The United States Food and Drug Administration (FDA) announced, yesterday, that it has issued warning letters to 14 US-based companies who sell or distribute more than five dozen products, collectively, which claim to cure cancer. These products range from herbal teas to asparagus extract and are marketed and sold without approval from the FDA, most commonly through direct business-to-consumer websites or through social media.
According to the director of FDA Office of Regulatory Affairs’ Office of Enforcement and Import Operations, Douglas W. Stearn, “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.”
He goes on to say, “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.”
These 14 companies receiving warning letters have been found to be in violation of the US Federal Food, Drug, and Cosmetic Act that explicitly makes it illegal for any company to market and sell “products that claim to prevent, diagnose, treat, mitigate or cure” disease without first demonstrating its efficacy and safety to the US FDA.
Stearn continues, “These companies used slick ads, videos, and other sophisticated marketing techniques, including testimonials about miraculous outcomes,” in a blog post co-authored FDA Center for Drug Evaluation and Research director of the Office of Compliance, Donald D. Ashley. “Often a single product was promoted as a treatment or cure for multiple diseases in humans and animals.”
The agency warning requests that these 14 companies respond with plans regarding how they will correct the violation, further listing potential repercussions should they fail to do so. These consequences can include up to one year in a federal prison, up to five years of probation, and fines of either $100,000 or twice the gains taken as a result of the violation.
Some of these unsafe products might have actually been taken off the market before, after FDA enforcement intervention, but can reappear online when a company just moves its marketing operations to a new website or a different platform. Its kind of like rebranding and relaunching (only nothing really changes). As such, the FDA warns consumers should be cautious of buzz words like, “cures all forms of cancer.”