The U.S. Food and Drug Administration (FDA) recently took action against a number of companies making claims about their for-sale products. A total of seventeen companies, both foreign and domestic, were issued 12 warning letters and five online advisory letters for illegally selling (in violation of the Federal Food, Drug, and Cosmetic Act) over 58 products (tablets, capsules and oils), many as dietary supplements, that claim to prevent, treat or cure Alzheimer’s disease, and a number of other serious diseases and health conditions. These products were all unapproved, new and/or misbranded drugs.
The companies must respond to the FDA within 15 days of receipt of the letters. In their responses, they must indicate how they will correct the specific violations outlined in the letters. If the violations are not corrected promptly, the FDA could take legal action, including product seizure and/or injunction.
FDA has issued more than 40 warning letters to companies illegally marketing over 80 products over the past five years. This includes making Alzheimer’s disease claims on websites, social media and in stores.
According to a statement made by FDA Commissioner Scott Gottlieb, M.D: “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 actions taken by the FDA are part of a larger effort to manage the growing 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), according to Gottlieb. The agency’ latest policy will attempt to further strengthen the regulatory framework overseeing dietary supplements and includes steps to promote industry innovation while upholding the safety of these products.
Other new actions and policy priorities planned by the FDA include efforts to more rapidly communicate potential safety issues with dietary supplement products with the public, establishing a flexible regulatory framework that promotes innovation and upholds product safety and other, new steps to better ensure product safety and integrity, according to an FDA statement.
Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.