03/10/2019
In September 2018, AOAC successfully completed a 5-year contract with the U.S. National Institutes of Health-Office of Dietary Supplements (NIH/ODS) to establish voluntary consensus standards for 25 high priority ingredients, with the goal of Official MethodsSM. The project resulted in 34 Standard Method Performance Requirements (SMPRs®) and 16 Official MethodsSM for priority dietary supplement ingredients that reflect the needs of the dietary supplement community.
?Many of our members and staff consider this one of the largest, most challenging, and successful projects in AOAC?s history,? said Executive Director David B. Schmidt. ?AOAC?s work in the dietary supplement area has resulted in an impressive list of standards developed and methods adopted. Yet, there is an opportunity to expand upon this seminal work to provide further analytical solutions for the dietary supplement industry, working in collaboration with NIH and AOAC. We are seeking stakeholder input on this at the Midyear Meeting.?
Critical to the success of the project was engagement of industry representatives participating on the advisory panel, stakeholder panel, working groups, and expert review panels (ERPs) to ensure that efforts are relevant, timely, and meet the needs of stakeholders.
Since the contract signing in September 2013, AOAC facilitated:
Six advisory panel meetings to identify key stakeholders, subject matter experts, issues, and ingredients, and set priorities for the stakeholder panel. The panel identified and prioritized 25 dietary supplement ingredients for which systematically reviewed analytical methods are needed.
Ten stakeholder panel meetings to examine voluntary consensus standards for possible adoption. SMPRs were adopted for all 25 priority ingredients, some of which required more than one standard.
Twenty-five working groups to develop and recommend SMPRs that meet the needs of stakeholders for each priority dietary supplement ingredient.
Seven ERPs to evaluate candidate methods against SMPRs for possible adoption as First Action Official MethodsSM for the prioritized ingredients. Most recently, AOAC ERPs granted Official First Action status to six methods during the AOAC Annual Meeting in August 2018: aloe vera, echinacea, ginseng, kavalactones (two), and ginger.
Approved SMPRs and First Action Official MethodsSM are codified and published in the Journal of AOAC INTERNATIONAL and Official Methods of Analysis.
Future Collaboration
The overall body of work between AOAC and NIH/ODS is enormous. The first contract took place from 2001 to 2008, and then annual contracts up to 2012.
?The knowledge we?ve gathered from experts on this project is unprecedented,? Sullivan said. ?Their expertise is valuable, and AOAC is exploring strategies to continue the good work coming out of this project, which is something that all can be proud of.? AOAC continues to engage the advisory panel for a renewal effort to advance SPDS standards development activities, for example, revisiting SMPRs and convening ERPs for ingredients for which no methods have been adopted. AOAC is also exploring other opportunities, such as training courses, consulting services, and a dietary supplement ingredient summit.
Full coverage of AOAC?s work on the dietary supplement project appears in the January/February 2019 issue of Inside Laboratory Management.
