Ephedra Public Protection Act

Summary

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. 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.

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Timeline

1. 4 March 2003

   Introduced

   Introduced in House

   Source: IntroReferral

2. 4 March 2003

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

3. 4 March 2003

   Introduced

   Introduced in House

   Source: IntroReferral

4. 17 March 2003

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 4 March 2003 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 4 March 2003

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 4 March 2003

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 4 March 2003

  Open at official source

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  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Sweeney, John E. [R-NY-20] · R · Sponsor
• Rep. Walden, Greg [R-OR-2] · R · Sponsor
• Rep. Tiberi, Patrick J. [R-OH-12] · R · Cosponsor
• Rep. Lofgren, Zoe [D-CA-18] · D · Cosponsor
• Rep. Osborne, Tom [R-NE-3] · R · Cosponsor
• · hsif00 · Standing

Related records

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