FDA Warns About Lipodissolve Product Claims
The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve
- are safe and effective
- have an outstanding safety record
- are superior to other fat-loss procedures, including liposuction
Additionally some of the letters indicate that the companies have made claims that lipodissolve can be used to treat certain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities.
The U.S. companies receiving warning letters in regard to lipodissolve products are
- Monarch Med Spa, King of Prussia, Pa.
- Spa 35, Boise, Idaho
- Medical Cosmetic Enhancements, Chevy Chase, Md.
- Innovative Directions in Health, Edina, Minn.
- PURE Med Spa, Boca Raton, Fla.
- All About You Med Spa, Madison, Ind.
FDA is requesting a written response from these U.S. companies within 15 business days of receipt of the letters stating how they will correct these violations and prevent similar violations in the future. These firms were told that failure to promptly correct the violations may result in legal action.
The Brazilian firm getting a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com. FDA will notify regulatory authorities in Brazil of this 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. Importing and distributing unapproved drug products is a violation of the Federal Food, Drug, and Cosmetic Act.
How to Report Side Effects
Consumers and health care professionals may report serious side effects with the use of lipodissolve products to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).