New Dietary Ingredient Notifications (NDIN)

There has been buzz in the trade press and industry as to when a company is required under the Federal Food, Drug and Cosmetic Act to submit a 75-day premarket notification to the FDA for a new dietary ingredient (NDI). Often a company unfamiliar with the NDI notification process may find it difficult to determine whether they need to file an application and how to go about it.

The new guidelines are not always straightforward. Our experienced regulatory team can help companies work through the NDI process and supply the road map to determine the best course of action for your submission.

Our team at GRAS Associates is well versed with these requirements and assists clients in compiling the needed information to prepare and submit the notification.

Contact a member of our team today or email us directly at You may also request a customized quote and we will contact you with details within two business days.