By Justin Blum
June 17 (Bloomberg) -- U.S. regulators told 25 companies and individuals to stop making ``fraudulent'' claims that their tablets, teas, tonics, salves and creams may cure cancer and other ailments.
The Food and Drug Administration issued warning letters to the companies and urged consumers not to use the products, sold under various brand names, according to a statement today from the agency. Those receiving warnings included Herb Time of St. Augustine, Florida, and Ageless Cures LLC of Houston, which are closely held companies.
Many of the treatments have been marketed on Web sites and contain ingredients such as bloodroot, shark cartilage and mushrooms, the FDA said. Regulators are concerned that patients could suffer side effects or forgo treatments that work, said Michael Levy, director of the FDA's division of new drugs and labeling compliance.
``FDA is very concerned that consumers will purchase these products from the Internet and use them instead of products that have been proven safe and effective,'' Levy said in a conference call with reporters today.
Deaths or injuries haven't been reported from the roughly 125 products covered by the FDA warning letters, said David Elder, director of the FDA's enforcement office in its regulatory affairs division, during the conference call.
Patients may not report side effects, according to the FDA. Regulators said some of the products can burn skin and leave scars.
Raids and Charges
The treatments haven't been approved by regulators for the ailments advertised by the companies, according to the FDA. If the companies fail to comply with the agency's warning, the FDA may seize products or pursue criminal charges, regulators said.
Unproven cancer treatments have long been promoted, though the Internet has allowed expanded marketing, according to the FDA. The agency, along with regulators in Canada and Mexico, are targeting marketing of cancer treatments this year after focusing on diabetes and weight-loss products in previous years.
One of the warning letters went to Richard McPhail of Gastonia, North Carolina. The FDA said his firm sold an herbal skin cream marketed online as a product that may be used after a doctor diagnoses a lesion as skin cancer.
`NO FAILURES!'
``While no claims are made by the distributor, a dose of P.D.Q.! Herbal Skin Cream may be effective in aiding the body's immune system to dissolve the skin lesion as it has for over 3,000 users and me and members of my family (considerably more than 10,000 lesions overall, with NO FAILURES!),'' the Web promotion said, according to the FDA warning letter.
McPhail couldn't be located for comment. Two Web sites cited by the FDA in its letter to McPhail didn't display any products today. A message on the sites said they were suspended ``by request of the FDA to remove all forms and statements of suggested benefits'' and would be ``altered to conform within a few following weeks.''
A phone message left at Herb Time wasn't returned.
According to the FDA, the Herb Time Web site said of a product called C-Herb: ``A significant number of individuals have topically removed cancers, warts, moles and other foreign cells from various skin areas of the body. The removal success rate approaches 100%.''
Ageless Cures sells variations of a product called Curcumin. The company's Web site said research has demonstrated that Curcumin has ``cancer curing properties,'' according to the FDA letter.
The company has removed health claims and references to cancer, said Jotika Ramchandani, who described herself as the owner of the business, in a telephone interview today. She said she sells ``a couple hundred bottles a month.''
``I'm just a single mom and mine is just a small business,'' she said. ``We always said it wasn't FDA approved and it was not used to diagnose or treat or cure.''
To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net.
Last Updated: June 17, 2008 18:11 EDT
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