Trade associations: 45-day NDI draft guidance extension request ‘reasonable’

By Stephen Daniells

- Last updated on GMT

"Extending the comment period in perpetuity merely delays the inevitable and will only result in diminishing returns" - Dr Harry Rice, UNPA
"Extending the comment period in perpetuity merely delays the inevitable and will only result in diminishing returns" - Dr Harry Rice, UNPA
The request from the main trade associations to extend the period for comments on the NDI draft guidance is ‘reasonable’ and the result of ‘carefully weighing the matter at hand’.

Spokespeople from the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) were responding to requests from other quarters of the industry to extend the comment period from 90 days to one year.

Last week, supplement manufacturer Jarrow Formulas added its voice to those of an initial request on July 26, 2011 by law firm Hyman, Phelps & McNamara, P.C. to extend the comment until July 5, 2012.

45 days

In contrast, five main trade associations for the dietary supplements and functional foods industry requested a 45-day extension to the 90-day public comment period on the guidance.

The request was sent to FDA by the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), UNPA, CRN and NPA.

Following the Jarrow Formulas request, Cara Welch, PhD, VP of scientific and regulatory affairs with the NPA, explained that the trade associations asked for 45 days as “a result of carefully weighing the matter at hand.

“We, at NPA, felt an extension was necessary to properly prepare extensive and valuable comments for the FDA but didn’t want to push our luck by asking for too long of a time, especially when we’d been asking them for this guidance document,” ​said Dr Welch.

“And I think the FDA also realized this document would require a longer comment period to appropriate address the issues at hand so they provided 90 days outright, I don’t think asking for another 45 days is unreasonable.”


Duffy MacKay, ND, VP of scientific & regulatory affairs, echoed Dr Welch's comments, telling NutraIngredients-USA that trade associations came from the perspective that the industry asked for the NDI document.

“This document came as a surprise in its extent,” ​said Dr MacKay, “but there had been harbingers all along the way, several clues as to the contents, so we weren’t as surprised as many others.”

“There is clearly stuff [in the guidance document] that we hope to have changed in the final guidance.”

Comments from CRN are “fairly far along”​, he said, but the 45 day extension is needed to finalize the comments and “to make them meaningful”​.

Diminishing returns

Harry Rice, PhD, director of regulatory and scientific affairs for UNPA, told NutraIngredients-USA: "All things considered, 45 days is what we considered to be a balance between the time we needed to compile coherent, comprehensive comments and what FDA would likely be willing to grant us.

"While we're not necessarily opposed to a longer comment period, extending the comment period in perpetuity merely delays the inevitable and will only result in diminishing returns."

Any day now?

CRN's Dr MacKay added that, based on requests made in relation to GMPs, the agency has a precedent of responding to requests some four weeks from the time of the request. “That would be right about now,”​ he said.

Regarding the requests of one year, he said it was unknown if they would affect the 45-day request.

Dr MacKay noted that no dialogue took place with the companies/organisations seeking the one year extension, something he described as “unfortunate”​.

Related topics: Regulation, NDI draft guidance

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