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  1. Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Food Allergens/Gluten-Free Guidance Documents & Regulatory Information

What’s New

On May 16, 2023, the FDA announced the availability of DRAFT Compliance Policy Guide Sec 555.250: Major Food Allergen Labeling and Cross-contact. The purpose of this draft Compliance Policy Guide is to provide guidance for FDA staff on the FDA’s enforcement policy regarding major food allergen labeling and cross-contact.  When finalized, it will replace the existing CPG 555.250 for FDA staff.

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. 


Program Specific Topics



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.




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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