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 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 Standard Reference Materials for Analysis of Dietary Supplements

2008 ◽  
Vol 91 (6) ◽  
pp. 1298-1302 ◽  
Author(s):  
Katherine E Sharpless ◽  
David L Duewer
Keyword(s):  
Quality Control ◽  
Dietary Supplements ◽  
Method Validation ◽  
Drug Administration ◽  
Reference Materials ◽  
Food And Drug Administration ◽  
Standard Reference Materials ◽  
Quality Control Materials ◽  
The U.S

Abstract National Institute of Standards and Technology (NIST), in collaboration with the National Institutes of HealthOffice of Dietary Supplements and the U.S. Food and Drug Administration, is producing Standard Reference Materials (SRMs) for dietary supplements. These and other natural-matrix SRMs should be used in method validation, characterization of in-house quality control materials, and to establish traceability.

Analytical Methods and Development of Reference Materials for Toxic Metals and Metal Species in Food and Dietary Supplements

2017 ◽  
pp. 639-678
Author(s):  
Stephen E. Long ◽  
Michael Ellisor ◽  
Frances Nilsen ◽  
Laura Wood ◽  
Karen Murphy ◽  
...  
Keyword(s):  
Dietary Supplements ◽  
Reference Materials ◽  
Toxic Metals ◽  
Analytical Methods ◽  
Metal Species

International Survey on Dietary Fiber: Definition, Analysis, and Reference Materials

1995 ◽  
Vol 78 (1) ◽  
pp. 22-36 ◽  
Author(s):  
Sungsoo C Lee ◽  
Leon Prosky
Keyword(s):  
Quality Control ◽  
Liquid Chromatography ◽  
Dietary Fiber ◽  
Reference Materials ◽  
Analytical Methods ◽  
Gas Liquid Chromatography ◽  
Nutrition Labeling ◽  
International Survey ◽  
Total Dietary Fiber ◽  
Nutrition Research

Abstract An international survey was conducted to get the views of 147 professionals in the field on the definition of dietary fiber. The survey also solicited opinions on analytical methods for nutrition labeling, quality control, and nutrition research. The survey finds that dietary fiber is generally defined as polysaccharides and lignin that are not hydrolyzed by human alimentary enzymes. Support is strong for expansion of the definition to include oligosaccharides that are resistant to hydrolysis by human alimentary enzymes. Among techniques for nutrition labeling and quality control, enzymatic-gravimetric methods get the highest support. For nutrition research, more detailed methods such as gas-liquid chromatography and liquid chromatography were considered more appropriate. Respondents support labeling of total, soluble, and insoluble dietary fiber or total dietary fiber alone as sufficient for nutrition labeling of food packages. However, for nutrition research, detailed analytical methods, improvements in accuracy (i.e., closer simulation of in vitro techniques to conditions of human gastrointestinal tract), and improvements in precision and simplicity are suggested. Less than 20% of the participants use reference materials for dietary fiber analysis.

Quality control of lipid measurements in epidemiological studies: the U.S. Air Force HEART program.

1985 ◽  
Vol 31 (2) ◽  
pp. 261-263 ◽  
Author(s):  
A Hainline ◽  
P Hill ◽  
L Garbaczewski ◽  
C Winn
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Air Force ◽  
Reference Materials ◽  
Internal Control ◽  
Density Lipoprotein ◽  
Quality Assurance Program ◽  
Internal Quality ◽  
Surveillance Program ◽  
The U.S

Abstract A special standardization and quality assurance program, similar to that created for the Lipid Research Clinics Program (LRC), was developed for the American Health Foundation Laboratory by the Centers for Disease Control (CDC) to assure the quality of lipid measurements in the U.S. Air Force Health Evaluation and Risk Tabulation (HEART) Program. This study was designed to test the feasibility of reducing the incidence of heart disease in active-duty U.S. Air Force personnel through life-study intervention. During the 18-month study, CDC provided serum calibrators and reference materials for internal control and an external surveillance program for measurements of total cholesterol (TC) and high-density-lipoprotein cholesterol (HDLC). The Laboratory, using an automated enzymic method to measure cholesterol, achieved an overall goal for accuracy of less than 2% error (av systematic error, -30.6 mg/L) for TC, as measured on nine reference pools for which values were assigned by CDC. The average bias of measurements of HDLC with heparin-manganese to separate the lipoproteins in five CDC reference pools was -4.6 mg/L. Bias was estimated relative to the values assigned to the reference materials by the CDC reference methods for TC and HDLC. The average CV for TC was 0.89%, for HDLC 2.66%. Accuracy of cholesterol measurements can be assured over time with a standardization and quality-assurance program that incorporates accurately labeled reference materials for calibration, internal quality control, and external surveillance.

scholarly journals The NIH analytical methods and reference materials program for dietary supplements

2007 ◽  
Vol 389 (1) ◽  
pp. 19-25 ◽  
Author(s):  
Joseph M. Betz ◽  
Kenneth D. Fisher ◽  
Leila G. Saldanha ◽  
Paul M. Coates
Keyword(s):  
Dietary Supplements ◽  
Reference Materials ◽  
Analytical Methods

Development of a New Series of Agricultural/Food Reference Materials for Analytical Quality Control of Elemental Determinations

1994 ◽  
Vol 77 (6) ◽  
pp. 1605-1626 ◽  
Author(s):  
Milan Ihnat
Keyword(s):  
Quality Control ◽  
Elemental Composition ◽  
Wheat Flour ◽  
Reference Materials ◽  
Analytical Methods ◽  
Corn Starch ◽  
Analytical Data ◽  
Standard Reference Materials ◽  
Substantial Contribution ◽  
Agricultural Food

Abstract Ten new Agricultural/Food Reference Materials — Bovine Muscle Powder (National Institute of Standards and Technology [NIST], code NIST RM 8414), Whole Egg Powder (NIST RM 8415), Microcrystalline Cellulose (NIST RM 8416), Wheat Gluten (NIST RM 8418), Corn Starch (NIST RM 8432), Corn Bran (NIST RM 8433), Whole Milk Powder (NIST RM 8435), Durum Wheat Flour (NIST RM 8436), Hard Red Spring Wheat Flour (NIST RM 8437) and Soft Winter Wheat Flour (NIST RM 8438) — were prepared by application of milling, irradiation, sieving, blending, and packaging procedures. Excellent material homogeneity was found for virtually all major, minor, and trace elements of interest. The reference materials were characterized with respect to elemental composition via an extensive international, interlaboratory characterization (certification) campaign. Chemical analyses conducted in 73 cooperating laboratories applying 13 major classes of independently different analytical methods led to 278 concentration values for 34 nutritionally, toxicologically, and environmentally pertinent elements. A total of 213 best-estimate and 65 informational concentration values are available for Al, As, B, Ba, Br, Ca, Cd, CI, Co, Cr, Cs, Cu, F, Fe, Hg, I, K, Mg, Mn, Mo, N, Na, Ni, P, Pb, Rb, S, Sb, Se, Sr, Ti, V, W, and Zn. These products make a substantial contribution to the existing world repertoire of biological reference materials with respect to natural matrix and elemental composition. They are expected to be useful to analysts for quality control of analytical data. Applications include evaluations of analytical methods and instruments used in nutritional, toxicological, monitory, regulatory, environmental, agricultural, and other investigations. These products are available to the analytical community from the Standard Reference Materials Program, NIST, Gaithersburg, MD.

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