FDA identifies food program priorities with its release of planned guidance documents: what’s on the list?

The Food and Drug Administration (FDA) has identified its food program priorities with the release of a list of “Food Program Guidance Documents Under Development.”

The list sets out draft and final food guidance documents which the agency plans to issue over the next 12 months. While guidance documents are not legally binding, they provide industry and other stakeholders with the agency’s current thinking on a variety of topics and can be useful in future decision making.

The list includes guidance documents to assist industry in complying with the Preventive Controls for Human Food (PCHF) and Produce Safety regulations issued under the FDA Food Safety Modernization Act (FSMA). More specifically, FDA plans to issue additional draft guidance documents on potential hazards for food and processes; allergen controls; validation of process controls; acidified food; and classifying food as ready-to-eat or not ready-to-eat. In addition, the agency plans to issue its final guidance on standards for the growing, harvesting, packing, and holding for sprout operations.

The agency is also focusing on guidances to assist industry in developing new technologies. The list includes a draft guidance on the premarket consultation process for cultured animal cell foods, as well as one on food derived from plants produced using genome editing. In addition, FDA plans to issue a draft guidance on the labeling of plant-based alternatives to animal-derived foods.

With the majority of food recalls based on undeclared allergens, FDA also plans to issue several guidances on allergens, including a final guidance on allergens that included allergen labeling, a draft guidance for FDA staff on labeling and cross-contact, and a final guidance to FDA staff and stakeholders on evaluating the public health importance of allergens other than the major food allergens identified under the Food Allergen Labeling and Consumer Protection Act f 2004 (FALCPA). The current major allergens include milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame, the last of which was added in April 2021 and went into effect in January 2023.

In addition, the agency intends to issue its final guidance on new dietary ingredient notifications and related issues, as well as draft guidance documents on tattoo ink, premarket submissions for food contact notifications, and nutrition labeling.

While FDA publishes a list of intended guidance documents annually, the agency does not always issue all the documents on the list due to a lack of resources, competing priorities, and difficulties in clearing the documents through HHS and OMB. Indeed, several of the documents on this year’s list are holdovers from last year’s list. While comments on a guidance document can be submitted at any time, it is best to submit comments within the requested timeframe listed in the Federal Register notice to ensure it is considered as the agency develops the final guidance.

For a full list of anticipated guidance documents, see the FDA’s Foods Program Guidance Under Development. We will continue to provide updates when the guidance documents are issued.

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