FDA supplement industry functions on hold during shutdown; backlog foreseen

By Hank Schultz

- Last updated on GMT

Photo: Wikimedia Commons
Photo: Wikimedia Commons
The federal government shutdown has thrown a wrench into the works of the Food and Drug Administration. While food safety might not have been compromised, many of the agency’s more routine assignments are on hold and it may take months to catch up.

Daniel Fabricant, PhD, president and CEO of the Natural Products Association, has first hand experience of a federal shutdown. One occurred in 2013, when political brinksmanship about funding or not funding the government was still something of a novel idea (there were two prior shutdowns, one in 1978 and another in 1995-96). Fabricant was at the time head of FDA’s Division (now Office) of Dietary Supplement Programs. 

In that case, his position was deemed to be ‘essential,’ so he continued to work and be paid. The essential character of his job was determined by a public crisis related to an outbreak of liver injuries associated with a product called OxyElite Pro that included a shady ingredient of purportedly botanical origin.

Public safety not compromised

“In 2013 I was deemed essential. Some of that had to do with what was going on in Hawaii and nationally with aegeline,”​ Fabricant told NutraIngredients-USA. 

“If there were a significant public health issue, then the agency still has the tools to deal with that. But we also want routine inspections to happen and that has ground to a halt,”​ he said.

Steve Mister, president and CEO of the Council for Responsible Nutrition said not all workers at FDA are on furlough.

“People whose jobs are funded by user fees are still working. So the people in CDER can continue to work because their salaries are not paid out of general appropriations,”​ Mister said.

FDA Commissioner Scott Gottlieb has been sending out a blizzard of tweets to try to clarify what’s on and what’s off during the shutdown. The parts of FDA that are still running more or less as usual have little to do with the supplement industry.

“We’re fortunate that many employees can continue work for the immediate future mostly because of carryover user fees. User fees support approvals of new medical products, our ability to review requests to conduct important clinical research, and issue certain guidance documents,”​ he tweeted yesterday.

Backlog will develop

Both Mister and Fabricant said a backlog will inevitably develop in GMP inspections and New Dietary Ingredient notifications and other functions at the agency. How long it will take to clear that up will depend on how long the shutdown goes on.

“It’s looking like there will be an impasse for at least a couple of weeks and it looks like neither side is going to blink any time soon. We have been on Capitol Hill meeting with new members of Congress and it seems as if the Democrats feel like they have a pretty clear mandate from the voters for their positions,”​ Mister said.

“This will absolutely reverberate through the industry. Routine inspections for GMPs will not get done, and if there is an NDI before the agency, they are probably not going to meet their 75-day deadline,”​ he said.

FDA is shuttered, but issues aren’t

Fabricant said it’s an open question about how fast the agency can catch up after the funding impasse is resolved. Much of that will depend on the morale of the various departments in the agency, something that’s hard to judge before those workers return to their jobs. But he said many government functions critical to the supplement industry continue on, even if FDA is hamstrung for the moment.

“Don’t forget, the federal courts aren’t close. And some public comment dockets are still open. We pride ourselves on being ahead of the curve on these things. We want to make sure our issues are heard, and in the meantime we will continue working toward our agenda,” ​he said.

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