Warning letters have been sent to twenty-three U.S. companies and two foreign entities marketing a wide range of products fraudulently claiming to prevent and cure cancer, the U.S. Food and Drug Administration (FDA) announced in June.
The FDA also warns consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. (See in this issue: “FDA to Consumers: 125 Fake Cancer ‘Cures’ to Avoid)”
“Although promotions of bogus cancer ‘cures’ have always been a problem, the Internet has provided a mechanism for them to flourish,” said Margaret Glavin, the FDA’s associate commissioner for regulatory affairs. “These warning letters are an important step to ensure that consumers do not become the victim of false ‘cures’ that may cause greater harm to their health.” (See related article in March 2008 eHealth Connection: “Study on Vitamin Use among Cancer Survivors Brings Patients, Doctors to Task”)
The FDA urges consumers to consult their health care provider about discontinuing use of these products and to seek appropriate medical attention if they have experienced any adverse effects.
The products contain ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, cat’s claw, an herbal tea called essiac, and mushroom varieties such as agaricus blazeii, shitake, maitake, and reishi.
Because these products claim to cure, treat, mitigate or prevent disease, and because these products have not been shown to be safe and effective for their labeled conditions of use, they are “unapproved new drugs marketed in violation of the Federal Food, Drug, and Cosmetic Act,” according to the FDA.
Examples of fraudulent claims for these products include:
“Treats all forms of cancer”
“Causes cancer cells to commit suicide!”
“80% more effective than the world’s number one cancer drug”
“Skin cancers disappear”
“Target cancer cells while leaving healthy cells alone”
“Shrinks malignant tumors”
“Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments”
The warning letters are part of the FDA’s ongoing efforts, in collaboration with the Federal Trade Commission (FTC) and Canadian government agencies, to prevent deceptive products from reaching consumers. The initiative originated from consumer complaints and a web search for fraudulent cancer products conducted by the FDA, FTC and members of the Mexico–United States–Canada Health Fraud Working Group. Earlier this year, FTC sent warning letters to 112 web sites falsely promoting cancer “treatments” and referred several others to foreign authorities.
Parties that fail to properly resolve violations cited in warning letters are subject to enforcement action up to and including seizure of illegal products, injunction, and possible criminal prosecution.
Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.