To legally market an NDI in a dietary supplement, companies must submit a New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before commercialization.
The NDIN must demonstrate that the ingredient is reasonably expected to be safe under its intended conditions of use. This requires a comprehensive evaluation of safety data, including toxicology, historical use, and exposure.
In many cases, the challenge is not just preparing the NDIN—it is determining whether the NDI pathway is appropriate at all.
dicentra works with clients early to assess regulatory eligibility, evaluate alternative pathways, and build a strategy that supports both compliance and commercial success.
This approach ensures that NDIN submissions are scientifically sound, regulator-ready, and aligned with FDA expectations.
Schedule a discovery call to explore how our team can support your NDIN program.
A New Dietary Ingredient (NDI) is a dietary ingredient that was not marketed in the United States before October 15, 1994. These ingredients require regulatory evaluation before being used in dietary supplements.
A New Dietary Ingredient Notification (NDIN) is a submission to the FDA required for NDIs. It must be submitted at least 75 days before the ingredient is introduced into the market.
Failure to submit an NDIN when required may result in the product being considered adulterated. This can lead to FDA enforcement actions, including warning letters, product recalls, or removal from the market.
Determining NDI status requires assessing whether the ingredient was marketed before October 15, 1994, and evaluating its intended use. Misclassification is a common risk and should be assessed early in development.
Preparation timelines vary depending on available data. Once submitted, the FDA review period is typically 75 days, although preparation and data development may take several months.
An NDIN requires:
The level of evidence depends on the novelty of the ingredient.
If your ingredient does not qualify as an NDI, it may fall under other pathways such as GRAS, Old Dietary Ingredient (ODI), or food additive regulations. Selecting the correct pathway is critical to avoid compliance risks.
Yes. dicentra evaluates all potential regulatory pathways, including NDI, GRAS, and food additive options, to determine the most appropriate strategy for your ingredient and commercial goals.