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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3122 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3122
To amend the Federal Food, Drug, and Cosmetic Act to require
notifications to the Food and Drug Administration regarding food
substances generally recognized as safe, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
November 6, 2025
Mr. Marshall (for himself, Mrs. Britt, and Mr. Scott of Florida)
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 require
notifications to the Food and Drug Administration regarding food
substances generally recognized as safe, 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 ``Better Food Disclosure Act of 2025''
or the ``Better FDA Act of 2025''.
SEC. 2. MANDATORY REPORTING OF SUBSTANCES GENERALLY RECOGNIZED AS SAFE.
(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by inserting after section 409
the following:
``SEC. 409A. FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE.
``(a) In General.--Beginning on the date that is 2 years after the
date of enactment of the Better Food Disclosure Act of 2025, a food
substance generally recognized as safe shall, with respect to any
particular use or intended use, be deemed to be unsafe for the purposes
of the application of clause (2)(C) of section 402(a), unless--
``(1) the Secretary includes the food substance on the list
described in subsection (c); or
``(2) the food substance is under review under subsection
(e)(1)(A) and the Secretary has not yet made a final
determination under subsection (e)(2).
``(b) Notice to FDA.--
``(1) In general.--Any person may, with respect to any
intended use of a food substance generally recognized as safe,
file with the Secretary a notice proposing inclusion of such
food substance on the list described in subsection (c).
``(2) Timeframes.--The timeframes for filing of a notice
under paragraph (1) are as follows:
``(A) With respect to a food substance used in food
offered in interstate commerce as of the date of
enactment of the Better Food Disclosure Act of 2025,
and, as of such date of enactment, considered to be a
food substance generally recognized as safe, not later
than 2 years after such date of enactment.
``(B) With respect to a food substance first used
in food offered in interstate commerce after the date
of enactment of the Better Food Disclosure Act of 2025,
not later than 120 days before the first use of the
food substance in such food.
``(c) Regulations.--Not later than 2 years after the date of
enactment of the Better Food Disclosure Act of 2025, the Secretary
shall promulgate regulations to establish the procedures to establish
and maintain a publicly accessible list of food substances generally
recognized as safe.
``(d) FDA Listing.--
``(1) In general.--Not later than 180 days after receiving
a notice under subsection (b)(1), the Secretary shall accept
such notice and--
``(A) add the food substance to the list described
in subsection (c); or
``(B) subject to subsection (e), make a preliminary
determination to exclude the food substance from such
list.
``(2) Effectiveness of notice.--If the Secretary does not
make a preliminary determination to exclude a food substance
under subparagraph (B) of paragraph (1) by the deadline
described in such paragraph, such food substance shall be
deemed to be added to the list described in subsection (c).
``(e) Excluded or Delisted Substances.--
``(1) In general.--If the Secretary makes a preliminary
determination under subsection (d)(1)(B) to exclude a food
substance for which a notice was submitted under subsection
(b)(1) from the list described in subsection (c), or removes a
food substance from such list after reevaluation in accordance
with section 409B, the Secretary shall require any person using
such food substance in food to submit to the Secretary, not
later than 180 days after issuance of an preliminary or removal
determination, at the option of such person--
``(A) a request for the Secretary to reconsider
such preliminary determination or removal
determination, including any additional information the
Secretary may request in order to make a final
determination of whether the food substance is a food
substance generally recognized as safe;
``(B) a food additive petition under section 409;
or
``(C) a plan for phasing out use of the food
substance.
``(2) Final determinations.--If a person requests under
paragraph (1)(A) that the Secretary reconsider a preliminary
determination under subsection (d)(1)(B) to exclude a food
substance for which a notice was submitted under subsection
(b)(1) from the list described in subsection (c) or the removal
of a food substance from such list after reevaluation in
accordance with section 409B, not later than 180 days after
receiving sufficient information paragraph (1)(A), the
Secretary shall make a final determination of whether the food
substance is a food substance generally recognized as safe.''.
(b) Definitions.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended--
(1) in paragraph (s)--
(A) by striking ``, if such substance is not
generally recognized, among experts qualified by
scientific training and experience to evaluate its
safety, as having been adequately shown through
scientific procedures (or, in the case of a substance
used in food prior to January 1, 1958, through either
scientific procedures or experience based on common use
in food) to be safe under the conditions of its
intended use'';
(B) in paragraph (5), by striking ``or'' at the
end;
(C) in paragraph (6), by striking the period and
inserting ``; or''; and
(D) by adding at the end the following:
``(7) a food substance generally recognized as safe, as
defined in paragraph (tt).''; and
(2) by adding at the end the following:
``(tt) The term `food substance generally recognized as safe' means
any substance the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a component
or otherwise affecting the characteristics of any food (including any
substance intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food; and including any source of radiation intended for any such use),
if such substance is generally recognized, among experts qualified by
scientific training and experience to evaluate its safety, as having
been adequately shown through scientific procedures (or, in the case of
a substance used in food prior to January 1, 1958, through either
scientific procedures or experience based on common use in food) to be
safe under the conditions of its intended use, except that such term
does not include--
``(1) food additives, as defined in paragraph (s), that are
subject to section 409; or
``(2) any article described in subparagraphs (1) through
(6) of paragraph (s).''.
(c) Adulterated Food.--Section 402(a)(2)(C) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 342(a)(2)(C)) is amended--
(1) by striking ``or (ii) a new'' and inserting ``(ii) a
new''; and
(2) by inserting ``or (iii) a food substance generally
recognized as safe that is not included on the list maintained
by the Secretary pursuant to section 409A(c) or is under review
pursuant to section 409A(e);'' after ``section 512;''.
(d) Conforming Amendments.--
(1) Section 301(ll)(3)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(ll)(3)(A)) is amended by inserting
``, or the requirements of section 409A, as applicable'' before
the semicolon.
(2) Section 408(l)(5)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 346a(l)(5)(B)) is amended by inserting
``listing of a food substance generally recognized as safe
under section 409A(c),'' after ``food additive regulation''.
(3) Section 721(b)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379e(b)(4)) is amended by striking
``while there is in effect a published finding of the Secretary
declaring such substance exempt from the term `food additive'
because of its being generally recognized by qualified experts
as safe for its intended use, as provided in section 201(s)''
and inserting ``if it is included on the list maintained by the
Secretary pursuant to section 409A(c)''.
(4) Section 801(d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 381(d)) is amended by inserting ``food substance
generally recognized as safe,'' after ``color additive,'' each
place such term appears.
(5) Section 803(c)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 383(c)(2)) is amended by striking ``and
color additives'' and inserting ``color additives, and food
substances generally recognized as safe''.
SEC. 3. POSTMARKET ASSESSMENT OF FOOD ADDITIVES, COLOR ADDITIVES, AND
FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341 et seq.) is amended by adding after section 409A (as added by
section 2) the following:
``SEC. 409B. POSTMARKET ASSESSMENT OF FOOD ADDITIVES, COLOR ADDITIVES,
AND FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE.
``(a) In General.--If the Secretary receives a citizen petition or
a notice from a State governmental official regarding concerns about
the safety of a food additive for which 1 or more regulations
prescribing conditions of safe use have been issued under section 409,
a color additive used in accordance with the requirements of section
721, or a food substance generally recognized as safe included on the
list described in section 409A(c), or if the Secretary determines
through the Secretary's initiative that such a concern exists, the
Secretary may reevaluate the additive or substance in accordance with
section 409, 721, or 409A, as applicable, and, as appropriate--
``(1) with respect to a food additive, amend or revoke the
1 or more regulations issued under section 409 with respect to
the food additive;
``(2) with respect to a color additive, amend or revoke the
1 or more regulations issued under section 409 with respect to
the food additive; and
``(3) with respect to a food substance generally recognized
as safe--
``(A) determine the food substance to be a food
additive subject to the requirements of section 409;
and
``(B) by rulemaking under section 553 of title 5,
United States Code, remove the food substance from the
list described in subsection 409A(c).
``(b) Priority Considerations.--In considering citizen petitions
and notices from State governmental officials received under subsection
(a), the Secretary shall give priority to petitions and notices
regarding food additives, color additives, and food substances
generally recognized as safe for which clear and convincing scientific
evidence supports the concerns raised in the petition or notice.
``(c) Safety Information.--The Secretary shall publish in the
Federal Register a request for safety information for any food
substance subject to reevaluation under subsection (a).
``(d) Review Requirements.--
``(1) In general.--Any determination, reevaluation, or
final action taken by the Secretary under this section
regarding the safety, exclusion, delisting, or reclassification
of a food additive, color additive, or food substance generally
recognized as safe shall be subject to--
``(A) review and recommendation by individuals
serving in positions in the Food and Drug
Administration under career appointments and who have
relevant scientific and regulatory expertise; and
``(B) the notice and comment rulemaking procedures
under section 553 of title 5, United States Code.
``(2) Limitation.--The Secretary may not delegate the
review under paragraph (1)(A) to--
``(A) an individual occupying a position for which
appointment is made by the President; or
``(B) an individual who is not serving in a
position in the Food and Drug Administration under a
career appointment.''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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