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  5. Food Allergens/Gluten-Free Guidance Documents & Regulatory Information
  1. Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Food Allergens/Gluten-Free Guidance Documents & Regulatory Information

What’s New

On November 29, 2022, the FDA issued two guidance documents about food allergen labeling requirements to help the food industry meet the requirements to list any major food allergen on the labels of FDA-regulated foods. One of the guidance documents is a draft guidance titled Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry. This draft guidance updates the previous edition (4th Edition) with new and revised questions and answers related to the labeling of food allergens, including requirements in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition (4th Edition) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.  Comments about the draft guidance should be submitted within 60 days of publication of the notice in the Federal Register announcing the availability of the draft guidance to ensure we consider your comment before we begin work on the final guidance. Submit comments electronically on www.regulations.gov, using Docket ID: FDA-2022-D-0099.

Food allergies are a significant public health concern with allergic reactions varying in severity from gastrointestinal disturbances and skin irritations, to anaphylaxis, anaphylactic shock and death. Consumers with allergies must avoid food with allergenic materials to prevent serious health consequences since there is no cure.

The following is guidance and regulatory information. For general information, including consumer education and other fact sheets, visit the Food Allergies main page.

Guidance documents contain nonbinding recommendations. 

General

Program Specific Topics

Biotechnology

FSMA

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

Gluten-Free

Juice HACCP

Labeling

To help U.S. consumers avoid the health risks posed by food allergens, the FDA enforces the Food Allergen Labeling and Consumer Protection Act of 2004 (the Act). The Act applies to the labeling of foods regulated by the FDA which includes all foods except poultry, catfish, most meats, certain egg products, and most alcoholic beverages which are regulated by other Federal agencies. The Act requires that food labels must clearly identify the food source names of any ingredients that are one of the major food allergens or contain any protein derived from a major food allergen.

Retail Food Industry Assistance

The FDA publishes the Food Code, a model that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry (restaurants and grocery stores and institutions such as nursing homes). Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy.

Seafood HACCP

Historical Information

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