This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
IMF: fragmented commodities markets threaten food security and the green transition. The international Monetary Fund is warning that fragmented commodities markets are threatening world food security – and also may raise the price of clean energy. In a section of its World Economic Outlook released on October 3, the IMF said the threat is driven by Russia’s invasion of Ukraine and consequent economic sanctions, which have disrupted the global marketplaces for food, fuel, and fertilizer and have broadly worsened inflationary pressures and “geo-economic fragmentation.” Particularly vulnerable: highly traded agricultural items such as grains, and minerals critical for the green transition such as lithium, cobalt, and copper. The IMF said, “Our findings present yet another argument for multilateral cooperation on trade policies to prevent such outcomes.” But, in the absence of such agreements, the IMF called on nations to collaborate on food corridor and green corridor agreements that would ensure equal access to agricultural products and protect the global flow of the minerals needed for decarbonization.
FSMA Food Traceability Rule. FDA has provided additional information around its implementation of the FSMA Food Traceability Rule. In its update to its Frequently Asked Questions: FSMA Food Traceability Rule, the agency announced that, while the first compliance date remains January 20, 2026, the agency will not begin routine inspections for compliance with this rule until 2027 so that covered entities will have additional time to work toward compliance. FDA confirmed that it is taking an “educate before and while we regulate” approach, working to bring the inspected entity into compliance, rather than issuing warning letters or taking enforcement actions FDA will still do “for cause” inspections, particularly in conjunction with outbreaks and other food safety problems and may still issue warning letters in conjunction with serious violations that impact public health. FDA also announced that it is establishing a secure portal – the Product Tracing System or PTS – that would allow the agency to receive and analyze industry’s food traceability data required by the rule. Industry would have the option of using this system to upload the required information but would also have the option to send the information in the electronic sortable spreadsheet (or other information) in an email for FDA to upload. This system will allow FDA respond to food safety problems more quickly.
Guidance tries to make it easier for sprout operations to comply with safety rule. On September 28, the FDA released two guidance documents that outline its recommendations for how sprout operations may comply with the agency’s Produce Safety Rule. The first document updates a previous guidance, “Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations.” It includes chapters on cleaning and sanitizing produce, the use of agricultural water in sprout operations, the use of seeds for sprouting, environmental monitoring, and record keeping. The second document primarily reissues a previous document. The agency said it is interested in comments from the public, about testing of spent sprout irrigation water or in-process sprouts that sprout operations are currently conducting for non-O157:H7 pathogenic E. coli.
Health Canada updated policy on Listeria monocytogenes. Health Canada’s updated policy on Listeria monocytogenes, which came into effect on October 1, 2023, aims to provide clarity on how the food industry, government, and consumers can minimize the risk of contracting food-borne illness from products contaminated by Listeria. Notably, the policy places significant focus on domestic manufacturers, importers, and exporters of ready-to-eat (RTE) foods – foods which require no additional preparation prior to being consumed. The new Listeria policy aims to reduce the presence of the pathogen in RTE foods through improved practices in manufacturing, preparation, preservation, packaging and storage.
USDA plans sampling program for antibiotic-free beef. On September 22, the USDA’s Food Safety and Inspection Service and Agricultural Research Service confirmed they have launched an exploratory sampling program to determine whether antibiotics residues are detectable in cattle that producers intend to market with “raised without antibiotics (RWA)” claims. Under the program, the FSIS will collect liver and kidney samples from eligible cattle, and the ARS will analyze the samples using a method that targets more than 180 veterinary drugs from major classes of antibiotics. If antibiotic residues are detected, the FSIS will issue a letter to the company advising it to conduct an analysis and take action to prevent selling a misbranded product in commerce. If no residues are found, the beef could legally be labeled as “Antibiotic Free” or with a similar label.
Health Canada approves adding a choline source to supplemented foods. Health Canada’s Food directorate has concluded an analysis on the safety of L-alpha-glycerylphosphorylcholine, also known as alpha GPC or choline alfoscerate, as a source of supplemental choline. Choline is a nutrient found in a wide variety of foods and plays a role in metabolism and brain function in humans. Health Canada has now approved the use of L-alpha-glycerylphosphorylcholine in supplemented foods, to a level that does not exceed prior established maximum levels for choline. Supplemented foods containing L-alpha-glycerylphosphorylcholine are also required to comply with labelling requirements as specified in the Government of Canada’s List of Permitted Supplemental Ingredients.
Health Canada announces proposal on buffer zone between nutrition symbols and SFCI. Health Canada is proposing to modify the Directory of Nutrition Symbol Specifications and the Directory of Supplemented Food Caution Identifier (SFCI) Specifications to permit displaying the front-of-packaging (FOP) nutrition symbol and SFCI with no buffer between them. Current guidelines, in contrast, require both the FOP nutrition symbol and the SFCI to have a minimum buffer zone surrounding the symbols to ensure they are distinct from the background. The proposal suggests a buffer as small as 0 mm between the FOP nutrition symbol and the SFCI or between nutrition symbols on prepackaged products that contain an assortment of food where they share a border. Comments related to this proposal may be submitted to this email address by December 8, 2023 using the subject line “FOP-SFCI Buffer Zone 9NOP SFCI-001).”
FDA tries to help manufacturers deal properly with sesame as an allergen. On September 26, the FDA announced a draft guidance designed to help food facilities comply with the requirements for current good manufacturing practices and preventive controls for human food. In particular, the new chapter on food allergens outlines ways to ensure that foods are protected from cross-contacts with major food allergens and that the finished food is properly labeled with respect to the allergens. The FDA said it was acting because some manufacturers, in response to the FDA’s recent decision to declare sesame a major allergen, have started to label their products as containing sesame rather than taking measures to prevent cross-contamination. The agency said it is encouraging industry to follow the draft guidance on the best ways to significantly minimize or prevent allergen cross-contact and undeclared allergens, rather than intentionally adding sesame to their products and then declaring it on their labels. to gain technical compliance with the law.
Canada temporarily restricts France’s live poultry, poultry products, and by-products. In October 2023, France initiated mandatory Highly Pathogenic Avian Influenza (HPAI) vaccination in ducks raised for meat production as a result of the EU legislation governing the use of vaccination as a strategy for the mitigation of outbreaks of animal diseases. Pending an evaluation of possible risks posed by these imports, the Canadian Food Inspection Agency (CFIA) has temporarily suspended all live poultry, hatching eggs, and raw fresh/frozen poultry products originating in France, effective October 1, 2023. Products affected by this suspension are live birds and hatching eggs, all unprocessed avian and poultry products and by-products, laboratory material containing poultry products and by-products, raw or unprocessed pet food containing poultry products or by-products, and edible or inedible raw poultry meat. Notably, cooked and canned or hermetically sealed, commercially sterile meat products are still eligible for import.
FDA announces new approach to innovative veterinary products. On September 15, the FDA announced it is taking steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products, in order to increase regulatory flexibility, predictability, and efficiency. The Animal and Veterinary Innovation Agenda that the agency announced lists four objectives and details the supporting actions by the agency’s Center for Veterinary Medicine to foster product development and to implement smart, risk-based approaches to regulating modern animal and veterinary products. The agency said that these actions will further position the agency towards continued scientific and technological evolution while helping to bring safe and effective products to the market. Specifically, the new agenda applies to products like novel food ingredients that work solely in the animal’s gut to increase nutritional efficiency and production, animal biotech products such as cell- and tissue-based products, and intentional genomic alterations in animals.
FDA moves forward on new portal for cosmetics registration. On September 15, the FDA announced it is seeking comments on its newly developed draft electronic submission portal, known as Cosmetics Direct, and new paper forms (Forms FDA 5066 and 5067). Cosmetics Direct, the agency said, includes the required registration and listing submission information from the paper forms in a standard electronic format. This will help companies organize their registration and listing submissions to include the information needed for the FDA and will give them access to their previous Cosmetics Direct registrations and listing submissions. The new portal will permit cosmetics makers to satisfy their obligations under the new Modernization of Cosmetics Regulation Act of 2022, which, among other things, requires that a responsible person at each company must list each marketed cosmetics product with the FDA, including the product ingredients, and provide any updates annually. The deadline for comments is October 18, 2023.
FTC attorney says not all claims for dietary supplements need backing of clinical trials. Despite the existence of language in the Federal Trade Commission’s 2022 Health Products Compliance Guidance that suggests all health claims for dietary supplements must be substantiated by clinical trials, an agency attorney said at a recent conference that not all such claims require that level of substantiation. Speaking September 19 at a conference in Bethesda, Maryland, FTC staff member Christine DeLorme said the agency needs to “prioritize” and that there “are certainly cases where you don’t need [randomized controlled trials].” However, she noted, “for the serious cases, experts would say you need [the trials] and those [trials] should be statistically and clinically significant.”
US Congress will consider bill to expand investigative powers of FDA and CDC. On September 13, Senator Cory Booker (D-NJ) and Representative Rosa DiLauro (D-CT) introduced the Expanded Food Safety Investigation Act, which would grant the FDA and the Centers for Disease Control and Prevention the authority to collect microbial samples from concentrated animal feeding operations during outbreaks or when there is a public health need. They noted that currently, when investigators from the two agencies trace outbreaks and other public health concerns to animal farms, the owners can refuse permission for investigators to enter the farm to sample for microbes. No other business that produces food can do this. The bill’s sponsors say that the animal industry has taken advantage of this gap in food safety regulatory authority and has prevented crucial investigations from taking place.
AHA moves to foster research on “Food Is Medicine” concept. A September 28 article in Circulation, the journal of the American Heart Association, provides a roadmap to the current state of the “Food Is Medicine” field and a recommendation for further action in the area. If the “Food Is Medicine” concept gains full scientific approval, food companies might soon be able to market appropriate products as beneficial for curing or preventing disease. “Food Is Medicine” programs focus on providing medical prescriptions for healthy foods to manage, treat, and prevent chronic health conditions, such as congestive heart failure and diabetes. The article points out that an estimated 90 percent of the $4.3 trillion annual cost of healthcare in the US is spent on medical care for chronic diseases. For many of these diseases, it is known that diet is a major risk factor, so even modest improvements in diet could have a significant impact, the article says.