[Congressional Record Volume 168, Number 68 (Tuesday, April 26, 2022)]
[Senate]
[Pages S2156-S2157]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. DURBIN (for himself and Mr. Braun):
S. 4090. A bill to improve transparency and 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. Mr. President, I ask unanimous consent that the text of
the bill be printed in the Record.
Without objection, the text of the bill was ordered to be printed in
the Record, as follows:
S. 4090
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 2022''.
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 the following:
``SEC. 403D. DIETARY SUPPLEMENT LISTING REQUIREMENT.
``(a) In General.--Each dietary supplement shall be listed
with the Secretary in accordance with this section.
``(b) Listing Submissions.--
``(1) In general.--Each responsible person, or, if the
responsible person is a foreign entity, the United States
agent, shall submit to the Secretary in accordance with this
section the following information for each dietary supplement
that will be marketed:
``(A) Any proprietary name of the dietary supplement and
the statement of identity, including brand name and specified
flavors, if applicable.
``(B) The full name, address, and telephone number for the
responsible person, and the name and e-mail address of the
owner, operator, or agent in charge of the responsible
person.
``(C) The full name, address, telephone number, and e-mail
address for the United States agent, if the responsible
person is a foreign entity.
``(D) The full business name and address of all locations
at which the responsible person manufactures, packages,
labels, or holds the dietary supplement.
``(E) An electronic copy of the label for the dietary
supplement, and an electronic copy of the package insert, if
any.
``(F) A list of all ingredients in the dietary supplement
required to appear on the label under sections 101.4 and
101.36 of title 21, Code of Federal Regulations, including--
``(i) the amount per serving of each listed ingredient, if
such information is required to appear on the label; and
``(ii) if required by section 101.36 of title 21, Code of
Federal Regulations, the percent of the daily value of each
listed ingredient.
``(G) The number of servings per container for each
container size.
``(H) The conditions of use.
``(I) Warnings and precautions.
``(J) Statements regarding major food allergens, as defined
in section 201(qq) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(qq)).
``(K) The dosage form, such as pill, capsule, liquid, or
powder.
``(L) Any claim that--
``(i) characterizes the relationship of any nutrient which
is of the type required by section 403(q)(1) or section
(q)(2) to be in the label or labeling of the food to a
disease or a health-related condition; or
``(ii) is subject to notification under section 403(r)(6)
that appears in the supplement's labeling.
``(M) The unique dietary supplement identifier for the
product, provided in accordance with paragraph (3).
``(2) Format.--A listing submitted under this section shall
be in such electronic form and manner as the Secretary may
prescribe. The Secretary shall promptly confirm,
electronically, receipt of a complete listing under this
section.
``(3) Unique listing identification numbers.--
``(A) In general.--The Secretary shall establish a unique
dietary supplement identifier system that shall be used by
the responsible person under this section.
``(B) Reservation of numbers.--The system shall allow a
responsible person to reserve multiple dietary supplement
identifier numbers in advance of listing.
``(C) Use requirement.--Any unique dietary supplement
identifier shall be used only in connection with the product
for which the identifier was used during the listing process.
``(4) Submission dates.--A responsible person under this
section shall report to the Secretary the listing information
described in paragraph (1) pursuant to the following
timelines:
``(A) In general.--
``(i) Existing dietary supplements.--In the case of a
dietary supplement that is being offered in interstate
commerce on the date that is 18 months after the date of
enactment of the Dietary Supplement Listing Act of 2022, a
listing for each such dietary supplement formulation
introduced or delivered for introduction into interstate
commerce by the responsible person for commercial
distribution shall be submitted by the responsible person
with the Secretary under this section not later than 60 days
after the date that is 18 months after the date of enactment
of such Act.
``(ii) New dietary supplements.--In the case of a dietary
supplement that is not being offered in interstate commerce
on the date that is 18 months after the date of enactment. of
the Dietary Supplement Listing Act of 2022, a listing for
each such dietary supplement formulation introduced or
delivered for introduction into interstate commerce by the
responsible person for commercial distribution which has not
been included in any listing previously submitted by the
responsible person to the Secretary under this section shall
be submitted to the Secretary prior to introducing the
dietary supplement into interstate commerce.
``(B) Reformulations.--A listing of each dietary supplement
formulation introduced by the responsible person for
commercial distribution that has a label that differs for
such dietary supplement from the representative label
provided under subsection (a) with respect to the product
name, amount of dietary ingredients, or other distinguishing
characteristics such as dosage form (such as pill, capsule,
liquid, or powder) shall be submitted to the Secretary not
later than 15 business days after introducing the dietary
[[Page S2157]]
supplement with the change into interstate commerce.
``(C) Discontinued dietary supplements.--If the responsible
person has discontinued the commercial marketing of a dietary
supplement formulation included in a listing submitted by the
responsible person under subparagraph (A) or (B), the
responsible person shall report to the Secretary the date of
such discontinuance, within 90 days of the discontinuance of
the dietary supplement.
``(5) Supplier information record keeping requirement.--
Each responsible person subject to the requirements of this
subsection shall maintain a record of the full business name
and address from which the responsible person receives any
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. The responsible
person shall make this information available to the Secretary
within 72 hours of request from the Secretary.
``(c) Electronic Database.--Beginning not later than 2
years after the Secretary specifies a unique dietary
supplement identifier system pursuant to subsection (b)(3),
the Secretary shall maintain an electronic database that--
``(1) is publicly accessible;
``(2) is populated with information regarding dietary
supplements that is provided under this section or any other
provision of this Act; and
``(3) enables the public to search the database by a
dietary supplement's unique dietary supplement identifier or
other field of information or combination of fields.
``(d) Authorization of Appropriations.--For purposes of
conducting activities under this section and hiring personnel
to carry out this section, there are authorized to be
appropriated $4,000,000 for fiscal year 2022 and $1,000,000
for each of fiscal years 2023 through 2026.''.
(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 is required to file a listing under section 403D and
such responsible person has not made a listing 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:
``(fff) 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.''.
(d) Rule of Construction.--Nothing in the amendments made
by subsections (a) through subsection (c) shall be construed
to expand the existing authorities of the Food and Drug
Administration, other than as specified in such amendments.
This subsection shall not be construed to--
(1) limit the existing authorities of the Food and Drug
Administration; or
(2) limit the authorities specified in the amendments made
by subsections (a) through subsection (c).
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