The Food and Drug Administration (FDA) posted 12 warning letters and 5 online advisory letters issued to 17 foreign and domestic companies that illegally sell more than 58 products. Many of the products claim to treat or cure Alzheimer’s disease and other serious diseases and conditions.
The unapproved new drugs and/or misbranded drugs are often sold on websites and social media platforms but have not been reviewed by the FDA and are not proven safe and effective. They are being sold with labeling and marketing in violation of the Federal Food, Drug, and Cosmetic Act. The companies must respond to the FDA within 15 days of receiving the letters, stating how the violations detailed in the letters will be corrected. If they fail to correct violations promptly, legal action could be taken, including product seizure and/or injunction.
The products cited in the warning and advisory letters include a variety of dietary supplements, minerals, and oils in multiple formulations and include colostrum, coconut oil, colloidal silver, curcumin, green tea extract, melatonin, piracetam, uridine, ubiquinol, vitamin B, vitamin D, and other substances. This highlights the importance for neurologists to discuss with their patients any herbal or dietary supplements they may be taking, review any evidence for benefit or danges from such treatments, and consider both the health and financial risk-benefit profile of continued use.
The products could prevent people from seeking appropriate diagnosis and treatment. “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,” said Scott Gottlieb, MD, FDA commissioner. “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."
Deena E. Kuruvilla, MD, FAHS
Lee I. Kubersky, MD
Leeann B. Burton, MD, and Amanda C. Guidon, MD