Medical Cosmetic Enhancements – FDA Warning Letter

On April 5, 2010, the FDA issued a Warning Letter to Dr. Drew Varano of Medical Cosmetic Enhancements, following a review of their website, www.medicalcosmetic.org. The FDA determined that the firm's Lipodissolve products are unapproved drugs, as defined by section 201(g)(1) of the FDCA, and prescription drugs under section 503(b)(1), due to their intended use to affect the body's structure or function and requiring professional supervision. The website's false or misleading claims caused these products to be misbranded in violation of FDCA sections 352(a), 352(n), and 321(n), and FDA regulations. Specific violations included unsubstantiated efficacy claims, unsubstantiated superiority claims, and unsubstantiated safety claims for Lipodissolve products. Furthermore, the claim that phosphatidylcholine (PC) and sodium deoxycholate (DC) have been individually FDA-approved for medical conditions was found to be false or misleading, as no injectable PC or DC is currently FDA-approved. The FDA mandated prompt corrective action within fifteen working days, requiring a written response detailing specific steps taken to correct violations, prevent recurrence, and provide supporting documentation. Failure to comply could result in legal actions, including seizure and injunction.