Silver Spring, MD—The American Herbal Products Association (AHPA) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion. (Background: CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance.)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 AHPA contends that the 4,600 figure in the draft guidance lacked appropriate evidentiary support, and that including any such estimate would not prove necessary to advance the purposes of the draft guidance;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.
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.