SenateS. 5498119th Congress

Alpha-gal Allergen Inclusion Act

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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 5498 Introduced in Senate (IS)]

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119th CONGRESS
  2d Session
                                S. 5498

 To amend the Federal Food, Drug, and Cosmetic Act to add alpha-gal to 
               the definition of ``major food allergen''.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           September 24, 2026

  Mr. Warner introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
 To amend the Federal Food, Drug, and Cosmetic Act to add alpha-gal to 
               the definition of ``major food allergen''.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 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:
            ``(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.
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