FDA Issues Warnings to 17 Companies Illegally Selling Alzheimer’s Treatment Products

The U.S. Food and Drug Administration (FDA) on Monday sent 12 warning letters and five advisory letters to 17 companies for the illegal sale of products that claim to prevent, treat, or cure Alzheimer’s disease. The letters acknowledge more than 58 products, none of which have been approved by the FDA.

The companies, which are both foreign and domestic, have 15 days from the letter’s receipt to respond, detailing how they will correct the violation. Failure to do so “may result in legal action, including product seizure and/or injunction,” according to an FDA press release.

According to the Centers for Disease Control and Prevention (CDC), Alzheimer’s disease is the most common form of dementia, affecting at least 5 million people nationwide. The CDC estimates that by 2020, its prevalence will nearly triple to 14 million. It remains unclear what causes Alzheimer’s disease, and there is 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,” said FDA Commissioner Scott Gottlieb, MD, in a statement addressing the letters. “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 action brought forth by the FDA, according to Gottlieb, is part of a larger effort to regulate the ever-growing dietary supplement industry, which Gottlieb addressed in a separate statement.

“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,” he said. “It’s clear to me that dietary supplements play an important role in our lives as we strive to stay healthy. It’s also clear that the U.S. Food and Drug Administration plays an important role in helping consumers make use of safe, high-quality dietary supplements while also protecting Americans from the potential dangers of products that don’t meet the agency’s standards for marketing.”

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Source: FDA