NDI Draft Guidance Comments in brief
Atrium Innovations on NDIs: The system isn’t broken, so why fix it?
!["The Draft Guidance, in its current form, [...] is tantamount to obtaining FDA approval for dietary supplement products" Atrium](/var/wrbm_gb_food_pharma/storage/images/_aliases/wrbm_small/7/2/9/7/827927-1-eng-GB/Atrium-Innovations-on-NDIs-The-system-isn-t-broken-so-why-fix-it.jpg)
The Quebec-headquartered company questioned the stringency of the draft guidance, given that, 17 years after the passage of the Dietary Supplement Health and Education Act (DSHEA), no “consumer crisis exists” regarding dietary supplements.
“We support industry’s call for FDA to withdraw this iteration of the Draft Guidance,” wrote Barry Ritz, PhD, VP of scientific & regulatory affairs and Michael Colodney, Esq., legal & regulatory counsel in a six-page submission to the Food and Drug Administration (FDA).
“Atrium Innovations believes this [draft guidance] is wholly unnecessary when there is no evidence to suggest the current system is broken.
“This new draft guidance must limit NDI notifications to truly new dietary ingredients without history of safe use where the ingredient’s ‘reasonable expectation of safety’ has yet to be determined,” added Ritz and Colodney.
Pragmatism
“We hope the Agency will work closely with industry to develop a new NDI guidance that better balances the paramount public policy consideration of ensuring consumer safety with pragmatic considerations such as cost, burden to industry, scientific realities, and overall benefit to consumers.
“Great deference should also be given to Congress’s intent that DSHEA preserve consumer access to dietary supplements, recognizing the long-term societal health benefits engendered by our products.”
