H.R.1075 - Ephedra Public Protection Act108th Congress (2003-2004)
Summary: H.R.1075 — 108th Congress (2003-2004)
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.
Introduced in House (03/04/2003)
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.