FDA WARNING_LETTER - Generation's Black Salve

On May 20, 2008, the FDA issued a Warning Letter to Peggy Booth of Generation's Black Salve concerning the marketing of Generation's Black Salve Tablets on www.generations.bz. The FDA determined the product is an unapproved new drug and misbranded.

The product is deemed a drug under section 241(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to website claims indicating intent to prevent, treat, or cure diseases, or affect body structure/function. Examples include claims of eliminating carcinogens, treating internal abnormal cell growth (liver, kidneys, colon, prostate, etc.), detoxing, inducing oxygen to inhibit carcinogen growth, and ejecting tumors. Metatags like "natural malignant tumor and growth cure" and "natural cancer cure" further support these intended uses.

Generation's Black Salve Tablets is also considered a new drug under section 201(p) of the Act because it is not generally recognized as safe and effective for its labeled uses. Its introduction into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

Furthermore, the product is misbranded under section 502(f)(1) of the Act because it is offered for conditions not amenable to self-diagnosis and treatment, meaning adequate directions for safe layman use cannot be provided