Following the introduction of the New Dietary Ingredient Notification (NDIN) scheme, the US Food and Drug Administration (FDA) has released a porfolio of industry-focused tools.
The educational resources are designed to support dietary supplement manufacturers and distributors in submitting a complete NDIN form, which the regulator claims will "facilitate an efficient and timely FDA review."
This follows the passing of Section 413 of the Federal Food, Drug, and Cosmetic Act, which requires manufacturers and distributors to submit a premarket safety notification to the FDA before marketing certain new dietary ingredients intended for use in supplement products.
This is the regulatory agency's only opportunity during the supplement commercialisation process to evaluate the safety and identity of a new dietary ingredient before it's sold to consumers, and "having a well-organised and scientifically supported NDIN" will expedite the process significantly.
The first tool is a video, titled “Important Aspects of the NDIN Process,” which is accompanied by a fact sheet outlining and addressing common pain points the FDA has observed in the NDIN submission process.
The second is a video outlining what manufacturers should expect after an NDIN has been submitted; this section primarily focuses on correspondence expectations between the FDA and the notifier.
Entitled “Correspondence Between FDA and the Notifier," the video aims to facilitate effective communication between brands and the regulator, improving the overall efficiency of the review process.
According to a press release from the FDA, the materials are designed to simplify the NDIN submission process, "resulting in more complete NDINs submitted to the FDA, facilitating the agency's scientific review."
The regulator suggests that if anybody has questions about the NDIN process, they should contact the Office of Dietary Supplement Programs by email at NDITeam@fda.hhs.gov.
