FDA WARNING_LETTER - Herbs for cancer

On May 27, 2008, the FDA issued a Warning Letter to Mary Spohn of Herbs for Cancer regarding the marketing of numerous products, including various "Cancer Tea Formulas" and "Ellagic Acid." The FDA determined that these products are marketed with claims on the company's website, www.herbsforcancer.com, indicating their intent to prevent, treat, or cure disease, or affect body structure/function. Examples of such claims include treating specific cancers, dissipating nodules, decreasing swelling, increasing oxygen to destroy cancer cells, and enhancing chemotherapy effects. The FDA noted that a disclaimer on the website stating the products are not intended to cure, treat, or diagnose illness does not mitigate these misleading claims.

The FDA classified these products as unapproved new drugs under sections 201(g)(1) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), because they are intended for disease treatment and are not generally recognized as safe and effective for their labeled uses. Their introduction into interstate commerce without FDA-approved applications violates sections 301(d) and 505(a) of the Act. Furthermore, the products are deemed misbranded under section 502(f)(1) of the Act because they are offered for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for safe use by a layman.

The letter requires prompt corrective action