By Sean Moloughney, Editor02.12.19
The U.S. Food and Drug Administration will embark on a plan to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” according to FDA Commissioner Scott Gottlieb, MD, who laid out the agency’s goals and priorities in a statement on Feb. 11.
Gottlieb noted significant industry growth since the passage of the landmark Dietary Supplement Health and Education Act (DSHEA) of 1994, which established the industry’s current regulatory framework.
“I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks,” Gottlieb said. “To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products.”
At the same time the agency announced it sent 12 warning letters and five online advisory letters to companies w
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