The US Food and Drug Administration (FDA) recently said it was unable to respond to the NPA-ANH Citizen Petition because of “competing agency priorities”, a response that Fabricant said was “half anticipated.” So, what’s next for this ingredient?
Speaking with NutraIngredients-USA at SupplySide West 2023, Dr Fabricant said that some of the battles now are more on the commerce side.
“The folks who advise third parties… we’ve seen communication that they’re advising them [retail platforms] that FDA’s been very clear in their message,” he said. “It’s time to split the baby on that and go, ‘FDA themselves says they haven’t been clear on the message’.
“I think it’s time to put FDA in a position where it’s, ‘You need to tell these platforms that you haven’t made a final decision’. You can’t have it both ways. You created a market on a good day letter for an NDI. You created a binding norm. I don’t think [FDA] has the statutory authority to undo it.”
25-(OH)D
Dr Fabricant also discussed a new issue bubbling up that is related to NMN: The potential use of 25-hydroxyvitamin D (25(OH)D), the non-active 'storage' form of the vitamin, as a dietary ingredient.
“We just enquired with the Agency about 25-hydroxyvitamin D and it being a supplement. Their response pointed us to a 2017 NDI where it wasn’t allowed, but then they added some language about studies going back to the 70s.
“We’re talking about vitamin D. If this is a better form of vitamin D, [but] people shouldn’t have access to it through the supplement or food supply? That’s a huge problem.”
FDA
The Agency and the changes to its human foods program remain a key interest for the industry, with both Dr Robert Califf, FDA’s Commissioner, and Jim Jones, the new head of the Human Foods Program, both making recent statements about structure/function claims.
“I think the implication that they [Califf and Jones in their recent statement] put out there is that nobody at the Agency understands Structure/Function claims,” said Dr Fabricant. “The Agency can do better. Somebody there understands it. Some of the people I hired [when I was Director of the Division of Dietary Supplement Programs] understand it, had training in this area. That sort of language – what’s the point of that?
“Do you want to set up an adversarial situation with an industry that 80% of the country uses every day?”
Watch the video for the full interview.
