HouseH.R. 10336119th Congress
Dietary Supplement Innovation Act
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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 10336 Introduced in House (IH)]
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119th CONGRESS
2d Session
H. R. 10336
To amend the Federal Food, Drug, and Cosmetic Act to encourage
innovation and increase and protect consumer access with respect to
dietary supplements by clarifying the regulatory framework governing
drug preclusion, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 10, 2026
Mrs. Harshbarger introduced the following bill; which was referred to
the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to encourage
innovation and increase and protect consumer access with respect to
dietary supplements by clarifying the regulatory framework governing
drug preclusion, 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 ``Dietary Supplement Innovation Act''.
SEC. 2. CLARIFICATION OF DRUG PRECLUSION WITH RESPECT TO FOOD AND
DIETARY SUPPLEMENTS.
(a) Prohibited Act.--Section 301(ll) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(ll)) is amended to read as follows:
``(ll) The introduction or delivery for introduction into
interstate commerce of any food (including a dietary supplement) to
which has been added a drug approved under section 505 of this Act, a
biological product licensed under section 351 of the Public Health
Service Act, or a drug or biological product for which Phase 2 or Phase
3 (as such terms are described in section 312.21(b) of title 21, Code
of Federal Regulations (or successor regulations)) clinical
investigations have been instituted and for which the existence of such
investigations has been made public, unless--
``(1) the drug or biological product was marketed in the
United States before October 15, 1994, as or in--
``(A) food; or
``(B) a product that, if the definition of the term
`dietary supplement' under section 201(ff) had been in
effect at the date of marketing, would have met such
definition (other than the labeling requirement in
section 201(ff)(2)(C));
``(2) such drug or biological product was marketed as food
or in a dietary supplement before--
``(A) any approval of the drug under section 505;
``(B) any licensure of the biological product under
such section 351; or
``(C) any Phase 2 or Phase 3 clinical investigation
involving the use of the substance as a drug or
biological product has been instituted and the
existence of such investigation has been made public;
``(3) each Phase 2 or Phase 3 clinical investigation
referred to in the matter preceding subparagraph (1) has been
on inactive status, withdrawn, or both for a continuous period
of at least seven years preceding the addition of the drug or
biological product in food (including a dietary supplement), or
the sponsor has publicly announced discontinuation of drug
development activities;
``(4) the drug is a new animal drug whose use is not unsafe
under section 512;
``(5) the use of the drug or the biological product in the
food (including a dietary supplement) is to enhance the safety
of the food to which the drug or the biological product is
added or applied and not to have independent biological or
therapeutic effects on humans, and the use is in conformity
with--
``(A) a regulation issued under section 409
prescribing conditions of safe use in food;
``(B) a regulation listing or affirming conditions
under which the use of the drug or biological product
in food is generally recognized as safe;
``(C) the conditions of use identified in a
notification to the Secretary of a claim of exemption
from the premarket approval requirements for food
additives based on the notifier's determination that
the use of the drug or biological product in food is
generally recognized as safe, provided that the
Secretary has not questioned the general recognition of
safety determination in a letter to the notifier; or
``(D) a food contact substance notification that is
effective under section 409(h);
``(6) such drug or biological product had been marketed for
smoking cessation prior to the date of the enactment of the
Food and Drug Administration Amendments Act of 2007; or
``(7) the Secretary, in the Secretary's discretion, has
issued an administrative order through a proceeding initiated
by the Secretary approving the use of such drug or biological
product in food (including a dietary supplement).''.
(b) Determinations With Respect to Drug Preclusion.--The Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by
inserting after section 413 (21 U.S.C. 350b) the following:
``SEC. 413A. DETERMINATIONS MADE WITH RESPECT TO DRUG PRECLUSION OF
FOOD AND DIETARY SUPPLEMENTS.
``(a) Standards of Evaluation.--For purposes of determining whether
a drug (including a biological product) has been added to a food
(including a dietary supplement) for purposes of section 301(ll)(1) or
(2), the Secretary shall consider any difference between such drug and
the substance when added to such food, including with respect to--
``(1) route of administration;
``(2) recommended dosage and serving amount;
``(3) concentration or composition; or
``(4) the degree of safety of the substance when added to--
``(A) a food; or
``(B) a dietary supplement subject to the safety
requirements and burden of proof for dietary
supplements as described in section 402(ff).
``(b) Judicial Review.--
``(1) Immediately reviewable.--A warning letter, response
to a notification submitted pursuant to section 101.93(a) of
title 21, Code of Federal Regulations (or successor
regulations), response to information provided pursuant to
section 413(a)(2) of this Act, or statement made on a website
controlled by the Secretary, finding or otherwise asserting
that the introduction or delivery for introduction into
interstate commerce of a food (including a dietary supplement)
violates section 301(ll) of this Act shall be immediately
reviewable by a court of jurisdiction under applicable law,
irrespective of whether such warning letter, response, or
statement is considered to be final agency action under chapter
7 of title 5, United States Code.
``(2) Burden of proof.--In any action for which immediate
review is sought pursuant to paragraph (1), the United States
shall bear the burden of proof to show that such introduction
or delivery for introduction would violate such section
301(ll).''.
(c) Conforming Changes to Definition of Dietary Supplement.--
Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(ff)) is amended--
(1) in subparagraph (1)(F), by adding ``and'' at the end;
(2) in subparagraph (2)(C), by striking ``; and'' at the
end and inserting a period; and
(3) by striking ``(3) does--'' and all that follows through
``would be lawful under this Act.''.
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