U.S. Pharmacopeial Convention – 2014
12601 Twinbrook Pkwy.
Rockville, MD 20852
Phone: (800) 227-8772 • (301) 230-7452
USP: Setting Standards for Dietary Supplements, Food Ingredients & Pharmaceuticals
Who Is USP?
The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP is headquartered in the United States and has facilities in Europe, India, China and Brazil. USP standards are set by volunteer experts from around the world in an open and public process based on scientific exchange. USP standards are used in more than 140 countries.
What Does USP Do?
Product Quality—Documentary Standards and Reference Materials USP establishes documentary standards and chemical reference materials for demonstrating and authenticating the identity, strength, quality, and purity of dietary supplements, food ingredients, and pharmaceuticals.
• USP Dietary Supplements Compendium (DSC)
The DSC combines dietary supplement standards from the United States Pharmacopeia–National Formulary (USP–NF) with food ingredient standards from the Food Chemicals Codex. It features a compendium of monograph standards, test procedures and acceptance criteria, Admissions Criteria Safety Reviews, regulatory guidance, and full-color illustrations of macro/microscopic photographs and HPLC/TLC/GC chromatograms of selected botanical articles. The DSC offers a comprehensive resource for suitable, scientifically sound specifications for components used in dietary supplement manufacturing.
• Food Chemicals Codex (FCC)
The FCC is a compendium of internationally recognized documentary standards for authenticating the purity and quality of food ingredients, including processing aids, preservatives, flavorings, colorants, nutrients and other ingredients. It includes monographs, tests and assays, general good manufacturing practice (GMP) guidelines for food ingredients, and excerpted data from the USP Food Fraud Database.
• USP Reference Standards
USP offers highly characterized chemical specimens for use in conducting quality control tests and analytical test procedures associated with documentary standards found in the USP–NF, DSC, and FCC. The catalog features more than 250 Reference Standards for dietary supplements (e.g., vitamins, minerals, amino acids, botanicals, fish oils), more than 200 for excipients, and more than 225 for food ingredients (e.g., flavorings, preservatives, nutrients, colorants).
USP Dietary Supplement Verification Program
USP’s voluntary, third-party testing and auditing program helps dietary supplement manufacturers confirm the quality of their products. Supplements that meet USP’s stringent criteria are awarded use of the USP Verified Dietary Supplement Mark for display on labeling, packaging, and promotional materials. Finding the USP Verified Mark on a label makes it easy for consumers to identify supplements whose quality, purity, and potency have been verified by a reputable independent organization.
When consumers see the USP Verified Mark on a dietary supplement label, they know that the quality of the product has been verified under USP’s rigorous USP Dietary Supplement Verification Program. This means that the dietary supplement contains the ingredients listed on its label in the declared potency and amounts, does not contain harmful levels of specified contaminants, will break down and release ingredients into the body within a specified amount of time, and has been made according to current U.S. Food and Drug Administration (FDA) GMPs.
USP Dietary Ingredient Verification Program and USP Excipient Verification Program
USP also offers voluntary, third-party verification services to help manufacturers and suppliers demonstrate the quality of the ingredients they sell for use in the manufacture of dietary supplements. Dietary ingredients and excipients that meet USP’s comprehensive, stringent testing and auditing criteria are awarded a Certificate of Standards Compliance and use of the USP Verified Dietary Ingredient Mark or the USP Verified Excipient Mark, respectively, to display on the label of bulk ingredient containers and the corresponding certificates of analysis. These two ingredient verification programs provide an easy means by which dietary supplement manufacturers can qualify their suppliers.