Overview
On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new dietary ingredient notification (NDIN) process. These materials aim to assist the dietary supplement industry in correctly preparing and submitting NDINs for FDA approval and highlight common issues in the NDIN submission process. The FDA uses the notification process as a crucial tool to identify and evaluate the safety of new dietary ingredients (NDIs) in dietary supplements prior to market authorization and customer consumption.
In Depth
Background
The FDA’s authority to oversee dietary ingredient notifications is established under Section 413 of the Federal Food, Drug, and Cosmetic Act. Under the act, manufacturers and distributors of an NDI that has not been present in the food supply as an article used for food, or of a dietary supplement that contains the NDI, must submit a premarket safety notification to the FDA at least 75 days before introducing the product to the market. Notifications should generally include information conveying the basis for why the manufacturer or distributor reasonably concludes that the NDI will be considered safe for its recommended use. NDINs should specify the category that the NDI belongs to, describe the physical and chemical composition and structure of the NDI, depict the NDI’s manufacturing process, and include a specification sheet that describes the NDI’s critical identity and safety attributes along with any impurities and contaminants.
If the required premarket notification is not submitted to the FDA, the dietary supplement is deemed to be adulterated. The FDA will not evaluate incomplete NDINs. Therefore, ensuring complete and accurate NDINs is crucial since they represent the FDA’s only opportunity to assess the safety and identity of NDIs in dietary supplements before they becomes available to consumers.
The NDIN submission process
To facilitate an efficient and timely FDA review of NDINs, the agency released two educational videos and a supplemental fact sheet. The materials provide guidance to NDI manufacturers and distributors to ensure that notifications are complete and accurate, and to avoid delays in the review process. These educational materials aim to simplify and increase the transparency of the NDIN process.
The first video, “Important Aspects of the NDIN Process,” and the fact sheet outline common issues the FDA has observed in the NDIN submission process that may lead to unnecessary delays. These issues can be addressed by ensuring that notifications:
- Specify the dietary category to which the NDI belongs
- Cover the broadest possible use of the NDI
- Include sufficient identity information for the NDI (e.g., physical and chemical composition, manufacturing process, identity and safety attributes) and how scientific evidence supports such information
- Exclude irrelevant or extraneous information that does not support the notifier’s conclusions about the identity or safety of the NDI
- Properly reference and provide complete copies of referenced articles or other underlying materials to support the safety of the NDI along with any necessary English translations
The second video, “Correspondence Between FDA and the Notifier,” provides further clarification on what manufacturers can expect after an NDIN has been submitted to the FDA. The video encourages electronic submission through the Center for Food Safety and Applied Nutrition Online Submission Module ePortal, which guides users through required elements and enables email updates. Paper submissions are also accepted with specific formatting and follow-up requirements.
Once a notification is received, the FDA issues an acknowledgment letter with the official filing date, triggering a 75-day review period during which the product cannot be marketed. The video explains that FDA reviewers may request additional information, and if a substantive amendment is submitted, the review clock resets. The video also covers the types of response letters manufacturers may receive, including a no objection letter, a letter raising concerns about identity or safety, a letter identifying regulatory deficiencies, or a letter indicating that the ingredient is not a dietary ingredient or is intended for a non-supplement use. NDINs and response letters remain confidential for 90 days post-filing, after which they are posted on regulations.gov, excluding trade secrets or confidential commercial information. Finally, the FDA encourages potential notifiers to request a pre-submission meeting to help ensure their NDINs are complete and compliant.
Next steps
Recent developments in FDA regulations resulting from the Trump administration’s Executive Order (EO) 14221, “Making America Healthy Again by Empowering Patients With Clear, Accurate, and Actional Healthcare Pricing Information,” have emphasized transparency within the drug industry and consumer empowerment to make well-informed healthcare decisions. Manufacturers and distributors of dietary supplements should take proactive steps to ensure that their NDIs are safe and effective for consumer use. Companies involved in the dietary supplement industry should conduct a thorough review of their current protocols to ensure that their NDIs are fully compliant with the NDIN process and that they align with the objectives of EO 14221.
The McDermott difference
McDermott will continue to monitor any changes to the FDA’s dietary ingredient notification procedures and timeframes. If you have questions about how this notification process could impact your business, please contact the authors of this article or a member of McDermott’s Food, Drug & Medical Device Regulatory Group.
