AHPA submits comments to FDA about its draft guidance for overdue NDI notifications

The American Herbal Products Association has issued comments to the U.S. Food and Drug Administration (FDA), regarding the Agency’s “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry.”

The American Herbal Products Association (AHPA; Silver Srping, MD) has issued comments to the U.S. Food and Drug Administration (FDA), regarding the Agency’s “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry.” The draft guidance provides a 180-day discretion period in which late New Dietary Ingredient Notifications (NDINs) may be submitted. The intent of this guidance, says FDA, is “to encourage firms to correct past failures to submit an NDI notification.”

AHPA expressed support for the draft guidance, but did offer specific recommendations for its revision. For one, AHPA requested that FDA remove its estimate of 4,600 new dietary ingredient notifications (NDINs) that should have been submitted, but were not. AHPA questions the validity FDA’s estimate (as did the Council for Responsible Nutrition in its comments).

“Estimates are generally made with reference to some source of evidence from the environment, but the 4,600 value is explicitly not based on any assessment justifying its inclusion in an FDA guidance document,” writes AHPA in its comments. “AHPA has no alternative basis to assess the scope of late NDINs, but, at root, an ‘estimation’ is not necessary to support the purposes of the May 20 draft guidance, and the agency should not include an unsupported assumption as an “estimate” of unsubmitted but required NDINs in any final guidance.”

Additionally, AHPA requested that FDA “deploy the appropriate resources to ensure that it substantively responds to all NDINs, including those submitted pursuant to any finalized version of the May 20 draft guidance, within 75 days.” This is to allow submitters to respond to FDA’s comments prior to public display of NDINs. AHPA also notes that FDA needs to provide an accurate address with which to submit NDINs in physical media and paper forms.

Outside of the draft guidance on overdue NDINs, AHPA’s comments requested additional NDI guidance and enforcement. “On January 31, 2022, FDA released a list of foods program guidance under priority development during 2022 and issued an updated list of these priorities on June 30, 2022. These communications record the agency’s intention to issue further guidance addressing ‘NDI notification procedures and timeframes’ before the end of this year,” writes AHPA. Because this guidance would address outstanding questions about the NDIN process, its publication too would increase the number and quality of NDIN filings if published prior to final version of the draft guidance. As such, AHPA recommends that FDA prioritize the issuance of these guidance documents prior to the finalization of its enforcement discretion policy.

For further NDI guidance, AHPA requests that FDA issues a standalone guidance on NDI identity issues. “Based on a review of past agency NDIN responses, AHPA finds that FDA’s assertion that an NDIN includes inadequate information on identity is among the most commonly cited reasons for FDA’s identification of ‘significant concerns’ regarding an NDIN,” writes AHPA. The association also requested FDA to prioritize compliance assessment, and when appropriate, take enforcement action against firms flouting the law and inappropriately rely on competitor’s NDINs. This would be deter noncompliance, but also incentivize compliance, since FDA has historically not enforcement NDIN submission requirement sufficiently enough.