, as discussed on this blog. The next complete revision will be published in 2026.

  • In October 2023, Governor Newsom signed into law California’s AB 899, which requires that any baby food products sold or made in the state be tested for arsenic, cadmium, lead, and mercury.  This testing requirement became effective January 1, 2024.  Beginning January 1, 2025, the law also requires test results to be posted on the manufacturer’s website. 
  • Manufacturers of baby food (not including infant formula) for sale or distribution in California must test a representative sample of each production aggregate of the final baby food product at least once a month.  Test results must be provided to the California Department of Public Health upon request.
  • Starting January 1, 2025, manufacturers must make publicly available on the manufacturer’s website, for the duration of the product shelf life for a final baby food product plus one month, the name and level of each toxic element present in each production aggregate of a final baby food product.  Baby foods that contain a toxic element at levels higher than the FDA action level can still be sold in the state, but the QR code disclosure is required.