FDA warns companies selling drugs as supplements for Alzheimer’s and other diseases

FDA has warned several companies to stop selling and marketing unapproved new drugs and/or misbranded drugs as dietary supplements to prevent, treat or cure Alzheimer’s and other serious diseases.

The agency posted 12 warning letters and five online advisory letters issued to foreign and domestic companies for selling such illegal products, including pills, patches and essential oils. The sale of these products violates the Federal Food, Drug and Cosmetic Act, FDA noted.

“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 noted in a press release.

The FDA letters posted on the same day FDA's top official released a statement on the agency’s plan to modernize its regulation of dietary supplements to keep up with innovation and changes in the booming industry since the passing of the Dietary Supplement Health and Education Act (DSHEA) almost 25 years ago.

FDA advised the public these products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.

FDA requested companies receiving warning letters respond within 15 days with how the violations will be corrected. Failure to correct the violations may result in additional enforcement, including seizure and injunction, the agency cautioned.

The advisory letters, which were sent in November 2018 to owners of websites taking orders online for illegal Alzheimer’s disease products, requested corrections to the violations within 30 days or the letters, with company name and website information, would be published.

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

Peter Lurie, M.D., president of the Center for Science in the Public Interest (CSPI), noted the Alzheimer’s community is especially vulnerable to illegal marketing, and he commended FDA for targeting companies seeking to exploit such a vulnerability. 

“This is a useful shot across the bow of the supplement industry on the part of the FDA, and there is certainly no shortage of other targets that the agency could pursue,” he said in a statement. “In January 2018, FDA took similar action against supplements marketed as treatments for opioid withdrawal after a complaint from CSPI in December 2017.”