| Public Health Service Food and Drug Administration |
Department of Health and Human Services
April 7, 2011
United Parcel Service
Delivery Signature Requested
KT Botanicals, LLC
Attn: Tyler Blythe
4084 Bridge St Ste 1
Fair Oaks, CA 95628-7171
Warning Letter
Dear Tyler Blythe:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.ktbotanicals.com in March 2011 and has determined that your product, “Acute Radiation Exposure Support Formula,” is promoted for conditions that cause the product to be 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 your web site establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims observed on your website include:
- “As a result of the recent unfortunate events in Japan, Potassium Iodide is almost impossible to find world wide! We have produced an excellent radioprotective formula that provides the CDC-recommended 130mg of Iodine per dose for protecting the thyroid gland during acute radiation exposure! While protecting the thyroid by saturating it with dietary iodine....”
Under the heading, “WHAT ABOUT THE REST OF THE BODY?!?!”:
- “Our formula provides several well studied, potent radioprotective compounds derived from POTENT extracts of several mushrooms as well as Green Tea to yield a fully functional whole-body support for acute radiation exposure.”
- “Laminaria Japonica 60: 1 Extract - …. [I]t contains approximately 130mg of Iodine per serving, which is what the Center for Disease Control recommends for acute radiation exposure.”
Under the heading, “Mushrooms and Radiation!”:
- “Agaricus Blazei Mushroom 20:1 Extract - …. They have found it to be a broad spectrum anti-cancer agent which has a proven track record both in vivo and in vitro studies! Through various mechanisms, Agaricus Blazei was found to inhibit tumor growth in almost every type of tumor that it came into contact with! Aside from its anti-tumor properties, there are literally thousands of studies showing its amazing therapeutic potential for a wide range of other conditions including diabetes, Blood pressure and cholesterol, hepatitis, rheumatoid arthritis and other auto-immune disorders….”
- Lion's Mane Mushroom 20:1 Extract - …. Beta Glucan has demonstrated remarkable radio-protective properties and has been shown to protect bone marrow and blood cells from radiation exposure…. It has been proven to re-grow damaged nerve cells…. We have had extensive experience with this particular extract over the past few years and can say from personal experience that it has markedly improved neuropathic conditions resulting from spinal cord and brain trauma related nerve damage. In Japan it is used as the immediate treatment for strokes!”
- “Reishi Mushroom 10: 1 Extract - Reishi mushroom is a well known anti-tumorigenic.”
- “Cordyceps Mushroom 10: 1 Extract - Cordyceps has been shown to increase the survival times of radiation exposed lab animals....”
- “Green Tea 98% ECGC - …. It is a powerful free-radical scavenger and has been shown to protect the DNA of cells that have been exposed to radiation!”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The above violation is not meant to be an all-inclusive list of deficiencies in your product and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the attention:
Darlene Almogela
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issue in this letter, please contact Carl Lee, Compliance Officer at 510-337-6737.
Sincerely,
/S/
Barbara J. Cassens
District Director
San Francisco District
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