FDA WARNING_LETTER - Hampton, Burt

The FDA issued a Warning Letter to Mr. Burt Hampton regarding the marketing of various "black salve" products for human and veterinary use on www.altcancercream.com. The products include Cansema Black Salve Mix, Mild Black Salve Mix, "Indian Mudd" Mix, and XX Sarcoid Salve Mixes/Kits with DMSO, among others.

The FDA determined these products are unapproved new drugs and new animal drugs under the Federal Food, Drug, and Cosmetic Act. The website makes numerous claims, including "97% success rate with most skin cancers" and effectiveness against "equine sarcoids, warts, squamous cell carcinoma," indicating intent to diagnose, cure, mitigate, treat, or prevent disease. These claims, along with metatags like "skin cancer cure," classify the products as drugs.

Since these products are not generally recognized as safe and effective for their labeled uses and lack FDA-approved applications, their introduction into interstate commerce violates sections 301(d), 505(a), 512(a), and 301(a) of the Act. Furthermore, the products are misbranded under section 502(f)(1) because they are offered for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for lay use.

Mr. Hampton must take prompt action to correct these violations within fifteen working days, providing written notification of specific steps taken to prevent recurrence