FDA Cracks Down on Unapproved Direct-to-Consumer Cancer ‘Cures’

The FDA is cracking down on products illegally advertised as cancer treatments

The US Food and Drug Administration (FDA) has sent warning letters to 14 companies marketing dozens of unapproved “miracle cure” products online with fraudulent claims that they prevent or cure cancer, the agency announced.

The products the FDA determined to be illegally advertised as cancer treatments ranged from deer antler powder and vitamin C to numerous herbal or plant products. They were advertised and sold primarily on health-oriented websites.

“We encourage people to remain vigilant whether online or in a store, and [to] avoid purchasing products marketed to treat cancer without any proof they will work,” cautioned Douglas W. Stearn, JD, the director of the FDA’s Office of Enforcement and Import Operations in Rockville, Maryland, in a press release.

Among claims that the FDA determined to be violations of the federal Food, Drug, and Cosmetic Act were claims that unapproved products were nontoxic alternatives to chemotherapy, “dissolved” tumors. Many of the products were marketed as curing a wide range of diseases, including cancers, autoimmune diseases, and infections-including drug-resistant tuberculosis and Ebola virus.

One herbal salve was advertised as having been “designed to help those with cancer sores” and warts, and as a treatment for skin cancer, according to an FDA warning letter. That company marketed the salve on Facebook and Amazon. Reached by phone, the owner told Cancer Network that he had discovered the salve by curing himself of a self-diagnosed mouth tumor. He said that he had made changes to one of his company website’s health claims, removing statements about cancer, but that he had not yet changed his product’s Amazon.com site or another company website that was not named in the FDA warning letter. 

The FDA demanded corrective action plans from the 14 companies and warned that continued violations will trigger “legal action, including product seizure, injunction, and/or criminal prosecution.”

Unsafe products previously taken off the market following FDA enforcement actions have reappeared online because companies simply moved their marketing operations to new websites, the agency noted. Consumer education is therefore key to protecting patients from fraudulent cancer “cures.”

The FDA asked that healthcare professionals report adverse events associated with the use of such products to its MedWatch program. The agency also offers an online list of fraudulent cancer “cures” and treatments that consumers should avoid.