The Product Liability & Mass Tort Monitor is a monthly newsletter delivering critical updates, data insights and actionable strategies for navigating the complexities of product liability and mass tort litigation. McGuireWoods’ team of experienced litigators defends leading companies in high-stakes cases, using a deep understanding of clients’ products, businesses and regulatory environments. The newsletter highlights key data and trends shaping the product liability landscape, offering valuable insights to inform litigation strategies and risk management practices aimed at helping clients stay ahead of evolving challenges and achieve favorable outcomes.
This month’s issue addresses the U.S. Food and Drug Administration’s announcement that it will promulgate a uniform definition for “ultra-processed foods” (UPFs). Food manufacturers and distributors can take proactive action now by submitting a comment to the FDA and help mitigate the potential of future regulatory burdens and mass-tort actions. The comment period is open through Sept. 23, 2025.
On July 23, 2025, the FDA announced that it planned to develop in conjunction with the U.S. Department of Agriculture a uniform definition for ultra-processed foods as part of Department of Health and Human Services Secretary Robert F. Kennedy, Jr.’s “Make America Healthy Again” program. Before the FDA’s announcement, 10 states had proposed bills in 2025 that define ultra-processed foods based on processing steps, nutritional content or inclusion of certain ingredients. The FDA raised concerns over the percentage of the American food supply that is considered ultra-processed and referenced scientific studies linking UPFs to adverse health outcomes, including Type 2 diabetes, obesity, cardiovascular disease and neurological disorders. Given the purported link between such foods and adverse health outcomes and to avoid an inconsistent patchwork of definitions by different states, the FDA views creation of a uniform definition as a necessary precursor to research and regulate ultra-processed foods.
To draft this uniform definition, the FDA issued a request for information (RFI) allowing members of the public to submit comments and data that will inform the agency’s development of the uniform definition. Questions that the FDA seeks to address include which existing definitions best fit the U.S. food supply, which ingredients may help identify a food as ultra-processed and whether “ultra-processed foods” is the best term for such foods. How the FDA answers these questions in its final definition will form the basis for future regulations. Given the variety of approaches states have taken so far, there is significant room for different definitions to emerge from this process. The comment period is a chance for the public to potentially influence the FDA definition regarding modern manufacturing of food products.
While this regulation is in its infancy, it poses risks to manufacturers and distributors if the FDA creates a definition that is overbroad or inaccurately characterizes certain foods as ultra-processed. Prior FDA actions and new scientific studies regarding categories of pre-existing products have led to years-long nationwide mass tort litigation (e.g., In re: Testosterone Replacement Therapy Products Liability Litigation, MDL 2545; In re: Hair Relaxer Marketing, Sales Practices, and Products Liability Litigation, MDL 3060).
