FDA proposes overhaul of dietary supplement industry
FDA Commissioner Scott Gottlieb, MD, recently proposed several regulatory and communication initiatives that he said would lead to “one of the most significant modernizations of dietary supplement regulation" in nearly 3 decades.
According to a press release, Gottlieb seeks to: create a tool that quickly notifies the public and appropriate manufacturer when a product with an illegal or possibly dangerous ingredient is discovered; revisit the 1994 Dietary Supplement Health and Education Act that provides the current FDA regulations regarding dietary supplements, ensure the FDA regulatory framework is fluid enough to adequately assess product safety while encouraging innovation; and form new relationships and cultivate existing ones to achieve these objectives.
"Our first priority for dietary supplements is ensuring safety,” the commissioner said in the release. “Our second priority is maintaining product integrity: we want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards. ... Our third priority is informed decision-making.”
Gottlieb noted the FDA’s announcement earlier this week that certain manufacturers received warning letters indicating the FDA’s awareness that their products that have not been approved and/or are misbranded as claiming to prevent, treat or cure Alzheimer’s disease is an example of what the initiative would do.
He also said additional steps regarding the proposed overhaul and meeting logistics detailing how the public can provide input on it are forthcoming. – by Janel Miller
Disclosures: Gottlieb is FDA commissioner.