GRAS/NDI Declaration

"GRAS" is the acronym for Generally Recognized As Safe in English. According to Chapters 201(s) and 409 of the U.S. Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is considered a food additive and requires mandatory FDA premarket approval, with a few exceptions. GRAS is one such exception, where substances functionally qualify as food additives but are exempt from the lengthy and rigorous FDA approval process due to their "high safety profile."

For food companies, botanical enterprises, and traditional Chinese medicine manufacturers, entering the mainstream U.S. health product market through NDI registration is a more economical and expedient approach.

The FDA's approval process for GRAS and NDI is highly complex and specialized. The approval rate is low, so Chinese companies seeking GRAS or NDI certification are advised to work with expert agencies that have professional expertise and background.