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Feb. 28, 2003

Statement by Sidney M. Wolfe, M.D., Director, Public Citizen’s Health Research Group, Concerning FDA’s Failure to Ban Ephedra

Commissioner Mark McClellan, M.D., has violated a principle of the Hippocratic Oath he once swore to – "First, Do No Harm" – in his cowardly refusal to ban ephedra products. This refusal comes in the face of clear, unequivocal evidence of the dangers of these products, more than 100 reports of death in the possession of the FDA, and the admitted legal authority for a ban. The legal standard, under the Dietary Supplement Health and Safety Act (DSHEA) of unreasonable risk of harm when used at the recommended dose, is clearly met.

Whether, as rumored, the failure to ban is in response to pressure from the White House or not, Dr. McClellan has demonstrated he lacks the ethics to be a physician, let alone FDA Commissioner, and should be forced out of office as should his boss, HHS Secretary Tommy Thompson, who similarly knows these products are too dangerous to stay on the market but refuses to use his authority to call for a ban.

Public Citizen, which petitioned FDA for a ban of these products in September 2001, is seriously considering a lawsuit against FDA/HHS to force a ban, which will even more clearly put the government in the position of defending this deadly, indefensible industry.

Proposing a warning label instead of a ban guarantees additional deaths and permanently disabling injuries to unsuspecting users. There is nothing on the proposed label that will assure that more people will not die or be injured since many such adverse events have occurred in people who are not strenuously exercising and who are using the recommended doses.

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