FDA cracks down on fake Alzheimer’s products

February 11, 2019

FDA warns companies illegally selling drugs and dietary supplements claiming to cure Alzheimer’s and other conditions.

FDA is warning several companies that are illegally selling drugs and dietary supplements that the makers claim can cure Alzheimer’s disease and other conditions.

The agency issued 12 warning letters and 5 online advisory letters to foreign and domestic companies illegally selling more than 58 products. Many of the products are sold as dietary supplements.

“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,” FDA said in a statement.

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The suppliers that were sent warning letters include: Sovereign Laboratories, John Gray’s Mars Venus LLC, Nutrition Coalition, and Blue Ridge Silver.

“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. Alzheimer’s is a challenging disease that, unfortunately, has no cure,” said FDA Commissioner Scott Gottlieb, MD, in the statement. “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.”

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FDA has issued more than 40 warning letters in the past 5 years to companies illegally marketing over 80 products making Alzheimer’s disease claims on websites, social media, and in stores.

“We’ve also taken action in recent years against companies and dietary supplements making similar claims for the treatment of serious conditions such as cancer and opioid addiction. Although these companies may have stopped selling the products or making unproven claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites,” Gottlieb said.

FDA also issued new actions and policy priorities to improve the safety of dietary supplements. The agency will establish a “flexible regulatory framework that promotes innovation and upholds product safety” and more rapidly communicate potential safety issues involving dietary supplement products with the public, according to the agency.

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