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Strengthening Knowledge and Understanding of Dietary Supplements
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The measure of exactness of an analytical method, or a measure of how close the "measured" value is to the "true" value or an accepted reference value.
American National Standards
The American National Standards Institute facilitates the development of the ANS by accrediting the procedures of standards developers. This accreditation signifies that the procedures used by the standards developer in connection with ANS meet the Institute's essential requirements for openness, balance, consensus, and due process.
American National Standards Institute
ANSI is a private, nonprofit organization that coordinates the US voluntary standardization and conformity assessment system. Its mission is to enhance US global competitiveness and the American quality of life by promoting, facilitating, and safeguarding the integrity of the voluntary standardization system. ANSI represents the interests of its company, organizational, government, institutional and international members. ANSI accredits national standards developing organizations and approves American National Standards. It represents US interests in international standards development activities.
The Dietary Supplements Analytical Materials/Reference Materials Program of the Office of Dietary Supplements, National Institutes of Health.
AOAC International is a not-for-profit voluntary consensus standards body cited in the US Code of Federal Regulations under Title 21: "It is the policy of FDA in its enforcement program to use methods of analysis of AOAC International when available and applicable." AOAC is also cited under Title 9 within this context by the USDA. AOAC was founded in 1884 as the Association of Official Agricultural Chemists; in 1965 the Association's name changed to the Association of Official Analytical Chemists to reflect expansion of scope. The organization now refers to itself as AOAC International.
AOAC Official Methods of Analysis
These methods are recognized worldwide as an authoritative resource because of thorough and rigorous testing characterization. The methods are written into the US Code of Federal Regulations, product specifications and product acceptance; relied on in legal proceedings; and required as a basis of national and international trade. They are adopted by other national and international standards organizations. They can be used with confidence by regulatory agencies, regulated industries, product testing laboratories, and academic institutions to determine compliance with government regulations, to maintain quality control and process requirements, to set and evaluate compliance with terms of procurement contracts, to conduct national and international trade, and to support research.
AOAC Official Methods of Analysis
This program of AOAC International is designed to provide methods of analysis for which performance characteristics have been determined and tested.
Botanical Review Team of the Center for Drug Evaluation Research of the US Food and Drug Administration (FDA). BRT provides scientific expertise on botanical issues to CDER's reviewing staff and ensures consistent interpretation of FDA's "Guidance for Industry: Botanical Drug Products."
An operation that, under specified conditions, in a first step establishes a relation between the quantity values with "
" provided by measurement standards and corresponding indications with associated "
" and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
A measurement standard with a known absolute value. It is a single chemical entity developed to ensure high purity and uniformity for specific analyte.
Center for Food Safety and Applied Nutrition
CFSAN, US Food and Drug Administration, Department of Health and Human Services. CFSAN is responsible for developing policy and regulations for dietary supplements.
certified reference material
A reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability. Certified reference materials are traceable to international standards with a known uncertainty and therefore can be used to address all aspects of bias (method, laboratory, and within-laboratory) simultaneously, assuming that there is no matrix mismatch.
Chemical Science and Technology Laboratory
CSTL, National Institute of Standards and Technology, Department of Commerce. CSTL supports the food and dietary supplement industry by providing reference measurements and reference standards for quality assurance and to help ensure compliance with nutritional labeling regulations.
collaborative study validation
The interlaboratory collaborative study is the most widely accepted procedure to validate any new analytical method. Methods are validated through independent testing in separate laboratories following the same protocol and analyzing the same samples. The purpose of the study is to establish the characteristics of the methods with respect to accuracy, precision (repeatability and reproducibility), sensitivity, range, specificity, ruggedness, limit of measurement, and practicality under typical laboratory applications.
Food and Drug Administration
FDA, Department of Health and Human Services. FDA is the Federal government agency responsible for ensuring that foods and dietary supplements are safe, wholesome and sanitary, and that drugs, medical devices, cosmetics, and food are honestly, accurately and informatively represented to the public. FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products (prescription and over-the-counter). The dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to get FDA approval before producing or selling dietary supplements.
Food Composition and Methods Development Laboratory
FCMDL, US Department of Agriculture. The mission of FCMDL is to develop innovative measurement systems for the determination of food components that influence human health.
National Center for Complementary and Alternative Medicine
NCCAM explores complementary and alternative healing practices in the context of rigorous science, trains CAM medicine researchers, provides accurate information about CAM, and helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.
National Formulary of the United States Pharmacopeia
NF is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.
National Institute of Standards and Technology
NIST, Department of Commerce. NIST is a nonregulatory Federal agency that promotes US innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve quality of life.
NIST Standard Reference Materials®
A certified reference material issued by the National Institute of Standards and Technology (NIST) that meets additional NIST-specific certification criteria and is issued with a certificate or certificate of analysis that reports the results of its characterizations and provides information regarding the appropriate use(s) of the material.
NSF International, a not-for-profit, nongovernmental organization, is a leader in standards development, product certification, education, and risk management for public health and safety. While focusing on food, water, indoor air, and the environment, NSF (founded in 1944 as the National Sanitation Foundation) develops national standards, provides learning opportunities, and provides third-party conformity assessment services related to dietary supplements. NSF's American National Standards for dietary supplements includes Good Manufacturing Practices requirements to ensure consistency with FDA regulations. They are used to evaluate and analyze dietary supplements to ensure they do not contain undeclared ingredients or unacceptable levels of contaminants such as pesticides and heavy metals.
Nutrient Data Laboratory
NDL, US Department of Agriculture. NDL develops authoritative food composition databases and state-of-the-art methods to acquire, evaluate, compile and disseminate composition data on foods available in the United States.
Office of Dietary Supplements
ODS, Office of Disease Prevention, Office of Director, National Institutes of Health, Department of Health and Human Services. ODS strengthens knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the US population.
The initial sets of conditions that have evolved from developing a method are improved or maximized in terms of predefined criteria, such as detection limits, limits of quantitation, accuracy, and precision. A method that provides all or most of the original method requirements is deemed optimized and becomes ready for validation. It requires an iterative procedure, constant replication, and the acquisition of a large amount of quantitative statistical data.
The measure of degree of repeatability of an analytical method under normal operation. The closeness of agreement between independent test results obtained under stipulated conditions. A measure of how close discrete measurements are to each other.
A generic term that refers to a material or substance whose property values are sufficiently homogeneous and stable with respect to one or more specified properties, and whose fitness is well established for its intended use in a measurement process (e.g., calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials). Reference materials may be materials characterized by a reference material producer, but whose values are not accompanied by an uncertainty statement or are otherwise qualified. Traceability of these materials may be questionable.
The degree of reproducibility of the results obtained under a variety of conditions. The resistance to change in the results produced by an analytical method when minor deviations are made from the experimental conditions described in the procedure. Ruggedness of a method is tested by deliberately introducing small changes to the procedure and examining the effect on the results.
A method validation performed within only one laboratory. The results of this validation cannot necessarily be compared with results obtained using a different method or the same method in a different laboratory. The single-laboratory validation debugs the method before it is subjected to a collaborative study and can be considered the first step toward a full AOAC Official Methods of Analysis
standard reference material
An authenticated material.
United Status Pharmacopeia
USP is a voluntary, science-based, nonprofit, standards-setting organization. It is an official public standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. Its publications, the USP and the National Formulary (NF), are recognized in the US Federal Food, Drug, and Cosmetic Act as official compendia for the United States. Monographs for dietary supplements and ingredients appear in a separate section of the USP. The tests and procedures cited in the monographs require the use of official USP Reference Standards.
US Department of Agriculture
USDA promotes America's health through food and nutrition, and advances the science of nutrition by monitoring food and nutrient consumption and updating nutrient requirements and food composition data. USDA is responsible for food safety, improving nutrition and health by providing food assistance and nutrition education, expanding markets for agricultural products, managing and protecting US public and private lands, and providing financial programs to improve the economy and quality of rural American life.
A process of distinct steps providing documented evidence that an analytic method does what it is intended to do. Validation applies to a defined protocol, for the determination of a specified analyte (the substance being analyzed) and range of concentrations in a specified type of test material (matrix) with a high degree of accuracy and precision, used for a specified purpose.
voluntary consensus standards body
The Office of Management and Budget within the US Executive Office of the President defines voluntary consensus standards bodies as domestic or international organizations that plan, develop, establish, or coordinate voluntary standards using agreed-upon procedures. These bodies may include nonprofit organizations, industry associations, accredited standards developers, professional and technical societies, institutes, committees, task forces, or working groups. Participation of government representatives in these bodies is encouraged to increase the likelihood that the standards they develop will meet both public and private sector needs. A voluntary consensus standards body observes principles such as openness, balance of interest, and due process. Voluntary consensus standards bodies operate by consensus (general agreement), but not necessarily unanimity, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests. Consensus requires that all views and objections be considered and that an effort be made toward their resolution.
AMRM Program Description
Quality Assurance Program
Training, Education, Outreach
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