On January 25, 2024, FDA’s Foods Program published an updated list of topics on which the agency intends to publish draft and final guidance documents by the end of 2024. The list provides an update to the guidance agenda that FDA released in July 2023, adding guidance documents on the following five topics:
- The Food Traceability Rule. FDA intends to publish a draft guidance for industry in the form of a Q&A regarding its Food Traceability Rule. The Food Traceability Rule was issued in November 2022 to facilitate faster identification and rapid removal of potentially contaminated food from the market and comes into effect in January 2026.
- Disruption in manufacture of infant formula. FDA plans to publish a draft guidance for industry on notifying FDA of a permanent discontinuance or interruption of the manufacture of an infant formula, which will presumably assist FDA in monitoring the U.S. supply of infant formula.
- Lead levels. FDA plans to finalize its draft guidance on action levels for lead in food intended for babies and young children. FDA originally published a draft guidance on action levels for lead in food intended for babies and young children in January 2023 as part of its Closer to Zero action plan.
- Voluntary sodium reduction goals. FDA intends to publish the second edition of a draft guidance for industry on voluntary sodium reduction goals targeting mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods. The first edition of this guidance was published in October 2021. These sodium reduction goals remain voluntary and do not require companies to reduce the sodium content of food, though sodium reduction efforts remain a priority focus area for FDA.
- Preventive Controls for Chemical Hazards. FDA plans to publish Chapter 12 of the Hazard Analysis and Risk-Based Preventive Controls for Human Food on preventive control for chemical hazards in a draft guidance for industry. Once completed, the Hazard Analysis and Risk-Based Preventive Controls for Human Food guidance will consist of 17 chapters that will help industry to establish risk-based preventive controls to apply a proactive and systematic approach to food safety programs.
Additionally, a number of significant guidance documents the agency has been considering remain outstanding. These include guidance on food allergens, premarket consultation on cultured animal cell foods, foods derived from plants produced using genome editing, Listeria monocytogenes, the labeling of plant-based alternatives, classification of foods as ready-to-eat (RTE) or not RTE, and the use of nutrient content claims for added sugars. FDA’s long-anticipated guidance on New Dietary Ingredient Notifications also remains pending, though it has been on FDA’s priority guidance agenda since its inception in July 2021.
FDA has also published a new website that compiles the food-related items on the Office of Management and Budget’s (OMB) Unified Agenda of Regulatory and Deregulatory Actions and provides goal publication dates, which are the same as those posted on OMB’s website.
Covington will continue to closely monitor 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.
Public comments on the list of guidance topics can be submitted to https://www.regulations.gov/ using Docket ID FDA-2022-D-2088.
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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