ENFORCEMENT

FDA Sends 14 Warning Letters Regarding Cancer Products

The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients from suspect products. "Unfortunately, rogue operations exploiting those fears [relating to cancer] peddle untested and potentially dangerous products, particularly on the internet," said Donald D. Asley, J.D. and Douglas Stearn, J.D. in a recent FDA Voice blog post announcing the agency’s enforcement efforts concerning cancer related products.

In late April, the FDA issued a series of warning letters to 14 manufacturers of over 65 products the agency claims are being illegally sold without FDA approval because they "fraudulently claim to prevent, diagnose, 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, warned Stearn, the FDA’s Office of Regulatory Affairs director of the Office of Enforcement and Import Operations. The FDA warned consumers to be "vigilant" when shopping online or in a store and be wary of products marketed for cancer "without any proof they will work." "Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer." It also encourages patients to report adverse reactions to these or other products to the MedWatch program.

The 65+products included pills, creams, oils, drops, syrups, teas and diagnostics and the FDA’s warning letters request that the companies respond with a plan for correcting the violations. If they don’t, the FDA could take legal action such as seizure, injunction or criminal prosecution. The violations are also grounds for a one-year prison sentence, five years probation and a fine equal to $100,000 or two times the gain from the offence.

Among the 14 companies, one company was alleged to be illegally selling a diagnostics product—a telethermographic camera system, "intended for adjunctive diagnostic screening for detection of breast cancer." The FDA said the company was improperly marketing the device for use as a sole screening device. Such systems are Class I devices requiring 510(k) premarket clearance before marketing and are not intended to be used alone as a diagnostic screening device—which would make it a class III device requiring premarket approval.

Takeaway: The FDA continues to monitor and take action to protect consumers by challenging manufacturers of products advertised or sold direct to consumers.

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