OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from October that should be highlighted. If you have any questions or would like more information, please do not hesitate to reach out to us.
U.S. Food and Drug Administration (FDA)
- On October 12, 2022, as part of FDA’s Closer to Zero Action Plan, FDA announced the launch of an independent study by the National Academies of Sciences, Engineering, and Medicine (NASEM) on the “Role of Seafood Consumption in Child Growth and Development.” The study is meant to provide the agency with the most up-to-date understanding of how seafood, and specifically mercury exposure from seafood, may impact child growth and development.
- On October 20, 2022, FDA issued the final guidance on “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” The final guidance provides information for foreign establishments (and their governments) that are subject to FDA inspection on how the agency determines when to refuse to permit entry or to inspection a foreign establishment (pursuant to section 807(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)).
- During the month of October, the FDA took various actions against e-cigarette manufacturers and their products. For example:
- On October 18, 2022, the U.S. Department of Justice (DOJ), on behalf of the FDA, filed six different complaints against e-cigarette manufacturers for permanent injunctions in Federal district courts because these defendants failed to submit premarket applications for their e-cigarettes and have continued to illegally manufacture, sell, and distribute products despite FDA’s warning.
- On October 26, 2022, FDA issued marketing denial orders (MDOs) for several e-cigarette products currently marketed. These are the first menthol e-cigarette products to receive a marketing decision based on FDA’s full scientific review.
United States Department of Agriculture (USDA)
- On October 14, 2022, USDA’s Food Safety and Inspection Service (FSIS) announced its long-awaited proposed framework to reduce the number of Salmonella illnesses that are attributable to poultry. FSIS indicated this “framework under consideration has been shaped by months of information-gathering and discussions with a wide range of stakeholders, researchers, and scientists.” The proposed framework consists of three components that support a comprehensive approach to controlling Salmonella in poultry:
- Requiring that incoming flocks be tested for Salmonella before entering an establishment;
- Enhancing establishment process control monitoring and FSIS verification; and
- Implementing an enforceable final product standard.
Other
- On November 15, 2022, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will hold a virtual public meeting to discuss the following:
- USDA-FSIS: “Enhancing Salmonella Control in Poultry Products” and take a vote on the NACMCF final report that was put together by the relevant subcommittee;
- FDA: Provide an update on the Cyclospora cayetanensis charge from the relevant subcommittee; and
- FDA will also issue an additional work charge to NACMCF on Cronobacter spp. in powered infant formula.
