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 June that we took note of. 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 June 23, 2022, FDA issued marketing denial orders (MDOs) to JUUL Labs Inc. (JUUL) for all JUUL products currently on the market in the U.S. (i.e., the JUUL device and four types of JUULpods. The FDA said that the MDOs reflect the agency’s current thinking that there is “insufficient evidence to assess the potential toxicological risks of using the JUUL products.” On June 24, JUUL asked the U.S. Court of Appeals for the District of Columbia Circuit to temporarily lift the FDA’s ban until the company could challenge the legality of the agency’s action before the Court. Several hours later, the Court granted this request, temporarily stayed the FDA’s MDOs, and ordered JUUL and FDA to complete a legal briefing on the legality of FDA’s ban by July 12. The result is that, at least until July 12, retailers and wholesalers may elect to continue to sell and distribute JUUL products otherwise banned by the FDA’s MDOs.
- On June 17, 2022, the FDA announced the availability of Final Guidance on “FDA Oversight of Food Covered by Systems Recognition Arrangements.” The Guidance provides FDA current thinking on regulatory oversight activities for food covered by a partnership, known as a “Systems Recognition Arrangement(s)” (SRA) between the agency and its foreign regulatory counterparts. Although FDA is expected to expand these foreign partnerships, FDA currently has SRA partnerships with Canada, New Zealand, and Australia. The Guidance is part of the FDA’s effort, consistent with the Food Safety Modernization Act (FSMA), to take a risk-based approach to ensure the safety of imported food.
- On June 2, 2022, the agency launched a new initiative, Supplement Your Knowledge, to help educate, inform, and broaden understanding of dietary supplements. More than half of all Americans take dietary supplements daily or on occasion. The new initiative will provide reliable information about the potential benefits and risks associated with dietary supplements, such as vitamins, minerals, and herbs, they may consume.
United States Department of Agriculture (USDA)
- On June 14, 2022, Secretary of Agriculture Tom Vilsack announced that USDA is making $200 million available in the Meat and Poultry Intermediary Lending Program (MPILP). Grants of up to $ 50 million will be awarded to lenders to establish revolving loan funds to strengthen the financing capacity for independent meat processors, and to create a more resilient, diverse, and secure U.S. food supply chain. Grants will be made available in two cycles – the first will be available starting July 25, 2022.
- On June 21, FSIS updated the Salmonella Verification Testing Program Monthly Posting page to include the individual establishment Salmonella performance standard category information for raw poultry carcasses, raw chicken parts, and comminuted poultry products. Additionally, FSIS posted the aggregate sampling results showing the number of establishments in categories 1, 2, or 3 for establishments producing young poultry carcasses, raw chicken parts, or not ready-to-eat (NRTE) comminuted poultry products at the location linked above.
- On June 9, 2022, the Centers for Disease Control and Prevention (CDC) released an Investigation Notice, “Salmonella Outbreaks Linked to Backyard Poultry.” The Notice provided flock owners, stores, and poultry hatcheries with information on how to prevent and mitigate Salmonella from backyard poultry (i.e., chicken and ducks).