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Unapproved fat-dissolving products sold online

This article was originally published in The Tan Sheet

Executive Summary

FDA sent warning letters to U.S. health spas and a Brazil-based online retailer, which operates the Web sites and, about unapproved "lipodissolve" products and procedures. Lipodissolve involves drug injections intended to dissolve and permanently remove pockets of fat. The most commonly injected substances are the lecithin phosphatidylcholine and the bile acid dioxycholate, usually together and combined with vitamins, minerals and herbal extracts. A third substance that is an approved drug to treat respiratory problems in premature infants, Forest's Infasurf (calfactant), also has been found in lipodissolve formulations, according to FDA. The agency has received reports of permanent scarring, hard lumps and dark spots on consumers' skin after lipodissolve treatments. While FDA sent a warning letter about lipodissolve to only one Web retailer, more sites likely sell the products directly to consumers, Kathleen Anderson, deputy director in the Center for Drug Evaluation and Research's Division of New Drugs and Labeling Compliance, said during an April 6 conference call

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