New Dietary Ingredients (NDIs)

New Dietary Ingredients (NDIs) are defined as “dietary ingredients that were not marketed in the United States before October 15, 1994”.

Any dietary ingredient that entered commercial circulation after this date requires a submission of a premarket notification to FDA. This is achieved through a submission of a NDI Notification (NDIN) at least 75 days before release of the dietary ingredient into market commerce.

The complexity of the submission requires applicants to exemplify and prove the intended use of the dietary ingredient as or in a dietary supplement is safe. It is estimated the FDA receives approximately 50 NDIN per year and the agency recognizes there are many ingredients on the market that are being sold illegally. Thus, this market fluctuation prompted a new guidance in 2016 to help better illustrate when a NDIN is required and what the FDA’s recommendations are on safety data.

The submission paperwork is quite lengthy and the new revisions proposed in the 2016 guidance effectively made the procedure even more confusing. Our team of experts at dicentra can help your company navigate through this complex procedure by assisting with components or the entire paperwork submission. Our services include:

  • Determine if your ingredient is a New Dietary Ingredient
  • Perform a documentation gap analysis and outline any additional data required
  • Complete a full dossier for a New Dietary Ingredient Notification (NDIN)
  • Request and prepare for an FDA pre-submission meeting
  • Address any questions or requests for clarification from the FDA during the notification process