On 11 February 2019, the United States Food and Drug Administration (FDA) issued warnings to 17 companies that illegally sold more than 50 products claiming to prevent, treat or cure Alzheimer’s disease and other serious conditions.
Sold on websites and social media platforms, the unapproved or misbranded drugs – sometimes marketed as dietary supplements – have not been proven safe and effective in the claimed indications.
“Alzheimer’s is a challenging disease that, unfortunately, has no cure,” said FDA Commissioner Scott Gottlieb, MD. “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.”
The warnings, split into 12 letters and 5 online advisories, are part of the FDA’s larger effort to improve regulation and protect consumers in the booming dietary supplement market. Companies have 15 days to respond to the warnings, and must describe their plans to rectify these direct violations of the FDA Federal Food, Drug and Cosmetic Act. Failure to respond or correct the violations could be met with legal action and product seizure.
“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,” said Dr Gottlieb.
Read the full FDA press release here.