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FDA Issues Warning Letters for Weight Loss "Supplement"FDA Issues Warning Letters for Weight Loss "Supplement"

November 27, 2001

1 Min Read
FDA Issues Warning Letters for Weight Loss "Supplement"

WASHINGTON--The Food and Drug Administration (FDA) issued a warning to health care professionals, consumers and the product's distributor that a weight loss aid marketed as a dietary supplement may cause liver damage (http://www.fda.gov/medwatch/safety/2001/lipokinetix.htm). The product in question--LipoKinetix by Chaffee, Mo.-based Syntrax Innovations Inc.--might be linked to acute hepatitis and/or liver damage in at least six people between the ages of 20 and 32 who developed these conditions while using the product over a two-week to three-month span. The product contains norephedrine (also known as PPA, a drug), yohimbine, diiodothyronine and caffeine.

FDA also sent a letter to Syntrax (www.syntrax.com), directed to Syntrax founder, Derek Cornelius. "Given the serious hazard presented by the use of your product, we strongly recommend that you take prompt action to remove LipoKinetix from the market," wrote Christine Lewis Taylor, director of FDA's Office of Nutritional Products, Labeling and Dietary Supplements. FDA did not issue a product recall because it is up to the company in question to offer that issuance.

FDA is urging consumers who have taken this product to contact its MedWatch program by calling (800) 332-1088. When Syntrax was contacted, a company representative was uncertain when someone might be available to comment on the issue. Syntrax is not a member of either the National Nutritional Foods Association (NNFA) or the American Herbal Products Association (AHPA).

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