The FDA’s Center for Food Safety and Applied Nutrition and Office of Food Policy and Response have published a list of draft and final guidance topics that the agency intends to issue this year. The list provides an update to the guidance agenda that FDA released in February 2023, adding the following topics to this year’s agenda:
- Arsenic and cadmium action levels. FDA intends to publish draft guidance with arsenic and cadmium action levels for foods consumed by babies and young children. These action levels will be proposed in coordination with FDA’s Closer to Zero initiative.
- Dietary supplement master files. Companies use Drug Master File (DMF) submissions to submit detailed, confidential information about drug articles to FDA in support of drug submissions. FDA plans to issue draft guidance on Dietary Supplement Master Files, which presumably will be similar to DMFs but used to support New Dietary Ingredient Notifications.
- Low-moisture ready-to-eat foods, including infant formula. FDA intends to issue guidance on evaluating and establishing the safety of low-moisture ready-to-eat foods following equipment microbiological contamination events.
- Testing to show sufficient biological quality of protein in new infant formula. FDA intends to finalize its draft guidance on the use of protein efficacy ratio (PER) rat bioassay studies to show that a new infant formula contains sufficient biological quality protein.
- Menu labeling supplemental guidance. FDA plans to amend its Menu Labeling Supplemental Guidance released five years ago, in May 2018.
Notably, two of the proposed guidance documents will impact infant formula, suggesting that infant formula issues remain an area of focus for FDA. Heavy metals in foods intended for infants and young children also remains a key priority for the agency. A proposed guidance on Dietary Supplement Master Files will likely be consistent with FDA’s larger effort to encourage the submission of New Dietary Ingredient Notifications. Companies can submit comments on the guidance topics at www.regulations.gov at Docket FDA-2022-D-2088.
A number of significant guidance documents the agency has been considering remain outstanding, including guidance on the labeling of plant-based alternatives, foods derived from plants produced using genome editing, premarket consultation on cultured animal cell foods, and use of nutrient content claims for added sugars. FDA’s long-anticipated guidance on New Dietary Ingredient Notifications remains pending, though it has been on FDA’s priority guidance agenda since its inception in July 2021.
Covington will continue to monitor closely developments on these and other issues of importance to the food industry. Even while FDA's guidance documents and rules are pending, Covington would be happy to share insights on how the agency is thinking about these key issues, based on our interactions with FDA to date.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
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