Kt Botanicals – FDA Warning Letter, Apr 7, 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.