FDA Commissioner Mark McClellan and Secretary of Health and Human Services Tommy Thompson said they will publish a final rule 'within a few weeks' that will ban the use of ingredients that contain ephedrine alkaloids in dietary supplements.
They said FDA has found such supplements to present 'an unreasonable risk of illness or injury', a decision allowed under the US' Dietary Supplement Health and Education Act (DSHEA), which regulates the industry. It is however the first time FDA has banned a product by rulemaking under DSHEA since the law's enactment in 1994.
While the law will be effective 60 days after publication in the Federal Register, the agency has already sent letters to over 60 firms that sell dietary supplements containing ephedrine alkaloids to give them advance notice of the rule. And at a press conference, McClellan called on retailers and marketers to discontinue sales of ephedra products in advance of the publication of the rule.
FDA also issued an alert to consumers, urging them to stop buying and using the products immediately.
By the end of last year however, several supplement makers, including Rexall Sundown, previously owned by Dutch firm Numico, had already stopped making ephedra products, some with a significant hit to sales.
Ephedra, also called Ma huang, contains the active ingredient ephedrine, which when chemically synthesized is regulated as a drug. In recent years, ephedra products have been extensively promoted for weight loss and to help enhance sports performance and increase energy.
The stimulant can however have potentially dangerous effects on the heart, according to FDA, which based its decision on an extensive review of evidence by the RAND Corporation. This found little evidence for effectiveness other than for short-term weight loss, as well as evidence suggesting safety risks.
Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes.
In 1997, FDA proposed a rule on dietary supplements containing ephedra including requiring a warning statement on these products. It modified this proposed rule in 2000, and last February opened a comment period on a proposed warningstatement. It claims to have received tens ofthousands of comments.