FDA’s Intended Guidance List Foretells Agency Focus
I often get asked “Where do you think FDA is heading in the near future around food regulations and enforcement?” It is often a hard question to answer, but now we have a bit of a road map since FDA has released a list of guidance documents for its Food Program that it expects to publish over the next year. Although the agency made a point of stating that the list includes “possible new topics” and it is “neither bound by this list of topics, nor required to issue every guidance document on this list,” there is enough repetition in the topic areas that we feel it can be seen as essentially detailing the key areas of on which FDA expects to focus for the food industry.
With a combination of drafts for industry, finals for industry, and guidance for FDA staff, the list follows a few key themes, which FDA helpfully includes as categories. These include allergens, dietary supplements, food additives, food safety, FSMA, labeling and nutrition. (See table below.)
While noting several factors could impact its ability to issue the listed guidances, such as new Administration priorities and emerging public health issues, we see exactly those things as having impacted the topics on the list. For example, the first item on the list (albeit because the topics are listed alphabetically) is allergens – for which FDA is required to conduct assessments and report back to Congress on non-regulated allergens; a key element of the food safety topic is that of action levels for lead in baby foods – again a response to a Congressional report on heavy metals in these foods.
Further down the list – but prominent in the number of guidances intended to be issues is FSMA. With a focus on further interpretation of varies aspects of the rules, as well as enforcement policies for certain provisions, the continuing focus on FSMA shows that it is a living document, with its full development very likely continuing to evolve and “modernize.”
Interestingly, FDA also includes two food safety FDA Staff Guidance documents on the list: Listeria monocytogenes in human food (CPG Sec. 555.320) and Scombrotoxin (Histamine)-Forming Fish and Fishery Products–Decomposition and Histamine. While being written for FDA Staff, the guidance – and the intention to publish the guidance – also provides the industry with a look toward areas FDA intends to place its focus.
With COVID protections lifting, FDA is, once again, becoming active in the field, and showing up on food facility doorsteps. Being given this list of intended guidance for this upcoming year gives the industry a strong indication of what the priorities are in FDA and where the agency investigators will be looking at and for when they arrive for an inspection. In a nutshell: allergens, heavy metals and continued FSMA focus is where FDA is looking at the moment. TAG will continue to keep an eye on FDA publications to keep you informed and provide our insights on what they mean.
A Summary of the FDA Intended Guidance through June 2022
Public Health Importance of non-regulated food allergens
Food allergen Q&A
New dietary ingredients/supplements requiring pre-market notifications
Best practices for convening a GRAS panel
Action levels for lead in juice
Action levels for lead in food categories for babies/young children
Evidence for release/removal of fish/products held for Detention Without Physical Examination (DWPE) (i.e., bacterial pathogens, animal drugs, scombrotoxin/Histamine or Decomposition)
Action level for inorganic arsenic in apple juice
Final rule Q&A: Salmonella Enteritidis prevention in shell eggs in production, storage, transportation
Reducing microbial food safety hazards in the sprout seed production
FDA Staff Guidance
Listeria monocytogenes in human food (CPG Sec. 555.320)
Scombrotoxin (Histamine)-Forming Fish and Fishery Products–Decomposition and Histamine
Enforcement policy for certain provisions of FSMA Rules (CGMPs/Preventive Controls, FSVP, IA, Produce Safety)
Preventive Controls/Human Food for Appendix 1: Potential Hazards for Foods and Processes; Chapter 11: Food Allergen Controls; Chapter 16: Validation of Process Controls; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready-to-Eat; Chapter 18: Acidified Foods
Q&A on the Accredited Third-Party Certification Program
Refusal of inspection by a foreign food establishment or foreign government
FSVP for importers of food for humans and animals
Labeling of plant-based milk alternatives
Q&A on dietary guidance statements in food labeling
Protein Efficiency Ratio (PER) rat bioassay studies to demonstrate a new infant formula has sufficient biological quality of protein
Target mean/upper bound concentrations for voluntary reduction of sodium in processed, packaged, prepared foods