April 19, 2011
FAIR OAKS, Calif.KT Botanicals LLC received a warning letter from FDA in early April, after the agency determined claims about the companys product Acute Radiation Exposure Support Formula on its website position it as a drug, marketed with claims in violation of federal law. The product is promoted as a "radioprotective formula" providing 130 mg iodine per dose to "protect the thyroid gland during acute radiation exposure." Additional ingredients include green tea extract and various medicinal mushrooms, with descriptions such as:
Agaricus Blazei Mushroom: "found to inhibit tumor growth in almost every type of tumor" and "amazing therapeutic potential for conditions including diabetes and other auto-immune disorders."
Lions Mane Mushroom: "protect bone marrow and blood cells from radiation exposure" and "markedly improved neuropathic conditions resulting from spinal cord and brain trauma related nerve damage."
Reishi Mushroom: "a well-known anti-tumorigenic."
Cordyceps Mushroom; "shown to increase the survival times of radiation exposed lab animals."
The agency noted the product has not been approved as a new drug for the referenced uses, meaning it cannot be legally marketed in the United States. It requested the company take prompt action to correct all violations, or further regulatory action, such as seizure and/or injunction, could take place.
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