EAS authored an article discussing options for dietary supplement ingredient submissions – New Dietary Ingredient (NDIs) and Generally Recognized as Safe (GRAS) on August 8, 2018, of the AHPA Report (AHPA membership required to view). Botanical chemicals may be isolated and also sold as dietary supplements, and in some cases, FDA’s interpretation of botanical and plant parts would qualify them for an NDI submission. In some cases, GRAS is a more appropriate submission for this unique category of botanicals. EAS can discuss your particular situation and help you to determine the right path for your product.
Posted in EAS in Action.