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 May 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 May 16, 2023, FDA announced an updated draft Compliance Policy Guide entitled, “CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-Contact” (“Draft CPG”). The Draft CPG, if finalized, would update and replace the Current CPG. The Draft Guidance would reflect FDA’s current thinking on major food allergen enforcement policy based on the current regulatory framework and the latest science. Comments are due by July 17, 2023.
- On May 18, 2023, FDA published a Small Entity Compliance Guide (SECG) for the Federal Food Safety Modernization Act (FSMA) Food Traceability Rule (issued November 2022). The SECG describes the requirements of the Food Traceability Rule and is meant to assist small entities in complying with the applicable recordkeeping requirements. The Food Traceability recordkeeping requirement compliance date is January 20, 2026.
- On May 31, 2023, FDA shared an update on the agency’s Per- and Polyfluoroalkyl Substances (PFAS) activities including testing results for PFAS in the general food supply, progress activities to better understand PFAS in seafood, and advances in the science of testing methods for PFAS in foods.
U.S. Department of Agriculture (USDA)
- On May 5, 2023, USDA’s Food Safety and Inspection Service (FSIS) published the “Ready-To-Eat Fermented, Salt-Cured, and Dried Products Guideline.” The Guideline provides information for small and very small meat and poultry establishments manufacturing ready-to-eat, shelf-stable, fermented, salt-cured, and dried meat and poultry products, that do not use cooking as the primary lethality step and are produced under the Not Heat-Treated Shelf-Stable Hazard Analysis Critical Control Point (HACCP) category or Heat-Treated Shelf-Stable HACCP category. The Guideline addresses commonly asked questions surrounding food safety hazards and key steps to ensure the safety of these products.
- On May 19, 2023, USDA FSIS’s Office of Program Development identified several obsolete FSIS directives and announced their cancellation on June 1, 2023.
- On May 26, 2023, FSIS provided tips for faster USDA label approval. FSIS also shared that currently, labels are taking about 3-5 business days to evaluate.
Other
- On May 11, 2023, the U.S. Supreme Court published its opinion in National Pork Producers Council v. Ross. In a 5-4 decision, the justices agreed to uphold provisions of California’s ballot initiative, Proposition 12, that require whole, uncooked cuts of pork sold at retail in California to be produced in accordance with California’s farm animal confinement standards, regardless of whether the pork is derived from swine raised in or outside of California. With the Court upholding Prop 12, stays of enforcement will be lifted in both California and Massachusetts. The California Department of Food and Agriculture (CDFA) will begin enforcing its Prop 12 regulations on breeding pigs and pork beginning on July 1, 2023. Similarly, the Massachusetts Department of Agricultural Resources (MDAR) may begin enforcing its Question 3 regulations on pork sales beginning June 10, 2023.
- This month, during the Drug Enforcement Administration (DEA) 2023 Supply Chain Conference, the agency shared they will soon propose a rule clarifying that synthetically manufactured cannabinoids (ex. Delta-8 THC) are prohibited controlled substances. Terrance Boos, Chief of DEA’s Drug and Chemical Evaluation Section (DCES) said the agency is “in the process of modifying our [regulations]” on cannabis constituents based on recommendations from the U.S. Department of Health and Human Services (HHS).
