The U.S. Food and Drug Administration has issued warning letters today to 14 companies based out of U.S., who are selling more than 65 products illegally making false claims to prevent, diagnose, treat, or cure cancer. The products are promoted and sold most commonly on the company websites and social media platforms without the approval of FDA.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. “We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”
Promoting or selling products claiming to diagnose, treat, prevent, alleviate, or cure the diseases without first demonstrating to FDA that they are safe and effective for their labeled use is a breach of the Federal Food, Drug, and Cosmetic Act. The warning letter sent out today cited a list of illegally sold product types that include pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostics such as thermography devices. The list that included illegal products promoted for use by humans or pets were not proved to prevent, reverse, or cure cancer, destroy cancer cell or tumors, or other similar anticancer claims.
The FDA has demanded the 14 companies to provide their answers for correcting the violation, while failing to do so may lead to legal action, seizing products, injunction, and/or criminal suit.
In the past 10 years, more than 90 letters have been issued by FDA warning companies that market hundreds of fake products in their stores, websites, and on social media sites for cancer cure claims, as a part of FDA’s efforts to safeguard consumers from frauds related to cancer health. Although many of these companies have stopped selling fake products or making false claims, partially, numerous products that are not safe and not approved by FDA are being sold directly to consumers due to the ease of migrating marketing efforts to new websites. In an attempt to educate consumers and to reduce possible risks, FDA continues to check and act against companies marketing and selling treatments that are not proved.
The agency encourages consumers and those involved in the healthcare profession to voluntarily report any serious adverse event connected with these products to FDA through MedWatch.
About the FDA
FDA is an agency within the Department of Health and Human Services overseeing the core functions of the agency such as Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. The agency is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and ensuring the safety of the nation’s food supply, cosmetics, and products from radiation.