The FDA continues to work closely with the Federal Trade Commission to make sure that dietary supplement products that contain ephedra do not make misleading and false claims. "If an advertisement states that a product is 'safe,' the advertiser's must show reliable and competent evidence to prove the claim," said Timothy J. Muris, Chairman of the Federal Trade Commission. "Consumers depend on advertising for factual information and deceptive ad claims can put a consumer's health at risk. This is why the FTC is currently investigating a number of weight loss products containing ephedra and we will continue to pursue aggressively marketers making unsubstantiated claims about product safety or effectiveness." Proposed a warning label for all ephedra-containing dietary supplements. The proposed label warns about the risks of serious adverse events, including seizure, heart attack, stroke, and even death. The label also cautions consumers that the risk may increase with the dose, with strenuous exercise, and with other stimulants such as caffeine; specifies certain groups (such as women who are pregnant or breast feeding) who should never use these products; and lists other conditions, such as diseases and the use of certain medications, that rule out the use of ephedrine alkaloids.

"The steps being announced today demonstrate FDA's commitment to taking the most effective actions possible under current law, given the state of the scientific evidence," said Dr. McClellan. "It may be possible to use ephedra safely, in small doses, for some purposes. But in the face of continued serious adverse events following the use of ephedra, there is a problem. It is a problem we are determined to fix."

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Many physicians feel that some dietary supplements' should be considered drugs' because they contain known active ingredients, whereas dietary supplements' have little or no physiologic effects.

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