Dive Brief:
- A group of 14 U.S. companies have found themselves on the receiving end of the Food and Drug Administration's regulatory oversight for illegally peddling false "cures" for cancer.
- The agency announced Tuesday it had issued warning letters to each company for marketing the fraudulent treatments, which ranged from Vitamin C tabs billed as "non-toxic chemo" to a Jetsons-sounding Protandim NRF2 Synergizer depicted as a "powerful weapon against cancer."
- All 65 of the products targeted by the FDA's sweeping oversight action were sold without FDA approval, typically through web-based or social media platforms. The companies have 15 days to come into compliance, or the regulator could chose to escalate to criminal prosecutions or product seizures.
Dive Insight:
The Food, Drug and Cosmetic Act requires any company seeking to market or sell products which claim to prevent, treat or cure diseases to first prove the safety and efficacy of those products to the FDA for each labeled use.
In the case of the 65 products flagged by the regulator, none were backed up by evidence to demonstrate the wide array of deceptive marketing promises used to sell each purported drug.
The Vitamin C Foundation, for example, claimed on one of its websites that treatment with Vitamin C could cure everything from cancer to tuberculosis and protect against the Ebola virus.
"Most experts recommend incorporating high-dose intravenous vitamin C (IV/C) infusions to achieve the high blood concentrations necessary to kill the most tumor cells," read one fabricated claim on the company's webpage.
Another company, AIE Pharmaceuticals, marketed its product Cevrogin as capable of lowering blood sugar, reducing cholesterol and treating the symptoms of diabetic neuropathy. On another webpage, the company pitched nutrition supplements as helpful in preventing cancer.
"These companies used slick ads, videos, and other sophisticated marketing techniques, including testimonials about miraculous outcomes," wrote two officials from the FDA in a blog post on the actions.
Any company which fails to come into compliance by the end of the 15-day time period could face criminal prosecution or court-ordered injunctions. According to the FDA, the violations cited are punishable by up to one year in federal prison, five years of probation and a fine of either $100,000 or twice the amount made in violation of the Food, Drug and Cosmetic Act.