Pre-notification Consultation
Engage with regulatory experts to determine if your ingredient qualifies as "new" and develop a strategic plan for the NDIN process.
New Dietary Ingredient (NDI) Notification is a process mandated by the U.S. FDA for any dietary supplement containing ingredients not marketed in the U.S. before October 15, 1994. Manufacturers or distributors must provide evidence demonstrating these new ingredients’ safety before marketing the product.
Let’s say you want to make a new kind of vitamin or supplement to help people stay healthy. Before you can sell it, you must notify the FDA about your new ingredients. The notification includes details about the ingredients, the supplement, recommended usage, and evidence of safety.
Compliance with this process is essential for ensuring consumer safety and adherence to FDA regulations.
Dietary supplement manufacturers, importers and distributors are responsible for submitting an NDIN for any ingredient that meets the definition of “new dietary ingredient”. This includes:
Compliance ensures regulatory adherence and consumer safety, as it allows the FDA to evaluate the safety of the NDI before it enters the market. Failure to submit an NDI notification can result in regulatory action. Therefore, relevant parties need to understand and fulfill their obligation to submit NDI notifications as required by FDA regulations.
Submitting a successful NDIN requires careful preparation and a comprehensive dossier outlining the safety of your new dietary ingredient. Here’s a simplified breakdown of the process:
Engage with regulatory experts to determine if your ingredient qualifies as "new" and develop a strategic plan for the NDIN process.
Conduct thorough safety studies or compile existing data to demonstrate the safety of your ingredient for its intended use in a dietary supplement.
Develop a comprehensive NDIN notification package that includes all required information, such as the ingredient's identity, manufacturing process, safety data, and labeling.
The FDA will review your NDIN submission and may request additional information or clarification.
The FDA will issue a letter indicating their decision regarding the safety of your new dietary ingredient.
Navigate the complex regulatory landscape with confidence and ensure your product’s safety and market readiness with GRAS Experts.
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No time to waste! We help you get to the market quickly without compromising quality.
Every ingredient is unique, and so is our approach. We tailor our services to your specific needs.
Safety is our top priority. We make sure your ingredients meet all the requirements.
Avoid costly delays, fines and potential product recalls with our expert guidance.
Regulations can change. We’ll keep you compliant for the long haul.
The GRAS notification process ensures the FDA formally reviews and evaluates your ingredient’s safety for its intended use. This evaluation helps build consumer trust, comply with FDA safety standards, and reduce regulatory risks. By submitting a detailed GRAS notice, you can gain official recognition that strengthens your market position. GRAS Experts specializes in guiding businesses through this process to ensure timely approval and compliance.
The New Dietary Ingredient (NDI) Notification process complements FDA GRAS compliance by addressing dietary supplements containing ingredients introduced after October 15, 1994. GRAS compliance ensures that ingredients used in food are “Generally Recognized as Safe” for specific uses, while NDIN focuses on the safety of dietary ingredients in supplements. Both processes work to align with FDA safety standards, but they serve different regulatory purposes.
An NDI submission must include safety studies, toxicology data, and evidence demonstrating the ingredient’s safe use in dietary supplements. While not mandatory, a detailed letter of certification for GRAS ingredients strengthens the submission by showing prior safety evaluations. This certification can highlight an ingredient’s established safety for food use, building a strong foundation for the NDIN process.
Yes, GRAS ingredients can be included in dietary supplements through an NDI submission. If an ingredient already has GRAS certification for a specific use, this can support the safety evaluation. However, the ingredient must still meet the NDI requirements for its intended use in the dietary supplement.
A food safety audit ensures your manufacturing practices and safety assessments align with FDA standards. This proactive approach minimizes potential compliance issues during the FDA’s review of your NDIN submission and enhances your ingredient’s safety profile.
The FDA typically reviews NDI submissions within 75 days. Including the certification of GRAS ingredients as part of your submission can enhance the safety profile and streamline the review process. GRAS certification provides a robust safety foundation, reducing the likelihood of delays or requests for additional data.
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