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S. 722 · 108th Congress

Dietary Supplement Safety Act of 2003

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IntroducedPassed one chamberPassed both chambersBecame law (gold)Resolution agreed to (full, dark)Failed or vetoed (gray)

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Never voted on. It didn't reach a floor vote before the 108th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

4 cosponsors · 3 D, 1 R

0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

Amends the Federal Food, Drug, and Cosmetic Act to require each manufacturer of a dietary supplement (supplement), and each packer or distributor of a supplement the name of which appears on the labeling, to report serious adverse experiences to the Secretary of Health and Human Services and to investigate such occurrences.

What it does: CRS summary · Introduced in Senate · Mar 26, 2003
Amends the Federal Food, Drug, and Cosmetic Act to require each manufacturer of a dietary supplement (supplement), and each packer or distributor of a supplement the name of which appears on the labeling, to report serious adverse experiences to the Secretary of Health and Human Services and to investigate such occurrences. Defines a serious adverse experience as an adverse event associated with the use of a supplement in a human that involves death or one of other serious calamities. Directs the Secretary to conduct a clinical evaluation of each such reported experience.

Requires the manufacturer of a dietary supplement to report periodically on other adverse experiences and to review such occurrences.

Allows the Secretary to grant a waiver from the above reporting, reviewing, and investigating requirements with respect to a dietary supplement upon determination that compliance is not necessary to protect the public health.

Authorizes the Secretary to require a manufacturer to conduct postmarket surveillance for a supplement under specified circumstances.

Permits the Secretary to require a manufacturer of a supplement or of an ingredient in a supplement to demonstrate that its product is safe under specified circumstances. Directs the Secretary to approve the continued marketing of such a supplement or ingredient or to disapprove it.

Prohibits any introduction into interstate commerce of a supplement containing a stimulant unless it is approved by the Secretary under this Act.

Amends the Act to exclude a product that bears or contains an anabolic steroid from the definition of a dietary supplement for a specified chapter of the Act.

Eliminates a provision of the Act requiring the United States to bear the burden of proof to show a supplement or an ingredient in a supplement is adulterated due to a safety violation.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Dietary Supplement Safety Act of 2003

Latest action (Apr 1, 2004): Sponsor introductory remarks on measure. (CR S3547-3548)

Policy area: Agriculture and Food · Origin: Senate · Introduced: Mar 26, 2003

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.