VanderVeer Center – FDA Warning Letter
The FDA issued a Warning Letter to Dr. Elizabeth VanderVeer of www.vanderveercenter.com on November 18, 2010, following a review of her website. The letter states that the website contains false or misleading claims regarding Lipodissolve products (also referred to as mesotherapy and meso-lipotherapy), causing them to be misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA), specifically 21 U.S.C. §§ 352(a), 352(n), and 321(n), and FDA regulations 21 CFR 202.1(e)(5)(i) and (e)(6)(i).
The FDA determined that Lipodissolve products are drugs, as defined by section 201(g)(1) of the FDCA, due to their intended uses, such as "spot fat reduction, cellulite reduction...scar revision...reduction of wrinkles," and "non-surgical treatment of lipomas." The injectable Lipodissolve products are also classified as prescription drugs under section 503(b)(1) of the FDCA.
The misbranding violations stem from unsubstantiated efficacy and safety claims. Unsubstantiated efficacy claims include statements like "Meso-lipotherapy has also proven effective for the non-surgical treatment of lipomas" and "Meso-Lipotherapy is revolutionizing facial
- Company
- VanderVeer Center
- Product type
- Drugs
ID · 98f3a70d-1cc4-4ffb-bbb2-51ba93a4bfe8
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