Ephedra

New company challenges FDA ban with launch of ephedra line.

Last month, American Generic Laboratories introduced a line of four SKUs of ephedra 10 mg, becoming the first company to challenge directly the Food and Drug Administration ban of the supplement ingredient. I would hope that [the executives] on the retail side would make the responsible decision not to take those products and put them on their shelves, said Steven Mister, president and chief executive officer for the Council of Responsible Nutrition.

"I think there s a place for ephedra, countered Scott Van Winkle, an analyst with Adams Harkness. "And I bet it's going to sell--it's not going to be anywhere near where it was, but it's going to sell."

The demand for the proverbial magic diet pill in a bottle is, in fact, real. Such diet aid tablets as Trimspa and CortiSlim continue to sell very well in chain drug stores, and ephedra-based diet pills were perhaps even bigger than that. According to ACNielsen data, appetite suppressants are up 213 percent in chain drug, reaching $6.7 million for the 13 weeks ended Sept. 10, a strong indication of how big of an impact the ephedra flap had on the category in recent years.

American Generic, incorporated in August, is pricing its ephedra offerings--Ripped Power, Superdrine RX-10, Metabothin and Super Ephedra Extreme, products reminiscent of once-leading ephedra-based diet aids-which already are sold online, between $39.99 and $59.99.
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It's just not likely to sell in drug stores, however, despite the great success ephedra supplements once delivered to the channel. Ephedra sales totaled almost $130 million across food/drug/mass for the 12 months ended in October 2001, according to SPINS data from that period--which was more or less the beginning of the end for the maligned ingredient.

Such retailers as GNC, 7-Eleven, Walgreens, CVS and Rite Aid all had made announcements years ago that they no longer would sell ephedra-based supplements--well before the FDA ban. It had been suspected that escalating product liability insurance costs played a significant role in driving ephedra off shelves.

The FDA banned the ingredient in 2003, not too long after retailers pulled the products. Earlier this year, a court ruled in favor of Nutraceutical Corp., arguing that the FDA couldn t enforce its ephedra ban against the company should Nutraceutical decide to introduce a low-dose version of the ingredient without proof that low-dose ephedra caused harm. The FDA in June appealed that decision.

Both CRN and the American Herbal Products Association argue that the ruling does not lift the ban against the sale of ephedra for the industry at large, noting that American Generic may be launching at considerable risk.

There also is the question of state-by-state regulations on the sale of ephedrine, a synthetic version of the ephedra supplement. Already, 29 states have passed legislation restricting the sale of ephedrine, and as many as 12 of them require product placement behind the counter or in a locked display. Six states define ephedrine as a controlled substance. And while current legislation may not explicitly include ephedra supplements, ephedra can be used in the illicit manufacture of methamphetamine, according to the Office of National Drug Control Policy.

Should the FDA not challenge the latest ephedra introduction, the notion that the FDA can't regulate the dietary supplement industry effectively would be further justified in many critics minds. "There will be reporters who write about this and don't understand the nature of the litigation," Mister said. The danger is in the inaccurate portrayal of the dietary supplement industry, a portrayal that could lead lawmakers to revisit the Dietary Supplement Health and Education Act of 1994. This is absolutely not a reason to revisit DSHEA. This is a reason for FDA to enforce the law that's on the books," he said.

MICHAEL JOHNSEN

CATEGORY SPECIALIST

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