Where do the allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) come from?

The allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) come from two laws. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Public Law 108-282) was enacted in August 2004, and, in part, amended the FD&C Act by defining the term “major food allergen”. It also stated that foods regulated under the FD&C Act are misbranded unless they declare the presence of each major food allergen on the product label using the name of the food source from which the major food allergen is derived.  More recently, the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) (Public Law 117-11) was enacted in April 2021 and, in part, amended the definition of major food allergens in the FD&C Act to include sesame, effective January 1, 2023. These requirements apply to all packaged foods sold in the United States.