The rule will be published on Wednesday and will become effective 60 days later, on April 12, 2003.
"This FDA rule reflects what the scientific evidence shows - that ephedra poses an unreasonable risk to those who use it," Health and Human Services secretary Tommy G. Thompson said, adding, "we intend to take swift action against anyone who puts consumers at risk by continuing to sell such products after the prohibition takes effect."
FDA advised consumers to stop using ephedra products in December last year and also asked companies to stop selling ephedra-containing products in anticipation of the law.
Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA may remove a dietary supplement from the market if it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use. This is the first time the FDA has used the DSHEA framework to ban a supplement.
FDA based its decision on a review of evidence about ephedra's pharmacology and safety, adverse event reports and a seminal report by the RAND Corporation, an independent scientific institute. It also says it has reviewed tens of thousands of public comments on the agency's request in March 2003 for information about ephedra-associated health risks. Some industry members still feel that the FDA's decision did not take into account the full evidence available.
The American Herbal Products Association (AHPA) said it will examine the 'entire preamble' issued by the FDA on this rule to evaluate the potential impact of the agency's rationale on dietary supplements in general.
Ephedra supplements were hugely popular for aiding weight control and boosting sports performance and energy. But FDA says the available data showed little evidence of ephedra's effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These effects have been linked to significant adverse health outcomes, including heart attack and stroke.
"Until the final rule prohibiting the sale of ephedra-containing dietary supplements takes effect, FDA reiterates its warning to consumers: 'Do not take these products. They are simply too risky,'" said Dr McClellan.
FDA first issued a proposal that required a warning statement on dietary supplements containing ephedrine alkaloids in June 1997. It also proposed to restrict the amount of ephedrine alkaloids in dietary supplements and to prevent combining ephedra with other ingredients that have a known stimulant effect.
The rule was modified in 2000 and in February 2003 the agency announced a series of measures that included taking enforcement actions against firms making unsubstantiated claims regarding enhanced athletic performance for their ephedra-containing products.
This process has been ongoing and only last week the agency seized hundreds of bottles of ephedra-containing dietary supplements, marketed under the Betatrim, Thermbuterol, and Stacker 2 brands, from Musclemaster.com in Northboro, after it was alleged that the company was making unsubstantiated claims on its websites for the products.
Most firms have however complied with FDA's warning and removed products targeted at sports enhancement.
AHPA however notes that FDA stated in December that the final rule would not pertain to 'traditional Chinese herbal remedies' or 'products like herbal teas that are regulated as conventional foods'. The association adds that language in the pre-publication preamble suggests that FDA will exercise enforcement discretion for products that are marketed to health care practitioners for traditional use so long as their labeling does not identify them as dietary supplements.
It has invited marketers of ephedra products for traditional use to get in contact to address the issues raised for such products.
Additional information relating to ephedra is available online.