With FDA’s release of its priority guidance topics for the Foods Program for the next 12 months, we see the agency as tipping its hand to its overall priorities for the year. To wit: of the 18 food-related guidances on the list, one-third of them (6) were FSMA focused and another five focused on labeling (including two planned allergen guidances). The list included both draft and final guidance intended for industry or FDA staff.
FSMA. So why is FDA reverting back to FSMA 12 years after its signing? In addition to publishing a second update of the Preventive Controls Rule draft guidance on Appendix 1: Potential Hazards for Foods and Processes and Final Guidance Sprouts, FDA is planning to make good on its 2018 “Coming Soon” commitment to publish draft guidance on chapters 11 (Food Allergen Controls) and 16 (Validation of Process Controls) along with two new chapters: 17 (Classifying Food as Ready-To-Eat or Not Ready- to-Eat) and 18 (Acidified Foods) – leaving a number of chapters still listed as coming soon, with the last found update remaining as 2018.
While the lack of the completion of these chapters was an industry call out for a while, the passage of time has diluted the focus, with industry working to comply with the letter of the rule without guidance, as well as it is able. So these guidance documents may or may not be welcome additions if they veer far from what has become accepted compliance.
Labeling. FDA is focused on labeling for plant-based alternatives for animal-derived foods, dietary guidance statements, nutrient content claims for added sugars, and major food allergens (including a compliance policy guide and a Q&A). Allergens also get a focus in draft guidances including a FALCPA Q&A, cross-contact compliance, and public health importance evaluations of non-major food allergens.
Miscellaneous. The remaining documents are a mixed bag, but include a number of areas on which we have seen recent FDA focus including draft guidance for industry on inorganic arsenic action levels for apple juice, cultured animal cell foods, genome-edited plant-derived foods, food contact substances, and importing – particularly DWPE of fish/fishery products, as well as that for FDA staff on Listeria monocytogenes compliance.
The agency anticipates publication of many of the documents by January 2024.
What does all this tell us?
FDA makes a point to note that the list focuses on Level 1 guidances. That is, they “set forth the agency’s initial interpretations of new significant regulatory requirements; describe substantial changes in FDA’s earlier interpretation or policy; and deal with complex scientific or highly controversial issues.” Seeing key words of that statement as being “significant regulatory requirements”; “substantial changes”; and “highly controversial issues,” and recognizing that many of them truly are significant, substantial and/or controversial, it would seem that the guidances should be of high priority.
Further, there is increasing pressure being applied to FDA from several outside groups to continue to push for the enforcement of FSMA. So, it is not surprising that many of the guidance documents relate to FSMA.
Unfortunately, however, in conducting a comparison with the list published January 31, 2022, the 2023 list is simply a carryover of a number of guidances which FDA listed a year ago as planned for publication by December 2022. In fact, only two of the 2023 food-related guidance topics are new: food contact substances and labeling of nutrient content claims for added sugars. (Note: This list is no longer available online, as the page has been updated with the 2023 list, but TAG had downloaded a copy of it.) So, while we may or may not see the actual guidances, the list does tell us that these are areas on which FDA plans to focus. So (1) ensuring your programs are current and compliant in these areas and (2) being prepared to comment should drafts be published are two things you can do to be prepared for the remainder of 2023. And likely into 2024, as we would expect at least some of the items on the list to be pushed forward again.