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For years, the dietary supplement industry, the US Food and Drug Administration (FDA) and Congress have been grappling with how to deal with the herb ephedra. Numerous public hearings have been held, regulations issued (then withdrawn), congressional resolutions passed, special investigations launched, reports released, theories put forward and deductions challenged.
And, as always, questions continued to abound: Did ephedra really work and for what? Could it be used safely and by whom? Were warning labels on the bottles necessary or enough? But few answers were definitive. Until now.
Out with a Ban
Late last December, the secretary of Health and Human Services himself (indicating how seriously the government was taking this issue), along with the commissioner of the FDA, announced that they had determined that ephedra presented such a severe health hazard that they would ban it from the market.
The effective date for the ban was 60 days from the publication of the final regulation, which was supposed to happen sometime in January. [Editor's note: Just as this story went to press, the FDA released its final regulation banning ephedra. The ban is scheduled to go into effect on April 12.]
Just the Beginning?
Since the FDA's announcement, speculation has abounded about what the ban on ephedra bodes for other dietary supplement products and the industry, as a whole. Some worry that it signals a new era of FDA aggressiveness where even the safest products could be in jeopardy of extinction.