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Posted February 13, 2019

Supplements Promoted for Alzheimer's Disease and Dementia Sell "False Hope," Warns FDA

On February 11, 2019, the FDA warned consumers to beware supplements promoted to prevent or treat Alzheimer's disease or dementia. The agency warned that many products are marketed with unproven claims, and companies selling these products are selling "the false hope that there is an effective treatment or cure."

The FDA urged consumers to question any product that claims to be a "scientific breakthrough," noting that companies that market such products take advantage of people when they are most vulnerable and often looking for a miracle cure. It also advised consumers check with their doctor or health care professional before buying or using any over-the-counter product, including those labeled as dietary supplements.

The warning to consumers was posted just days after the FDA issued warning letters to 12 companies selling products that claim to prevent, treat or cure Alzheimer's disease or other serious diseases and health conditions (use the links below to read the full warning letter): The FDA also posted online advisory letters to five companies that made claims about Alzheimer's disease or other serious diseases. Advisory letters are emailed to companies and are only posted online if companies fail to make the corrections requested by the FDA within 30 days of receiving the letter. Use the links below read the full advisory letter issued to each company: In a statement about the recent warnings and advisory letters, FDA Commissioner Scott Gottlieb, M.D. said, "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. Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care -- and we will continue to take action to protect patients and caregivers from misleading, unproven products."

The warnings appear to be a part of the FDA's recent efforts to strengthen its role in the regulation of dietary supplements.