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FDA Extends Comment Period on NDI Draft Guidance

FDA Extends Comment Period on NDI Draft Guidance

<p>FDA has now extended the comment period to Dec. 12, 2016 to give interested parties more time to weigh in on the guidance.</p>

FDA has granted requests to extend the comment period for interested parties to weigh in on revised draft guidance for the dietary supplement industry.

In a Federal Register notice on Aug 12, 2016, FDA announced the availability of the revised draft NDI (new dietary ingredient) guidance, a 102-page document that has drawn mixed reactions from industry. The notice offered a 60-day period for comments, with the original comment period scheduled to end on Oct. 11, 2016.

The guidance represents the agency's thinking on dietary supplement companies' obligations to submit to FDA safety-related NDI notifications.

Several parties sought an extension of time to comment on the draft guidance, which supersedes a controversial document that was published in 2011. For instance, the Natural Products Association (NPA) sent a formal request to FDA, requesting 30 additional days to file comments. FDA granted an even longer extension—until Dec. 12, 2016.

“We received requests for 30- and 90-day extensions of the comment period," FDA stated in a document that is scheduled to be published Oct. 4 in the Federal Register. “In general, the requests conveyed concern that the current 60-day comment period does not allow sufficient time for interested parties to develop a meaningful or thoughtful response to the draft guidance.”

Steven Tave, acting director of FDA’s Office of Dietary Supplement Programs, has characterized the revised guidance as "an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients."

“Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers," he explained in a press release at the time the new document was published. "The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements."

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