Dietary Supplement Standards Development Process

Dev Process header

USP develops public standards to provide quality oversight for dietary supplements and their ingredients. Public input and interaction are vital to the development of these standards, which originate from the draft monographs and data provided by dietary supplement manufacturers, users, and suppliers. USP's scientific staff and the volunteer Dietary Supplements Expert Committee review data, conduct necessary laboratory tests, and ensure that the information is subject to a process of public review and comment.

The standards development process begins with the submission of a dietary supplement product or ingredient monograph draft or a request for a revision to an existing monograph. The process culminates with approval by USP's Dietary Supplements Expert Committee and publication in one of USP's compendia (DSC, USP–NF, or FCC).

Proposal for New Monographs and Revisions

Proposals for new or revised dietary standards from USP–NF and FCC that appear in the DSC are first published for public review and comment in either the Pharmacopeial Forum or the FCC Forum. Through these free online forums, interested parties have the ability to provide feedback on the proposed standards and revisions and participate in the USP standards-setting process. Access the forums below (please note: a one-time, free registration is required).

Accelerated Revision Process

In certain instances as specified by the Rules and Procedures of the USP Council of Experts (e.g., errata and expedited and immediate standards), revisions to dietary supplement standards in the USP–NF and FCC can be made more quickly through special accelerated processes. See the guidelines below for details:

Admission Criteria and Safety Classification Guideline