• FDA Commissioner Robert M. Califf, along with Deputy Commissioner for Human Foods Jim Jones and Senior Clinical Advisor for Chronic Disease Haider J. Warraich, published an article recently highlighting the critical need for better research and action on ultra-processed foods (UPF).   
  • Carlos Augusto Monteiro and his team developed the NOVA classification system in 2009 which categorizes all foods based on the industrial processes they undergo into four groups.  Group 1 consists of unprocessed or minimally processed foods, while Group 4 consists of “Ultra-Processed Foods.”  Monteiro defines ultra-processed foods as, “formulations of ingredients, mostly of exclusive industrial use, typically created by a series of industrial techniques and processes.”
  • However, there are a range of definitions being used for “Ultra-Processed Foods”, and as noted in the article, “[n]utritious foods such as whole grain bread may be considered ultra-processed, but they are not necessarily associated with the same negative health outcomes and indeed have shown to be beneficial.”
  • This nuance is often overlooked in broad recommendations to avoid all ultra-processed foods, driven in part by a lack of research and consistent, clear definitions.
  • The article notes that research shows an association between ultra-processed foods and diet-related conditions, however, causality still has not been determined.
  • FDA is working to promote healthier diets through collaboration with the food industry, researchers, and public health advocates.  As we previously blogged, FDA and NIH are holding a joint nutrition regulatory science workshop in December, where ultra-processed foods will be discussed.  The article also notes that while FDA is waiting for further research on ultra-processed foods, the agency is actively addressing other prevalent nutrition issues related to UPF, such as added sugars, salt, and saturated fat.  For example, FDA issued its draft guidance on Phase II Voluntary Sodium Reduction Goals and has proposed a rule to update the definition of “healthy” claims on front of package labeling.  Addressing diet-related diseases is at the top of the agency’s priority list.
  • Dr. Califf, Mr. Jones, and Dr. Warraich also call on researchers, public health and health care groups, advocates, industry, and the public to put tackling diet-related disease at the top of their priority list. “This includes pushing for high-quality nutrition research related to ultra-processed foods, as well as supporting and strengthening ongoing efforts focused on increasing consumption of nutritious foods that are limited in sodium, added sugars and saturated fat.”
  • Keller and Heckman will continue to monitor and report on developments related to Ultra Processed Foods and Nutrition.
  • As we blogged about earlier in the month, a district court judge rejected Upside Foods’s request for a preliminary injunction blocking enforcement of Florida’s ban on cultivated meat. As we noted, the decision was not a final decision on the merits and since the decision Upside has filed an amended complaint and, most recently, Florida has filed a motion to dismiss the amended complaint.
  • The motion to dismiss covers much of the same ground that was briefed during the motion for a preliminary injunction, including the question of whether Florida’s ban is preempted by the Poultry Products Inspection Act (unsurprisingly, Florida has maintained its position that it is not).
  • The motion to dismiss also responds to Upside’s argument that the law violates the dormant commerce clause. Under dormant commerce clause precedent a facially neutral law effectuating a legitimate local interest is not invalid unless it imposes a substantial burden on interstate commerce which clearly outweighs the local benefits. Florida argues that Upside has alleged only speculative harm to potential sales in Florida and has not alleged any burden on interstate commerce.
  • We will continue to monitor and report on updates to this case (Upside Foods, Inc. v. Simpson, C.A. No. 4:24-cv-316). 
  • The 9th Circuit Court of Appeals affirmed the dismissal (Law360 subscription required) of a class action alleging that Del Monte Foods, Inc., falsely advertised its “Fruit Naturals” fruit cups as “natural” despite containing synthetic preservatives. The original lawsuit was filed in early 2023 and dismissed in October of that year.  
  • The fruit cups, which are labeled as “Fruit Naturals,” contain ingredients like potassium sorbate and methylcellulose gum. According to the plaintiff, Del Monte did not disclose that these ingredients are synthetic, and consumers are not “expected or required to ‘scour’ a product’s listed ingredients” to determine whether products are, in fact, natural. However, the district court found that, because the ingredients are specifically listed on the back label, the label was not “unambiguously deceptive” because the “front label, as clarified by the back label, [would not] mislead a reasonable consumer into thinking that the products don’t contain synthetic ingredients.”
  • In affirming the district court ruling, a 9th Circuit panel found that a survey cited by the plaintiff to support the deceptive nature of the label was uninformative because it asked respondents about the adjective “natural,” rather than the noun “naturals.” Here, the word is used as a noun in the name of the product. Further, the label depicts the picture and name of the fruit in the cups followed by the phrase “in extra light syrup.” This conveys that the fruit itself is natural, but the syrup may not be.
  • According to the panel, the labels are ambiguous, meaning that “’reasonable consumers would necessarily require more information before they could reasonably conclude’ that the front label makes a specific factual representation.” A reasonable consumer would look to the back label, which, here, “accurately and clearly discloses several synthetic ingredients,” thus resolving the ambiguity.
  • The U.S. Food and Drug Administration (FDA) is extending the comment period for its proposed systematic process for post-market assessment of chemicals in foods.  FDA will give stakeholders until January 21, 2025 to submit comments, which is an additional 31 business days from the previous December 6, 2024 deadline.
  • As we previously reported, FDA’s proposed approach includes three stages: food chemical signal monitoring, a quality and impact assessment, and a focused and/or comprehensive assessment.  FDA’s proposal seeks to proactively initiate post-market assessments of GRAS ingredients, food additives, color additives, food contact substances, and contaminants under its new Human Foods Program.  FDA’s updated approach comes as multiple states propose legislation targeting additives and ingredients of public concern, such as “generally recognized as safe” (GRAS) substances, synthetic food dyes, and other chemicals.
  • FDA specifically requests input on public engagement, review frequency and mechanisms, the potential integration of an advisory committee review, the appropriateness of the Fit-for-Purpose Decision Tree, the appropriateness of the Prioritization of Risks scheme, and the appropriateness of the two-pronged Focused and Comprehensive approaches.
  • Keller and Heckman would be happy to prepare comments and we will continue to monitor and relay updates on FDA’s post-market review process.
  • Earlier this year the California Department of Public Health (CDPH) rejected a petition filed in 2022 by the Center for Science in the Public Interest (CSPI) which had requested that the agency promulgate regulations requiring warnings labels on food and dietary supplements containing seven of the synthetic food dyes subject to batch certification by FDA: Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5, and Yellow 6. These warnings would have indicated that “the State of California has determined [that the synthetic dyes] can result in hyperactivity and other neurobehavioral problems in some children.”
  • The petition follows a 2021 report issued by California’s Office of Environmental Health Hazard Assessment (OEHHA) which concluded that these seven synthetic food dyes can result in hyperactivity and other neurobehavioral problems in some children, and that children vary in their sensitivity to synthetic food dyes.
  • After noting that Red 3 had since been banned in California, CDPH indicated that there was no scientific consensus regarding the adverse effects of these dyes, which subpopulations might be sensitive, and what the level of concern might be. In light of the uncertainty, it concluded that warnings may not be effective, and might even be counterproductive, and that ingredient declarations already allowed consumers to choose products based on ingredient composition.
  • On November 19, 2024, FDA issued a request for information on per- and polyfluoroalkyl substances (PFAS) in seafood in an effort to understand the potential for PFAS exposure from seafood and reduce dietary exposure to PFAS that may cause a health concern. According to FDA, seafood presents a unique challenge and opportunity to prevent contamination because many potential hazards can be introduced at the source, such as in growing areas, aquaculture farms, and on fishing vessels.
  • For purposes of this request, FDA defines “seafood” as fresh or saltwater finfish, crustaceans, other forms of aquatic life (e.g., alligator) other than birds or mammals, and all mollusks, which are intended for human consumption. Testing of samples in the general food supply has indicated that seafood may be at higher risk for environmental PFAS compared with other types of food. To expand on the results of these samples, FDA collected additional seafood samples of the most commonly consumed seafood in the United States, including clams, cod, crab, pollock, salmon, shrimp, tilapia, and canned tuna, most of which were imported. Based on perfluorooctanoic acid concentrations in canned clams from China, FDA concluded that their consumption is likely a human health concern, resulting in two voluntary recalls of canned clams from China.  Thus, FDA is requesting information to help enhance the Agency’s knowledge about the types of seafood prone to accumulate PFAS and harvest locations with PFAS contamination, ultimately supporting a comprehensive approach to advance clean air, water, and food.
  • Specifically, FDA is seeking data and information regarding PFAS concentrations in seafood, the environment, and processing water, as well as mitigation strategies for PFAS in seafood. FDA has provided specific questions for each of these categories to help identify where PFAS has been observed. The request for information will be published in the Federal Register on November 20, 2024, with a 90-day comment period ending February 18, 2025.
  • Comments can be submitted electronically on Regluations.gov to docket number FDA02024-N-4604. Keller and Heckman will continue to monitor developments in this area.
  • 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.