Our NDI & GRAS Review Services provide comprehensive assessments, regulatory submissions, and scientific evaluations to help you navigate FDA requirements and ensure uninterrupted market access.
The FDA regulates dietary supplement ingredients to protect consumer safety and ensure accurate product claims.
Failure to comply with NDI notification and GRAS regulations can result in:
Our NDI & GRAS review services ensure your products meet ingredient safety standards, allowing for faster market entry and reduced compliance risks.
We will help you determine whether your dietary supplement ingredient qualifies as a New Dietary Ingredient (NDI) and requires a notification submission to the FDA.
If your ingredient qualifies as an NDI, you must submit a notification to the FDA at least 75 days before marketing the product. We handle the entire submission process.
For food additives and ingredients to be used in dietary supplements, GRAS status is essential. We conduct scientific evaluations to determine whether ingredients meet GRAS criteria
The FDA requires robust safety data for new ingredients. We coordinate with third-party laboratories and conduct scientific reviews to substantiate ingredient safety.
To demonstrate an ingredient’s safety and history of use, we conduct in-depth literature reviews and global regulatory comparisons.
Our experts provide tailored regulatory guidance to ensure your ingredients meet U.S. market requirements and navigate potential compliance challenges.
Specialists in 21 CFR Part 190 regulations for dietary supplement ingredients.
Our assessments are based on robust scientific data, clinical evidence, and toxicological evaluations.
From ingredient classification to final FDA submission, we handle every step of the process.
We help avoid recalls, detentions, and non-compliance penalties through regulatory readiness.
Read what our clients have to say about our services and how we have helped them export product.
An NDI is an ingredient that:
GRAS status means that a substance is:
GRAS status is established through:
Our team is friendly, responsive and we love to talk to people interested in what we do. Feel free to get in touch and one of our team will always get back to you. Guaranteed!
Ensuring your dietary supplement ingredients comply with FDA NDI and GRAS regulations is critical for successful market entry. Our NDI & GRAS Review Services provide the scientific, regulatory, and strategic support you need to avoid import delays, reduce compliance risks, and launch your products confidently.
Our friendly team is always happy to help and will reach out as soon as possible.
Find out more about our solution, team andhow we can help through the content we publish.
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