By David Brown
Washington Post Staff Writer
Wednesday, June 18, 2008
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.
Yesterday, the Food and Drug Administration told the companies selling them to stop asserting 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 are a varied lot: shark cartilage, turmeric extract, flaxseed oil, 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 the 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 purport to cure melanoma and other skin cancers -- do not have that protection and are more likely to disappear.
The FDA is also urging consumers who come across products sold as cancer cures to report them.
"We are not going to be able to get everybody," Elder said. "We do hope that this initiative significantly reduces health fraud."
The campaign is the latest effort in the agency's systematic targeting of 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. The FDA views a Web site's claim of what an herbal product may cure or prevent as a "drug label" -- a highly regulated description that must be backed by scientific evidence.
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.
Earlier this year, the Federal Trade Commission sent warning letters to 112 Web sites for falsely promoting cancer treatments, a complaint legally different from the FDA's.
Several companies said yesterday that they will immediately comply with the FDA.
"We are just changing the language on our Web site," said John Stigaard, 72, owner of FernHealth.com and SuperHerbs.com, which were cited for nine products whose reputed benefits included anti-tumor activity. "We are removing everything that the FDA finds objectionable."
Otto Roder, president of Vitapurity Nutraceuticals in Central Point, Ore., said he will "absolutely" comply. He said his company never advises that cancer patients use its products instead of licensed pharmaceuticals, but it does cite scientific research supporting the use of the vitamins, cartilage extracts and other substances it sells.
"We are not doctors," he said. "We are trying to educate the public."
Elder, the FDA official, called the marketing of the products "a cruel form of greed," but at least one of the purveyors said yesterday that he loses money on them.
Neil Baker, a retired maker of truck canopies in Helena, Mont., fills about two orders a month for E-Mune through his company, Herbal Remission. It is made from bloodroot, a plant that contains sanguinarine, which has been studied for possible anti-tumor activity. He says one customer's melanoma was cured.
"I really don't know a whole lot about it. All I know is it works," said Baker, 63. "As far as I'm concerned, humanity should have it. But if the FDA doesn't like it, that's okay with me, too."
The FDA's list of "fake cancer cures" is athttp://www.fda.gov/bbs/topics/factsheets/fakecancercures.html.