FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

Feb. 12, 2019

The U.S. Food and Drug Administration posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions.

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. These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.

The products cited in the warning and online advisory letters are unapproved new drugs and/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.

The FDA said it has issued more than 40 warning letters in the past five years to companies illegally marketing over 80 products making Alzheimer’s disease claims on websites, social media and in stores. Similar action has been taken in recent years against companies and dietary supplements making similar claims for the treatment of cancer and opioid addiction. FDA added those companies may have stopped selling the products or making unproven claims, but many unsafe and unapproved products continue to be sold directly to consumers in part, because companies advertise the products on new websites.

FDA has the announcement.