FDA grants comment period extension for NDI draft guidance

By Stephen Daniells

- Last updated on GMT

FDA grants comment period extension for NDI draft guidance
The US Food & Drug Administration (FDA) has granted a 60-day extension to the comment period for the New Dietary Ingredient (NDI) draft guidance, NutraIngredients-USA.com can reveal.

The announcement, published today under the Federal Register Notice for Extension of Comment Period; Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, will extend the comment period from October 3 to December 2, 2011.

Click here to read the announcement​.

The extension comes in response to a request from the the Natural Products Association (NPA), Council for Responsible Nutrition (CRN), United Natural Products Alliance (UNPA), American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA) for a 45-day extension to the 90-day public comment period from October 3 to November 17.

Thoughtful comments

The 60-day extension was welcomed by Harry Rice, PhD, director of regulatory and scientific affairs for UNPA.

“UNPA is grateful for the extension,”​ said Dr Rice. “This should be considered a win-win for those of us preparing comments as well as those receiving them. That is, the industry will have additional time to prepare thoughtful comments and, as a result, the Agency will receive constructive feedback.

“For us, at the end of the day, the goal is to find common ground that is in line with the intent of DSHEA.”

Cara Welch, PhD, VP of scientific & regulatory affairs for NPA, said that the association was pleased to see the FDA provided an extension for responding to the NDI draft guidance.

"As we have realized over the last couple months, commenting in response to this draft guidance will require extensive time and resources as we work with our member companies and our industry colleagues.

"It’s important for the industry to use these additional 60 days prudently and continue preparing comments that reflect the gravity this document holds for the industry but work toward a solution where all are satisfied," ​added Dr Welch.

Council for Responsible Nutrition (CRN) chief executive Steve Mister also welcomed the extension, adding: "The draft guidance will provide critical direction for the industry. The extension will give us the opportunity to provide a more thoughtful and comprehensive response.”

Adequate time

In its response, FDA states: “FDA has considered the [45-day extension] request and is extending the comment period for the notice entitled ‘Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability,’ until December 2, 2011.

“The Agency believes that this extension allows adequate time for interested persons to submit comments without significantly delaying action by the Agency.”

Other requests from industry stakeholders were also made for an extension of one year, most notably by law firm Hyman, Phelps & McNamara, P.C. and California-based supplement manufacturer Jarrow Formulas Inc (JFI).

Related topics: Regulation, NDI draft guidance

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3 comments

Draft NDI Guidance

Posted by Marc Ullman,

The document can be found here:
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm

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Is this a stupid question?

Posted by R. Dancause,

Where can we find a copy of the original draft guidance?

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Emords Comments to FDA NDI Guidance Should Be Flooded In To Them En Masse

Posted by John Hammell, President, Intenational Advocates for Health Freedom,

That would show FDA that a huge number of people would be behind a lawsuit against them, and it would also show Congress that there is a serious need to hold oversight hearings to rein in this rogue agency which is clearly attempting to overstep the will of congress as clearly expressed via passage of DSHEA. Emord's comments can be seen here http://www.emord.com/FDA-2011-N-0410%20-%20Comments%20of%20Alliance%20for%20Natural%20Health-USA%20%28Aug%202,%202011%29.pdf

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