Q&A: FDA seeks comments on food allergen labeling guidance for industry

The FDA has issued Draft Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling, for which it is seeking expert comment.

This fifth edition of the guidance makes additions and revisions to comply with the Food Allergy Safety, Treatment, Education and Research (FASTER) Act of 2021 and the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.

Specifically, sesame has been added to the FDA’s list of ingredients that require labeling as an allergen, and the FDA has made other additions that address the role of labeling in dietary supplements; provide examples of food allergy labels; and clarify issues surrounding the labeling of tree nuts, fish and crustacean shellfish.

Interested parties can contact the FDA with their comments about Edition 5 by January 29, 2023, online or by letter.

Healio spoke with Robert Earl, MPH, RDN, FAND, vice president of regulatory affairs at Food Allergy Research & Education (FARE), to find out more about the FDA’s efforts and how they will impact patients with food allergy.

Healio: What are the current benefits of the food allergen labeling Q&As?

Robert Earl

Earl: The FDA’s Q&As on food allergens and labeling are meant to inform the public and the food industry about labeling requirements, including what to do and what not to do related to the labeling of foods and dietary supplements. Accurate food allergen labeling and production controls by industry reduce cross-contact during manufacturing and assist those with food allergy and their caregivers to make safe food choices and reduce the risk of food allergy reactions.

Healio: Are there any areas where these Q&As in the draft guidance fall short?

Earl: The draft Q&As thoroughly cover labeling requirements of the FALCPA and the FASTER Act related to sesame and clarify items in a few other areas. As written, the Q&As could go even further related to the responsibilities of food manufacturers to control food allergen cross-contact during production and packaging for the top nine food allergens requiring labeling.

Healio: How does this request for comment help address those shortcomings?

Earl: The FDA’s request for public comment allows those with food allergy and their caregivers, as well as consumer groups, health professionals and food allergy advocacy organizations like FARE to provide input to the FDA on ways to improve the new draft Q&As on food allergen labeling required under FALCPA and the FASTER Act.

Healio: In addition to this request for comment, what else can the FDA be doing to improve food allergen labeling?

Earl: In 2022, the FDA published draft guidance on the evaluation of data regarding additional food allergens requiring labeling. The draft guidance elaborated the framework for adding new priority food allergens requiring labeling but did not address the regulatory process also required by the FASTER Act. We hope the FDA will address FARE’s and other public comments and modify the guidance accordingly to best serve our food allergy community.

Healio: Some critics contend that current labels are too vague. Could and should these labels be more specific?

Earl: The FDA’s requirements for food allergen labeling and food safety regulations about controls to prevent food allergen cross-contact at the manufacturing plant level are quite clear. However, precautionary allergen labeling (PAL) statements in labeling (eg, “May contain...” or “Manufactured in a facility that also processes...”) are not regulated by the FDA, were not envisioned when FALCPA was enacted in 2004, are diverse and confusing, and should be used only when absolutely necessary.

FARE agrees that such PAL statements are confusing and reduce trust in food manufacturers. Our consumer research shows a top preference for “Not suitable for [x allergen(s)]” PAL statements in labeling. FARE supports the FDA’s efforts to adopt food allergen thresholds and develop a regulatory framework to regulate the use of PAL statements only when absolutely necessary following qualitative and/or quantitative risk assessment at the food plant level.

Also, FARE recommends better food allergen controls. Additionally, food manufacturers should not intentionally add food allergens as minor ingredients or flavors to avoid good manufacturing practices and food allergen controls.

Healio: What role do you think clinicians should have in this guidance regarding food allergen labeling?

Earl: Health care professionals who interact with those who have food allergy and their parents and caregivers should educate patients about food allergen labeling as the primary tool to understand whether a food is safe to consume. This includes staff of the USDA Special Supplemental Nutrition Program for Women, Infants, and Children (WIC Program) because many women and children in the WIC Program have food allergies and need appropriate substitutions.

Further, given the 2020-2025 Dietary Guidelines for Americans recommendation to introduce food allergens in infants’ diets when they are ready to consume complementary foods to reduce the risk for developing food allergies, all health professionals and WIC Program staff should educate parents and caregivers of newborns about early introduction. This early introduction approach has the potential to virtually eliminate the development of food allergy in a generation.

Healio: Do you have any other comments about this current, ongoing process?

Earl: FARE encourages all interested parties to comment on the FDA’s Q&As with the goal to better protect individuals with food allergy and assist their caregivers.

Reference:

• Draft guidance for industry: Questions and answers regarding food allergen labeling (edition 5). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5. Published Nov. 29, 2022. Accessed Dec. 12, 2022.