I
119THCONGRESS
1
STSESSION H. R. 1178
To amend the Federal Food, Drug, and Cosmetic Act to add alpha-gal
to the definition of ‘‘major food allergen’’.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY10, 2025
Mr. V
ANDREW(for himself, Mr. MURPHY, Mr. DAVISof North Carolina, Mr.
B
ALDERSON, Mr. CARTERof Texas, Mr. LAMALFA, Mr. GRIFFITH, Mr.
M
AGAZINER, Mr. MOOREof Alabama, Ms. NORTON, Mr. RULLI, Mr.
C
LINE, Mr. WITTMAN, Mrs. CHERFILUS-MCCORMICK, and Mr. SMITHof
New Jersey) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce
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 Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Alpha-gal Allergen In-4
clusion Act’’. 5
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•HR 1178 IH
SEC. 2. ADDING ALPHA-GAL TO DEFINITION OF ‘‘MAJOR 1
FOOD ALLERGEN’’. 2
(a) I
NGENERAL.—Section 201(qq) of the Federal 3
Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) is 4
amended by adding at the end the following: 5
‘‘(3)(A) Galactose-alpha-1,3-galactose (com-6
monly known as ‘alpha-gal’). 7
‘‘(B) For purposes of this subparagraph, the 8
term ‘galactose-alpha-1,3-galactose’ includes— 9
‘‘(i) ingredients derived from non- 10
catarrhine primate mammals; and 11
‘‘(ii) red algae in the order Gigartinales. 12
‘‘(C) For purposes of this subparagraph, the 13
term ‘galactose-alpha-1,3-galactose’ does not include 14
mammal-derived ingredients for which the Secretary 15
determines there is no galactose-alpha-1,3-galactose 16
above an established, detectable limit (such as ingre-17
dients made from alpha-gal-knockout mammals).’’. 18
(b) E
FFECTIVEDATE.—The amendment made by 19
subsection (a) shall apply beginning on the date that is 20
18 months after the date of enactment of this Act. 21
Æ
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