WASHINGTON — The Food and Drug Administration is cracking down on what are billed as fat-melting injections in spas, saying the drugs have not been proved safe or effective.
Lipodissolve injections, a popular nonsurgical alternative to liposuction, are used to dissolve small fat deposits around the legs, arms and belly. The FDA said Wednesday that the drugs have not been cleared by federal scientists, as required by law.
The agency issued warning letters to a half-dozen spas nationwide that offer the injections, citing them for making unsubstantiated claims about lipodissolve therapy.
“The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” states a letter to All About You Medspa in Madison, Ind.
Other spas cited by the FDA included Pure Med Spa of Boca Raton, Fla., Monarch Med Spa of King of Prussia, Pa., and three others.
The website for Monarch Med Spa says: “Rather than go through the pain and discomfort associated with liposuction, patients now have the option of a series of injections with very minimal discomfort.”
Calls to Monarch Med Spa were not immediately returned Wednesday.
FDA regulators called on the spas to stop using such claims and notify the agency within 15 working days of steps they are taking to correct the violations.
Spas that offer the injections say they are safe and effective. But public-safety advocates have called for proof and urge patients to think twice before paying thousands of dollars for an unproven procedure.
The FDA also issued a warning to a Brazilian company that sells lipodissolve treatments on two websites: and .
Spa treatments at issue
The FDA warned a half-dozen U.S. spas offering the “fat-melting” injections for making unsubstantiated claims.
Lipodissolve injections: Lipodissolve and similar treatments use two chemicals, phosphatidylcholine and sodium dioxycholate. These chemicals occur naturally in the human body, but that doesn’t necessarily make them safe. The compounded cocktails often include the drug Infasurf, which is used to treat respiratory problems in premature infants, according to the FDA.
Ugly adverse reactions: The FDA said it had received reports of patients with permanent scarring, hard lumps and dark skin spots after receiving the therapy.
