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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On April 18, 2022, the FDA issued a draft guidance for FDA staff and other stakeholders titled Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act. The draft guidance, when finalized, will outline our current thinking on the approach we generally intend to take when we evaluate the public health importance of food allergens that are not one of the major food allergens identified by law in the U.S. The major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Sesame becomes the ninth major food allergen effective January 1, 2023. For the purposes of this draft guidance, we refer to food allergens that are not major food allergens as non-listed food allergens. This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about non-listed food allergens in a consistent and transparent manner to inform potential future actions.

To ensure comments about this draft guidance are considered before the FDA begins work on the final guidance, please submit written or electronic comments within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Learn more about how to comment. 

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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