Silver Spring, MD—The American Herbal Products Association (AHPA) has submitted commentsin response to FDA’sdraft guidanceon new dietary ingredient (NDI) filings and enforcement discretion.(Background: CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance.)

While expressing support for FDA’s proposal to offer a period of enforcement discretion for the late submission of new dietary ingredient notifications (NDINs), AHPA outlined several revisions that it would like to see made. These include:
  • Removing any quantitative estimate of unfiled but required NDINs. AHPA contends that the 4,600 figure in the draft guidance lacked appropriate evidentiary support, and that including any such estimate would not prove necessary to advance the purposes of the draft guidance;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;
  • 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.

Related: CRN: 6 Issues with FDA’s NDI Draft Guidance for Dietary Supplements

AHPA also pointed out that FDA has stated that it 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. This should be a priority. AHPA suggested that FDA focus on the publication of this document before finalizing the enforcement discretion guidance.

AHPA also asked FDA to focus on developing of draft guidance targeted specifically to issues and elements of the NDIN process that concern companies likely to consider filing NDINs, such as ingredient identity and cGMP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. And finally, AHPA encouraged FDA to enforce NDIN submission requirements to a degree sufficient to deter noncompliance and encourage 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“Issuance of a final version of the NDIN enforcement discretion draft guidance may result in the submission of at least some NDINs that FDA may not have otherwise received,” said AHPA President Michael McGuffin.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.”