The FDA is cracking down on the sale of illegal cancer drugs by sending warning letters to 14 US companies selling the unapproved products. According to the agency, the manufacturers have been selling a combined 65 products through websites and social media which claim to prevent, treat or cure cancer.
“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.”
Like all pharmaceutical products, drugs claiming to treat a disease must support that claim with clinical data submitted to the FDA for review. While nutraceuticals and other supplements are less stringently regulated, they are unable to make concrete health claims on their label.
The FDA warning letters were sent to manufacturers selling a variety of product types, from pills, creams and oils, to teas and even diagnostic devices. These products were found to be misbranded, potentially misleading consumers into thinking the health claims made about the product were supported by evidence.
The manufacturers will have 15 working days to let the FDA know what measures have been taken to correct the violations and prevent the same incidents from occurring again in the future. If the companies fail to respond to the FDA they could be faced with legal action and potential criminal prosecution.
In the past 10 years, the FDA had issued over 90 warning letters to manufacturers claiming that their products prevent, diagnose, treat or cure cancer. Most of these unregulated products have been sold directly to consumers, representing a major risk to public health.