2 FL companies caught in FDA 'cancer fraud' crackdown
By Carol Gentry
6/17/2008 © Florida Health News
In a federal crackdown Tuesday on what it called “online cancer fraud,” the Food and Drug Administration released the names of suspected violators who have received warning letters, including two in Florida.
The letters, which warn that the recipients are marketing supplements online in a way that states or implies that they can prevent or treat diseases, went to Karyl Sellinger of Herb Time in St. Augustine and Mark Rosenberg of the Institute for Healthy Aging in Delray Beach.
The Herb Time site made claims for its products that were clearly in violation of law, the FDA letter said. For example, the letter said, the site claimed C-Herb “consistently and regularly removes skin cancers, moles and warts.” Testimonials for the herb said it had cured lung, colon and liver cancer, as well as HIV, the FDA said.
Rosenberg’s site sells a number of supplements, including green tea extract, melatonin, selenium and shark liver oil. The company cites studies done by others as evidence that the products have an effect on cancer.
The letters, dated May 22 to Sellinger and June 2 to Rosenberg, ordered them to stop violating the law within 15 days or be prepared to have their products seized. They were signed by Emma Singleton, Florida district director for FDA, whose office is in Maitland.
Herb Time complied with FDA's request at once, said Sellinger's daughter Stephanie Newman. Herbtime removed the testimonials and references to cancer regarding products. "We in no way want to treat, diagnose or cure any disease on our site," Newman wrote in an e-mail. "We recommend they speak to their primary care health provider."
Rosenberg told Florida Health News that he has done nothing wrong. “I’m amazed I got a letter like this,” Rosenberg said. “I’m not saying I’m curing cancer, I’m just putting the studies up.”
Rosenberg said he followed the same format as other online supplement companies, by listing studies done on the products rather than making claims for the products himself. The studies were done by bona fide research teams, he said, and some were printed in recognized medical journals.
But the FDA letter said the citations indicate that the supplements have a “therapeutic use,” and thus are legally considered drugs that must go through the agency’s drug-review process to show they are safe and effective.
The name of the website --www.alternativecancersolution.com -- “suggests the products are intended for use in curing, mitigating, treating or preventing cancer,” the letter states. FDA also cited Rosenberg’s use of smoking-gun “metatags” – the key phrases used to bring consumers to a web site through Internet searches, such as “cancer treatment,” “holistic treatment for cancer,” and “cancer healing.”
The 15-day warning expired on Tuesday, but Rosenberg said he had been assured by FDA that he didn’t need to worry about the deadline since he has already been in conversations with an official there, whom he declined to name. “What I told the lady from the FDA is ‘you tell me what I need to do to comply.’ I’m waiting to hear back from her.”
The FDA said consumers should not use or buy the 125 products on its list of fake cancer “cures,” since they have not been proven safe. Some of the products, such as a black salve that is said to “draw out” the disease through the skin, are actually harmful, according to the agency Web site.
--Contact Carol Gentry at www.FloridaHealthNews.org or at 727-410-3266.
