In the past week, the U.S. Food and Drug Administration (FDA) has published an updated list of its Human Foods Program priority guidance topics, resources to help industry comply with the Food Traceability Final Rule (FSMA 204), and a new Employee Health Policy Tool for food establishments.

Updated Human Foods Program Priority Guidance Topics

Earlier in 2024, FDA released the draft and final guidance topics that are a priority for the agency’s Human Foods Program to complete during 2024. Since January, FDA has issued the following guidances that were on the list:

  • 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  • New Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry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Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry

Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to using Docket FDA-2022-D-2088.

The guidance documents that have issued so far in 2024 have been removed from the complete list.

Updated FSMA 204 Resources

FDA has published additional resources to its website to help industry comply with the Food Traceability Final Rule. These include:

  • A downloadable, electronic sortable spreadsheet template (download)
  • Minor revisions to the Food Traceability List clarifying the status of previously frozen foods on the list, as well as a new FAQ summarizing the changes
  • A chart summarizing exemptions relevant to produce farms for both the Produce Safety Rule and the Food Traceability Final Rule
  • A supply chain example for sprouts
  • New translated material about the Traceability Lot Code and the Traceability Plan.

In addition, FDA has partnered with the Food Safety Preventive Controls Alliance (FSPCA) to develop training for the food industry on the Food Traceability Rule. Curriculum development has been initiated by a team including subject matter experts from FDA, industry, and academia. The team is working to create training exercises to help food industry personnel to understand FDA’s Food Traceability Rule requirements. Training is anticipated to be available by mid-2025.

Employee Health Policy Tool

FDA developed an Employee Health Policy Tool to encourage practices that can help prevent the transmission of foodborne viruses and bacteria in food establishments from ill employees. The tool will help users navigate restriction and exclusion requirements identified in Part 2-201 of the 2022 FDA Food Code using clickable pathways dependent upon the role of the user and the symptoms and/or diagnoses presented.