|Company:||Key of Destiny|
|Subject:||Labeling/Promotional Claims False & Misleading/New Drug/Misbranded|
|Issuer:||San Francisco District Office|
|Issued:||Oct. 31, 2006||Closed:||
Department of Health and Human Services
Public Health Service
San Francisco District
October 31, 2006
Key of Destiny
1550 West Ashlan # 107
Fresno, CA 93705
Dear Dr. Morgan:
This letter concerns your firm's marketing of the product "Nytrylowsde" on your website, www.cure-my-cancer .com. According to information on your website, Nytrylowsde" is a natural alternative cure for cancer." This product is intended to prevent, treat, or cure disease conditions. Statements on your website that document these intended uses include, but are not limited to, the following:
"We can cure your disease . . . with our natural cancer treatment. Recently, there has been scientific studies that the natural, alternative cure or treatments are effective at
destroying cancerous cells[.]"
"This alternative cancer cure is suitable for ALL types of cancer, including breast cancer, prostate cancer and lung cancer and does not destroy your body like
chemotherapy and radiotherapy."
"It is a natural product that is found in trees and plants and once it has been taken, it actually seeks out the cancerous cells and destroys them "
"Wilhout going into to too much detail, other cancer treatments on the market today contain a type of Nytrylowsde but the tablet manufacturing process involves heat treating
and heat treating Nytrylowsde, actually kills the cancer treatment ability of the organism[.]"
"Our product is not heat treated . . . which is why it is the best cancer cure available on the market today[.]"
"A natural cancer cure designed to seek and destroy the disease."
"We do not have cancer as we take our product to prevent us from getting cancer."
"Offer Of Proof.- Bring us a person that you know has Cancer. We will cure or kill their Cancer as living proof [IfJ their PSA or CEA is high, we can still kill their Cancer,
however they may die from the [collaterialj damage already done by the Cancer. "
"Recent scientific research just released in the United Kingdom has now shown the need for further study in the use of natural treatments for this disease as there is evidence that they could be beneficial to curing cancer. "
"Once taken, this Cancer Cure Nytrylowsde actually seeks out the live cancer cells and kills them."
"We cured a 60 y/o female's cancer with 1 bottle of the Product -her CFA was 6.3 . . . so, you can see this is the best Cancer Cure[.]"
"Any Cancer Killers or Cures, including Natural Cancer Cures and Liver Cancer Cures you can buy in America are discredited, because they have heat treated it. This process destroys the cancer killer in the product. Knowing this we made a non-disclosure contract with a Foreign Lab that does not heat treat their product, so we are just about the only source in America for a non - heat - treated natural cancer cure. In fact, if your Doctor tells you about this cheap Natural Cancer Cure, they would loose their Federal Funding and Grants, so we are just about your best bet if you have Cancer . . . "
Nytrylowsde is a drug, as defined by Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application is in effect for it. Your sale of Nytrylowsde without such an approved application violates these provisions of the Act.
Furthermore, because this product is offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use this product safely for its intended uses. Thus, Nytrylowsde's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under Section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
Additionally, you appear to make false and misleading promotional statements on your website regarding the product. For example, your website states, "Cancer and whether you will get it [,] or not depends on the following factors . . . Your Diet (You will get cancer if you don't take supplemental Nytrylowsde in your diet). " Absent any scientific evidence to validate this claim, your product is misbranded under Section 502(a) of the Act, 21 U.S.C. § 352(a).
Moreover, you suggest that Nytrylowsde be ingested with "H202 Food Grade 35 %". FDA warns consumers not to purchase or to use high-strength hydrogen peroxide products, including products marketed as "35 Percent Food Grade Hydrogen Peroxide," for medicinal purposes because they can cause serious harm, including death, when ingested or taken intravenously. A copy of FDA's press release regarding hydrogen peroxide is available on FDA's website, at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01420.html .
The above violations are not intended to be an all-inclusive list of deficiencies . It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.
You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer . If the firm from which you receive the product is not the manufacturer, include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070, Attention: Russell A. Campbell Compliance Officer.
A description of the new drug approval process can be found on FDA's internet website at http:/Nwww.fda.govlcderlregulatorylapplications/default .htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
Joseph P. Iser for Barbara Cassens
Director, San Francisco District