“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 lifesaving cancer diagnosis or treatment,” said director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs, Douglas Stearn.
“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.”
Companies use social media to market unproven therapies
The companies have violated the Federal Food, Drug and Cosmetic Act, by using slick marketing techniques, such as product testimonials about miraculous outcomes, to promote unproven claims regarding treatment and cure for various diseases – before demonstrating to the FDA that these products are safe and effective for their labelled uses.
Over 65 products were illegally marketed and sold, including a variety of pills, topical creams, syrups, ointments, and teas for both humans and pets. One of the companies is also promoting “thermography” – the use of digital infrared thermal imaging – as an unapproved diagnostic device for breast cancer, with claims that “thermography is far more sensitive than mammography.”
Such companies are taking advantage of patients who are desperate for a cure and have a tendency to believe in “natural” therapies over conventional medicines.
"Substantial numbers of Americans spent billions of dollars out of pocket on these approaches, an indication that users believe enough in the value of these approaches to pay for them," according to the National Center for Health Statistics last year.
However, products that are labelled as “natural” can contain harmful ingredients.
"Contained within these kernels is a very small amount of a substance called nitriloside amygdalin. It goes directly to a cancer cell, stings it, and kills it," claimed a company which promoted apricot kernels as an anti-cancer therapy, despite the fact that eating them can lead to cyanide poisoning.
Health frauds persist despite FDA’s efforts
Some of these sellers attempt to skirt the law by providing disclaimers , in small print, that their products are not intended to prevent, diagnose, treat or cure any disease – after making such misleading claims.
"Making such obvious claims and then saying later that you are not doing so might seem clever, but the technique does not comply with federal laws intended to protect public health,” Stearn said.
In the past 10 years, the FDA has issued over 90 warning letters to other companies that were caught marketing and selling products with fraudulent claims. Despite the agency’s effort to closely monitor and take action against such companies, many other harmful and unapproved products are still sold directly to consumers.
Each company has been given 15 days to correct the violations pertaining to marketing claims or provide the agency with a plan on how they will correct them and come into compliance with the law. Should the firm fail to respond to the FDA, they will face further action including criminal prosecutions, product seizures and court injunctions on the trade of their products.
Sellers who fail to correct any violation identified in the warning letters may also face one year in federal prison, five years’ probation and a fine of either $100,000 or twice the gain from the offense. Meanwhile, the FDA is urging consumers to remain vigilant and to report any adverse reactions associated with use of these products to the authorities.
"The message to consumers is this: These products are untested. Some contain ingredients that may be a direct risk to your health," the FDA said.
"The ingredients may interact in a dangerous way with professionally-prescribed treatments. They are not a substitute for appropriate treatments. Using these products can waste your money, and, more importantly, endanger your health." MIMS
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