I 
119TH CONGRESS 
2D SESSION 
H. R. 7291 
To direct the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, to establish a board to review 
certain designations that a substance used in food is generally recognized 
as safe, with respect to the intended use of such substance, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 30, 2026 
Mr. LAWLER introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To direct the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, 
to establish a board to review certain designations that 
a substance used in food is generally recognized as safe, 
with respect to the intended use of such substance, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘GRAS Oversight and 
Transparency Act’’. 
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SEC. 2. GRAS REVIEW BOARD; REVOCATION OF CERTAIN 
GRAS DESIGNATIONS. 
(a) ESTABLISHMENT.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs (in this section referred to as the ‘‘Sec-
retary’’), shall establish a board (in this section referred 
to as the ‘‘Board’’) to review the validity of covered GRAS 
designations. 
(b) MEMBERSHIP.— 
(1) IN GENERAL.— 
(A) VOTING MEMBERS.—The Board shall 
be composed of the following voting members: 
(i) The Secretary of Health and 
Human Services. 
(ii) The Secretary of Agriculture. 
(iii) 
Two 
representatives 
of 
the 
Human Foods Program of the Food and 
Drug Administration, to be appointed by 
the Secretary. 
(iv) One representative of each of the 
following organizations, to be appointed by 
the Secretary: 
(I) The Office of the Chief Coun-
sel of the Food and Drug Administra-
tion. 
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(2) CHAIRPERSON.—The Secretary shall des-
ignate a chairperson of the Board from among the 
voting members described in paragraph (1). 
(3) TERMS.—Each voting and non-voting mem-
ber of the Board appointed by the Secretary shall be 
appointed for a term of five years. 
(4) COMPENSATION.—Each member of the 
Board shall serve without compensation. 
(c) DUTIES.— 
(1) IN GENERAL.—The Board shall carry out a 
review of each covered GRAS designation in accord-
ance with the requirements of this subsection. 
(2) STAGES OF REVIEW.—In carrying out the 
review, the Board shall— 
(A) identify the scope of covered GRAS 
designations by soliciting the participation of 
food manufacturers under subsection (d); 
(B) categorize each covered GRAS des-
ignation so identified into a tier 1, tier 2, or 
tier 3 review category, with tier 1 indicating the 
highest priority for review; 
(C) carry out a review of the covered 
GRAS designations in each review category to 
determine the validity of each such designation; 
and 
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(D) report the results of each such review 
in accordance with subsection (f). 
(3) NOTIFICATION
RECOMMENDING
REVOCA-
TION OF GRAS DESIGNATION.—Not later than 90 
days after the date on which the Board completes 
the review of a covered GRAS designation under 
paragraph (2)(C), the Board shall notify the Sec-
retary and Congress of— 
(A) a determination that the substance 
that is the subject of such designation has not 
been shown to be safe; and 
(B) a recommendation that the Secretary 
revoke such designation under subsection (e). 
(d) PARTICIPATION OF FOOD MANUFACTURERS.— 
(1) IN GENERAL.—The Secretary shall require 
a food manufacturer to provide to the Board, not 
later than 90 days after the date of enactment of 
this Act, a notice that— 
(A) identifies each covered GRAS designa-
tion attributable to such manufacturer; and 
(B) contains any other such information 
the Board determines to be appropriate. 
(2) FAILURE TO COMPLY.—If a food manufac-
turer does not comply with paragraph (1), the Sec-
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retary may take actions to require such compliance, 
including— 
(A) imposing a civil penalty on such manu-
facturer in accordance with the amounts de-
scribed in section 307(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 335b(a)); 
or 
(B) with respect to a substance subject to 
a covered GRAS designation attributable to 
such manufacturer— 
(i) treating such substance as an un-
approved food additive under section 409 
of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 348); and 
(ii) deeming such substance to be un-
safe under such section as appropriate. 
(e) REVOCATION
OF
CERTAIN
GRAS DESIGNA-
TIONS.— 
(1) IN GENERAL.—Upon receiving a notification 
under subsection (c)(3), the Secretary may, using 
evidence before the Secretary, revoke a covered 
GRAS designation in accordance with the require-
ments under paragraph (2). 
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(2) REQUIREMENTS FOR REVOCATION.—If the 
Secretary decides to revoke a covered GRAS des-
ignation under paragraph (1), the Secretary shall— 
(A) notify the food manufacturer that pro-
vided a notice identifying such designation 
under subsection (d) of such decision, including 
a description of the evidence used in making 
such decision; 
(B) provide 180 days for such manufac-
turer to provide sufficient scientific evidence 
that the substance subject to such designation 
is shown to be safe; 
(C) review such decision using any such 
evidence; and 
(D) notify such manufacturer of the out-
come of such review, including a description of 
how the Secretary carried out such review. 
(3) COMPLIANCE WITH REVOCATION.—The Sec-
retary shall establish procedures to ensure a manu-
facturer complies with a revocation of a covered 
GRAS designation under this subsection, including 
an appropriate timeline for ceasing distribution of 
any substance subject to such designation and recall-
ing such substance. 
(f) REPORTS.— 
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(1) IN GENERAL.—The Board shall submit to 
the Secretary and Congress, and make publicly 
available on the website of the Food and Drug Ad-
ministration, a report containing— 
(A) information related to the review car-
ried out under subsection (c); and 
(B) any recommendation related to such 
review, including whether the Board made a no-
tification under subsection (c)(3). 
(2) TIMING OF REPORTS.—A report shall be 
submitted under paragraph (1)— 
(A) with respect to a covered GRAS des-
ignation the Board categorizes into tier 1, not 
later than 2 years after the date of enactment 
of this Act; 
(B) with respect to a covered GRAS des-
ignation the Board categorizes into tier 2, not 
later than 4 years after the date of enactment 
of this Act; and 
(C) with respect to a covered GRAS des-
ignation the Board categorizes into tier 3, not 
later than 10 years after the date of enactment 
of this Act. 
(g) DEFINITIONS.—In this section: 
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(1) COVERED GRAS DESIGNATION.—The term 
‘‘covered GRAS designation’’ means a designation 
made by a manufacturer prior to 2000 that a sub-
stance used in food is generally recognized as safe, 
as described in section 201(s) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(s)), includ-
ing any such designation made in which such manu-
facturer has not filed a petition under section 409 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 348) or otherwise notified the Secretary of 
such designation. 
(2) FOOD.—The term ‘‘food’’ has the meaning 
given such term in section 201(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)). 
(h) TERMINATION OF BOARD.—The Board shall ter-
minate, and this Act shall cease to be effective, 10 years 
after the date of enactment of this Act. 
Æ 
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