[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4090 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
2d Session
S. 4090
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
April 26, 2022
Mr. Durbin (for himself and Mr. Braun) 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
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
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).
<all>