NDI draft guidance comments
CRN on NDI draft guidance: ‘A choir has many voices but we’re all singing the same song ‘
CRN chief executive Steve Mister was speaking to NutraIngredients-USA after submitting comments to the FDA calling for it to withdraw the controversial document and go back to the drawing board.
We don’t want companies to be stuck in a fog
While other commentators have suggested the guidance could work if substantially revised, the basic message was the same, said Mister.
Whether it is withdrawn and then rewritten, or retained (but not enforced) and substantially revised, in its current form, it is unreasonable and unworkable, he said.
“We’re just saying withdraw it now and then work on a new one as we don’t want companies to be stuck in this fog for months [wondering whether the FDA is going to enforce the draft guidance as it stands].”
He added: “There are going to be nuances in the various submissions. A choir has many voices, but we’re all ultimately singing the same song. The FDA has overreached itself and created a system that is unworkable, and that’s what I hope the FDA takes away from this, rather than looking at differences between submissions.”
His comments were re-iterated by Natural Products Association (NPA) boss John Gay in a conference call with reporters this morning, who said that the associations had exchanged drafts of their comments prior to submission and were "overall, on the same page".
He added: "On all the substantive points, the industry is together."
What happens next?
As to what happens now, the FDA will need time to process the torrent of comments pouring in and so the CRN will not push for an immediate meeting, said Mister, another reason why it is calling for the draft guidance to be withdrawn so that firms are not left in limbo while the FDA decides what to do.
“I would not expect we’ll hear anything from the FDA initially. But in the meantime, we’re continuing to work with our Congressional allies who are very concerned about the effect this guidance could have on the industry.
“We’ll see some political pressure brought to bear on the agency.”
No basis in sound science or public policy
The CRN’s submission contains a series of recommendations on very similar lines to the NPA’s 11-point wish list – published yesterday – but also provides lengthy explanations of why it believes the draft guidance is inconsistent with the law (the 1994 Dietary Supplement Health and Education Act - DSHEA) it was designed to clarify.
Said Mister: “The draft guidance contradicts DSHEA, Congressional intent, and 17 years of agency policy, while having no basis in either sound science or public health policy.
“It would impose significant and unnecessary new burdens on the dietary supplement industry without conferring safety benefits to consumers. It far exceeds the permissible scope of a guidance document, proposing substantive requirements that must be the subject of notice-and-comment rulemaking.
“We request that FDA withdraw the draft guidance, give careful consideration to these comments, and begin the process anew with a draft guidance that reflects the statutory language and legislative intent of DSHEA.”
Along with the NPA, the CRN (which filed a joint submission with the Consumer Healthcare Products Association) calls on the FDA to:
- Ditch its insistence on multiple end-product specific notifications.
- Scrap calls for food additive-style testing requirements.
- Revise its view that synthetic botanical constituents, even if they are chemically identical to their ‘natural’ counterparts - are not dietary ingredients.
- Scrap the requirement on industry to prove the grandfathered status of their products and instead shift the burden of proof into the FDA “if it chooses to challenge” industry determinations.
- Open up the definition of which processes do NOT constitute chemical alteration.
Check into NutraIngredients-USA on Monday for more coverage of NDI guidance comments.
Click here to read about the Natural Products Association's (NPA's) submission.
Click here to read the FDA's draft guidance.