FDA WARNING_LETTER - Healing With Essiac Tea - March 31, 2012

The FDA issued a Warning Letter to Healing With Essiac Tea after reviewing their website, http://healingwithessiactea.com, in March 2012. The FDA determined that the "Essiac Tea" product is promoted for conditions that classify it as a drug 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 website establish the product as a drug intended for the cure, mitigation, treatment, or prevention of disease, violating the Act. Examples of claims include treating arthritis, rheumatism, psoriasis, destroying bacteria and fungus, anti-tumor properties, breaking down tumors, relieving stomach hemorrhage and jaundice, and benefiting various ailments like cancer, AIDS, allergies, and diabetes. The website also featured testimonials claiming cancer remission and other disease cures.

The FDA states that "Essiac Tea" is not generally recognized as safe and effective for these uses, making it a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs require prior FDA approval based on scientific data demonstrating safety and effectiveness, which this product lacks.

Furthermore, the product is misbranded under section 502(f)(1) of the Act [21 U.S