Section 1 Short title
This Act may be cited as the “Alpha-gal Allergen Inclusion Act”.
Alpha-gal Allergen Inclusion Act
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to add alpha-gal to the definition of major food allergen.
Sec. 2 Adding alpha-gal to definition of “major food allergen”
In general— Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) is amended by adding at the end the following:
“(3)
“(i) Galactose-alpha-1,3-galactose (commonly known as “alpha-gal”).
“(ii) For purposes of this subparagraph, the term galactose-alpha-1,3-galactose includes—
“(I) ingredients derived from non-catarrhine primate mammals; and
“(II) red algae in the order Gigartinales.
“(iii) For purposes of this subparagraph, the term galactose-alpha-1,3-galactose does not include mammal-derived ingredients for which the Secretary determines there is no galactose-alpha-1,3-galactose above an established, detectable limit (such as ingredients made from alpha-gal-knockout mammals).”
Effective date— The amendment made by subsection (a) shall apply beginning on January 1, 2026.