Introduction
An NDIN (New Dietary Ingredient Notification) application is required if you plan to introduce a new dietary ingredient in the U.S. market. The FDA mandates that any ingredient not marketed before October 15, 1994, must undergo this process. Failure to comply could result in regulatory action or product recalls.
The NDIN application process can be complex, but proper preparation can improve your chances of success. This guide outlines the seven key steps to help you navigate the process smoothly.
1. Confirm If Your Ingredient Requires an NDIN Application
Not all ingredients require an NDIN. The FDA defines a New Dietary Ingredient (NDI) as one that was not marketed in the U.S. before October 15, 1994. If your ingredient has been self-affirmed as Generally Recognized as Safe (GRAS), an NDIN may not be necessary. To determine if an NDIN application is required, you can:
- Review the FDA’s dietary ingredient database
- Search the GRAS Notices Inventory for existing approvals
- Consult regulatory experts if you’re unsure (Contact GRAS Experts)
Even if you’re uncertain whether your ingredient qualifies as an NDI under the FD&C Act, you may still submit a notification to the FDA as a precaution.
Skipping this step could result in unnecessary regulatory filings — or worse, missing a required submission. If an NDIN is required, it must be submitted at least 75 days before the ingredient is introduced or delivered for introduction into interstate commerce.
You must submit a premarket notification if you are a:
- manufacturer who intends to market a new dietary ingredient;
- manufacturer who intends to market a dietary supplement that contains a new dietary ingredient;
- distributor who intends to market a new dietary ingredient; or
- distributor who intends to market a dietary supplement that contains a new dietary ingredient.
2. Gather Scientific Evidence to Support Safety
The FDA requires strong scientific evidence to demonstrate that your ingredient is safe for human consumption. Insufficient data is one of the most common reasons for NDIN rejection. You must provide the following information in the notification:
- Your name and complete address.
- The name of the new dietary ingredient. If the new dietary ingredient is an herb or other botanical, you must include the Latin binomial name (including the author).
- A description of the dietary supplement or dietary supplements that contain the new dietary ingredient, including the:
- Level of the new dietary ingredient in the product;
- Conditions of use of the product recommended or suggested in the labeling or if no conditions of use are recommended or suggested, the ordinary conditions of use; and
- History of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe.
- Any reference to published materials must be accompanied by reprints or photocopies.
- Any material in a foreign language must be accompanied by an English translation.
- The signature of a person you designate who is responsible for the content of the notification and can be contacted if we have questions.
Well-documented safety data reduces the likelihood of FDA objections and ensures a smoother review process.
3. Prepare a Complete NDIN Application
A well-prepared NDIN application minimizes delays and increases the chances of a successful outcome. The application should provide a detailed overview of the ingredient, its intended use, and supporting scientific evidence.
The NDIN application must include ingredient identity details such as the level of the new dietary ingredient, condition of use, history of use, and safety evidence.
You conduct a thorough search of the scientific literature and consider the evidence of safety found there, including an examination of adverse effects associated with the use of the ingredient. For further guidance on FDA requirements, refer to the FDA’s NDIN submission guidance.
4. Submit Your NDIN Application to the FDA
Once your NDIN application is complete, submit it to the FDA’s Office of Dietary Supplement Programs (ODSP). The FDA does not charge a fee for NDIN submissions, but costs may arise from safety testing and regulatory consulting. Ways to submit an NDIN application include:
- Electronic Submission Gateway (ESG) – The FDA provides an e-portal (CFSAN Online Submission Module or COSM) for electronic submissions. You may use the same COSM account for future submissions. FDA encourages submitters to utilize the portal in order to receive confirmation of receipt by FDA and to facilitate review. This will also allow submitters to obtain status updates on their notifications via email.
- Hard copy submission – Sent to the CFSAN Document Control Center. FDA recommends submitting a new dietary ingredient notification (NDIN) electronically, if possible. However, if you send a written submission, send it to: Office of Dietary Supplement Programs (HFS-810).
After submission, keep a copy of all documents and monitor the FDA’s acknowledgment to ensure it has been received.
5. Monitor the 75-Day FDA Review Period
Once submitted, the FDA has 75 days to review your NDIN application. During this time, the agency assesses the safety data, ingredient identity, and intended use.
The FDA may either accept the application with no objections, request additional safety data or clarifications, or object to the application if it does not meet safety requirements. If no objections are issued within 75 days, the ingredient can be introduced to the market. However, this does not mean the FDA has approved the ingredient, only that it has no immediate safety concerns.
6. Address Any FDA Deficiencies or Additional Requests
If the FDA finds gaps in your submission, they may request additional information. The most common issues involve lack of adequate safety evidence and submission of an incomplete application.
Addressing these concerns promptly helps keep the application on track. Companies should ensure they have the necessary scientific evidence and work with regulatory experts to resolve any issues efficiently.
7. Maintain Compliance After Your NDIN Application is Accepted
Even after an NDIN application is successfully processed, compliance does not end. The FDA requires companies to adhere to ongoing compliance, including post-market surveillance for adverse effects and maintenance of accurate product labeling. Regular compliance checks help avoid regulatory issues and ensure continued market approval.
Final Thoughts
An NDIN application is a critical step for companies introducing new dietary ingredients to the U.S. market. Following these seven steps will help you submit a well-prepared application, avoid unnecessary delays, and meet FDA compliance requirements.
For expert assistance with your NDIN application, contact GRAS Experts today.
