Ephedra to Be Banned by FDA
The Food and Drug Administration (FDA) today put manufacturers and consumers on notice that the agency will soon ban sales of ephedra-containing dietary supplements because they "present an unreasonable risk of illness or injury" when used in accordance with their labeling.
Today's dual announcements follow actions initiated earlier this year when the agency asked the public to comment on a rule originally proposed in 1997 but not finalized. Comments were invited on the adequacy of an FDA-written warning statement for inclusion in the labeling of all ephedra-containing dietary supplements. FDA also asked the public whether safety-related evidence accumulated in recent years was sufficient to support an outright ban of ephedra sales to protect consumers' health.
ASHP in April urged FDA to ban sales of dietary supplements containing ephedrine alkaloids. The ASHP Board of Directors had recently approved a formal policy supporting a ban on the manufacture and sale of dietary supplements containing ephedrine alkaloids. This policy was adopted as an ASHP professional policy in June by the ASHP House of Delegates.
FDA said its upcoming final rule on the subject will state that the unreasonable risk of illness or injury presented by ephedra-containing products makes them adulterated dietary supplements and, thus, illegal to sell in the United States.
In letters reportedly sent today to 62 manufacturers of ephedra-containing dietary supplements, FDA said it intended to publish the rule "in the coming weeks." Once published in the Federal Register, FDA said, the rule would become effective 60 days later.
FDA also issued a "consumer alert" urging the public to immediately stop buying and using ephedra-containing dietary supplements.