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Specializing in FDA Regulatory Matters

Food Allergen Requirements under FSMA

by: Robert Lake, Senior Consultant

While it has always been lawful to add food allergens as ingredients to human food, the Food Allergy Labeling and Consumer Protection Act (FALCPA) added section 403(w) to the Food Drug and Cosmetic Act (FD&C Act) in 2004 to specify the label declaration requirements for major food allergens. FALCPA also added the definition for major food allergens in section 201(qq).

The following are identified as major food allergens: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, & soybeans.  Although food allergen labeling has been required for several years, undeclared allergens remain a very common cause of food recalls.

FSMA Adds New Food Allergen Requirements for Human Food

The FD&C Act as amended by the FSMA now identifies food allergens as a food safety hazard that must be evaluated and controlled in section 418(b) of the FD&C Act. In particular, section 418(c)(3) requires preventive controls to assure that food is not adulterated under section 402 or misbranded under section 403(w).

FDA included provisions to prohibit unintended “cross-contact” between food not intended to contain allergens and food allergens throughout the original Part 117 proposal for CGMPs. FDA changed the term “cross-contact” to “food allergen cross-contact” in the supplemental Part 117 proposal to clarify its intent.

The Preventive Controls provisions of the FDA Part 117 proposal require a hazard analysis of known or reasonably foreseeable hazards to human food, including food allergens. The manufacturers, processors, packers, & holders of human food that must comply with Part 117 are then required to comply with the other preventive controls provisions for the identified food hazards, including food allergens.