FDA issues warning to companies that claim cures for cancer

WASHINGTON — Tumorex, Immune Ace, Ellagic Insurance Formula, PC Hope, Pacific Ocean Shark Cartilage, Breast Cancer Tea Formula. They are all products sold to desperate cancer patients or people worried they might become one.

On Tuesday, the Food and Drug Administration told the companies selling them to stop claiming that their products will work like drugs or face seizures, and possibly criminal charges, as well.

"The claims are unproved and unreliable and they are unkind to the patient who is seeking health," said David Elder, director of FDA's Office of Enforcement. "Some of the products may also present a direct safety hazard."

The agency action came in warning letters to 23 companies and two individuals selling 127 herbal, fungal and animal-based health products. Many of the enterprises are home-based and trade only over the Internet. The substances range from shark cartilage, turmeric extract and flaxseed oil to dried mushrooms, herbal teas and irritating skin salves made from bloodroot.

"FDA is concerned consumers will see these on the Internet and will buy them and use them instead of products that have been proved safe and effective," said Michael Levy, director of FDA's Division of New Drugs and Labeling Compliance.

Many of the products may continue to be sold as legal "dietary supplements," as long as claims that they can treat or prevent cancer are eliminated. Items that are not meant to be eaten — such as creams that reputedly cure melanoma and other skin cancers — do not have that protection and are more likely to disappear.

The campaign is the latest of the FDA's systematic attack on products that are being sold to treat or prevent illness but have not weathered the elaborate proofs of safety and effectiveness required of licensed pharmaceuticals.

Last year, the agency sent letters to more than 30 companies selling diabetes treatments and followed up with two seizures and one criminal case. Two years ago, the target was weight-loss products.