Regulators say the companies are illegally marketing products that haven’t been reviewed by the federal agency.
The products identified by the FDA range from “safe” substances such as vitamin C and fish oil to potentially life-threatening substances such as mineral, herbal, and chemical mixes.
Scott Gottlieb, the FDA’s commissioner, announced in a statement this week that “As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer.”
He added, “Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions.”
Gottlieb announced in a separate statement, “These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat the diseases and health conditions they claim to treat.”
The association cautions that the claims about how safe and effective these products are only based on testimonials and a small body of scientific research.
“The Alzheimer’s Association welcomes action by the U.S. Food and Drug Administration (FDA) to crack down on companies that are illegally selling products — mostly sold as dietary supplements — that claim to prevent, treat or cure Alzheimer’s disease,” Nigel Frantz, media relations representative for the Alzheimer’s Association, said in a statement to Healthline.
One company, Pure Nootropics, was sent a letter explaining, “Your products Alpha GPC, Lion’s Mane, CDP Choline Capsules, Piracetam, Vitamin D3 5000 IU, and Ginkgo Biloba Capsules are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.”
Officials at Pure Nootropics told Healthline in an email, “We are currently in the process of developing a corrective action plan in response to the FDA letter and the issues it raises; we will act swiftly to update our website to be in compliance with all applicable rules and regulations.”
Steve Mister, president and chief executive officer of the Council for Responsible Nutrition, told Healthline, “We applaud the agency for using the tools that it has to address claims that are either drug claims that should not be made for products or ones that can’t be substantiated as in the case of some of these claims to treat and cure diseases.”
The council is the leading trade association representing dietary supplement and functional food manufacturers and ingredient suppliers.
“We would like to see them do more in the way of enforcement to send a strong message to the industry that they are not going to tolerate illegal behavior,” Mister said. “In fact, we regularly lobby Congress to try to get more resources directed at FDA specifically for enforcement in this area.”
Research recently published in the New England Journal of Medicine concluded that supplements marketed to treat a broad range of conditions, particularly obesity, may be sending 23,000 people to emergency rooms every year.
Six of these deaths were the result of the now-banned weight loss supplement ephedra. One person died after taking the supplement yohimbe, promoted as treatment for erectile dysfunction.
According to the FDA, these products have neither been reviewed by the agency nor are they proven safe and effective to treat the diseases and associated health conditions.
These companies have two weeks to respond. One company, Pure Nootropics, has told Healthline that they’re working to meet FDA guidelines as quickly as possible.
Supplements are potentially dangerous, and studies have found emergency room visits and deaths related to their use have increased substantially in recent years.