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’s topic is GRAS — Generally Recognized As Safe — and specifically the difference between the GRAS notification procedure and the self-affirmation process.
GRAS status is relevant when a substance is used as an ingredient in a food or dietary supplement. If a substance meets the GRAS standard — meaning it’s generally recognized among qualified experts as safe under its intended conditions of use — it doesn’t need to go through the full FDA food additive petition process.
There are two ways to establish GRAS status. The first is through the FDA’s voluntary GRAS notification program. You compile a GRAS dossier, submit it to the FDA, and the agency reviews your conclusion. If the FDA has no questions, they issue a “no questions” letter, which is a significant validation.
The second is self-affirmation, also called self-determination. Your experts independently conclude that the substance is GRAS without notifying the FDA. This is legal, but it carries more risk — if your determination is challenged, you’re on your own to defend it.
For dietary supplement ingredients, the GRAS pathway is distinct from the new dietary ingredient pathway, and choosing the right approach for your specific ingredient matters. The wrong choice can create significant compliance problems.
If you’re working with an ingredient where GRAS status is a question, we can help you navigate the right pathway. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.