Introduction
An NDIN 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)
Skipping this step could result in unnecessary regulatory filings or, worse, missing a required submission.
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.
Your application must include toxicology studies that establish safe consumption levels, clinical trials that support safety and efficacy, historical use data if the ingredient has been consumed in other markets, and manufacturing details outlining purity, contaminants testing, and quality control measures.
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 composition, source, and purity. It should outline the proposed use of the ingredient in dietary supplements and provide a recommended dosage based on safety evaluations. The submission must also include a summary of relevant scientific studies and manufacturing process documentation to demonstrate quality control.
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’s preferred method
- Hard copy submission – Sent to the CFSAN Document Control Center
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 missing toxicology or clinical safety data, incomplete ingredient identity details, and inconsistencies in manufacturing documentation.
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 Good Manufacturing Practices (GMPs), monitor for adverse effects, and ensure accurate labeling.
If there are any changes in ingredient sourcing, manufacturing processes, or intended use, a new NDIN application may be required. 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.
