FDA Warns Companies to Stop Claiming Their Products Cure Alzheimer's
Recently, the Food and Drug Administration (FDA) warned 12 companies to stop claiming their dietary supplements can cure Alzheimer's and other diseases like cancer and diabetes.
Included among the 12 companies are TEK Naturals, Pure Nootropics, and Sovereign Laboratories. In a letter to TEK Naturals, the FDA chastised the company for marketing its product as "clinically shown to help diseases of the brain such as Alzheimer's and even dementia." TEK Naturals responded by saying it was reviewing the letter and was committed to complying with legal requirements.
Dr. Scott Gottlieb, the FDA's commissioner, says, "We know there are effective therapies that can help patients with Alzheimer’s. But unproven supplements that claim to treat the disease but offer no benefits can prevent patients from seeking otherwise effective care.”
The FDA's authority is based on a 1994 federal law, which had minimal requirements because the industry was so small at the time. The law requires that the FDA prove a product is unsafe in order to prevent the company from selling it. It also requires that businesses notify the FDA they are making a dietary supplement but not to say what's in it.
In today's industry, it is nearly impossible for the FDA to police all the products, many of which are sold online. There are currently between 50,000 and 80,000 dietary supplements on the market. Three out of every four Americans regularly take a dietary supplement and among older Americans, four out of every five regularly take one.
Dr. Gottlieb would like to see Congress strengthen the FDA's authority over the dietary supplement industry. The products can range from benign substances like vitamin C to more risky concoctions that can be fatal. Dr. Gottlieb is particularly concerned about supplements that claim to cure diseases that require medical attention.
On the other hand, Steve Mister, representative of the dietary supplement business, believes that the industry is "remarkably safe." He says, "These products are not drugs and should not be regulated like drugs."
You should always consult your doctor before taking a new dietary supplement. Especially because Alzheimer's and dementia have no cure yet, it is important to seek medical attention as needed.
Source: New York Times "Supplement Makers Touting Cures for Alzheimer's and Other Diseases Get FDA Warning" by Sheila Kaplan