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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nutrition 2000 03-Jun-08

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

Public Health Service
Food and Drug Administration

 

New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217

Telephone: (615) 366-7801
FAX: (615) 366-7802


June 3, 2008

WARNING LETTER NO. 2008-NOL-14

FEDERAL EXPRESS
DELIVERY SIGNATURE REQUESTED

Nutrition 2000
4108 Rucker Boulevard
Enterprise, Alabama 36330

Dear Sir or Madam:

This is to advise you the U. S. Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.nutrition2000.com and has determined the products "Cesium and Potassium Combo," "Curcumin," "Men's Prosta-Life," "PC Hope," "Platinum," "Protocel Formula 23," "Protocel Formula 50," and "Surcan" are promoted for conditions which cause the products to be drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code, Section 321(g)(1)(B)] (21 USC 321). The therapeutic claims on your website establish 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 web site include:

Cesium and Potassium Combo with DMSO

• "Cesium is toxic to cancer cells"

• "Cesium both halts and neutralizes lactic acid"

• "Lactic acid causes pain and is a source of energy/fuel for cancer"

• "Cesium disrupts the ionic balance of cancer cells[sic] membrane"

• "... treatment of cancer with cesium, to quickly arrest growth and then gradually kill the cells, is an almost perfect approach. It would be consistent with some of the amazing reports of late stage cancer being arrested in a matter of days."

• "As the cell continues to ingest both cesium and potassium, the effects to the cancer cell are toxic."

• "... the physical results [of taking cesium] are a rapid shrinkage of the tumor masses."

• "In addition to the cancer therapy, ... Cesium is very effective in regulating heart arrhythmia. ... Based on experimental data available Cesium may also be useful in the treatment of manic-depressives."

Curcumin

• "Scientists showed that curcumin ... restores key immune cells that fight off cancer."

• "... curcumin boosts the immune system of tumor-bearing mice by restoring key immune cells called CD4 and CD8 T cells."

PC Hope

• Helps alleviate symptoms associated with prostatitis, BPH, elevated PSA and all stages of prostate cancer.

• Shown to reduce PSAs and inhibit tumor growth in men who are refractory and have metastatic cancer.

• Shown to extend survival of people with pancreatic cancer.

Your website also contains disease claims in the form of personal testimonials, including:

• "Diagnosed with prostrate [sic] cancer in 1999. ... Two months ago my PSA was 5.2; Now I am using PC Hope and it has reduced to 1.7."

• "I started taking PC HOPE June 26. At that time my PSA was 17.3, it was rechecked July 3 and was down to 7.39. ... You can quote me as saying 'PC HOPE works!"'

Platinum

• "Platinum is used in the treatment of cancer and as a base in some of the chemotheraputic [sic] treatments in conventional hospitals ..."

• "Platinum may be effective in killing disease- causing bacteria, fungus, viruses ...."

Protocel Formula 23 and Protocel Formula 50

• "Protocel comes in two slightly different formulas. Analysis of the formulas indicate that the following lists represent the better of the two formulas to start your protocol.

Formula 23

Formula 50

Auto-immune diseases

Cervical cancer

Bladder cancer

Colon cancer

Brain tumors (primary)

Esophageal cancer

Breast-cancer

Leukemia

Kidney cancer

Liver cancer (primary)

Multiple melanoma

Lung cancer

Prostrate [sic] cancer

Melanoma

Wilmes tumor

Non-Hodgkin's lymphoma

Autoimmune disorders

Ovarian cancer

Crohn's disease

Pancreatic cancer

Diverticulitis

Rhabdoid brain tumors

Endometriosis

Sarcomas

Multiple sclerosis

Stomach cancer

Parkinson's . . .

Squamous cell cancer

Viral infections

Throat cancer

(herpes, shingles) . . .

Uterine cancer

Mononucleosis

Lupus"

• "... taking Protocel while taking chemo reduces the side effects of chemo ...."

Surcan

Your webpage titled "Lung Cancer" lists Surcan as a "Recommended" product, and provides a link to purchase the product on the same webpage. The listing of your Surcan product as "Recommended" on your lung cancer webpage is clearly meant to indicate the product's intended use as a cancer treatment.

Your website also contains a disease claim in the form of a personal testimonial:

• "I had some prostate cancer diagnosed by a biopsy in November 1999.... I had another PSA test in January 2006, and the result was 5.65.... [I took] a regimen of Surcan and PC Hope, which I started taking together on February 5, 2006. I had another PSA test on April 14[th]. I found out on April 19[th] that my PSA reading was 2.2 and my free PSA was 50%! I am now taking Surcan and PC Hope on a maintenance basis."

The claims quoted above are supplemented by the meta tags used to bring consumers to your website through Internet searches. The meta tags include "Bladder Cancer," "Bone Cancer," "Brain Cancer," "Breast Cancer," "Colon Cancer," "Liver Cancer," "Lung Cancer," "Lymphatic Cancer," "Metastatic Cancer," "Oral Cancer," "Pancreatic Cancer," "Prostate Cancer," "Skin Cancer," "Testicular Cancer," "Thyroid Cancer," "Cancer Protocols," "Leukemia," and "Cancer Diet."

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 USC 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 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective. Your products "Cesium and Potassium Combo DSMO," "Curcumin," "Men's Prosta-Life," "PC Hope," "Platinum," "Protocel Formula 23," "Protocel Formula 50" and "Surcan" are also misbranded within the meaning of Section 502(f)(1) of the Act, because labeling for these drugs fails to bear adequate directions for use [21 USC 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure products marketed by your firm comply with the Act and its implementing regulations. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure 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 USC 332 and 334).

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time which the corrections will be completed.

Your response should be sent to Nicole F. Hardin, Compliance Officer, U.S. Food and Drug Administration at the address above. If you have any questions about the content of this letter, please contact Ms. Hardin at (504) 219-8818 extension 102.

Sincerely,

/S/

H. Tyler Thornburg
District Director
New Orleans District

cc: Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580