FDA Once Again Takes Aim at Ephedra
FDA announced Feb. 28 that the agency will reopen the comment period for a proposed rule originally published in the Federal Register in 1997. According to FDA, the action was prompted by the release of a RAND Corp. report evaluating the safety and efficacy data on ephedra and its synthetic counterpart, ephedrine, that have become available during the past six years.
The portions of the RAND report dealing with the question of efficacy focused mainly on whether dietary supplements containing ephedra stand up to manufacturers claims that the products aid in weight loss and help improve athletic performance. Ephedra-containing supplements, the report concluded, may be effective for short-term weight loss. No good evidence was found to support claims that the products improve athletic performance.
Safety data evaluated by RAND were gleaned from published clinical studies as well as some 16,000 adverse-event reports from a major manufacturer of ephedra-containing products. The report identified two deaths, three cases of myocardial infarction, and 17 other so-called sentinel events linked to ephedra use and described numerous less serious adverse events among ephedra users.
According to FDA, the regulatory agency is seeking comments on the health risks described in the RAND report. FDA is also requesting comments about a proposed warning statement and labeling information for ephedra-containing supplements.
The warning statement proposed by FDA would advise consumers that myocardial infarction, stroke, and seizures have occurred after the use of ephedra-containing products. This statement would also caution against concurrent use of ephedra and products with caffeine or other stimulants and advise consumers not to exercise strenuously while taking ephedra.
FDA further noted that it intends to examine whether the available data indicate that consumers face a "significant or unreasonable risk of illness or injury" from the use of ephedrine alkaloids. But FDA did not explicitly state whether such a finding would prompt the agency to remove ephedrine-containing products from the market.
FDAs response to the RAND report marks the third time that the agency has reopened the comment period for the proposed rule on ephedra. According to FDA, comments on the latest revision to the proposed rule are due April 7.
In its Feb. 28 announcement, FDA stated that it had sent numerous warning letters to dietary supplement makers that claim their ephedra-containing products improve athletic performance. According to FDA, the letters warn manufacturers that the available data do not support performance-enhancement claims. The agency has given manufacturers that market their products as performance enhancers 15 working days to submit data supporting these claims.