Introduction of GRAS and NDI Management in the US and Analysis of the Relationship between FDA and USP

In 2024, the restructuring of the US Food and Drug Administration (FDA) was approved and officially took effect on October 1, 2024. A key change in this restructuring is the creation of the Human Foods Program (HFP) and the adoption of new models for on-site operations, along with other significant modernization efforts. As a result, changes have also occurred in the management of Generally Recognized as Safe (GRAS) substances and New Dietary Ingredient (NDI). 

Introduction of the reorganized FDA GRAS and NDI management

• After the restructuring, the organizational structure of human food GRAS and NDI management is as follows:

• In this FDA restructuring, the animal food GRAS evaluation has not been affected, and its management structure is as follows:

The relationship between the FDA and USP

Functions of the FDA and the United States Pharmacopeia (USP):

FDA: A government regulatory agency responsible for ensuring the safety and effectiveness of food, drugs, medical devices, etc., and enforcing relevant laws and regulations.

USP: An independent scientific organization focused on developing quality standards for dietary supplements, food ingredients, drugs, etc., which are included in the United States Pharmacopeia-National Formulary (USP-NF) and the Food Chemical Code (FCC).

Relationship between FDA and USP:

In short, the FDA is a government regulatory agency and the USP is an independent organization. There is no organizational affiliation between the two agencies, but the FDA will refer to the quality standards issued by the USP, namely FCC and USP-NF, in the management of some foods, drugs, and dietary supplements.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.