The FDA is taking action against 17 companies for illegally selling dietary supplement products that claim to treat or cure Alzheimer’s disease. The agency posted 12 warning letters and 5 online advisory letters to those corporations.
The companies are illegally selling more than 58 products, many sold as dietary supplements, that are unapproved new drugs or misbranded drugs. These products have not been reviewed by the FDA and are not proven safe and effective to treat these diseases and health conditions. In fact, these products could be unsafe and could prevent a patient from seeking proper treatment.
FDA Commissioner Dr. Scott Gottlieb said in a statement, “Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s. Alzheimer’s is a challenging disease that, unfortunately, has no cure. 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.”
The FDA is going to be taking more action on this matter to help improve the safety of dietary supplements. They want to communicate potential safety issues and establish a flexible regulatory framework that upholds product safety.
The products in question include tablets, capsules, and oils. Some of them include Mind Ignite, sold as a “safe and highly effective alternative to Adderall … clinically proven to help diseases of the brain such as Alzheimer’s and even dementia,” Piracetam Capsules, which claims it “protects the brain after injury” and “Major diseases, such as dementia, schizophrenia, Alzheimer’s and Parkinson’s, have all been treated using piracetam.” Earth Turns, LLC has this on their webpage: “Can Green Tea Help Alzheimer’s disease?”
These companies have 15 days to respond to the FDA’s letter, telling the agency how they are going to correct these violations. And the FDA is asking consumers and doctors to report any adverse reactions associated with these or other similar products to the agency’s MedWatch program.
