S. 5498

Alpha-gal Allergen Inclusion Act

Sponsor: Mark R. Warner · 0 cosponsors

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Sec. 1. Short title

This Act may be cited as the Alpha-gal Allergen Inclusion Act.

Sec. 2. Adding alpha-gal to definition of major food allergen

(a) 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:

Text this section adds to the law

(3)

(A) Galactose-alpha-1,3-galactose (commonly known as alpha-gal).

(B) 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.

(C) 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).

(b) Effective date. The amendment made by subsection (a) shall apply beginning on the date that is 18 months after the date of enactment of this Act.