FDA WARNING_LETTER - Pure Med Spa

On April 6, 2010, the FDA issued a Warning Letter to Pure Med Spa regarding false or misleading claims on their website, www.puremedspa.com, concerning LipoDissolve products. The FDA determined these products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA) sections 352(a), 352(n), and 321(n), and 21 CFR 202.1(e)(5)(i) and (e)(6)(i).

The LipoDissolve products are considered drugs under FDCA section 321(g)(1) because they are intended to cure, treat, mitigate, or prevent disease or affect the body's structure/function, with claims such as causing fat cell lysis, treating fat deposits, cellulite, and lipomas. As injectable products, they are also prescription drugs per FDCA section 353(b)(1) due to unsafe use without practitioner supervision.

The website contained unsubstantiated efficacy claims, including permanent results and guaranteed fat loss of at least one inch per treatment, and unsubstantiated safety claims implying the product's natural, homeopathic ingredient (Phosphatidylcholine) is proven safe based on intravenous use in Europe. The FDA stated it is unaware of evidence supporting these claims.

Pure Med Spa was required to notify the FDA within fifteen working days of