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
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.