Table of Contents
Federal Government Agencies
Table of Contents
Food and Drug Administration (FDA)
Botanical Review Team (BRT) of the Center for Drug Evaluation Research (CDER)
The BRT provides scientific expertise on botanical issues to the CDER's reviewing staff and ensures consistent interpretation of the "Guidance for Industry: Botanical Drug Products."
Center for Food Safety and Applied Nutrition (CFSAN)
CFSAN is responsible for developing policy and regulations for dietary supplements.
Current Good Manufacturing Practices (cGMPs) in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements (2007)
This final rule establishes the minimum cGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.
Dietary Supplement Health and Education Act (1994)
This Act amends the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes.
Food, Drug & Cosmetic Act
This Act provides a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container, as well as labeling provisions, for dietary supplements.
Draft Report of the Food Advisory Committee Dietary Supplement Working Group on Ingredient Identity Testing Records and Retention (1999)
This report provides guidance in selecting the most appropriate and reliable test(s) for dietary supplement ingredients.
Guidance for Industry: Botanical Drug Products (2004)
This guidance explains when a botanical drug may be marketed under an Over-the-Counter Drug monograph and when FDA regulations require approval for marketing of a New Drug application. It describes the need for and content of an Investigational New Drug application for botanical drugs.
National Center for Complementary and Alternative Medicine (NCCAM) at NIH
National Institute of Standards and Technology (NIST)
Office of Dietary Supplements (ODS) at NIH
US Department of Agriculture (USDA)
Material Measurement Laboratory (MML)
MML supports the food industry by providing reference measurements and reference standards for quality assurance and to help ensure compliance with nutritional labeling regulations. The Food and Nutritional Products Web page of the Analytical Chemistry Division within MML leads to projects in this area.
NIST Standard Reference Materials® (SRM)
This site allows you to search for available SRM.
Food Composition and Methods Development Lab (FCMDL)
The home page for FCMDL which develops innovative measurement systems for the determination of food components that influence human health.
Nutrient Data Laboratory (NDL)
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.
National Nutrient Database for Standard Reference
This page provides access to the latest release of the USDA National Nutrient Database for Standard Reference. An online search is also provided.
NDL Products and Services
This page provides access to NDL products and services, particularly special databases for flavonoids, isoflavones, proanthocyanidins, and Oxygen Radical Absorbance Capacity (ORAC) of selected foods.
Key Nongovernment Institutions — Standards-Setting Bodies for Dietary Supplements Recognized by the Office of Management and Budget within the US Executive Office of the President as "Voluntary Consensus Standards Bodies"
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 is internationally recognized by Codex Alimentarius, the International Organization for Standardization, and the International Union of Pure and Applied Chemistry and has been the leader in analytical methods validation for 120 years.
AOAC was founded in 1884 as the Association of Official Agricultural Chemists and 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. It maintains no laboratories, conducts no research, and performs no tests. AOAC International coordinates scientific studies, receives and evaluates the results, gives official sanction to acceptable methods, and publishes and distributes the methods and performance data. FDA-NIH/ODS awarded a contract to AOAC International to find and validate methods for dietary supplement ingredients.
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. The NSF is recognized for its value in international trade around the world, has earned the Collaborating Center designations by the World Health Organization, and is respected by regulatory agencies at the local, state, and federal levels. NSF's laboratory services are recognized by international accrediting bodies, including the American National Standards Institute (ANSI) and Standard Council of Canada, according to the guidelines of the International Organization for Standards.
NSF has developed over 50 voluntary American National Standards (ANS) under the scope of public health and safety. NSF/ANSI Standards are developed through involvement of those who are directly and materially affected by the scope of the standard, including industry representatives, public health/regulatory officials, and users/consumer representatives. NSF's ANS for Dietary Supplements includes GMP requirements to ensure consistency with FDA's regulations. It is 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.
United States Pharmacopeia (USP)
USP is a voluntary, science-based, nonprofit, standards-setting organization for foods and drugs. Two of its principal publications, the USP and the National Formulary (NF), are recognized in the US Federal Food, Drug, and Cosmetic Act as official compendia of the United States. The USP–NF is a single–volume combination of the two official compendia. Monographs for dietary supplements and ingredients appear in a separate section of the USP. A monograph includes the name of the ingredient or preparation; the definition; packaging, storage, and labeling requirements; and the specification. The specification consists of a series of tests, procedures for the tests, and acceptance criteria. These tests and procedures require the use of official USP Reference Standards. USP's standards-setting body is the Council of Experts, which has five Expert Committees devoted to the creation of official standards for dietary supplements.
This Web site provides information about the USP-NF, monograph development, and access to USP-NF.
- USP Reference Standards
This Web site provides an overview of USP Reference Standards.