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S. 4215Senate118th Congress (2023-2025)In Committee

A bill to amend the Federal Food, Drug, and Cosmetic Act to establish new prohibited acts relating to dietary supplements.

Sponsored by Richard J. DurbinSen. Richard J. Durbin (D-IL)
Introduced April 30, 2024

AI-Generated Summary

Updated January 20, 2026 at 4:12 PM UTC

The bill amends the Federal Food, Drug, and Cosmetic Act to create new illegal actions for dietary supplements. It makes it unlawful to introduce or deliver into interstate commerce any product marketed as a dietary supplement that does not meet the legal definition, and to do so with a supplement that was prepared, packed, or held under the direction of a person who has been debarred. The changes also expand import exclusion and FDA seizure authority to cover these new violations, affecting manufacturers, distributors, and importers of dietary supplements.

Key Provisions

  • Prohibits introducing or delivering into interstate commerce any product marketed as a dietary supplement that fails to meet the statutory definition of a dietary supplement.
  • Prohibits introducing or delivering a dietary supplement that was prepared, packed, or held with the assistance or direction of a person debarred under the FD&C Act.
  • Expands import exclusion and FDA seizure powers to include products that violate the new prohibited acts, allowing the agency to block or seize such supplements.

Legislative Activity

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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S3081)

Health, Education, Labor, and Pensions Committee

April 30, 2024

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SenateIntro Referral

Introduced in Senate

April 30, 2024

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S3081)

Health, Education, Labor, and Pensions Committee

April 30, 2024

Floor Debate

1 member

What members said about S. 4215 on the floor

1 Democrat
Richard J. Durbin
Sen. Richard J. DurbinD-IL · Apr 30, 2024

Madam President, I ask unanimous consent that the text of the bill be printed in the Record.

Record
Richard J. Durbin
Sen. Richard J. DurbinD-IL · Apr 30, 2024

Madam President, I ask unanimous consent that the text of the bill be printed in the Record.

Record

Bill Text

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Introduced in SenateIssued April 30, 2024

II

118th CONGRESS

2d Session

S. 4215

IN THE SENATE OF THE UNITED STATES

April 30, 2024

Mr. Durbin (for himself and Mr. Blumenthal) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to establish new prohibited acts relating to dietary supplements.

1.

New prohibited acts relating to dietary supplements

(a)

In general

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

(jjj)

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).

(kkk)

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.

.

(b)

New import exclusion

Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended in paragraph (3) of the third sentence, by striking section 301(ll) and inserting paragraph (ll), (jjj), or (kkk) of section 301.

(c)

New seizure authorities

Section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) is amended—

(1)

in subsection (a)(1), in the first sentence, by striking section 301(ll) and inserting paragraph (ll), (jjj), or (kkk) of section 301; and

(2)

in subsection (d)(1), in the first sentence, by striking or cosmetic and inserting cosmetic, or product in violation of paragraph (jjj) or (kkk) of section 301.