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April 24, 2008
Ephedra product makers were hit hard by lawsuits and proposed bans late in 2002, prompting one supplements maker to dump its ephedra-based weight-loss line and one large retailer to begin carding customers trying to buy the controversial herb.
Politicians, doctors, consumers and even the U.S. Department of Defense are pressuring the Food and Drug Administration to remove ephedra from the market.
"The risk/benefit ratio for these products is unacceptable," American Medical Association Trustee Ron Davis, M.D., told Congress in October.
Twinlab Corp., which was recently granted a patent for an ephedra-free weight-loss formulation, will give up its share of that market voluntarily. By March 31, the Hauppauge, N.Y., company will stop selling dietary supplements made with ephedra. Twinlab executives said escalating insurance costs and regulatory uncertainties around the herb were the primary reasons for abandoning the line.
Total weight-loss supplement sales reached nearly $334 million in the 52 weeks that ended Nov. 3. Sales of Twinlab's Ripped Fuel, which contains ephedra, were up 12.6 percent, reaching $11.5 million for the same period.
On Long Island, where Twinlab is based, the Suffolk County Legislature heard public testimony Dec. 5 on two rules restricting the sale of ephedra products. The first would ban entirely the sale and purchase of products containing ephedra. The second would prevent the sale of ephedra products to minors. The lawmakers were to resume discussion of the issue on Dec. 17.
If Suffolk County bans ephedra sales, it will be the first county in the United States to do so. NBTY, a Suffolk County-based supplements manufacturer, marketer and retailer, challenged the proposed rule, saying it would be forced to leave Bohemia, N.Y., because it had no plans to stop selling ephedra products.
General Nutrition Centers have begun asking customers to show identification proving that they are at least 18 years old when they purchase products containing ephedra. GNC, a division of Royal Numico NV of the Netherlands, said that it was voluntarily adopting these measures. However, in California, a law that took effect Jan. 1 states that all retailers offering ephedra and other "steroid hormone precursors" must limit the sale of these products to adults over the age of 18.
The U.S. military is limiting access to ephedra for all of its active service personnel, reported Sharyl Attkisson at CBS News in early December. More than 30 service people have died while taking ephedra products, prompting top generals to call for the removal of all ephedra products from stores at its military bases worldwide. The ban does not make it illegal for men and women in the Army, Air Force or Marines to use ephedra, although the Army Surgeon General has issued a statement warning against its use, especially during physical training exercises.
In November, the Council for Responsible Nutrition released its "Guidelines for Young Athletes," a classification system for sports nutrition supplements. The Washington, D.C.-based trade association is hoping to educate young athletes about the proper use of sports supplements by establishing a green-light, yellow-light and red-light guideline system. "CRN has placed products containing ephedrine alkaloids and steroid hormone precursors in the red-light category because they clearly should not be used by individuals under the age of 18," said John Cardellina, vice president of botanical science and regulatory affairs.
Also in November, San Diego-based Metabolife International was ordered to pay $4.1 million to four people who sued the company over claims that they suffered heart attacks or strokes after taking Metabolife 356, a weight-loss product that contains ephedra.
The company, which is facing additional personal injury lawsuits in other state and federal courts, is appealing the Birmingham, Ala., federal jury decision on the grounds that the plaintiffs did not use the product as directed. The ruling stated that Metabolife 356 was "unreasonably dangerous" under Alabama's manufacturing liability laws.
Steve Taormina is a freelance writer in Nederland, Colo.
Natural Foods Merchandiser volume XXIV/number 1/p. 1, 16
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