USP Launches Supplement Certification Program

March 1, 2001

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USP Launches Supplement Certification Program

ROCKVILLE, Md.--The U.S. Pharmacopeia (USP) will launch a voluntarypilot program this month that will serve as a framework for a nationalcertification program for dietary supplement ingredients. Various dietarysupplement manufacturers in the United States will work with USP in reviewingand enhancing the criteria, standards and procedures required for a nationalquality assurance program. The program includes reviewing tests conducted bymanufacturers on ingredients; enforcing good manufacturing practices (GMPs); andtracking products after market introduction. As part of the pilot program, USPwill form a dietary supplement Industry Advisory Group (IAG), as well ascontinue to conduct stakeholder meetings, to gather input on how to develop theprogram.

"This certification program is a logical next step for USP," saidRoger Williams, M.D., executive vice president and chief executive officer ofUSP. "[USP has] 180 years of experience in drug standards-setting and morethan 100 years experience in dietary supplement standards-setting."

After a manufacturer successfully completes the pilot phase and passes themanufacturing audit, it will be granted approval to use USP's certificationmark. In addition, USP is presently conducting focus group tests to establishthe value of this certification mark in the consumer's mind and will provideconsumer and healthcare marketing tools accordingly. USP stated that after thepilot program ends, the launch of a national program is planned for later thisyear that will enforce product quality and GMPs. For additional information,visit www.usp.org.

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