Regulatory Focus™ > News Articles > FDA Warns 14 Companies for Selling Fake Cancer Treatments

FDA Warns 14 Companies for Selling Fake Cancer Treatments

Posted 25 April 2017 | By Michael Mezher 

FDA Warns 14 Companies for Selling Fake Cancer Treatments

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to 14 US-based companies for selling dozens of unapproved cancer treatments online and through social media.

The companies, FDA says, have 15 days to respond with plans to address the violations or face possible criminal prosecution, including up to a year in federal prison and fine of $100,000 or twice the companies' gains on the fraudulent products.

The agency is also advising patients and consumers to be wary of any unproven treatments, and to speak with their doctors about receiving proper treatment and care.

"A cancer diagnosis often provokes a sense of desperation. Unfortunately, rogue operations exploiting those fears peddle untested and potentially dangerous products, particularly on the internet," write Donald Ashley, director of the Office of Compliance at the Center for Drug Evaluation and Research and Douglas Stearn, director of the Office of Enforcement and Import Operations in the Office of Regulatory Affairs.

The products—which include various pills, herbs, teas and ointments—often appeared on sites alongside claims that they offer a "natural" way to treat or cure cancer.

In some cases, the companies would follow up these claims with a fine print disclaimer that they are "not intended to diagnose, treat, cure or prevent any disease."

"Making such obvious claims and then saying later that you are not doing so might seem clever, but the technique does not comply with federal laws," Ashley and Stearn write.

According to Vinay Prasad, a hematologist-oncologist and assistant professor of medicine at the Oregon Health and Sciences University, misinformation about these dubious products can make it more difficult to provide treatment to his patients.

"In my practice I sometimes encounter patients who have heard about all sorts of unproven remedies for cancer, and it takes a considerable amount of time to dissuade them of these beliefs. At their worst, these products can interfere with patients' desire to pursue proven therapies," Prasad said.

While FDA says it has issued more than 90 warning letters in the last decade to companies selling fraudulent cancer treatments, the slew of warning letters underscores the challenge the agency faces in keeping up with dubious online sellers.

In a similar announcement from 2008, FDA warned more than 20 US and foreign companies for selling fake cancer treatments.

Warning Letters, FDA Voice, Consumer Alert

Categories: Regulatory News

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