Market Updates

NPA Requests Extension for Commenting on Revised Draft Guidance for NDI Notifications

NPA submitted a formal request to extend the current 60‐day comment period.

The Natural Products Association (NPA) submitted a formal request to the Food and Drug Administration (FDA) for an extension of the comment period by 30 days regarding the opportunity for stakeholder comment on the newly released guidance re-draft for New Dietary Ingredient Notifications.
 
“Having been last updated in 2011, these changes were a long time coming, and given the importance of these issues to the industry, we believe additional time is needed to allow for sufficient stakeholder response,” said NPA CEO Dr. Dan Fabricant. “FDA’s re-draft, which includes points of clarification over the earlier draft, was no Magna Carta par excellence as we discussed in last week’s NPA Wednesday Webinar. In some cases, you could consider them a win for the industry, and in other cases, we still need further clarification,” stated Dr. Daniel Fabricant.
 
“We still have concerns in this re-draft, which we will address during the comment period, and we found inconsistencies and errors in the guidance. NPA believes that no harm will result from FDA extending the comment period due to the interest, significance, and complexities generated by the topics included in this re-draft,” added Dr. Fabricant. “NPA looks forward to working with its member companies to engage this important public notice and comment period to make changes in helping to bring novel, innovative dietary ingredients to the market safely.”
 
NPA is still taking orders for its Emergency NDI Webinar held last Wednesday. To order a CD click here.

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