FDA Cracks Down on Illegal Sale of Alzheimer’s ‘Cures’
February 11, 2019 (Medscape Medical News) – The US Food and Drug Administration (FDA) is cracking down on companies marketing dietary supplements and other products to prevent, treat, or cure Alzheimer’s disease and other conditions.
The FDA sent 12 warning letters and five online advisory letters to US and foreign companies that are illegally selling more than 58 products, many of which are sold as dietary supplements.
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 FDA said in a statement.
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, the agency said.
“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,” FDA Commissioner Scott Gottlieb, MD, said in the statement.
“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,” added Gottlieb.
Over the past 5 years, the FDA has sent more than 40 warning letters to companies illegally marketing more than 80 products making Alzheimer’s disease claims on websites, social media, and in stores.
In a separate statement issued today, Gottlieb outlined the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming the FDA’s oversight.
“I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as a part of a comprehensive care plan,” said Gottlieb. However, “as the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.”
“One of my top goals,” said Gottlieb, “is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.”