Ephedra Banned Once Again By US Court

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Ruling puts the final ban on Ephedrine.

Ephedra is banned once again. On July 18, 2006 the 10th U.S. Circuit Court of Appeals has ruled in favor of the ephedra ban by the Food and Drug Administration. It concluded the FDA adhered to Congressional mandate in conducting a risk-benefit analysis to determine if ephedra presents an "unreasonable risk of illness or injury".

This ruling in support of the FDA ban on ephedra at any dose reverses the April 2005 ruling by Salt Lake City federal judge Tena Campbell, who ruled in favor of lifting the ephedra ban. Her judicial review found no evidence to support FDA's conclusion that 10 mg per day of ephedra presented a significant or unreasonable risk.

While some manufacturers rushed to get ephedra products back on the shelf during the lift of the ephedrine ban in 2005, one company, Dynapure Nutrition (http://www.getleanquick.com), held its ground with its safe ephedrine replacement. In fact in April of 2006, the company’s, patent application for its weight loss product WARP 9, was granted by the United States Patent and Trademark Office as an ephedrine replacement, cited as a “composition for treatment of obesity or generally aiding weight loss by appetite reduction and metabolism increase.”

Company CEO Dan Maiullo spoke about the WARP 9 Ephedrine Replacement patent. “It’s not easy to receive a patent for a weight loss product. We showed the government that the product has the clinical research to be extremely safe at losing weight effectively. We’re very proud of the scientists and physicians that helped us formulate such an effective product.”

Over the past few years WARP 9 has been a top selling weight loss product in the US and many consumers are realizing that the ephedrine alternative is just as effective as ephedra once was. According to the company’s website, WARP 9 actually mimics ephedra by utilizing the same biochemical pathways in the body, but safely keeps the body's own natural metabolism in charge.

Chief Science Officer and formulator Pete Maletto explained how it was possible to mimic ephedra without using it in the WARP 9 formula "Ephedra reduced appetite by decreasing specific hunger signals in the brain. We studied this beneficial effect and take a responsible approach using safe, effective nutrients like 5-HTP and other amino acids in WARP 9 that mimic the same appetite reducing benefits as ephedra, but with none of the dangerous side effects. Then as an added benefit, we formulated WARP 9 to boost metabolism with safe, clinically proven nutrients like Green Tea that keep your body in control of the heat it produces. We made sure that all the ingredients in WARP 9 have a long history of safe usage before marketing the product."

Michael McGuffin, president of American Health Products Association. "This ephedra ban came as no big surprise." He said while the issue of ephedra is important, the other issue with the ruling is the precedent it sets for FDA assessment method as well as how the industry is going to regroup and figure out how to operate under this type of rulemaking.

Meanwhile, consumers aren't likely to see the return of ephedra supplements to the market anytime soon, according to a leading trade group for the herbal supplement industry.


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Pete Maletto
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