Ephedra Ban

 


On April 13, 2005 Judge Tina Campbell of the United States District Court of Utah threw out the part of the sweeping FDA ban of the herb ephedra that prohibited sale of products yielding less than 10 mg of ephedrine alkaloids (ephedra) per day.

Ephedra, the primary ingredient of the over the counter cough remedy Sudafed, has been used in Chinese Medicine for 5000 years to treat common colds, coughs, asthma, head-aches, and hay fever. Judge Campbell ruled that the FDA had failed to prove any danger from 10mg or less of ephedra daily and ordered it to do so if it wished to enforce the ban.

Immediately Democrats Senator Ted Kennedy and Congressman Henry Waxman, well known and implacable foes of dietary supplements, issued statements deploring the outcome, apparently without understanding it.

Senator Kennedy said "If F.D.A. can't take a supplement as dangerous as ephedra off the market, then Congress needs to change the law to allow it to do so." Congressman Waxman seconded the Senator saying he “hopes the FDA’s ban will be upheld on appeal”, and “if it is not, it will clearly be time for Congress to revisit [the law] and give FDA the authority it needs to protect American consumers from dangerous supplements.”


So the Judge, who carefully weighted all available evidence, presented by presumably competent FDA lawyers and their adversaries, and concluded, as had previously the Congressional Government Accountability Office and Rand an FDA retained reviewer, that the evidence relied on by FDA to ban low dose ephedra products failed to establish that these products posed a risk to consumers is set up to be overruled by congressional supplement foes. Ephedra Products