Official FDA Warning Letter

Excerpts from actual letter from the FDA Sept 2004

                                                  SEP 20 2004    -   WARNING LETTER

Dear Sir or Madam:

The Food and Drug Administration (FDA) has reviewed your website at www.CancerTea.com. ...we have determined that your ...product violates the Federal Food and Cosmetic Act (the Act) because it is promoted  for conditions that cause the product to be a drug under section 201(g)(1) of the Act...

...articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs...The labeling for your product Cellular Tea includes the following disease claims:

"Burdock was used as an ingredient in alternative cancer treatments. Burdock also contains polyacetylenes, a chemical that kills disease-causing bacteria and fungi. It will prevent formation of gall stones and kidney stones."

"Cat's Claw to promote wound healing and for arthritis, gastric ulcers, inflammation, rheumatism, and tumors. Cat's Claw has become a popular item for many HIV and cancer patients.

"Sheep Sorrel ...was used as a remedy for cancer. The herb relieves internal ulcers and, when used externally, helps clear skin problems such as herpes, eczema, and ringworm."

"Watercress has been used for gout, scurvy, anemia, and tuberculosis."

"Use of  Red Clover Extract by men with prostate cancer, led to noticeable anti-cancer results in their prostate." The isoflavones in red clover may assist in preventing certain forms of cancer such as breast and prostate."

"The Cellular Tea" formula may be so effective not only against cancer but a number of other diseases which include: Arthritis, Asthma, Allergies, Alzheimer's, Chronic Fatigue Syndrome, Diabetes, Hypoglycemia, Impotence, Malignancies, Multiple Sclerosis, Parkinson's..."

Stops hemorrhages, and builds up the blood

Boosts immune system (while undergoing cancer therapy)

Helps intestinal burns from radiation therapy

"Answer to Cancer"

...a new drug may not be legally marketed in the United States without an approved New Drug Application."

Finally, in July 2004, FDA obtained a product called "CancerTea"...The label for this product includes disease claims such as "Answer to Cancer". Further, the name of this product is a disease claim because it implies that it is for use in the cure, mitigation, treatment, or prevention of cancer."

Sincerely,

Director, Office of Compliance

Center for Food Safety and Applied Nutrition