H.R. 1178 — Alpha-gal Allergen Inclusion Act

This section establishes the short title of the Act as the “Alpha-gal Allergen Inclusion Act.”

This section expands the definition of a major food allergen under section 201(qq) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) to include galactose-alpha-1,3-galactose (commonly known as “alpha-gal”). As background, the major food allergen definition is used to identify ingredients that trigger labeling and other food allergen requirements under federal law. The section specifies that alpha-gal includes ingredients derived from non-catarrhine primate mammals and red algae in the order Gigartinales, but excludes mammal-derived ingredients for which the Secretary determines there is no detectable alpha-gal above an established limit (e.g., ingredients made from alpha-gal-knockout mammals). The amendment takes effect 18 months after enactment.