[Congressional Record Volume 170, Number 123 (Monday, July 29, 2024)]
[Senate]
[Pages S5553-S5554]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. DURBIN:
[[Page S5553]]
S. 4827. 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; to
the Committee on Health, Education, Labor, and Pensions.
Mr. DURBIN. Madam President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 4827
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
[[Page S5554]]
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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