Are dietary supplements containing ephedrine alkaoids banned in OTC sales?
EPHEDRINE The Food and Drug Administration (FDA) issued a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act (the act) because they present an unreasonable risk of illness or injury. Dietary supplements containing ephedrine alkaloids, are adulterated products and thus prohibited to be sold over-the-counter (OTC) effective April 11, 2004. These include, but not limited to, those from the botanical species Ephedra sinica Stapf, Ephedra equisetina Bunge, Ephedra intermedia var. tibetica Stapf, Ephedra distachya L., Sida cordifolia L. and Pinellia ternata (Thunb.) Makino or their extracts. OFFICIAL REGULATION: The full final regulation and any official interpretation should be determined from the final rule which can be viewed at Federal Register: February 11, 2004 (Volume 69, Number 28)Rules and Regulations [Page 6787-6854] From the Federal Register Online via GPO Access [wais.access.gpo.gov] Back To Top
EPHEDRINE The Food and Drug Administration (FDA) issued a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act (the act) because they present an unreasonable risk of illness or injury. Dietary supplements containing ephedrine alkaloids, are adulterated products and thus prohibited to be sold over-the-counter (OTC) effective April 11, 2004. These include, but not limited to, those from the botanical species Ephedra sinica Stapf, Ephedra equisetina Bunge, Ephedra intermedia var. tibetica Stapf, Ephedra distachya L., Sida cordifolia L. and Pinellia ternata (Thunb.) Makino or their extracts. OFFICIAL REGULATION: The full final regulation and any official interpretation should be determined from the final rule which can be viewed at Federal Register: February 11, 2004 (Volume 69, Number 28)Rules and Regulations [Page 6787-6854] From the Federal Register Online via GPO Access [wais.access.gpo.gov] Back To Top
