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New guide outlines allergen labeling requirements for businesses

2025-04-09 Food Safety News

Tag: allergen labels

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The Food and Drug Administration has published new information for businesses seeking guidance on how to label foods that include known allergens.

The new web page includes Frequently Asked Questions to be used as a resource for the Fifth Edition of the FDA’s Guidance for Industry titled “Questions and Answers Regarding Food Allergens, Including the Food Labeling Requirements of the Federal Food, Drug and Cosmetic Act.”

Information in the new Food Allergen Labeling Guide for industry covers questions asked by stakeholders including industry, trade associations and consumers that were submitted after the publishing of the final guidance.

The intent of the final guidance is to help the food industry meet the requirements for listing major food allergens — milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans and sesame — on the labels of FDA regulated foods.

“Food labels are an important tool that help protect consumers with food allergies. Consumers can avoid ingredients they may be allergic to in a food by looking for specific allergen labeling and reading the ingredient list,” the FDA announcement said.

The revised final guidance includes the draft and the final Food Allergen Q&A Guidance that was issued on Nov. 30, 2022. The updat contains new and revised questions about food labeling. It also includes updated information about sesame as a major food allergen and expanded interpretations of milk and eggs as major allergens. It discusses expanded interpretations of milk and eggs as major food allergens to include milk from ruminant animals other than cows and eggs from birds other than chickens.

Also, several tree nuts, including coconut, are no longer considered major food allergens and do not appear on the list of major food allergens in the revised Fifth Edition of the Food Allergen Q&A Guidance.

The FDA’s enforcement approach is generally risk-based and evaluates each situation on a case-by-case basis.

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