Recently, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification (NDIN) review process. Under Section 413 of the Federal Food, Drug, and Cosmetic Act, manufacturers and distributors must submit an NDIN to notify FDA before marketing a dietary supplement with a new dietary ingredient. These resources offer guidance on structuring submissions and outline what to expect during the agency’s review. Ultimately, they are intended to enhance the quality of NDIN submissions and minimize common pitfalls, with the goal of avoiding delays or unfavorable results in the agency’s review.
Key Takeaways:
- Clearly Establish Ingredient Identity: Include detailed manufacturing process information, chemical/physical properties and testing specifications (i.e., purity, strength and impurities).
- Precisely Define Intended Use: Avoid over-relying on previous NDINs for other manufacturers/distributors.
- Submit Relevant and Complete Safety Data: Focus on data supporting safety for the intended conditions of use and avoid including extraneous material.
- Provide Full Supporting References: Submit full texts (e.g., PDFs or scans) of cited studies and provide English translations where applicable.
- Expect and Prepare for FDA Follow-Up: Note that FDA may issue follow-up questions during its scientific review—typically within the 75-day review window. Additional inquiries may include clarification on the ingredient identity, safety evidence or manufacturing details.
Companies planning to market dietary supplements with new ingredients should view these materials as a roadmap for drafting more compliant NDIN submissions. Taking the time to align early with FDA’s expectations can help avoid costly delays and improve the likelihood of a successful review.
