FDA WARNING_LETTER - Best on Earth Products

On May 20, 2008, the FDA issued a Warning Letter to Best on Earth Products, specifically addressing the marketing of Black Salve, Black Salve with DMSO, Black Salve Bloodroot Capsules, and Ellagic Insurance Formula on their website, www.bestonearthproducts.com.

The FDA determined that the products are unapproved new drugs and misbranded. The website's claims, including those for "melanoma, basal and squamous cell carcinomas," and statements about ingredients like Burdock Root and Red Clover for "tumors" and "cancerous growths," along with Ellagic Acid's ability to "prevent many types of cancer cells from multiplying," indicate the products are intended to prevent, treat, or cure disease. Metatags like "skin cancer" further support this.

These products are classified as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) and new drugs under section 201(p) because they are not generally recognized as safe and effective for their labeled uses. Their sale without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are misbranded under section 502(f)(1) of the Act because they are offered for conditions not amenable to self-diagnosis and treatment, meaning adequate directions for lay use cannot be