Title: Dietary Supplement Listing Act of 2022
Policy area: Health

Summary:
Dietary Supplement Listing Act of 2022
This bill imposes various requirements on dietary supplements, including by requiring the person (an individual or entity) responsible for introducing a supplement into interstate commerce to register the supplement with the Food and Drug Administration (FDA).
Under this bill, the responsible person must register with the FDA specified information about each dietary supplement to be offered for sale, including (1) a list of all ingredients required by regulation to appear on the label; (2) the conditions of use; (3) any warnings and precautions; (4) certain claims characterizing the relationship between certain nutrients in the supplement and a disease or a health-related condition; (5) the responsible person's contact information; and (6) the locations where the supplement is manufactured, packaged, labeled, or held.
For a supplement that is offered for sale on the date that is 18 months after this bill's enactment (the effective date), the responsible person must submit the required information to the FDA no later than 60 days after the effective date. A supplement that is not offered for sale on the effective date may not be offered for sale until the responsible person has submitted the required information.
The FDA must establish a system that provides a unique identifier for each registered dietary supplement and a publicly accessible electronic database that allows a user to obtain certain information about a registered supplement.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4090 Introduced in Senate (IS)]

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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).
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