Today, the FDA scolded six U. S. spas and one Brazilian company for making fake and deceptive claims about fat-melting injections known as mesotherapy, lipodissolve, lipozap, lipotherapy, or injection lipolysis.
Kathleen Anderson, the Deputy Director of the FDA's Division of New Drugs and Labeling Compliance, during a news conference, said, “They make it sound so good and so safe. They claim it dissolves fat -- melts it away with no side effects -- and they have done thousands of procedures, and it really sells well”.
She said that they are truly concerned because they have information of complications, and they don’t have any good records, which say that it is safe and effective.
She also said that the side effects which have been reported to the FDA include permanent blemishes and deep, painful knots under the skin in parts where the lipodissolve shot has been injected.
The FDA also reprimanded a Brazilian company for retailing lipodissolve products on two web sites, zipmed. net and mesoone. com. The agency has issued a warning to avert the importation and circulation of unapproved lipodissolve drug products into the United States.
It is expected that the new warning will have an alarming effect on other medical spas and web sites that might also be culpable of advertizing the advantages of this unproven treatment.
Kathleen said that if other firms who did not get letters are making phony and misleading statements should also stop doing it.
If the companies do not take adequate steps to correct the infringements within 15 days, the FDA can confiscate the products or order a ban to lawfully stop the company from continuing to make these false and misleading claims.












