FDA issues warnings to companies selling unapproved products for Alzheimer’s disease
The FDA issued several warning letters and online advisory letters to domestic and foreign companies for illegally selling more than 58 products that have not been approved and/or are misbranded claiming to prevent, treat or cure Alzheimer’s disease, as well as many other serious diseases and health conditions, according to a press release by the agency.
The products are often being sold as dietary supplements in the form of tablets, capsules and oils online, but have never been reviewed by the FDA for safety and efficacy for the treatment of the diseases and conditions that they claim to improve, according to the FDA. The FDA expressed concerned that the products may prevent patients from seeking appropriate diagnosis and treatment.
“Alzheimer’s is a challenging disease that, unfortunately, has no cure,” Scott Gottlieb, MD, commissioner of the FDA, said in the release. “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 12 companies that received a warning letter for violating the Federal Food, Drug, and Cosmetic Act, include Pure Nootropics LLC; TEK Naturals; John Gray’s Mars Venus LLC; Nutrition Coalition Inc; Blue Ridge Silver; Sovereign Laboratories LLC; DK Vitamins; Peak Nootropics (also known as Advanced Nootropics); Gold Crown Natural Products; Emmbros Overseas Lifestyle PVT LTD; Earth Turns LLC; and Capris Associates Inc./BR Naturals.
The companies must respond to the FDA warning letters within 15 working days stating how the violations will be amended, according to the release. Failure to correct violations may result in seizure and/or injunction.
“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,” Gottlieb said.
Disclosure s : Gottlieb is the commissioner of the FDA.