The FDA moves to ban the popular dietary supplement ephedra, citing health concerns and risks including heart attack and death.
Health and Human Services Secretary Tommy Thompson says the ruling comes after at least 16,000 reports of adverse effects related to ephedra. Figures show ephedra accounts for seven percent of dietary supplement sales, and had about $1.4 billion in sales last year.
But ephedra has had problems. In 1997 the FDA proposed warning labels on ephedra and dosage limits, but the proposal was later withdrawn. In 2001, the NFL banned ephedra.
In early 2003, the FDA once again proposed warning labels after ephedra use was linked to the death of Baltimore Orioles pitcher Steve Bechler.
Then Tuesday, in an unprecedented move, the FDA announces a ban of ephedra.
Manufacturers insist ephedra is safe when used correctly, which is the operative phrase here. They say problems happen when people use the drug incorrectly, wrongly thinking if one pill helps them lose weight or run faster, two pills would work even better.
In a statement one company, Metabolife, said theFDA’s science actually supports the safety of ephedra. Metabolife says it will decide whether to challenge the ban, after it becomes final.
Ephedra speeds up the body’s metabolism and has been linked to heart problems, strokes, seizures, psychiatric problems and about a hundred deaths. The FDA found it to be a significant and unreasonable threat, which is what it takes for the government to ban a dietary supplement.
John Honnigford, MD says, “I think it’s a bold move by the FDA, and one that I applaud them for. They generally do not venture into the world of these non-prescription medications which are closer to food products, these herbal supplements. They’re not regulated by the FDA, and I think it was a very bold venture for them to limit this medication.”
The FDA says a final rule banning all products containing ephedra, will come in 60 days.
But Secretary Thompson says the time to stop using ephedra is now.