H.R. 8370

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8370 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 8370

To improve transparency and the availability of information regarding 
dietary supplements by amending the Federal Food, Drug, and Cosmetic 
Act to require manufacturers of dietary supplements to list dietary 
supplements with the Food and Drug Administration.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

April 20, 2026

Ms. Dexter introduced the following bill; which was referred to the 
Committee on Energy and Commerce

_______________________________________________________________________

A BILL

To improve transparency and the availability of information regarding 
dietary supplements by amending the Federal Food, Drug, and Cosmetic 
Act to require manufacturers of dietary supplements to list dietary 
supplements with the Food and Drug Administration.

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 Listing Act of 
2026''.

SEC. 2. REGULATION OF DIETARY SUPPLEMENTS.

(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 403C 
of such Act (21 U.S.C. 343-3) the following:

``SEC. 403D. DIETARY SUPPLEMENT LISTING REQUIREMENT.

``(a) In General.--Beginning on the date specified in subsection 
(b)(4), each dietary supplement marketed in the United States shall be 
listed with the Secretary in accordance with this section. Each such 
listing shall include, with respect to the dietary supplement, the 
information specified in subsection (b)(1).
``(b) Requirements.--
``(1) In general.--The manufacturer, packer, or distributor 
of a dietary supplement whose name (pursuant to section 
403(e)(1)) appears on the label of a dietary supplement 
marketed in the United States (referred to in this section as 
the `responsible person'), or if the responsible person is a 
foreign entity, the United States agent of such person, shall 
submit to the Secretary in accordance with this section the 
following information for a dietary supplement that is marketed 
in the United States:
``(A) Any name of the dietary supplement and the 
statement of identity, including brand name and 
specified flavors, if applicable.
``(B) The name and address of the responsible 
person and the name and email address of the owner, 
operator, or agent in charge of the responsible person.
``(C) The name, domestic address, and email address 
for the United States agent, if the responsible person 
is a foreign entity.
``(D) The business name and place of business the 
responsible person provided on the label pursuant to 
section 403(e)(1).
``(E) An electronic copy of the label for the 
dietary supplement.
``(F) A list of all ingredients in each such 
dietary supplement required under sections 101.4 and 
101.36, title 21, Code of Federal Regulations (or any 
successor regulations), to appear on the label of a 
dietary supplement, including--
``(i) where applicable, ingredients in a 
proprietary blend as described in section 
101.36(c) of title 21, Code of Federal 
Regulations (or any successor regulations);
``(ii) the amount per serving of each 
listed dietary ingredient;
``(iii) if required by section 101.36 of 
title 21, Code of Federal Regulations (or any 
successor regulations), the percent of the 
daily value of each listed dietary ingredient; 
and
``(iv) the amount per serving of dietary 
ingredients within a proprietary blend (which 
shall remain confidential and not subject to 
public disclosure).
``(G) The number of servings per container for each 
container size.
``(H) The directions for use.
``(I) Warnings, notice, and safe handling 
statements, as required by section 101.17 of title 21, 
Code of Federal Regulations (or any successor 
regulations).
``(J) Allergen statements for major food allergens 
(pursuant to sections 403(w) and 403(x)).
``(K) The form of the dietary supplement (such as 
tablets, capsules, powders, liquids, softgels, and 
gummies).
``(L) Any claim that appears on the label or 
package insert that--
``(i) characterizes the relationship of any 
ingredient to a disease or a health-related 
condition and is described in section 
403(r)(1)(B); or
``(ii) is subject to notification under 
section 403(r)(6), provided that no additional 
listing or change to listing information is 
required under this paragraph for any minor 
variation or modification to a claim for which 
notification under section 403(r)(6) is not 
required.
``(M) The dietary supplement product listing number 
for the dietary supplement provided by the Secretary in 
accordance with subsection (c).
``(2) Format; notification of receipt.--
``(A) Format.--The Secretary may require that a 
listing submitted under paragraph (1) be submitted in 
an electronic format.
``(B) Notification of receipt.--
``(i) In general.--Upon receipt of a 
listing under paragraph (1), the Secretary 
shall promptly notify the responsible person 
of--
``(I) the receipt of a complete 
listing; or
``(II) the receipt of a listing 
that is not complete, together with a 
statement describing the reasons why 
the listing is not complete.
``(ii) Complete receipts described.--A 
listing under paragraph (1) is deemed complete 
once all fields of required information have 
been completed by the responsible person who 
represents that the product will be marketed in 
the United States as a dietary supplement.
``(3) Listing content.--A single listing submission for a 
dietary supplement under paragraph (1) may include multiple 
dietary supplements with identical formulations and forms, or 
formulations of the same form, that differ only with respect to 
color, excipients, or flavorings, whether offered in a single 
package size or in multiple package sizes.
``(4) Timing.--
``(A) In general.--
``(i) Dietary supplements on the market.--
In the case of a dietary supplement that is 
being offered in interstate commerce on or 
before January 1, 2027, a listing for each such 
dietary supplement introduced or delivered for 
introduction into interstate commerce shall be 
submitted by the responsible person to the 
Secretary under this subsection not later than 
18 months after the date of enactment of the 
Dietary Supplement Listing Act of 2026. 
Beginning on the date that is 2 years after 
such date of enactment, the label for each such 
dietary supplement shall include the dietary 
supplement product listing number provided by 
the Secretary in accordance with subsection 
(c).
``(ii) New dietary supplements.--In the 
case of a dietary supplement that is not being 
offered in interstate commerce on or before 
January 1, 2027, a listing for each such 
dietary supplement introduced or delivered for 
introduction into interstate commerce that has 
not been included in any listing previously 
submitted by the responsible person to the 
Secretary under this subsection shall be 
submitted to the Secretary at the time of 
introduction into interstate commerce. The 
label for each such dietary supplement shall 
include, at the time of introduction or 
delivery for introduction into interstate 
commerce, the dietary supplement product 
listing number provided by the Secretary in 
accordance with subsection (c).
``(B) Discontinued dietary supplements.--The 
responsible person shall notify the Secretary not later 
than 1 year after the date the responsible person 
discontinues the introduction into interstate commerce 
of a dietary supplement required to be listed with the 
Secretary under paragraph (1).
``(C) Changes to existing listings.--The 
responsible person shall submit to the Secretary any 
change or modification to listing information submitted 
under paragraph (1) included on the label of a dietary 
supplement at the time the dietary supplement with the 
change or modification is first introduced into 
interstate commerce.
``(5) Additional information.--The responsible person shall 
provide, upon request from the Secretary, not later than 5 
calendar days after such request--
``(A) the full business name and physical and 
mailing address of all locations at which the 
responsible person manufactures, packages, labels, or 
holds the dietary supplement; and
``(B) the full business name and physical and 
mailing address from which the responsible person 
receives a dietary ingredient or combination of dietary 
ingredients that the responsible person uses in the 
manufacture of the dietary supplement or, if 
applicable, from which the responsible person receives 
the dietary supplement.
``(c) Product Listing Number and Dietary Supplement Electronic 
Database.--
``(1) Dietary supplement product listing number.--The 
Secretary shall provide each dietary supplement listed in 
accordance with subsection (b)(1) a dietary supplement product 
listing number, which may apply to multiple dietary supplements 
with identical formulations, or formulations that differ only 
with respect to color, excipients, or flavorings, including 
dietary supplements offered in a single package size or in 
multiple package sizes. The Secretary shall provide a process 
for a responsible person to reserve dietary supplement listing 
numbers in advance of listing under subsection (b)(1).
``(2) Electronic database.--Not later than 2 years after 
the date of enactment of the Dietary Supplement Listing Act of 
2026, the Secretary shall establish and maintain an electronic 
database that is publicly available and contains information 
submitted under subsection (b)(1) (except for the information 
submitted under subparagraphs (B), (C), and (F)(iv) of such 
subsection). The Secretary shall make such information 
maintained in the electronic database publicly searchable, 
including by dietary supplement product listing number, and by 
any field of information or combination of fields of 
information provided under subsection (b)(1) (except for the 
information submitted under subparagraphs (B), (C), and (F)(iv) 
of such subsection).
``(3) Confidential information.--In response to a request 
under section 552 of title 5, United States Code, information 
described in subparagraphs (B), (C), and (F)(iv) of subsection 
(b)(1) that is derived from a listing under this section, and 
information described in subparagraph (b)(5), shall be withheld 
under section 552(b)(3) of title 5, United States Code.
``(d) Rule of Construction.--Nothing in this section shall be 
construed--
``(1) to limit the authority of the Secretary to inspect or 
copy records or to require the establishment and maintenance of 
records under any other provision of this Act;
``(2) to authorize the disclosure of information that is 
prohibited from disclosure under section 301(j) of this Act or 
section 1905 of title 18, United States Code, or that is 
subject to withholding under section 552(b)(4) of title 5, 
United States Code;
``(3) to authorize or permit the release in the public 
database, or to make subject to disclosure under section 552 of 
title 5, United States Code, information that discloses the 
identity or location of a specific registered person or 
facility not identified on the label, or the quantity of any 
individual ingredients in a proprietary blend; or
``(4) to grant the Secretary authority to require the 
approval of a dietary supplement prior to marketing.
``(e) Authorization of Appropriations.--There is authorized to be 
appropriated $7,872,984 for fiscal year 2026, and $6,615,000 for each 
of fiscal years 2027 through 2030, for purposes of conducting the 
activities under this section and hiring personnel required to carry 
out this section.''.
(b) Misbranding.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
``(z) If it is a dietary supplement for which a responsible person 
or the United States agent of such a person is required under section 
403D to file a listing, file a change to an existing listing, or 
provide additional information to the Secretary, and such person or 
agent has failed to comply with any such requirements under section 
403D with respect to such dietary supplement.''.
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