[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4827 Introduced in Senate (IS)]
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118th CONGRESS
2d Session
S. 4827
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 SENATE OF THE UNITED STATES
July 29, 2024
Mr. Durbin introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
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
2024''.
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 adding 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.
``(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, package
insert, or website of the responsible person who
submits the listing 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).
``(M) The dietary supplement product listing number
for the dietary supplement provided by the Secretary in
accordance with subsection (c).
``(2) Format.--The Secretary may require that a listing
submitted under paragraph (1) be submitted in an electronic
format. Upon receipt of a complete listing under paragraph (1),
the Secretary shall promptly notify the responsible person of
the receipt of such listing. A listing 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, 2025, 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 2024.
``(ii) New dietary supplements.--In the
case of a dietary supplement that is not being
offered in interstate commerce on or before
January 1, 2025, 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.
``(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 not later than 30 days after 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 10
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
2024, 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 subparagraph (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 subparagraph (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 subparagraph (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; or
``(3) 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 2024, and $6,615,000 for each
of fiscal years 2025 through 2028, 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.''.
(c) New Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(jjj) The introduction or delivery for introduction into
interstate commerce of a dietary supplement that has been prepared,
packed, or held using the assistance of, or at the direction of, a
person debarred under section 306.''.
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