FDA Issues 'lipodissolve' Warning Letter

WASHINGTON, April 7 (UPI) — The U.S. Food and Drug Administration issued warning letters Wednesday to seven companies allegedly making false or misleading claims about drugs.

The FDA said six U.S. medical spas and a Brazilian company made false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called “lipodissolve.”

Lipodissolve is a procedure involving a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body, the FDA said. The procedure is also known as mesotherapy, lipozap, lipotherapy or injection lipolysis.

The most commonly injected drugs are phosphatidylcholine and deoxycholate, usually in various combinations with one another,

“The FDA is not aware of any credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in combination is unknown.

The warning letters were issued to Monarch Medspa of King of Prussia, Pa; Spa 35, of Boise, Idaho; Medical Cosmetic Enhancements, in Chevy Chase, Md.; Innovative Directions in Health, an Edina, Minn., firm; PURE Med Spa of Boca Raton, Fla., and All About You Med Spa of Madison, Ind. The Brazilian company receiving a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com.

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