Guideline for the Admission of Dietary Supplement Ingredients to the USP–NF Monograph Development Process
At a meeting of the Dietary Supplements Admission Evaluations JS3 (DSAE JS3) that was held by teleconference on March 11th, 2016 the JS3 made three minor revisions to the Guideline for the Admission of Dietary Supplement Ingredients to the USP-NF Development Process. The revisions included the following:
- The document title was changed to appropriately align with the function of the document so that it now reads as “Guideline for the Admission of Dietary Supplement Ingredients to the USP–NF Monograph Development Process”.
- The introductory paragraph was edited to clarify that the DSAE JS3 admits new dietary ingredients to the USP monograph development process rather than to the USP-NF compendium.
- Class A category in the classification system was expounded to clarify that in certain cases, for some articles, the DSAE JS3 may recommend that monograph development proceeds under Class A only if a cautionary label statement is included in the monograph.
The above changes were necessitated by challenges that the JS3 have faced when making determinations regarding admission of certain ingredients. These minor edits are thus intended to clarify specific aspects of the admission evaluation process and how it fits within the USP monograph development process1 while at the same time preserving the critical function performed by the JS3 and allowing additional flexibility in addressing safety issues, depending on the particular issues involved, the level of available safety data as well as other relevant considerations.
In keeping with USP's "continuous revision" approach, the JS3 will monitor the safety information for all dietary ingredients for which USP monographs are developed on an on–going basis for possible admission re-evaluation and re-classification should new safety signals become evident. The modified Guideline became effective on March 30th, 2016.
Guideline for the Admission of Dietary Supplement Ingredients to the USP–NF Monograph Development Process Download PDF