Food and Beverage News and Trends - December 6, 2024

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.

FDA sends proposed rule on front of package nutrition information to OMB. On November 21, the FDA sent its proposed rule on front of package (FOP) nutrition labels to the White House Office of Management and Budget (OMB). FOP labeling has been prioritized by the agency as part of a National Strategy to end hunger and increase healthy eating and physical activity by 2030, so that fewer consumers experience diet-related diseases like type 2 diabetes, obesity, and hypertension. The strategy includes several FDA initiatives to help accelerate efforts to empower consumers with information and create a healthier food supply. According to the agency, FOP labeling would complement the Nutrition Facts label that is required on food packages by displaying simplified, at-a-glance nutrition information that gives consumers additional context to help them quickly and easily make more informed food selections. Use of FOP nutrition labeling schemes has increased dramatically around the world in recent years.

FDA and USDA issue joint request for information on food date labeling. On December 3, the FDA and USDA issued a joint request for information (RFI) seeking input on industry practices and preferences for date labeling (eg, “sell by,” “use by,” “best by”), research results on consumer perceptions of date labeling, and any impact date labeling may have on food waste and grocery costs. This action is being taken to try to clarify consumer confusion over the many different approaches used by industry. More specifically, the RFI was issued in response to the National Strategy for Reducing Food Loss and Waste and Recycling Organics, which was released by the FDA, USDA and the US Environmental Protection Agency in June 2024. Responses to the agency’s request for information are due by February 3, 2025. See the request for information here. 

FDA issues request for information on PFAS in seafood. The FDA has released an RFI about per- and polyfluoroalkyl substances (PFAS) in seafood. The agency has been collecting and sampling testing for PFAS in a number of foods since 2019. Of the 810 samples the agency has analyzed, PFAS were detected in 23, 19 of which were seafood. Given these results, in 2021 and 2022 the FDA went on to collect additional seafood samples for PFAS analysis, targeting the most commonly consumed seafood in the US – clams, cod, crab, pollock, salmon, shrimp, tilapia, and canned tuna. Most of the sampled seafoods had been imported into the US. Canned clams from China were a particular concern, and two voluntary recalls resulted. The request seeks information about PFAS concentrations in seafood, the environment, and processing water, as well as mitigation strategies for PFAS in seafood. FDA will use information it collects to determine if further regulatory steps need to be taken. For example, the agency may establish action levels, which are voluntary, non-binding levels at which the agency may consider a food adulterated. Responses to the agency’s request for information are due by February 18, 2025. See the request for information here.

Lawmakers call on FDA to ban Red 3 from foods. Twenty-three members of Congress have called on the FDA to “finalize a ban on the use of the carcinogen FD&C Red No. 3, also known as Red 3, in foods.” In an open letter to the agency, the legislators note that the Federal Food, Drug and Cosmetic Act’s Delaney Clause requires the FDA “to ban any food or color additive that is found to cause cancer in humans or animals.” Use of Red 3 in cosmetics and externally applied drugs has been banned by the agency since 1990; California’s sweeping AB 418, enacted in October 2023, bans the dye as well as three other substances from foods. Calling on the agency to “ban Red 3 from our nation’s food supply before the end of this Congress,” the legislators wrote, “A ban on Red 3 is not only statutorily required, but it is also feasible – alternatives are widely available.”

Health Canada to modify Lists of Permitted Food Additives. In an effort to modernize food regulations in Canada, Health Canada and the Canadian Food Inspection Agency (CFIA) are removing almost all food additive provisions from the food compositional standards outlined in the Food and Drug Regulations (FDR). Instead, the use of food additives in these standardized foods will be maintained or specified in the Lists of Permitted Food Additives.

These changes relate to the proposed Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria, and Methods of Analysis for Food, which were pre-published in the Canada Gazette, Part I, in November 2023 for public and stakeholder consultation. Currently, the FDR standards for "(naming the flavour) Extract or (naming the flavour) Essence" and "(naming the flavour) Flavour" (outlined in sections B.10.003 and B.10.005) allow certain food additives, such as food colours, Class II preservatives, Class IV preservatives, and emulsifying agents (in the case of "(naming the flavour) Flavour"). However, these standards do not specify the maximum allowable levels of use for these functional classes in the flavouring preparations nor indicate which food additives from these functional classes may be used. Additionally, there are no entries in the relevant Lists of Permitted Food Additives that define the permitted uses of these food additives in "(naming the flavour) Extract or (naming the flavour) Essence." To address this gap, Health Canada intends to update the Lists of Permitted Food Additives to specify the permitted use of food colours, preservatives, and emulsifying agents in the relevant flavouring preparations. This update will bring consistency to the regulation of food additives in Canada, aligning these standards with those applied to most other food additives in compositional standards.

Trump picks Johns Hopkins surgeon to lead the FDA. On November 22, President-elect Donald Trump announced that he will nominate Dr. Marty Makary, a Johns Hopkins surgical oncologist, to lead the FDA. “FDA has lost the trust of Americans and has lost sight of its primary goal as a regulator,” the president-elect stated, and, if confirmed, would “course-correct” the agency. While Makary has been more outspoken on medical products issues (eg, advocating for federal authorities to develop nuanced recommendations for vaccines, criticizing the overtreatment of patients in the US), there have been press reports that he is also focused on chronic, diet-related diseases, as well as chemicals in the food supply, aligning him with the Department of Health and Human Services secretarial nominee, Robert F. Kennedy, Jr.

Incoming Administration said to be considering reform of GRAS exemption and other food policy changes. Media sources are reporting that Robert F. Kennedy, Jr., secretary-designate of the Department of Health and Human Services, is considering a number of significant reforms in US food policy should he be confirmed. Among them would be an important change to the FDA’s rules governing the GRAS process for food additives to eliminate the GRAS self-certification exemption to force companies through what is currently a voluntary GRAS notification process. The GRAS self-certification exemption has long been criticized by consumer groups. Attempts to eliminate it would face numerous obstacles; such a change, if put in place, would drastically increase the FDA's workload. Other food policy changes the secretary-designate favors: eliminating ultra-processed foods from school lunches, removing artificial dyes from cereals, and encouraging consumption of raw milk. Kennedy stated earlier this year that he would ask the president-elect to "declare a national emergency, but not for infectious disease, but for chronic disease" as another way to expand his authority over food production.

Canadian Food Inspection Agency expands salt recall. The Canadian Food Inspection Agency (CFIA) is expanding its recall of Sifto brand food-grade salts potentially contaminated with pieces of metal. The expanded recall includes additional products that were identified as part of the CFIA’s ongoing food safety investigation. Details of products that contain the recalled salt may be found at this link.

Carrot recall continues because of possible E. coli contamination. On November 22, the FDA announced the recall of four additional bag sizes of organic whole carrots from Grimmway Farms that may have been contaminated with E. coli. The original date of the recall was November 16. The ongoing outbreak has so far sickened 39 people across 18 states, and one death has been reported. The original recall included bagged organic baby and whole carrots, sold in major retail outlets across the country. “The health of our consumers and the integrity of our products are our highest priorities, and we will not rest until this issue is fully resolved,” said Jeff Huckaby, Grimmway’s CEO.