This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
FDA chief outlines his priorities. FDA Commissioner Robert M. Califf recently outlined a framework for the Agency’s new Human Foods Program and a new model for the Agency’s Office of Regulatory Affairs, reports James Jones, the deputy commissioner for human foods at the FDA. Writing on the FDA’s website, Jones said that he is “committed to upholding and executing this framework guided by the principle of protecting and promoting the health and wellness of all U.S. consumers.” He said the Agency will “start driving towards this goal by focusing our efforts on three priority areas: preventing foodborne illness, decreasing diet-related chronic disease through improved nutrition, and safeguarding the food supply through the safe use of chemicals and dietary supplements.”
Health Canada and CFIA invite comments on proposal to modernize food standards. Health Canada and the Canadian Food Inspection Agency (CFIA) have prepublished proposed Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods for Analysis. A goal of these regulations is to modernize the regulatory framework currently governing Canada’s food industry. Currently, Canada’s Food and Drug Regulations contain strict frameworks that do not accommodate innovations in food composition or health and safety rules without amendment. The new regulations will allow Health Canada and the CFIA to rely on science-based decision-making to administratively update standards under the Food and Drug Regulations by incorporating them by reference (IbR). Public commentary may be submitted online to Health Canada through February 2, 2024.
FDA: Next steps on front-of-package labeling. On October 17, in one of his periodic reports on the FDA’s website concerning the Agency’s work, FDA Commissioner Califf said the Agency is proceeding with its plans to consider proposing a front-of-package labeling system for food labels. He said that the congressionally funded Reagan-Udall Foundation will host a public meeting on November 17 to obtain input from stakeholders on this issue. “Given the potential significance of front-of-package labeling, we are hearing substantial interest from a wide variety of stakeholders, including consumer groups, public health organizations, academia, health care groups and industry,” Califf said. Interested parties must register to attend.
CFIA updates Food Export Certification process. The CFIA has made updates to the Food Export Certification process. Food exporters requesting an export certificate or export permission must provide the CFIA inspector with accurate, complete information and supporting documents. Supporting documents can be pictures of the container or seal, laboratory tests, and pictures or copies of the consignment product labels showing the establishment numbers, lot codes, and product name. Exporters are also required to demonstrate control measures in place to ensure food being exported meets the requisite Canadian and importing requirements. CFIA inspectors are entitled to, at any time, request supporting documents to ensure information submitted is factual, accurate and complete.
FDA delays enforcement of upcoming cosmetic registration and listing requirements. On November 8, FDA issued an enforcement discretion guidance delaying enforcement for facility registration and cosmetic product listing until July 1, 2024, providing an additional six months for industry to comply. The Agency stated that it will be ready to accept registration and listing information by the original December 29, 2023 deadline, but it will not enforce against companies for failing to do so until July 1, 2024. This announcement was made in response to industry concerns that they need additional time to gather the needed information.
FDA proposes banning BVA, continues assessments of other chemicals. On November 2, the FDA proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. This action is part of the Agency’s regulatory authority over ingredients added to food, which includes reassessing previously evaluated food ingredients and addressing safety concerns. Brominated vegetable oil (BVO) is used in small amounts to keep citrus flavorings from floating to the top in some beverages – there are no authorizations for other uses of BVO in food. The FDA is issuing a proposed rule now because recent Agency studies demonstrate adverse health effects from BVO ingestion in animals at levels closely approximating real-world human exposure. Based on these data and remaining unresolved safety questions, the FDA says it can no longer conclude that the use of BVO poses a reasonable certainty of no harm from continued use in food.
CFIA on trans-shipments of animal products and by-products. The CFIA has clarified the Terrestrial Animal Products and By-products Import Policy Framework with respect to trans-shipments of animal products and by-products. The general import requirements vary depending on where the shipment travels from and the risk level of commodities. When the shipment travels from the country of origin directly to Canada, the Automated Import Reference System outlines the specific import requirements based on the HS code levels, origin levels, and the end use of the product. Two zoosanitary certificates are required instead of an import permit if the trans-shipment is passing through the US only and is one of the follow low-risk commodities: milk and milk products; eggs and egg products; highly processed products from non-bovine species; highly processed products originating from bovine bones or hides and skins where the country of origin poses a negligible risk of BSE; integumentary tissues; fertilizers containing processed manure but no rendered materials. One zoosanitary certificate must be from the country of origin and the other must be from the US. An import permit will be required for trans-shipment of other commodities through the US and for trans-shipments through all other commodities.
FDA provides update on MoCRA implementation. FDA issued a summary of its efforts toward mandatory registration and listing of cosmetics products. In addition to the August 2023 FDA draft guidance, FDA announced in September 2023 an opportunity to comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067), prior to the Agency’s request for Office of Management and Budget (OMB) approval. In October 2023, FDA announced publication of the “Structured Product Labeling (SPL) Implementation Guide with Validation Procedures,” which will help develop SPL authoring tools and, in the future, allow users may transmit SPL-formatted submissions to the Agency. FDA strongly encourages electronic submissions to help facilitate efficiency and timeliness of data submission and Agency management. On November 1, FDA announced that it will provide more information on the launch date for submissions in the coming weeks.
USDA will conduct sampling program on dioxin in the diet. The USDA’s Food Safety and Inspection Service announced that on November 1 it will begin conducting a one-year sampling program to determine whether the levels of dioxin and dioxin-like compounds in domestic beef, pork, and catfish remain low. Dioxins are a group of compounds that are persistent environmental contaminants but generally occur at low levels. The FY 2024 Dioxin Survey is part of the agency’s effort to monitor dioxin in regulated products and to seek insights on changes in human exposure to dioxin-like compounds in the diet. FSIS personnel will collect fat and liver samples in federally inspected establishments, and the Agricultural Research Service (ARS) will analyze the samples. This is the latest survey in the recurring five-year cycle of dioxin surveys that FSIS conducts with other federal partners, including ARS, the EPA, and the FDA. The FSIS intends to publish the result of the survey on its website.
High court declines to review decision on North Carolina ag-gag law. On October 16, the US Supreme Court declined to hear an appeal by North Carolina in a case in which People for the Ethical Treatment of Animals (PETA) had challenged a state law aimed at preventing undercover filming of conditions at farms and workplaces. The justices thus leave in place a ruling by the US Court of Appeals for the Fourth Circuit that blocked enforcement of the state’s 2015 Property Protection Act. The appeals court had ruled that the law could not be enforced against PETA when its undercover work was being performed to conduct newsgathering activities. The North Carolina law is similar to other state “ag-gag” laws aimed against undercover activists who record footage of the animal agriculture industry – those laws largely have not survived court challenges. In this instance, the lower court sidestepped questions about the law’s validity in certain non-newsgathering contexts.
Maine is considering prohibition on PFAS substances in food packaging. On October 23, the state of Maine put forward a proposed rulemaking proposal that would incorporate an existing statutory sales prohibition on the use of phthalates in food packaging and would also add a new section that would prohibit for the first time the use of specific applications of intentionally added PFAS to certain types of food packaging. PFAS substances have become the subject of major concern in recent years. A public hearing on the issue will be held on November 16. In the proposed rulemaking, the term “Perfluoroalkyl and polyfluoroalkyl substances, or PFAS” is defined as “any member of the class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”
New York City to require warnings for overly sweet restaurant menu items. On November 2, the New York City Council passed legislation that will require chain restaurants to post warnings on all menu items containing a specified amount of added sugars. The legislation, sponsored by council majority leader Keith Powers, builds on the Sweet Truth Act, a set of sugar warnings policy passed in 2021 that covered only limited items sold in restaurants; that measure has not yet been implemented due to the pandemic. “We see a major crisis in the city – and beyond it – when it comes to nutrition and obesity,” Keith Powers said. “We are trying to make New Yorkers eat healthier and live healthier lifestyles.” The legislation applies to all chain restaurants with 15 or more locations. Restaurants that fail to comply could face fines of $200 per violation.
CSPI completes survey of foods available in schools. On October 16, the nonprofit Center for Science in the Public Interest announced the result of its study on the snacks, entrées, and beverages that students may purchase at school alongside the official school meal programs. It concluded that almost half of these products are high in added sugars, artificial sweeteners, and synthetic dyes. The report came as the USDA is finalizing new regulations that it issued in draft form in February 2023 which include, among other things, ed new limits on added sugars in school meal programs. “The good news is that about half of the competitive foods we found marketed to schools are already compliant with strong, science-based standards for added sugars, low-calorie sweeteners, and synthetic dyes,” said CSPI child nutrition campaign manager Meghan Maroney. “But the USDA needs to update its Smart Snack nutrition standards so that the foods available to school kids are aligned with the Dietary Guidelines for Americans.”
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