United Natural Products Alliance (UNPA) vice president regulatory and scientific affairs Harry Rice was speaking to NutraIngredients-USA after joining several industry bodies in asking the FDA to extend its comment period on the guidance by an extra 45 days.
“You can’t just say this needs to go away, as some people have been saying. We’ve been waiting 16 years for this and we needed it, it just needs to be revised - significantly. But we can hopefully find some middle ground.”
Ingredients or supplements?
One of the most obvious areas requiring revision related to the FDA’s insistence that NDI notifications should relate to every product containing an NDI rather than to the new ingredient itself, he said.
“[FDA dietary supplements chief] Dan Fabricant says that it’s always been the case that the notification is for the supplement, but when DSHEA was being drafted the issue of supplements didn’t come up until the eleventh hour and it’s not clear how it shifted [from focusing on ingredients to supplements].
“Historically notifications have always related to the ingredient, although firms will indicate how it will be used in supplements; the Congressional intent was that the notification was for the ingredient, not the supplement.
“There are companies that have hundreds of SKUs and reformulate annually, so there is a huge amount of concern about this."
As for the FDA’s view that synthetic versions of botanical constituents were not dietary ingredients at all, the industry needed time to present a rational explanation to FDA as to why they should be allowed, he said.
Meanwhile, although changes to the manufacturing process, new solvents or extraction methods could theoretically present toxicological concerns, the potential risk, rather than the change per se, was what mattered in determining whether an NDI notification is required, he said.
If this was not clarified in the guidance, scores of botanicals assumed to have been ‘grandfathered in’ under DSHEA would be required to submit fresh NDI notifications, which would be both “incredibly burdensome” and unnecessary, he argued.
CRN: NDI guidance can be salvaged
The Council for Responsible Nutrition (CRN) said it was cautiously optimistic that the FDA would listen to stakeholders’ concerns and “come back with something industry can live with”.
Chief executive Steve Mister told NutraIngredients-USA: “We won’t be first out of the box to file comments because we want to vent some anger.
“We are taking our time and when we do file our comments, we will make constructive suggestions [about how to amend it]. But I think that on a second try, the FDA could come back with something industry could live with, although it will take significant changes.
“I’m optimistic that the FDA will listen to us.”
ANH: A trap for a ’whole bunch of things that everyone knows are perfectly safe’
Robert Verkerk, executive and scientific director at the Alliance for Natural Health (ANH) International said the ANH-USA was still formulating its official response, but said it was critical to ensure that what was supposed to be a notification system did not turn into a pre-market approval system and “create a really nasty sticky trap for a whole bunch of things that everyone knows are perfectly safe.
“The real downside is that the scope is so wide, it will create the kind of mayhem that we’ve seen in Europe with the Novel Food Regulation.”
AHPA, CHPA, CRN, NPA, UNPA: ‘We need more time’
The CRN and UNPA have joined the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA) and the Natural Products Association (NPA) in asking for an extension to the 90-day public comment period on the guidance.
In a letter to the FDA, they write: “In the July 5th Federal Register notice, FDA allowed for a 90-day public comment period. However, members of our respective organizations believe additional time is needed to adequately prepare meaningful feedback for the agency’s consideration.
"Therefore ...we are requesting that FDA extend the submission deadline by an additional 45 days [from October 3 to November 17].”