Speaking with NutraIngredients on Oct. 29 at SupplySide Global in Las Vegas, Dr. Fabricant noted that, to his knowledge, no one at the Office of Dietary Supplement Programs (ODSP) at the U.S. Food and Drug Administration has been labeled essential and are therefore furloughed.
This has implications for GMP inspections, although some are ongoing, said Dr. Fabricant, because the FDA has contracted with about 15 states to conduct inspections on behalf of the agency.
The shutdown also appears to have affected the Agency’s own deadline of October to announce proposals to amend the Generally Recognized as Safe (GRAS) regulation.
“We’ve reached out to HHS,” Dr. Fabricant said. “We want to have a dialog… I think one of the good things about the shutdown is it’s given some time for people to kind of go, ‘Hey, can we have more of a dialog and see what’s moving there and what’s what?’ But nobody knows what the target is yet, either… It was clear that there may be some concerns about supplement ingredients, which [FDA] certainly hears and are going to look into at the same time.”
NMN
Dr. Fabricant also addressed his association’s recent success with its Citizen Petition concerning NMN.
“That was a good day for NMN, a good day for NPA,” he said. “We were excited as heck that we got the result we wanted. We got the relief we wanted. It’s back on the market, and FDA reconsidered, but […] people are talking about […] FDA kind of doubled down on, well, no, it’s the IND that’s the trigger that precludes it from the market, not the substantial clinical.
“Kudos to Kevin Bell, our legal folks at AGG, they wrote the questions in a way that we got answers from FDA we’ve never seen before, which is great, which gives us a roadmap to go, ‘Okay, what’s the best way to fix this?’
“We’ve got to do something about that. We’re looking at all options here.”
2026: 90 years of NPA
Dr. Fabricant also looked ahead to next year when NPA will celebrate its 90th anniversary.
“We want to make sure NPA is around for the next 90 years,” he said. “The organization’s history of standing up for the industry, no one [else] has that track record.
“Just look at the past year alone [with our work on] tariff exemptions […] Government can change your business faster than anything […] We’re really the leadership. Our board leadership’s great. They’re very proud of what the organization’s done. They want to see more people get involved and more people contribute. So we do have, you know, the business world’s changed so much, but it’s so important for an organization like ours to be able to get to stick their nose in their fight, and I think if everyone looked at the past year, if NPA wasn’t around, things would be quite different.”
Watch the video for the full interview that also explored action at the state level.
