February 28, 2019
The Food and Drug Administration is cracking down on makers of dietary supplements that claim to cure Alzheimer’s disease and other serious ailments, saying there is no proof that such supplements are safe and effective for treating the disease. Taking supplements can also steer patients away from receiving other therapies that may prove helpful.
“We know there are effective therapies that can help patients with Alzheimer’s,” said Dr. Scott Gottlieb, the FDA commissioner. “But unproven supplements that claim to treat the disease but offer no benefits can prevent patients from seeking otherwise effective care.”
Four in five older Americans take dietary supplements, such as vitamins, minerals and herbs, for a range of conditions, the FDA notes in a statement. Americans spend $40 billion a year on such supplements, despite limited proof they are effective.
“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s,” said Dr. Gottlieb. The process to obtain FDA clearance is long and methodical, requiring extremely rigorous testing and large cohorts of study volunteers. Tested products must show a statistical benefit compared to placebo effect.
“Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse as some fraudulent treatments can cause serious or even fatal injuries.” Even simple vitamins, for example, when taken in excess, can cause toxicity and symptoms that range from changes in vision and bone pain to skin changes and liver poisoning.
The FDA sent out warning letters to 12 makers of dietary supplements, telling them to stop claiming their products can cure Alzheimer’s disease and other conditions. The products cited in the warnings and online advisory letters are unapproved new drugs or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions, and have been sold in violation of the Federal Food, Drug, and Cosmetic Act. The products include a variety of product types, such as tablets, capsules and oils.
Among the warning letters were one to Tek Naturals, which makes a product called Mind Ignite that claims has been “clinically shown to help diseases of the brain such as Alzheimer’s and even dementia.” Among the 16 ingredients in the product that they falsely claim may treat Alzheimer’s are huperzine A (a dietary supplement derived from the Chinese club moss Huperzia serrata) and various B vitamins.
The FDA has sent out more than 40 warnings letters in the past five years to companies illegally marketing more than 80 products making Alzheimer’s disease claims on website, on Facebook and other social media forums, and in stores.
No dietary supplement, and not a single over the counter drug, vitamin or herbal mix or product, has been proven effective for treating or curing Alzheimer’s. Consumers would be wise not to buy untested products.
By ALZinfo.org, The Alzheimer’s Information Site. Reviewed by Marc Flajolet, Ph.D., Fisher Center for Alzheimer’s Research Foundation at The Rockefeller University.
Source: Food and Drug Administration.