So-called “fat dissolving treatments” offered by spas do NOT eliminate fat and the companies should stop saying so — at least according to a press release from the U.S. Food and Drug Administration. The FDA says the procedures are called by names such as lipodissolve, mesotherapy, lipozap, lipotherapy, or injection lipolysis — and all involve unproven injections. The AP reports that “the Food and Drug Administration is cracking down on what are billed as fat-melting injections used in spas across the US, saying the drugs” have not “been cleared by federal scientists, as required by law.”
“We are concerned that these companies are misleading consumers,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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 the FDA for fat removal.”
Reuters Health reports the agency issued warning letters to:
- Monarch Medspa in King of Prussia, Pennsylvania;
- Spa 35 in Boise, Idaho;
- Medical Cosmetic Enhancements in Chevy Chase, Maryland;
- Innovative Directions in Health of Edina, Minnesota;
- PURE Med Spa in Boca Raton, Florida, and
- All About You Med Spa in Madison, Indiana.
The FDA also warned a Brazilian company that markets so-called lipodissolve products on two Web sites found here and here. “The FDA will notify regulatory authorities in Brazil of this action,” the FDA said in the statement.
The Brazilian company and the six medical spas in the US have to provide a written response within 15 days with their action plan to correct the situation, the Wall Street Journal reports.
The Philadelphia Inquirer explains that in these procedures “patients receive a series of injections meant to ‘dissolve and permanently remove small pockets of fat from various parts of the body,’ the FDA said. The primary ingredients are phosphatidylcholine and deoxycholate, although vitamins and herbs may also be added.”
The agency “has not evaluated the drugs and says it knows of no ‘credible scientific evidence’ that shows they eliminate fat.”
Although no “definitive studies of side effects” have been reported, the risks of the injections “also aren’t understood,” the NPR “Shots” blog reported. Nevertheless, some patients have experienced “pain at the injection site, knots under the skin, and permanent scarring.”
The CNN “Paging Dr. Gupta” blog reported that “the companies have been cited for a variety of regulatory violations, including making unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction.”
According to HealthDay, “some of these companies have claimed that lipodissolve can treat certain medical conditions, such as male breast enlargement, benign fatty growths called lipomas, excess fat deposits, and surgical deformities.”
WebMD reported the FDA has also “issued an import alert to prevent the importation and distribution of unapproved lipodissolve drug products into the United States.”
MedPage Today reported that Kathleen Anderson, PharmD, of the FDA’s Center for Drug Evaluation and Research, explained that if the companies’ response to the FDA’s letter is unsatisfactory, “they could face injunctions, seizure of the products, and civil or criminal action.”
“The agency has issued an import alert against the zipmed.net and mesoone.com entities to prevent the importation and distribution of unapproved lipodissolve drug products into the United States.”
In the meantime, it seems that it would be best not to waste your hard earned money on these procedures that have neither been shown to be effective or safe.