Today, June 11, 2025, FDA released new materials regarding New Dietary Ingredient Notifications (NDINs). The agency  published two videos and a PDF fact sheet on NDINs. No changes have been made to the process, but FDA has provided simple, helpful details regarding the information required in an NDIN in order to assess whether the submission supports a finding that the new dietary ingredient meets the “reasonably be expected to be safe” standard. If the NDIN has all the information FDA is seeking, there is a better chance that FDA will find adequate data for the agency to send an acknowledgement letter with no objections to the filer’s conclusion of safety.

The fact sheet lists five common issues the agency sees with NDIN notifications, including

  1.  The NDIN does not concern a dietary ingredient. Meaning that FDA does not consider the ingredient to fit the definitions for a vitamin, a mineral, an herb or other botanical; an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above.
  2.  The NDIN does not cover the broadest possible use of the ingredient. That wording wasn’t entirely clear to me, but the subtext makes important points:
    1.  In some cases, manufacturers do not submit an NDIN because they believe the ingredient was covered by another NDIN that was not objected to by FDA. However…
    2.  …an NDIN for one manufacturer’s product does not eliminate the need for another manufacturer to submit an NDIN for their product.
  3.  The NDIN does not include sufficient identity information, including composition of the ingredient and details of the manufacturing process
  4.  The NDIN includes irrelevant information to support the notifier’s conclusions, such as promotional materials on the ingredient or a similar ingredient.
  5. Failure to submit proper references and/or copies of referenced articles or other underlying materials to support the safety of the ingredient.

The videos are brief but clear. The first of the two new videos elaborates on the fact sheet information. The second covers the submission process and how to communicate with FDA.

The development of NDIN process was a bit rocky after the passage of the Dietary Supplement Health Education Act of 1994 but the need to provide data to show that the new dietary ingredient would reasonably be expected to be safe under the proposed conditions of use has always been essential. Contact us with your questions or for help with your submission.