H.R. 1075 · 108th Congress
Ephedra Public Protection Act
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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.
R
SweeneySponsor4 cosponsors · 1 D, 3 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Ephedra Public Protection Act - Amends the Federal Food, Drug, and Cosmetic Act to classify a food as adulterated if it is a dietary supplement that contains any ephedrine group and is unsafe within the meaning of this Act.
What it does: CRS summary · Introduced in House · Mar 4, 2003
Classifies a new ephedrine supplement (a dietary supplement containing ephedrine alkaloids not generally recognized as safe) as unsafe if it has not received premarket approval from the Secretary of Health and Human Services. Directs the Secretary to approve supplements that do not present a significant or unreasonable risk of illness or injury under the recommended or ordinary conditions of use.
Requires manufacturers of ephedrine supplements (dietary supplements containing any ephedrine group alkaloids), and packers and distributors of such supplements whose names appear on the label, to investigate each claim of a serious adverse experience and report to the Secretary as to whether the ephedrine supplement involved was a causal factor. Makes failure to comply with such reporting requirements a prohibited act.
Directs the Secretary to publish in the Federal Register a proposed rule for good manufacturing practice regulations under the Act. States various elements the proposed rule shall contain, including that it shall require the testing of each production lot or batch of an ephedrine supplement to ensure the label's accuracy in stating the amount of ephedrine group alkaloids in such supplement. Classifies an ephedrine supplement as misbranded unless its label bears an expiration date.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Ephedra Public Protection Act
Latest action (Mar 17, 2003): Referred to the Subcommittee on Health.
Policy area: Agriculture and Food · Origin: House · Introduced: Mar 4, 2003
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.