July 19, 2022
National Center for Health Research’s Comments on Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification
[FDA-2022-D-0281]
We are writing to express our views on the Food and Drug Administration’s (FDA) draft guidance to allow companies that have previously failed to file a necessary New Dietary Ingredients (NDI) notification to do so without incurring any penalty for lateness if they file within 180 days of publishing the final guidance.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We support the proposed policy as a positive step to increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace and to promote risk-based regulation. Having data is essential; reducing manufacturers’ fear of reprisal for submitting late data creates an incentive to provide that information. However, we support greater monitoring and enforcement of premarket notifications to reduce late submissions in the future, and to reduce manufacturers’ failure to submit NDIs in a timely manner.
For question about this comment, please contact Dr. Diana Zuckerman at the National Center for Health Research at info@center4research.org or at (202) 223-4000.