FDA WARNING_LETTER - R Thomas Marketing, LLC

The FDA issued a Warning Letter to R Thomas Marketing and Just Enhance following a review of their websites, www.herbviagra.com and www.herbsviagra.com, which revealed the sale of products violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Products including "Black Ant," "Herb Viagra," "Stree Overlord," and "Real Skill" were identified as unapproved new drugs and misbranded drugs. Laboratory analysis confirmed these products contain undeclared sildenafil, a phosphodiesterase type-5 (PDE-5) inhibitor and the active ingredient in the prescription drug Viagra. These products are considered unapproved new drugs because sildenafil was not marketed as a dietary supplement prior to Viagra's approval, they are intended to treat disease conditions, and are not generally recognized as safe and effective. Furthermore, their labeling is false or misleading by failing to declare sildenafil, which poses serious health risks, especially for consumers taking nitrates, and lacks adequate warnings for users. The letter also noted other products offered, such as "African Superman," which FDA analysis from other distributors showed contain undeclared sildenafil, tadalafil, and/or noracetildenafil. The FDA emphasized the firm's responsibility to ensure all distributed products comply with federal law. Prompt corrective action is required, with a written response to FDA within fifteen working days detailing steps taken and a timetable for completion. Non-compliance may lead to legal action, including seizure, injunction, and prosecution.