FDA Warns 14 Companies for Sale of Fraudulent Cancer Treatments

May 1, 2017
BioPharm International Editors

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.

On April 25, 2017 FDA issued warning letters to 14 companies for selling fraudulent cancer treatments. FDA has issued more than 90 warning over the past 10 years to companies selling fraudulent products claiming to treat cancer, the agency said in a press release.

According to FDA, the companies referenced in this batch of warning letters market and sell products without FDA approval on websites and social media. Selling products that claim to prevent, treat, mitigate, or cure diseases such as cancer is a violation of the Federal Food, Drug and Cosmetic Act, FDA said.

“These companies used slick ads, videos, and other sophisticated marketing techniques, including testimonials about miraculous outcomes. Often a single product was promoted as a treatment or cure for multiple diseases in humans and animals,” Donald D. Ashley, JD, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research and Douglas Stearn, JD, director of the Office of Enforcement and Import Operations within FDA’s Office of Regulatory Affairs, wrote in an FDA Voice blog. “Hoping to skirt the law on a technicality, some sellers made false claims and then in small print provided a disclaimer that their products are not intended to diagnose, treat, cure or prevent any disease.”

The 14 companies referenced in the warning letters have 15 working business days to respond to FDA and come into compliance with the law. FDA said that if necessary, it has the authority to take further action, including criminal prosecutions, product seizures, and injunctions. If not corrected, the violations mentioned in the warning letters could result up to a year in federal prison, five years’ probation, and a fine of either $100,000 or twice the gain from the offense, FDA reported.

Source: FDA, FDA Voice blog