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

FDA updates its list of food chemicals currently under review. Aiming to provide more insight on the status of its post-market assessments of chemicals in the food supply, on March 4 the FDA updated its list of select chemicals currently being reviewed by the agency. The agency first published such a list in July 2023. The updated list includes select food ingredients (among them food and color additives), food contact substances, and contaminants under FDA review. New to the list is information about the status of the FDA’s post-market assessments, including where the agency stands in the risk assessment and management process. The FDA anticipates updating this list regularly. One of the key reasons for the FDA’s proposed creation of a Human Foods Program, the agency said, is to enhance its review of food chemical safety. The proposed new program would include an Office of Food Chemical Safety, Dietary Supplements and Innovation, where the FDA intends to develop a more nimble and systematic process for evaluating chemicals in the food supply.

Health Canada awareness initiative on supplemented food labelling. Health Canada has launched an initiative to raise public awareness about the new labelling elements on supplemented foods. The goal of this initiative is to help consumers use this information to make informed food choices. The campaign will primarily focus on those most at risk because they are under the age of 14; are sensitive to caffeine; are pregnant or breastfeeding; and/or consume supplements and supplemented foods.

FDA warns about lead contamination in ground cinnamons. On March 6, the FDA warned the public not to use an additional list of cinnamon products that are contaminated with lead. The warning comes in the wake of the recent recall of lead-contaminated cinnamon applesauce pouches. The Centers for Disease Control and Prevention has said that as of February 23, it has received 468 reports of confirmed, suspected, and probable cases of lead poisoning linked to those pouches from 44 states. The vast majority of the patients are age one or younger. Authorities in Ecuador, where the applesauces were manufactured, say that Carlos Aguilera, a processor of ground cinnamon, is “the likely source” of the poisonings; the FDA continues to regard that contamination as intentional. After that recall, the FDA initiated a targeted survey of ground cinnamons sold by discount retailers. The agency noted that while the lead levels found in the ground cinnamon products listed above “are significantly lower than lead levels in cinnamon in the recalled apple sauce pouches removed from the market this past fall," the spices still "could be unsafe for prolonged use." The FDA has limited regulatory power over foreign ingredient suppliers who do not directly ship their products to the United States.

USDA announces final “Product of USA” labeling rule for meat, poultry, and eggs. On March 11, the USDA announced it has finalized a rule that allows companies to make a voluntary “Product of USA” or “Made in USA” claim on meat, poultry, and egg products only when they are derived from animals born, raised, slaughtered, and processed in the United States. The rule, the department said, will prohibit companies from engaging in misleading labeling and will help ensure that consumers receive truthful information about where their food comes from. The labeling rule, set to go into effect on January 1, 2026, closes a loophole that allowed processors to claim their products are of US origin even if the animals were imported. It’s part of a Biden Administration effort to increase competition in the meat sector while providing accurate information to consumers. Agriculture Secretary Tom Vilsack stated, “This final rule will ensure that when consumers see ‘Product of USA’ they can trust the authenticity of that label and know that every step involved, from birth to processing, was done here in America.”

NDIs. On March 5, FDA issued Final Guidance on New Dietary Ingredient Notification Procedures and Timeframes, which finalized certain aspects of an August 2016 draft guidance. Under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the manufacturer or distributor of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or of a dietary supplement that contains the NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce, commonly referred to as a new dietary ingredient notification (NDIN). The guidance provides the agency’s current thinking about the NDIN submission and review process, answering such questions as: Who needs to submit an NDIN? How should the information be presented? What happens after an NDIN is submitted?

FDA also issued a Revised Draft Guidance on New Dietary Ingredient Notifications and Related Issues that replaces other aspects of the 2016 draft guidance. This draft guidance updates the agency’s current thinking on the following topics and requests additional comment on such issues as: what qualifies as an NDI; when an NDI notification is required; and what types of data the FDA recommends be considered in evaluating the safety of NDIs and dietary supplements containing an NDI.

Deputy Commissioner Jones in the news. On March 4, Food Navigator USA reported that at a recent conference, Jim Jones, FDA Deputy Commissioner for Human Foods, said the agency’s massive reorganization to create a unified Human Foods Program may take longer than anticipated but is “going quite well.” The program will ultimately gather together 12 offices and one center, all reporting to a single leader, who in turn will report directly to the FDA commissioner. At the Food Policy Impact Summit hosted by the Institute of Food Technologists’ Washington, DC section, Jones said the rollout of the new program, originally promised for June 2024, is now more likely to occur in September 2024. Jones also said at the conference that under the reorganization, nutrition issues will gain “much greater prominence in the FDA.”

Then, during a March 8 webinar sponsored by the Alliance for a Stronger FDA, Jones revealed some of the agency’s priorities for evaluating chemicals in foods. His comments are being viewed with interest because the agency speaks only rarely about its assessment of the safety of chemicals in the food supply. Jones said in the webinar that the chemicals that have already been targeted by various state bans, such as the new California Food Safety Act, are among the agency’s priorities. He acknowledged that while states have a role in banning ingredients of concern, this situation is “not ideal.” Jones contended that the FDA “needs to lead the way in food chemical safety, because your access to safe foods should not depend on where you live in the United States.”

New York bill would ban seven food additives, require GRAS disclosure. On March 5, the nonprofit Center for Science in the Public Interest called for support for two bills recently introduced in the New York state legislature. One would ban the use in the state of seven food additives – azodicarbonamide, brominated vegetable oil, butylated hydroxyanisole, potassium bromate, propylparaben, Red Dye No. 3, and titanium dioxide. The bill goes farther than California’s first-in-the nation law, the California Food Safety Act, effective in 2027, which bans Red Dye No. 3, potassium bromate, brominated vegetable oil, and propylparaben from foods sold in that state, and farther than a proposed Illinois bill, SB 263, which would ban those four additives plus titanium dioxide. The second New York bill would require companies in New York to disclose to the state whenever they add chemicals to foods and drinks that the company self-determines are “generally recognized as safe,” or GRAS, without notifying the FDA.

Canada: $177M extension to Wine Sector Support Program. The Minister of Agriculture and Agri-Food Canada have announced an extension of the Wine Sector Support Program, allocating up to $177 million over the next three years to bolster the Canadian wine sector. This program, originally launched in 2022, addresses certain challenges faced by the industry, among them input price increases, labor shortages, climate constraints, and severe weather events. In addition to extending the Wine Sector Support Program, the Minister revealed two initiatives under the Sustainable Canadian Agricultural Partnership, both spearheaded by the Canadian Grapevine Certification Network. These initiatives, with funding totaling up to $5.9 million and $836,220 respectively, focus on advancing research and enhancing the competitiveness of the grape and wine sector. The overarching goal is to provide the industry with tools to mitigate the impacts of climate change impact, address pest and disease challenges, and ensure the long-term sustainability and resilience of Canada’s grape and wine industry.