Aidance Skincare & Topical Solutions, LLC – FDA Warning Letter

On March 3, 2008, the FDA issued a Warning Letter to Aidance Skincare & Topical Solutions, LLC, regarding the marketing of their products Tetrasil and Genisil on their websites. The FDA determined that these products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The letter cited numerous claims on the company's websites (www.myskincure.com, www.genisil.com, www.aidanceskincare.com) and through metatags, indicating that Tetrasil and Genisil are intended to prevent, treat, or cure diseases such as herpes, shingles, and bacterial/fungal infections. Examples include claims that Tetrasil "kills the pathogens" responsible for skin conditions and "spells the end of Herpes Related Breakouts," while Genisil claims "NO CURE for Herpes. RIGHT? Think again!" and "will begin to kill the inflammation causing herpes virus quickly."

The FDA classified these products as drugs because of their intended use in disease treatment and prevention. They are considered "new drugs" as they are not generally recognized as safe and effective for their labeled uses, requiring an FDA-approved application for interstate commerce. The sale of these products without such approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are deemed "misbranded" under section 502(f