FDA WARNING_LETTER - Kt Botanicals - April 07, 2011

The FDA reviewed KT Botanicals' website in March 2011 and determined that their product, "Acute Radiation Exposure Support Formula," is promoted for conditions that classify it as a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on the website, such as providing 130mg of Iodine for thyroid protection during acute radiation exposure, offering whole-body support for acute radiation exposure, and various claims for ingredients like Agaricus Blazei Mushroom (anti-cancer, anti-tumor, therapeutic for diabetes, blood pressure, cholesterol, hepatitis, rheumatoid arthritis), Lion's Mane Mushroom (radio-protective, protects bone marrow and blood cells, re-grows damaged nerve cells, treats strokes), Reishi Mushroom (anti-tumorigenic), Cordyceps Mushroom (increases survival times of radiation-exposed animals), and Green Tea (free-radical scavenger, protects DNA from radiation), establish the product as a drug intended for the cure, mitigation, treatment, or prevention of disease.

Since the product is not generally recognized as safe and effective for these uses, it is considered a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs cannot be legally marketed in the U.