FDA WARNING_LETTER - cancerherbtea.com - December 31, 2014

The FDA issued a Warning Letter to Antonio Jimenez regarding products sold on http://www.cancerherbtea.com and http://www.anamucancerherbtea.com, specifically "Anamu CancerHerb Tea Box," "Anamu CancerHerb Tea Box with Honey," and "Organic Bottled Tea Drinks." The FDA reviewed these websites in December 2014.

The FDA determined that these products are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on the websites and promotional literature establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of claims cited include "Cancer Herb Tea –You have nothing to lose but your cancer," "Proven to help kill the cancer cells," and claims of efficacy against various cancers (e.g., leukemia, lymphoma, colon, breast, liver, brain), diabetes, arthritis, insomnia, and infections.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses. Introducing new drugs into interstate commerce without prior FDA approval violates section 505