FDA calls for new tools



Schiller, who is the principal associate commissioner for policy in FDA’s Office of Policy, made his observations as part of a speech at teh Council for Responsible Nutrition’s annual members meeting, which is taking place this week in Carlsbad, CA.

CBD explosion adds to burden

Schiller said the CBD issue has put into stark relief the mismatch between FDA’s capabilities and the responsibilities it faces. The dietary supplement marketplace continues to grow appreciably.  If all of the supplement-like CBD products now on the market are thrown into the mix, it’s exploding.  But FDA’s resources are not growing to match.

FDA is under significant pressure from lawmakers to come to a quick resolution on CBD. But Schiller warned that whatever happens on CBD, FDA can’t ignore its current responsibilities in favor of the new darling ingredient of the industry.

“By some estimates, the CBD market has already grown to roughly half the size of the entire dietary supplement market at the time DSHEA was passed. Think about that,” ​Schiller said.

“And think about this: If we were to create some kind of exception for CBD, how many new products would come on the market from manufacturers without a history of complying with basic requirements like good manufacturing practices, or truthful labeling?

“Do we at FDA have the tools and resources we would need to identify all the potential violations we might see, let alone address them? And what would that mean for our existing work?”​ Schiller added.

Mandatory product listing

Schiller noted that FDA is continuing to work through comments made as part of the meeting the agency convened in mid May on responsible innovation in the industry. The goal, he said, was to identify key points and get a dialogue started, not necessarily to come up with a finished plan on how DSHEA might altered or added on to.


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