Monday, August 28, 2006

The Final Blow for Ephedra

On August 17th, the US 10th Circuit Court of Appeals struck down the previous ruling by a Utah Judge that the FDA's banning of ephedra was invalid, thus allowing supplement manufacturers to sell it in over the counter supplements in 10mg per capsule amounts.

The Consumer Health Digest newsletter said the following:

Appeal court upholds FDA ephedra ban.

The U.S. Court of Appeals for the Tenth Circuit has upheld the FDA's ability to enforce a ban against the selling of ephedra products as dietary supplements. In 2005, a Utah federal judge limited the FDA's ability to enforce a ban against the selling of ephedra products as dietary supplements. That ruling temporarily prevented the agency from taking action against Nutraceutical Corporation, a Utah-based company that sued to block the ban. The 1994 Dietary Supplement and Health Education Act (DSHEA) states that to ban a product, the FDA
must prove that it poses an "unreasonable risk of illness or injury." Ephedra products have been linked to several deaths and thousands of complaints from consumers, many of whom have filed lawsuits. The FDA has concluded that "in the absence of a sufficient benefit, the presence of even a relatively small risk of an important adverse health effect to a user may be unreasonable." But the lower court judge ruled that to ban all ephedra products, the FDA would have to prove that they are unsafe "when used as recommended and suggested in the labeling." Concluding that a single dose of Nutraceutical's 10 mg product would not be dangerous, that judge ruled that the FDA could not stop the sale of dietary supplements containing 10 mg or less of ephedra alkaloids. He also ruled that DSHEA did not permit the FDA to compare benefits and risks as part of its evaluation of unreasonable risk. (In other words, whether a product is completely worthless is not relevant to judging whether it is reasonable to permit it to
continue to be sold.)

On August 17th, the Appeals Court disagreed and ordered the lower court judge to enter summary judgment in favor of the FDA. Its ruling concluded that Congress intended to integrate a risk-benefit analysis into DSHEA and that the FDA had met its legal burden by doing extensive research before ordering the ban.
After the Utah ruling, some manufacturers and vendors decided to sell the herbal ephedra, despite the shaky legal ground the ruling set. In January, the FDA seized supplies of the supplement, Lipodrene, which contained 10mg of ephedra, from a warehouse in Pennsylvania. This did not determine some, though, as the supplement continued to sell through other marketers. The main hindrance for most to decide whether or not to sell ephedra had more to do with legal and insurance reasons than monetary ones. Some companies are trying to get rid of their final stock of the product now, while others believe that this most recent ruling will start to be enforced after a certain time period. Whether or not this is true is unknown at this time.

However, not all - even some in the government, disagree with the ruling. In an article in the Salt Lake Tribune, Sen. Orrin Hatch (R-Utah) who authored the DSHEA, is quoted as saying "I can live with ephedra being off the market," Hatch says. "But if you give bureaucrats the right to determine the risks and benefits of supplements, the same standard used to evaluate drugs, [supplements] will be priced out of the marketplace just like drugs are now." The article goes on to discuss the possibility of supplement companies being forced to test new ingredients to the standards pharmaceutical companies are now required to do before bringing a new drug to the market. Sen. Hatch believes the original wording of the DSHEA is sufficient to allow for supplement makers to bring ingredients consumers want to the market without the lengthy evaluation process.

For now, however, consumers will no longer be able to purchase the natural herb, ephedra, and instead have to rely on the currently legal synthetic drug ephedrine HCl which is still available over the counter to anyone 18 and older.

FDA Statement on Tenth Circuit's Ruling to Uphold FDA Decision Banning Dietary Supplements Containing Ephedrine Alkaloids

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