AHPA submits comments to FDA on NDIN guidance

In comments submitted to the U.S. Food and Drug Administration (FDA) on July 19, AHPA expressed support for the agency’s proposal to offer a period of enforcement discretion for the late submission of new dietary ingredient notifications (NDINs) and requested revisions to the draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.”

AHPA’s requested revisions included:

• Removing any quantitative estimate of unfiled but required NDINs because the 4,600 figure in the draft guidance lacked appropriate evidentiary support and including any such estimate would not prove necessary to advance the purposes of the draft guidance;
• Clarifying that FDA would deploy the appropriate resources to ensure that it substantively responds to all NDINs, including those submitted during the proposed period of enforcement discretion, within 75 days; and
• Including an accurate physical address at which the Center for Food Safety and Applied Nutrition would accept late NDIN submissions made in paper or other forms.

In addition to specific recommended revisions, AHPA noted that FDA had stated plans to publish a new NDI guidance addressing notification procedures and timeframes in the agency’s updated list of foods program guidance under priority development, and AHPA encouraged the agency to prioritize publication of this document before finalizing the enforcement discretion guidance.

AHPA also repeated its request for FDA to focus on the development of draft guidance targeted specifically to issues and elements of the NDIN process that concern companies likely to consider filing NDINs, such as ingredient identity and cGMP requirements. Lastly, AHPA encouraged FDA to enforce NDIN submission requirements to a degree sufficient to deter noncompliance and incentivize compliance.

“Issuance of a final version of the NDIN enforcement discretion draft guidance may result in the submission of at least some NDINs that FDA may not have otherwise received,” said AHPA President Michael McGuffin. “However, we feel the agency must also prioritize compliance assessments and enforcement actions against non-compliant firms to keep unsafe products off of the market and protect consumers.”