In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa, an FDA compliance attorney. Today we’re breaking down dietary supplement ingredients — because not all ingredients are treated the same under FDA law.
Dietary supplement ingredients fall into two broad categories: old dietary ingredients, or ODIs, and new dietary ingredients, or NDIs.
Old dietary ingredients are those that were marketed in the United States in a supplement before October 15, 1994. If your ingredient has been on the market since before that date, you’re generally in a more straightforward compliance position.
New dietary ingredients — anything first marketed after October 15, 1994 — require an NDI notification to the FDA before you can legally market a supplement containing them. The notification must include safety data demonstrating there is a reasonable expectation that the NDI will be safe under the conditions of use.
Beyond the ODI/NDI distinction, you also need to verify the identity, purity, strength, and composition of every ingredient — that’s a cGMP requirement. And your ingredient suppliers matter too; you need documentation to confirm what you’re actually getting.
Understanding your ingredient regulatory status is foundational to everything else in supplement compliance. If you’re developing a new product or reviewing an existing formulation, we can help. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.