scholarly journals Dietary Supplement Laboratory Quality Assurance Program: The First Five Exercises

2011 ◽  
Vol 94 (3) ◽  
pp. 803-814 ◽  
Author(s):  
Melissa M Phillips ◽  
Catherine A Rimmer ◽  
Laura J Wood ◽  
Katrice A Lippa ◽  
Katherine E Sharpless ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Toxic Elements ◽  
National Institutes Of Health ◽  
Quality Assurance Program ◽  
Good Manufacturing Practices ◽  
Marker Compounds ◽  
Total Participation ◽  
The U.S

Abstract The National Institute of Standards and Technology (NIST) has established a Dietary Supplement Laboratory Quality Assurance Program (DSQAP) in collaboration with the National Institutes of Health Office of Dietary Supplements. Program participants measure concentrations of active and/or marker compounds as well as nutritional and toxic elements in food and dietary supplements distributed by NIST. Data are compiled at NIST, where they are analyzed for accuracy relative to reference values and concordance among the participants. Performance reports and certificates of completion are provided to participants, which can be used to demonstrate compliance with current Good Manufacturing Practices as promulgated by the U.S. Food and Drug Administration. The DSQAP has conducted five exercises to date, with total participation including more than 75 different laboratories and many more individual analysts.

scholarly journals Development of the Analytical Methods and Reference Materials Program for Dietary Supplements at The National Institutes of Health

2004 ◽  
Vol 87 (1) ◽  
pp. 162-165 ◽  
Author(s):  
Leila G Saldanha ◽  
Joseph M Betz ◽  
Paul M Coates
Keyword(s):  
Quality Control ◽  
Dietary Supplements ◽  
Reference Materials ◽  
Analytical Methods ◽  
Research Agenda ◽  
Control Unit ◽  
Lessons Learned ◽  
National Institutes Of Health ◽  
Good Manufacturing Practices ◽  
The U.S

Abstract The need for validated analytical methods and reference materials to identify and measure constituents in dietary supplements is essential. Such methods allow for the documentation that products meet manufacturer's specifications and contain what their labels declare. In March 2003, the U.S. Food and Drug Administration issued a proposed rule that would establish specific current good manufacturing practices for dietary supplements. This proposed rule requires that companies create a quality control unit to set specifications and ensure compliance with these specifications using scientifically valid procedures. This report provides insights and lessons learned from 3 meetings the Office of Dietary Supplements (ODS) at the National Institutes of Health helped organize. These meetings were structured to (1) educate individuals about the importance and need for validated analytical methods and reference materials to identify and quantify constituents of dietary supplements; (2) identify resources required to fulfill this need; and (3) serve as a platform to obtain input from interested parties to help frame the research agenda for the Dietary Supplements Methods and Reference Materials Program within ODS. Stakeholder's opinions and views expressed at these 3 meetings are outlined in this report.

scholarly journals Determination of Curcuminoids in Turmeric Dietary Supplements by HPLC-DAD: Multi-laboratory Study Through the NIH-ODS/NIST Quality Assurance Program

2020 ◽  
Vol 103 (6) ◽  
pp. 1625-1632
Author(s):  
Elizabeth M Mudge ◽  
Paula N Brown ◽  
Catherine A Rimmer ◽  
Melissa M Phillips
Keyword(s):  
Quality Assurance ◽  
Dietary Supplements ◽  
Laboratory Study ◽  
Bulk Material ◽  
Test Sample ◽  
National Institutes Of Health ◽  
Quality Assurance Program ◽  
Quality Markers ◽  
Repeatability And Reproducibility

Abstract Background Turmeric is a medicinal herb containing curcuminoids, used as quality markers in dietary supplements. In 2016, an AOAC First Action Official MethodSM was adopted for quantitation of curcuminoids and requires multi-laboratory reproducibility data for Final Action status. Objective To collect reproducibility data for the quantitation of curcuminoids in dietary supplements through the National Institutes of Health Office of Dietary Supplements/National Institute of Standards and Technology Quality Assurance Program (QAP). Method Laboratories that participated in the QAP by following the Official Methods of AnalysisSM Method 2016.16, submitted data for ten turmeric products. The data were analyzed for mean, repeatability, and reproducibility standard deviations, repeatability, and reproducibility. Results The initial data collection resulted in insufficient replicates (five) for each test sample to determine reproducibility, therefore laboratories were provided additional materials resulting in an incremental data approach. For homogenous products, reproducibility for curcumin ranged from 3.4 to 10.3%, bisdemethoxycurcumin with reproducibility ranging from 6.4 to 14.8%, and demethoxycurcumin ranging from 5.6 to 9.9%. The method was unsuitable for the quantitation of curcuminoids in complex smoothie products, products containing microbeads, or tinctures based on interlaboratory variances. Recommendations were provided for future multi-laboratory studies performed through QAPs and incremental approaches. Conclusions Method 2016.16 is suitable for the quantitation of curcuminoids and should be adopted for Final Action status for single and multi-ingredient dietary supplements containing dried roots, dried powders/extracts in bulk material, capsules, and softgels. Highlights Reproducibility for Method 2016.16 was collected through a non-traditional incremental data multi-laboratory study. The method is suitable for quantitation of curcuminoids in most common dietary supplements.

scholarly journals Dietary supplement laboratory quality assurance program: exercise N final report

2018 ◽  
Author(s):  
Charles A Barber ◽  
Melissa M Phillips ◽  
Catherine A Rimmer ◽  
Laura J Wood ◽  
Steven J Christopher
Keyword(s):  
Quality Assurance ◽  
Dietary Supplement ◽  
Quality Assurance Program ◽  
Final Report

scholarly journals Dietary supplement laboratory quality assurance program: exercise M final report

2018 ◽  
Author(s):  
Melissa M Phillips ◽  
Catherine A Rimmer ◽  
Laura J Wood ◽  
Maria R Ale ◽  
Charles A Barber ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Dietary Supplement ◽  
Quality Assurance Program ◽  
Final Report

Precision Parameters for the FDA Shellfish Laboratory Quality Assurance Program for 1973–1989

1995 ◽  
Vol 58 (6) ◽  
pp. 648-650
Author(s):  
JAMES T. PEELER ◽  
THOMAS E. GRAHAM ◽  
LARRY J. MATURIN
Keyword(s):  
Staphylococcus Aureus ◽  
Quality Assurance ◽  
Fecal Coliform ◽  
Quality Assurance Program ◽  
Plate Count ◽  
Most Probable Number ◽  
Probable Number ◽  
Standard Plate Count ◽  
Standard Plate ◽  
The U.S

Precision parameters from four microbiological analytical methods (coliform most probable number [MPN], fecal coliform MPN, Staphylococcus aureus plate count and standard plate count) were computed for the Shellfish Quality Assurance Program of the U.S. Food and Drug Administration (FDA). The pooled reproducibility variance (SR2) for the four methods from 1973 to 1989 were 0.0778, 0.1181, 0.0137, and 0.0087, respectively.

scholarly journals Dietary supplement laboratory quality assurance program: exercise N final report

2018 ◽  
Author(s):  
Charles A Barber ◽  
Melissa M Phillips ◽  
Catherine A Rimmer ◽  
Laura J Wood ◽  
Steven J Christopher
Keyword(s):  
Quality Assurance ◽  
Dietary Supplement ◽  
Quality Assurance Program ◽  
Final Report

scholarly journals Dietary Supplement Laboratory Quality Assurance Program : Exercise J Final Report

2014 ◽  
Author(s):  
Melissa M. Phillips ◽  
Catherine A. Rimmer ◽  
Laura J. Wood ◽  
Mary Bedner ◽  
Kaitlyn D. Chieh ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Dietary Supplement ◽  
Quality Assurance Program ◽  
Final Report

scholarly journals Dietary Supplement Laboratory Quality Assurance Program : Exercise I Final Report

2013 ◽  
Author(s):  
Melissa M. Phillips ◽  
Catherine A. Rimmer ◽  
Laura J. Wood ◽  
Karen E. Murphy ◽  
Thomas W. Vetter
Keyword(s):  
Quality Assurance ◽  
Dietary Supplement ◽  
Quality Assurance Program ◽  
Final Report
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