Sec. 811. Regulation of dietary supplements
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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: Beginning on the date specified in subsection (b)(4), each dietary supplement 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). 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:
Any name of the dietary supplement and the statement of identity, including brand name and specified flavors, if applicable. 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. The name, domestic address, and email address for the United States agent, if the responsible person is a foreign entity. The business name and mailing address of all locations at which the responsible person manufactures, packages, labels, or holds the dietary supplement.
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— 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); the amount per serving of each listed dietary ingredient; 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 the amount per serving of dietary ingredients within a proprietary blend.
The number of servings per container for each container size of the identical formulation. The directions for use. Warnings, notice, and safe handling statements, as required by section 101.17 of title 21, Code of Federal Regulations (or any successor regulations). Allergen statements for major food allergens (pursuant to sections 403(w) and 403(x)). The form of the dietary supplement (such as tablets, capsules). Any health claims or structure or function claims. The dietary supplement product listing number for the product provided by the Secretary in accordance with subsection
(c)for that product. 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 single listing submission for a dietary supplement under paragraph
(1)may include multiple dietary supplements with identical formulations, or formulations that differ only with respect to color, additives, or flavorings, whether offered in a single package size or in multiple package sizes. In the case of a dietary supplement that is being offered in interstate commerce on or before January 1, 2024, 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 Food and Drug Administration Safety and Landmark Advancements Act of 2022 . In the case of a dietary supplement that is not being offered in interstate commerce on or before January 1, 2024, 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. The responsible person shall notify the Secretary within one year of the date of discontinuance of a dietary supplement required to be listed with the Secretary under paragraph
(1)for which the responsible person has discontinued commercial marketing. The responsible person shall submit to the Secretary a change or modification to listing information submitted under paragraph
(1)included on the label for a dietary supplement at the time the dietary supplement with the change or modification is introduced into interstate commerce. The responsible person shall provide upon request from the Secretary, within 10 calendar days of such request, 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. 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, additives, 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). Not later than 2 years after the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022 , 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 subparagraphs
(D)and (E)(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). Nothing in this section shall be construed— 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; or to authorize the disclosure of trade secret or confidential commercial information subject to section 552(b)(4) of title 5, United States Code, as prohibited under section 301(j) of this Act or section 1905 of title 18, United States Code, including information provided to the Secretary under subsection (b)(1)(D) or (b)(1)(E)(iv). There is authorized to be appropriated $7,498,080 for fiscal year 2023, and $6,300,000 for each of fiscal years 2024 through 2027, for purposes of conducting the activities under this section and hiring personnel required to carry out this section. . Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall publish final guidance related to the draft guidance titled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Availability (81 Fed. Reg. 53486; August 12, 2016), consistent with section 403D of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). The Secretary of Health and Human Services shall direct resources to inspections of facilities, suppliers, and dietary supplement types that present a high risk to public health (as identified by the Secretary). Section 403 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343 ) is amended by adding at the end the following: If it is a dietary supplement for which a responsible person is required under section 403D to file a listing, file a change to an existing listing, or provide additional information to the Secretary, and such person has failed to comply with any such requirements under section 403D with respect to such dietary supplement. . Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by section 803(a), is further amended by adding at the end the following: The introduction or delivery for introduction into interstate commerce of any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under section 201(ff). 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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- 21 USC 343–3
- 81 FR 53486
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Sec. 811
Regulation of dietary supplements
Cite21 USC 343–3
Fed. Reg.81 FR 53486
Cites 5Cited by 0 across 0 sources