FDA and shareholders crack down on claims for cancer cures and weight loss promises

The US Food and Drug Administration sent warning letters to 23 American companies and two foreign individuals for allegedly marketing a range of products fraudulently claimed to prevent and cure cancer.

The FDA said it had also warned North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves and creams, all sold under various names on the internet.

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 claimed to cure, treat, mitigate or prevent disease and had not been shown to be effective for their labelled conditions of use, they are categorized as unapproved new drugs marketed in violation of the Federal Food, Drug, and Cosmetic Act, said 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 crackdown originated from consumer complaints and an internet search for fraudulent cancer products.

Parties that fail to properly resolve violations cited in the warning letters will be subject to enforcement action up to and including seizure of illegal products, injunction, and possible criminal prosecution, said the FDA.

"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, 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."

Meanwhile, in a subsequent case, dietary supplements maker Mannatech said it had settled lawsuits with shareholders who had accused the company of making false claims and using improper business practices to increase sales and boost the value of its stock.

This settlement, which is subject to preliminary and final court approval, would resolve all the claims in the litigation, said the Texas-based company, which makes weight loss and skin care products. "Without admitting any liability or wrongdoing of any kind, Mannatech has agreed to make, or has already made, certain corporate governance changes and pay $850,000 in attorney's fees to plaintiffs' counsel in the five cases," said Mannatech in a statement. "The settlement payment will be funded by the company's insurer."

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