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UNPA points out several provisions in the new NDI draft guidance that could hamstring industry innovation.
FDA’s newly released new dietary ingredient (NDI) draft guidance poses plenty of questions for the dietary supplement industry, but none more pressing than the question of which ingredients would be required to submit NDI notifications (NDINs) under the new guidance. Unfortunately, the way the guidance currently appears to be written, industry may be facing a call for tens of thousands more NDIs than it can reasonably be expected to submit.
Earlier today, the United Natural Products Alliance (UNPA; Salt Lake City) hosted a webinar on the many questions raised by the new NDI draft guidance as a preview of its upcoming all-day workshop on the same topic, which will take place on September 8. During the webinar, titled “The UNPA NDI Guidance Workshop Preview,” UNPA President Loren Israelsen outlined several reasons why the new NDI guidance could lead to a perpetual “spawning effect of new NDIs” that neither industry nor FDA is prepared to handle.
One of UNPA’s top concerns with the new NDI guidance is language that appears to call for a new NDIN be submitted every time a change is made to the manufacturing process of an ingredient, even if the change is relatively minor.
“As we scroll back and look at the kinds of things that would trigger new dietary ingredient status, it’s almost anything you would do routinely in the course of research and development, upgraded manufacturing and extraction procedures, filtration, fermentation, use of improved solvents, etc.,” Israelsen said. “We’re under the current understanding that these are all triggers to new NDI status.”
For instance, manufacturing changes including physiochemical structure changes, bioavailability changes, and the use of post-DSHEA solvents such as methanol, supercritical CO2, and hexane would all require a new NDI notification be submitted under the latest guidance language, Israelsen noted.
Instead, Israelsen suggested, FDA should include similar language in its NDI guidance as was used in its 2014 guidance on food additives, where only “significant” manufacturing process changes would require a new NDIN.
“It would be our view to ask FDA to apply the same logic and only look at significant manufacturing changes and have some definitions around that,” Israelsen suggested. “We simply cannot be held to a standard where any manufacturing change triggers NDI status.”
Another troubling area Israelsen pointed out is the issue of multiple ingredients combined in a single supplement product. As the NDI draft guidance appears to be written, when two or more ingredients are combined together, a company might have to submit an NDIN just for that combination, even if all the component ingredients already have NDINs submitted.
“Do they really mean that when you combine two NDINs that have both received FDA acknowledgment, you put those two together, do they really require a new submission?” Israelsen said. He added that if that is the case, the number of new NDIs required will rise exponentially due to the normal lifecycles of research and development, manufacturing, and product improvement.
An Enormous Price Tag
Considering the frequent changes in manufacturing processes of a given ingredient, as well as the many combinations of ingredients currently on the market, we could be looking at a call for tens of thousands of new NDINs, if FDA were to act the way its new guidance language may suggest.
Under such a scenario, UNPA suggested, a preliminary estimate of the potential cost burden on industry could range from $2 billion to $6 billion, depending on the number of NDINs required and the cost per NDIN. UNPA notes that its cost estimate is still a very early and tentative assessment of the potential burden on industry, but it’s hard not to bat an eye at such a high potential cost.
“If the price tag is anywhere close to what our first estimates look like, that will be a sticker-shock issue,” Israelsen said. Many industry members would be strongly opposed if the new NDI regulations prove that expensive, Israelson noted, while some companies might find it just plain too expensive to submit the required NDINs without going bankrupt. There’s also the issue of whether FDA would be able to handle that many submissions.
“If we have this very high burden of constantly refiling [NDINs] unnecessarily, you can imagine it will create a resistance [from industry] that over time will cause the system to break down,” Israelsen said. “And we haven’t even discussed how in the world will FDA staff and pay for all of this. They simply don’t have the resources to do it.”
Israelsen urged industry to work together to harmonize its response to the NDI draft guidance, predicting that the proposal’s economic impact will be “a primary pushback point as we really begin to see the likely costs of this proposed guidance.”
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