In an apparent first, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has published a list of priority guidance topics for the coming year. FDA intends to publish such lists at the beginning of each calendar year and update the list mid-year.
By June 2022, FDA intends to issue draft or final guidance documents on several topics of significant interest to the food industry.
- The labeling of plant-based milk alternatives. FDA has not spoken to this hotly-debated issue since September 2018, when it invited comments on the labeling of plant-based products that include the names of dairy foods, like milk, yogurt, and cheese.
- Voluntary sodium reduction goals. This final guidance will follow a draft published by FDA in June 2016 proposing voluntary 2- and 10-year reduction targets across 158 food categories.
- Lead and arsenic action levels. FDA intends to publish draft guidance with lead action levels for juice as well as foods consumed by babies and young children. FDA also intends to publish final guidance setting action levels for inorganic arsenic in apple juice. Action levels will likely be proposed or established in coordination with FDA’s Closer to Zero initiative, announced in April 2021.
- Food allergens. FDA plans to update both its draft Q&A allergen guidance and its draft guidance on food allergen hazard analysis and risk-based preventive controls. These updates will likely reflect sesame, the new major food allergen added by the FASTER Act.
- Best practices for convening a GRAS panel. Following the 2017 release of draft guidance on this topic, FDA plans to publish final guidance on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS) under the conditions of its intended use.
The dietary supplement industry can also expect to see draft guidance on FDA’s policy regarding certain new dietary ingredients and dietary supplements subject to pre-market notification requirements. This guidance appears to be intended to update at least a portion of FDA’s existing new dietary ingredient draft guidance, which has received significant pushback from industry since being published in 2011 and updated in 2016.
FDA’s priority guidance list does not reflect the proposed and final rules FDA intends to issue in the coming year. According to FDA’s Spring 2021 Regulatory Agenda, the agency currently aims to issue a proposed rule on the definition of “healthy” in September 2021 and a proposed rule on general principles for modernizing its food standards framework in April 2022, in addition to a number of other food-related proposed and final rules. FDA has not indicated in its Regulatory Agenda that it intends to issue a proposed rule on the use of CBD in food or supplements, nor has CFSAN indicated that it plans to issue guidance on this subject in its priority guidance list.
Covington will continue to closely monitor developments on these and other issues of importance to the food industry.
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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