The Food and Drug Administration (FDA) has taken action against 17 companies that are illegally selling unapproved and/or misbranded products that claim to prevent, treat, or cure Alzheimer disease and other serious diseases and health conditions.
Most of these products are sold as dietary supplements on websites and social media platforms, in various formulations including tablets, capsules, and oils. They have not been reviewed by the FDA and are not deemed safe and effective for the conditions they claim to treat. “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,” said FDA Commissioner Scott Gottlieb, MD.
In the past 5 years, the FDA has issued more than 40 warning letters to companies that have illegally marketed products making Alzheimer disease claims, although the Agency warns that many unsafe products continue to be sold as companies often move their marketing operations to different websites. Similar warnings have been issued to companies illegally marketing treatments for cancer and opioid addiction.
In a press statement, Gottlieb discussed the Agency’s new plan to significantly modernize the regulation and oversight of dietary supplements. Some of the new steps include faster communication with the public regarding potential safety issues and a flexible regulatory framework that promotes innovation and product safety. “Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago,” Gottlieb stated.
For more information call (888) 463-6332 or visit FDA.gov.