Navigating the regulatory landscape of dietary supplements can be complex—especially when it comes to introducing a New Dietary Ingredient (NDI). At GRAS Experts, we provide comprehensive support to help companies meet NDI compliance requirements and avoid costly delays or rejections from the U.S. Food and Drug Administration (FDA).

What is NDI Compliance?

NDI compliance refers to meeting the FDA’s regulatory requirements for introducing a new dietary ingredient that was not marketed in the United States before October 15, 1994. To lawfully include such an ingredient in a dietary supplement, manufacturers must submit a New Dietary Ingredient Notification (NDIN) at least 75 days before the product is marketed.

This notification must demonstrate that the NDI is reasonably expected to be safe under the recommended conditions of use. Failing to properly comply with NDI regulations can result in FDA warning letters, product recalls, or removal from the market.

Why NDI Compliance Matters

NDI compliance is not just a regulatory formality—it’s a critical step in ensuring consumer safety and building trust in your brand. Properly navigating the NDI process helps:

  • Avoid enforcement actions from the FDA

  • Strengthen your product’s scientific and safety profile

  • Support long-term brand credibility

  • Enable smoother product launches in the U.S. market

Our Expertise in NDI Compliance

At GRAS Experts, our team brings decades of experience in regulatory science, toxicology, and FDA submission strategy. We assist clients with every aspect of the NDI process, including:

  • Ingredient qualification – Assessing whether your ingredient qualifies as a new dietary ingredient

  • Scientific literature reviews – Compiling safety data from published studies

  • Toxicology and safety analysis – Evaluating your NDI for potential health risks

  • NDI Notification preparation – Drafting, formatting, and submitting your NDIN to the FDA

  • Regulatory strategy – Guiding you through FDA feedback and next steps

Streamline Your NDI Pathway with Confidence

Bringing a new dietary ingredient to market can be challenging, but you don’t have to do it alone. GRAS Experts provides personalized support to ensure your product is compliant, safe, and ready for launch. With our hands-on approach and regulatory insight, we simplify the process and give your business a competitive edge.