FDA’s top official on Wednesday announced the creation of a working group within his agency to improve oversight of the dietary supplement industry, reflecting concerns over FDA’s ability to manage risks in a sector that has grown 10-fold over the last quarter century.
“I’ve formed a dietary supplement working group within FDA to take a hard look at what more the FDA can be doing within our existing authorities, including re-examining our own internal operating structure and procedures—and what new authorities might make sense,” Gottlieb announced during a speech in Washington at the FDLI [Food and Drug Law Institute] Enforcement, Litigation and Compliance Conference. “We have some specific, new policy measures that we plan to pursue when it comes to modernizing our overall approach to dietary supplements.”
Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the industry has grown from US$4 billion to more than $40 billion, with more than 50,000 products on the market, Gottlieb observed.
“And while much of this industry is responsible to consumers and the public health, there are also too many bad actors who are not,” he said. “With the growth come new opportunities for consumers to improve their health, but also a lot of new risks.”
Gottlieb added, “I’m concerned that the industry has gotten bigger and riskier faster than our policies and our capacity to manage this risk. That needs to change. And so we plan on advancing new policies that will improve our oversight in this space.”
Gottlieb reported FDA’s success working with its partners at the U.S. Department of Justice (DOJ) on civil and criminal cases involving dietary supplements, an area where he said the agency has “encountered a range of problematic conduct.”
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