Admission Criteria and Safety Classification for Dietary Supplements Guideline

October 22, 2009

USP updated the dietary supplements safety classification system as an "Admission Criteria and Safety Classification for Dietary Supplements Guideline (Guideline)." The purpose of this Guideline is to set forth the criteria USP uses to determine whether a dietary ingredient as a component of a dietary supplement qualifies for admission into the United States Pharmacopeia and National Formulary (USP-NF) based on its level of safety concern. USP's evaluation of a dietary supplement ingredient under this Guideline is performed for the sole purpose of determining admission into the compendia and should not be relied upon as any finding about the intrinsic safety or effectiveness of the dietary ingredient under review. This Guideline was developed at the USP Dietary Supplements Information Expert Committee meeting in February 2009, and from public comments.

This Guidance updates and replaces Compendial Notice "Admission Criteria and Safety Classification for Dietary Supplements Guideline" of April 10, 2009

• Download Admission Criteria and Safety Classification for Dietary Supplements Guideline  (28KB)

Should you have questions, please contact Dandapantula N Sarma, Senior Scientific Liaison, Documentary Standards Division ().