Editor’s Note: FDA guidance documents are subject to the Data Quality Act’s requirements and correction procedures.
From: Regulatory Affairs Professional Society
By Jennifer M. Adams, JD, Ashish R. Talati, JD, MS, RAC
This article discusses FDA’s publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) and the implications regarding the lack of finalization in the year following its publication. The authors make suggestions regarding what companies may begin doing prior to and in anticipation of eventual finalization.
Introduction
Regarding how dietary supplements should be regulated, particularly with regard to New Dietary Ingredient (NDI) notifications, there have been a few differences in opinion between the dietary supplement industry and the US Food and Drug Administration (FDA). Yet, industry’s reaction to FDA’s publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) seemed to be measured in comparison to reactions following the previous draft’s release.1 Despite this, there was still a scramble to determine what the revisions were and how they would affect each company’s products. Many hoped there would be more answers after the “dust settled,” but industry is still trying to determine the long-term effect of the 2016 Draft Guidance. Without new information or an anticipated finalization date, questions remain about the impact and what to do about it.