[Congressional Record Volume 168, Number 157 (Wednesday, September 28, 2022)]
[Senate]
[Pages S5398-S5399]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 5937. Mr. DURBIN submitted an amendment intended to be proposed to 
amendment SA 5745 proposed by Mr. Schumer to the bill H.R. 6833, to 
amend title XXVII of the Public Health Service Act, the Internal 
Revenue Code of 1986, and the Employee Retirement Income Security Act 
of 1974 to establish requirements with respect to cost-sharing for 
certain insulin products, and for other purposes; which was ordered to 
lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. ___. 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 this section, 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 
     this section, a listing for each

[[Page S5399]]

     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).
                                 ______