[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7291 Introduced in House (IH)]
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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 Representatives 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''.
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 ``Secretary''), 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 Counsel
of the Food and Drug Administration.
(II) The Office of the Chief
Scientist of the Department of
Agriculture.
(III) The Office of the General
Counsel of the Department of
Agriculture.
(IV) The Food Safety and Inspection
Service of the Department of
Agriculture.
(V) The Center for Nutrition Policy
and Promotion of the Department of
Agriculture.
(VI) The Agricultural Research
Service of the Department of
Agriculture.
(VII) The Public Health and
Integrated Toxicology Division of the
Environmental Protection Agency.
(B) Non-voting members.--The Board shall be
composed of the following non-voting members, to be
appointed by the Secretary:
(i) An academic expert in food toxicology.
(ii) A representative from the food
manufacturing industry.
(2) Chairperson.--The Secretary shall designate a
chairperson of the Board from among the voting members
described in paragraph (1).
(3) Terms.--Each voting and non-voting member 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 accordance 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 designation 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
(D) report the results of each such review in
accordance with subsection (f).
(3) Notification recommending revocation 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 Secretary
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 designation
attributable to such manufacturer; and
(B) contains any other such information the Board
determines to be appropriate.
(2) Failure to comply.--If a food manufacturer does not
comply with paragraph (1), the Secretary may take actions to
require such compliance, including--
(A) imposing a civil penalty on such manufacturer
in accordance with the amounts described 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
unapproved 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 unsafe
under such section as appropriate.
(e) Revocation of Certain GRAS Designations.--
(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 requirements under paragraph (2).
(2) Requirements for revocation.--If the Secretary decides
to revoke a covered GRAS designation under paragraph (1), the
Secretary shall--
(A) notify the food manufacturer that provided 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 manufacturer 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 outcome of such
review, including a description of how the Secretary
carried out such review.
(3) Compliance with revocation.--The Secretary shall
establish procedures to ensure a manufacturer 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 recalling such
substance.
(f) Reports.--
(1) In general.--The Board shall submit to the Secretary
and Congress, and make publicly available on the website of the
Food and Drug Administration, a report containing--
(A) information related to the review carried out
under subsection (c); and
(B) any recommendation related to such review,
including whether the Board made a notification under
subsection (c)(3).
(2) Timing of reports.--A report shall be submitted under
paragraph (1)--
(A) with respect to a covered GRAS designation 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 designation 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 designation the
Board categorizes into tier 3, not later than 10 years
after the date of enactment of this Act.
(g) Definitions.--In this section:
(1) Covered gras designation.--The term ``covered GRAS
designation'' means a designation made by a manufacturer prior
to 2000 that a substance 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)), including any such
designation made in which such manufacturer 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 terminate, and this Act
shall cease to be effective, 10 years after the date of enactment of
this Act.
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