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Natural Products Global | Delivering the news in your Natural & Organic sector > Blog > Regulation and Policy > Legislation > FDA threatens criminal prosecution against supplement makers over cancer claims
Breaking NewsLegislationSupplements and Remedies

FDA threatens criminal prosecution against supplement makers over cancer claims

Jim Manson
Jim Manson April 27, 2017
Updated 2017/04/27 at 9:58 AM
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The US Food and Drug Administration today posted warning letters addressed to 14 US-based companies illegally selling more than 65 products that it says fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms

“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.”

The FDA point out that it is a violation of the (US) Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to it that they are safe and effective for their labeled uses. The illegally sold products cited in the warning letters posted today include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.

The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction and criminal prosecution.

The FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of products making illegal cancer claims on websites, social media and in stores. Although many of these companies have stopped selling the products or making the claims, the FDA says that “numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites”.

The FDA says it will continue to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.

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Jim Manson April 27, 2017
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