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FDA Cracks Down on Lipodissolve Procedures
Posted: April 8, 2010
It's a tempting premise: Get a series of drug injections and see pockets of fat on your body go away for good. But the U.S. Food and Drug Administration (FDA) is alerting consumers about false and misleading claims being made about products used in lipodissolve and about other misbranding of these products.
Recipients of lipodissolve get a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. The process is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.
“We are concerned that these companies are misleading consumers,” says Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal.”
The drugs most regularly used in the lipodissolve injection regimen are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively). Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.
What consumers should know
The FDA is alerting consumers that:
- It has not evaluated or approved products for use in lipodissolve.
- It is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination.
- The safety of these substances, when used alone or in combination, is unknown.
- It is not aware of clinical studies to support medical uses of lipodissolve.