FDA’s Foods Program: A Star-Spangled Update!

As we fire up the grills and get ready for fireworks this Independence Day, FDA is working to ensure that our food safety regulations are as American as apple pie and as dependable as Uncle Sam, providing a mid-year update on the Agency’s Food Program.

Earlier in the year, FDA outlined the draft and final guidance topics it sought to prioritize for completion as part of the Agency’s Foods Program for 2024 that we reported on here. Last week, FDA provided a mid-year progress report on the guidance documents that were on the list and that have now been issued as part of the revolution in food safety. 

As a reminder, the Office of Information and Regulatory Affairs in the Office of Management and Budget provides the Unified Agenda of Regulatory and Deregulatory actions twice a year, and reports planned actions by federal departments and agencies government wide. The Unified Agenda is aimed at increasing transparency and providing information that FDA and other administrative agencies plan to publish both in the short-term and long-term. This also helps industry understand and track FDA’s enforcement priorities to ensure compliance.

FDA has issued the following guidances since January 2024:

• New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes: Guidance for Industry

• New Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry

• Foods Derived from Plants Produced Using Genome Editing; Guidance for Industry

• Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE: Guidance for Industry

• Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry

While FDA has made some fireworks with its progress on several commitments, noticeably outstanding is FDA’s proposed regulation regarding detecting and identifying asbestos in talc-containing products, which we expected to issue Q1 of this year. Although we are still expecting FDA to issue the proposed rule this year, we recommend businesses continue to determine if talc is used in any products and work to obtain asbestos free certificates.

In the Agency’s recent update, FDA has also updated its list of guidance topics that the Foods Program is considering issuing to cover Food Safety Modernization (FSMA) and preventive controls guidance, nutrition and health claims with respect to added sugar, allergen labeling and innovative food products such as cell-cultured meats and plant-based alternatives to ensure these foods are safe and properly labeled. The updated list includes the following:

We will continue to track and monitor FDA’s progress.

For any questions on FDA related matters, including food or cosmetics regulatory compliance matters or enforcement issues, please contact us at info@garg-law.com.