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.
We’ve been doing this for over 18 years, with over 2,000 happy clients!
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.
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