By EAS Senior Consultant James Hoadley Ph. D.
Our July Issue of the Month article titled “Why Submit a GRAS Notification for a Dietary Ingredient?” drew a lot of attention from readers. In this follow-up note, Jim Hoadley responds to one significant question.
Is an NDI exempt from the NDI notification requirement when the same substance is the subject of a food ingredient GRAS determination, but the ingredient has not been marketed as a conventional food ingredient?
Good question – I’m glad you brought it up because the newsletter article was not as clear as it could have been on this point. The NDI notification requirement exemption is for “ingredients which have been present in the food supply as an article used for food…” Submitting a GRAS notification does not exempt a dietary ingredient from the NDI notification requirement – the GRAS determination is only the first step and it must be followed by actually getting this ingredient into the food supply through marketing it as a food ingredient. Submitting the GRAS notification to FDA is voluntary; however, when your use of a new ingredient as a GRAS food ingredient serves as an alternative to a NDI notification then it is wise to submit the GRAS notification as documentation of your conclusion that the consumption of the ingredient will be safe. In this sense the FDA’s GRAS Notification Program serves as a substitute to an NDI notification. GRAS self-determination as a food ingredient is not a path to be used to avoid submitting a safety notification for your NDI.
When you have submitted a GRAS notification for a food ingredient use; but, have not yet actually marketed the ingredient for the food use then the ingredient is NOT present in the food supply. The exemption from the NDI notification requirement kicks in only when the ingredient is present in the food supply.
When the marketing of a substance as a GRAS food ingredient is being used as a substitute for submitting an NDI Notification there are a couple points to keep in mind. Firstly, ingredients specified in the GRAS Notification and the NDI must be in the same chemical form without alteration. Secondly, the NDI consumption resulting from its dietary supplement use should be the same as, or lower than, the intake level that has been determined to GRAS.