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Fake Cancer Cures Draw FDA Wrath

Jun 18, 2008 | Parker Waichman LLP

In a move to reduce the ever-increasing glut of bogus cancer cures, the Food & Drug Administration (FDA) has sent 25 warning letters to 23 US companies and two foreign individuals which market a wide variety of products that fraudulently claim to prevent and cure cancer.  Such products include teas, supplements, creams, tablets, tonics, black salves, and other nonagency approved drugs.  The FDA also “warns North American consumers against using or purchasing the products sold under various names on the Internet.”  The complete list can be found on the FDA Website.

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,” according to the FDA.  The letters noted unproven claims including the ability to "destroy the enzyme on DNA responsible for cancer cells," and the power to "neutralize" carcinogens.  One product's Web site had a testimonial claiming it had cured a patient's skin cancer in three days.

"Although promotions of bogus cancer 'cures' have always been a problem, the Internet has provided a mechanism for them to flourish," said Margaret O'K. Glavin, FDA 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."  On its site, 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.”

FDA officials said the statements made about these products are dangerous because “they could prevent a patient from seeking proper cancer treatment and could harm a cancer patient by interacting with other drugs the patient is taking.”  “FDA is very concerned that consumers will purchase these products on the Internet and use them instead of products that have been proven safe and effective," said Michael Levy, director of labeling, the agency's new drug division.

The fraudulent products claim to ”cure, treat, mitigate or prevent disease” but have not been shown to be safe and effective for their labeled conditions of use.  These products are “unapproved new drugs marketed in violation of the Federal Food, Drug, and Cosmetic Act.”  The bogus cures contain a variety of ingredients including bloodroot; shark cartilage; coral calcium; cesium; ellagic acid; Cat's Claw; the herbal tea Essiac; and mushrooms such as Agaricus Blazeii, Shitake, Maitake, and Reishi.

The Warning Letters are part of the FDA's ongoing, collaborative efforts with the Federal Trade Commission (FTC) and Canadian government agencies, to prevent fraudulent products from reaching consumers and was prompted by consumer complaints and an Internet 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, the FTC also sent Warning Letters to 112 Websites falsely promoting cancer "treatments," referring several to foreign authorities.

"Health fraud has been around for years, and it is a cruel form of greed," said David Elder, director of the agency's enforcement office. "Fraud involving cancer treatments can be especially heartless."

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