The FDA has posted 12 warning letters and five online advisory letters identifying 58 products that illegally claim to prevent, treat, or cure Alzheimer’s disease and other health conditions. These products have not been reviewed by the FDA and, the Agency notes, could be ineffective or even unsafe.
“Alzheimer’s is a challenging disease that, unfortunately, has no cure,” FDA Commissioner Scott Gottlieb, M.D., said in a recent press release. “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.”
Companies identified by the FDA have been given 15 days to respond to the violations outlined in the letters.
This action is just one part of a new FDA policy targeting regulatory issues in the dietary supplement industry. The Agency plans to make further efforts to address this problem, including creating a rapid-response tool informing consumers of dangerous products or ingredients on the market.
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“Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health,” he says.
Over the past five years, the FDA has issued more than 40 warning letters to companies illegally marketing products that claim to treat or cure Alzheimer’s disease.
While there is no known cure for Alzheimer’s disease, researchers are making great strides in understanding it. Recent research has shown, for example, that gum disease and sleep deprivation could be risk factors for Alzheimer’s.
One recent study from the German Center for Neurodegenerative Diseases in Tübingen indicated that changes in the levels of a specific protein in the blood could signal the beginnings of Alzheimer’s more than a decade before symptoms actually develop. This discovery may allow researchers to gain further understanding of the disease and its development, as well as how it reacts to different medications.