Two months after it forced the popular diet drug combination known as fen-phen off the market, the Food and Drug Administration on Thursday issued a consumer warning about the possible dangers of herbal weight-loss cocktails, which are widely available in diet clinics and health food stores and over the Internet.
At the same time, the FDA threatened legal action against the manufacturer of “Herbal PhenFen,” the most popular of these alternatives. The agency accused the company of making false and illegal claims that its product promotes weight loss, and ordered it to stop using phen-fen in its name.
“It is not illegal for this company to sell this product,” said Michael Friedman, the acting FDA commissioner. “It is illegal for this company to call this product something that is exactly like a medication and to make medical claims that it will cause weight loss and treat obesity, like the prescription products do.”
Herbal Phen-Fen - which contains neither phentermine nor fenfluramine, the two ingredients in the diet drug combination - was introduced within the last year by the Nutri/System weight loss clinics, an industry analyst said. It gained such a big following that it was quickly sold in health food stores.
It is manufactured by HPF LLC of Trevose, Pa., which would not disclose its relationship to Nutri/System except to say that they shared some of the same owners. HPF’s president, Brian Haveson, would not identify the company’s owners but denied any wrongdoing.
“We believe we are not violating any applicable laws,” Haveson said. “We stand behind the product and the name. The product works.”
Drug agency officials are precluded by law from regulating the diet industry, and therefore they cannot take Herbal Phen-Fen off the market. But they can press for the product to change its name by asserting that the company is illegally marketing it as a drug.
Other experts are also concerned. “It’s a marketing ploy; I’m very worried about it,” said Richard Friedman, director of the psychopharmacology clinic at New York University-Cornell Medical Center. “These natural biologics can be just as potent and dangerous as manufactured drugs. Why would you put something in your mouth if they can’t assure you it’s safe?”
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