The Food and Drug Administration fired a warning shot across the bow today to anyone providing Lipodissolve therapy in their office, clinic, or medical spa (click here to read our news coverage, free registration required).
The agency sent warning letters to six medical spas and a Brazilian Web site operator stating that the claims being made by these companies were illegal, and that if they didn’t clean up their act in 15 days, the FDA could conceivably file an injunction, seize their products, or even seek criminal charges.
Lipodissolve, also known as mesotherapy or injection lipolysis, has its defenders. In fact, it is the subject of an FDA-approved clinical study being conducted by the Aesthetic Surgery Education and Research Foundation. There are no results yet.
The FDA is warning consumers (see new Web page here) that there is no evidence that Lipodissolve is effective, and that it is unapproved and can cause a variety of side effects.
When asked what the agency would tell clinicians who are using fat-dissolving injectables, a pharmacist in the FDA’s Division of New Drugs and Labeling Compliance said that they should submit a new drug application to prove safety and efficacy. And, she said, the FDA would not hesitate to go after doctors who make claims the agency deems false and misleading.
— Alicia Ault (on Twitter @aliciaault)