FDA issues warning letters for fat eliminating products

The FDA has issued warning letters to six medical spas for making false or misleading statements on their websites about drugs they claim will eliminate fat in a procedure called “lipodissolve,” or for otherwise misbranding lipodissolve products. These companies have made claims that the drugs used for their lipodissolve procedures are safe and effective; however, these products have not been evaluated or approved by the FDA for this use.

Lipodissolve is a procedure involving a series of drug injections intended to dissolve and permanently remove small pockets of fat from the body. It also is known as mesotherapy, lipozap, lipotherapy, or injection lipolysis. The most commonly injected drugs are phosphatidylcholine and deoxycholate, usually in various combinations with one another. In some cases, drugs or other products (eg, vitamins, minerals, and herbal extracts) are added to the mixture. 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 FDA has received reports of adverse effects including permanent scarring, skin deformation, and deep painful knots under the skin in areas where the lipodissolve products have been injected.

Warning letters were issued to the following companies:

• Monarch Medspa – King of Prussia, Pennsylvania
• Spa 35 – Boise, Idaho
• Medical Cosmetic Enhancements – Chevy Chase, Maryland
• Innovative Directions in Health – Edina, Minnesota
• PURE Med Spa – Boca Raton, Florida
• All About You Med Spa – Madison, Indiana

For more information visit www.fda.gov/ForConsumers/ConsumerUpdates/ucm206240.htm.