During yesterday’s Regulatory Update webinar, Jeni Lamb Rogers of Branded, discussed what to expect from the FDA in 2022, including the priorities of new FDA Commissioner, Dr. Robert Califf, and the resumption of routine surveillance inspections. Here are the major updates you need to know about:
1. FDA Commissioner, Dr. Robert Califf, was confirmed on February 15. Rogers shared that the priorities most likely to impact food brands are related to the Food Safety Modernization Act and nutrition. She explained that there’s a lot of trust in the institutional staff and permanent staff of the agency, so we can expect the revealing of guidance documents and a more business as usual type of approach on FSMA, nutrition, and expanding on the existing priorities rather than any new radical direction given the other important areas of focus for the FDA right now.
2. In reference to the Center for Food Safety and Applied Nutrition’s FSMA guidance document priorities, Rogers noted the following will be particularly important to pay attention to upon release as they have received the most offenses:
• HARPC for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
• HARPC for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
• HARPC for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry
• Food Safety Verification Program for Importers of Food for Humans and Animals; Guidance for Industry
3. If you are active in plant-based or looking to get into this category, Rogers recommends keeping a close eye on draft guidance document priorities that will focus on labeling of plant-based milk alternatives, labeling of plant-based alternatives to animal derived foods, and Q&A about dietary guidelines statements in food labeling.
4. The FDA has updated the ability to search and pull data on enforcement, so you can now search its website in a more targeted way, Rogers revealed. This publicly available resource automatically produces graphs and provides specific citation history, so you can research a facility. Rogers said this tool gives you a real advantage and encourages you to take the time to check it out.
5. Since the pandemic, we have seen inspections confined to mission critical. In 2022, Rogers said there will be a return to business as usual for FDA inspections including the resumption of “routine surveillance inspections,” the return of unannounced inspections, continued use of remote inspections, and foreign surveillance inspections targeted to resume in April.
If you are looking to learn more about FDA Updates for 2022, access the webinar recording here in our Learning Center. We also recommend reviewing the SFA’s December webinar, Remote and Virtual Audits and Inspections for FDA Compliance: Here to Stay
Related: Implementing FSMA In an Almost-Post-COVID-19 World; Rogers Outlines FDA Action to Modernize Standards of Identity.