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U.S. Department of Health and Human Services

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Enforcement Actions

Gemtronics Inc 17-Apr-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Atlanta District Office
60 8th Street. N.E.
Atlanta, Georgia 30309


April 17, 2008

VIA FEDERAL EXPRESS

William Isely
Gemtronics Inc.
964 Walnut Creek Road
Franklin, NC 28734-9533

WARNING LETTER
(08-ATL-07)

Dear Mr. Isely:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses http://www.agaricus.net and http://raaxagaricus.com and has determined that the products "Agaricus dried Grade A," "Agaricus dried Grade A Powder," "Agaricus Capsules," "Agaricus sweet Extract," "Agaricus strong Extract," "RF 1000 Extract," "APM Extract," "RAAX11 Extract," and "OPC Extract" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)(13)]. The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.

Examples of some of the claims observed on your websites include:

RAAX11 Extract

•"Raax 11 Agaricus Extract ... during laboratory tests the substance destroyed cancer cells that had been resistant to treatment up to now .... '[B]esides these cancer cells, leukemia cells that are normally resistant to a lot of medicines and methods of treatment, were also killed' reported the scientists."

•"Even very resistant Leukemia cells die off"

RAAX11 Extract and OPC Extract

• "The RAAX Agaricus protocol is working at over 99% of all stage IV cancer patients. Even patients with no hope are recovered, if they took the right dosage during the programed [sic] time. What makes the difference between a Chemo Therapy and this kind of treatment. The chemo therapy destroys everything. Using the RAAX agaricus protocol only the cancer cells are destroyed. As effect of this, tumors will shrink very fast."

RF 1000 Extract

•"RF 1000 Extract - Specially used to help at traditional treatments of cancer."

According to your website at http://www.agaricus.net, the products listed in this letter contain Agaricus. Your website lists several disease claims for Agaricus, including:

•"Cancer - Agaricus blazei Murill ... has an affinity for nourishing the immune system ... there is an inter-dependent relationship between immune status and cancer development."

•"[R]esearchers' findings suggest that the Agaricus water extract reduces the pain associated with breast cancer and may be a viable substitute for the pharmaceuticals that impose side effects. In addition, the researchers noted the anti-tumor effect of the mushroom extract ...." Further, the "Research" page of your website http://www.agaricus.net cites an article about an animal study of the "Agaricus blazei Murill" ingredient used in your products. This article concerns the use of this ingredient for treatment or prevention of cancer.

When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The citation "Tumor-specific cytocidal and immunopotentiating effects of relatively low molecular weight products derived from the basidiomycete, Agaricus blazei Murill .. Anticancer Res 1999 Jan-Feb;19(lA):113-8" is a reference citation used to market your Agaricus products for disease treatment and prevention on your website.

This reference citation and other claims quoted above are supplemented by the metatags used to bring consumers to your websites through Internet searches. Examples of the metatags include "alternative cancer therapies" and "cancer."

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" 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. Your products "Agaricus dried Grade A," "Agaricus dried Grade A Powder," "Agaricus Capsules," "Agaricus sweet Extract," "Agaricus strong Extract," "RF 1000 Extract," "APM Extract," "RAAX11 Extract," and "OPC Extract" are also misbranded within the meaning of section 502(f)( l) of the Act in that labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your websites, we noticed that you were also promoting these products for treatment and/or prevention of diseases other than cancer. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, within fifteen (15) working days of the 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. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be directed to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead. If you wish to discuss this letter, you should contact Mr. Campbell at (404) 253-1280.

Sincerely,

/S/

Mary H. Woleske, Director
Atlanta District