In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. If you’re developing a dietary supplement with a new dietary ingredient — an NDI — this video is essential for you.
A new dietary ingredient is any dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. If your supplement contains an NDI, you are required to notify the FDA at least 75 days before you begin marketing the product.
The NDI notification must include information about the ingredient’s identity — how it’s manufactured, its chemical composition, and how it’s standardized. It must also include the history of use or other evidence of safety establishing a reasonable expectation that the NDI will be safe under the conditions of use recommended in the supplement.
The safety standard is “reasonable expectation of safety” — not the same as GRAS or drug approval. But it still requires real evidence. Anecdotal use, general references, or studies on unrelated ingredients won’t satisfy the requirement.
If you submit an NDI notification and the FDA has safety concerns, they’ll issue an objection letter. You cannot market the supplement until you adequately address those concerns.
Failing to file a required NDI notification before marketing is a violation of the FD&C Act. The consequences can include warning letters, injunctions, and product seizure.
If you’re working with a novel ingredient and aren’t sure whether an NDI notification is required, get a regulatory assessment before you go to market. We can help. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.