TweetHigh-Dose Ephedra Pills Still Illegal, FDA Says
WASHINGTON (Reuters) - The ban on sales of weight-loss herb ephedra remains in place for higher doses despite a court ruling that regulators failed to meet the standard for outlawing low doses, the Food and Drug Administration said on Friday.
The FDA outlawed ephedra a year ago after linking the herb to deaths, heart attacks and strokes. Ephedra was promoted for shedding pounds, boosting energy and enhancing athletic performance, and makers insisted it was safe when used as directed.
On Thursday, a court in Utah ruled on a challenge to the ban from Nutraceutical International Corp. and said the FDA had failed to show low ephedra doses posed a "significant or unreasonable risk."
The decision prevents the FDA from enforcing its ban against products containing 10 milligrams or less of ephedra, FDA spokeswoman Kimberly Rawlings said.
"FDA interprets this to mean that the order remains in effect as to higher dosages of these products," Rawlings said.
The agency "is considering all of its options with respect to next steps," she added.
The nationwide ephedra ban that took effect in April 2004 was the first for a dietary supplement and is considered a key test of the FDA's power over the supplement industry.
Unlike prescription medicines, dietary supplements do not have to be proven safe before they can be sold. Under a 1994 law, the government must show a supplement is too risky to force it off the market.
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TweetThanks for the info! I wonder if compnanies will just start selling Ephedra in 10mg pills since that is the limit it seems now.
(https://www.reuters.com/newsArticle.j...rss/healthNews)