FAQs

From Dietary Supplements e-Newsletter - May 2009

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Q. Describe the USP standard development process, and how I can participate.

A. USP develops and publishes public standards and their revisions that are used to monitor the quality of diverse health-related products, including dietary supplements and their ingredients. The process is independent from governments and open to worldwide public input. The standards originate from data provided by experienced manufacturers, usually the originators or patent holders of the ingredients and products. USP’s scientific staff and volunteer experts review this input, conduct necessary laboratory tests, and ensure that the information is subject to a process of public review and comment. To that end, USP publishes the proposals for changes and additions to USP–NF in the PF, a bimonthly journal. Once the comment period has elapsed, the Scientific Liaisons collate the comments and forward them to the appropriate Expert Committee for their review. Based on the evaluation of these comments, the Expert Committee ballots and if in agreement, incorporates the changes into the next revision of the USP–NF. To add transparency to this process, a summary of the public comments elicited and the Expert Committee’s responses are published in the Commentary section of the USP Web site (see www.usp.org/USPNF/revisions/). Proposals that require further revisions are republished in PF with a briefing detailing the Expert Committee responses and the changes made.

Tables of contents of current and past PF issues are available at: www.usp.org/USPNF/pf/.

Participation in USP's public standards-setting process by the dietary supplements industry and other stakeholders is vital to the development of authoritative, relevant USP–NF monographs. Interested parties can participate in any of the following ways:

• Submit new draft monographs for dietary supplements and their ingredients.
• Review and comment on draft monographs published in PF.
• Propose revisions to monographs and procedures in the current official edition of USP–NF and submit data for proposed alternatives.
• Share with USP concerns regarding public comments on proposed new monographs and revisions published in PF.