USP & Dietary Supplement Manufacturers
When USP began setting therapeutic standards in 1820, many of the medicinal preparations it included in its first pharmacopeia were botanicals and minerals now considered to be dietary supplements. Today, there are official USP standards of identity, quality, purity, and potency for more than 240 vitamins, minerals, amino acids, botanicals, and other dietary supplements. In addition to authoritative standards, USP offers third–party verification services, reference materials, education courses, and opportunities for involvement in the standards-setting process.
USP's documentary, or written, standards for dietary supplements can be found in the United States Pharmacopeia and the National Formulary (USP–NF), which also features drug standards, and the Dietary Supplements Compendium (DSC)—a publication dedicated to dietary supplements and their ingredients. USP dietary supplement standards are federally recognized in the Dietary Supplement Health and Education Act, an amendment to the U.S. Food, Drug, and Cosmetics Act. Products that claim to conform to USP standards on their labels must do so or they may be deemed to be misbranded per FDA regulations.
USP Verified Services
To help manufacturers confirm the quality of their products and build customer confidence in their brands, USP offers comprehensive, third–party auditing and testing services for dietary supplement finished products and ingredients. In addition to product testing, USP conducts a thorough manufacturing and quality control documentation review and performs a Good Manufacturing Practices (GMPs) audit of the manufacturing facility. Dietary supplements, ingredients, and manufacturing processes are evaluated against USP written standards, current FDA GMPs, and applicable ISO standards. Participation is voluntary and available to manufacturers worldwide. Click on the links below to learn more.
- USP Verified Dietary Supplements (finished products): Finished products that meet USP's stringent verification criteria are awarded use of the distinctive USP Verified Dietary Supplement Mark (see image to right) to display on product labels. The mark makes it easy for consumers, healthcare practitioners, and retailers to identify products whose ingredients and manufacturing processes have been verified. Since the program began in 2001, the mark has appeared on more than 200 million labels. View Participant Manuals & Resources.
- USP Verified Dietary Ingredients: USP verifies active and inactive ingredients used in the manufacture of dietary supplement products, including fine chemicals, vitamins, minerals, amino acids, botanical extracts, and nonbotanicals. Dietary supplement manufacturers who buy USP Verified ingredients are assured of getting consistent quality in terms of potency and identity. View Participant Manuals & Resources.
USP Reference Standards
USP Reference Standards are highly characterized substances intended for use in conducting the quality control tests and analytical procedures found in the USP–NF and DSC. USP has more than 200 Reference Standards for dietary supplements and botanicals. A potential time– and cost–savings resource, USP Reference Standards can make it easier for manufacturers to comply with good manufacturing practices. Learn more about USP Reference Standards or view the dietary supplements section in the USP Catalog for available products.
Key Links for Manufacturers
Visit the following pages for helpful resources and tools:
- USP Verified Dietary Supplements - for Manufacturers: Learn about the verification process, discover what the Verified mark means to consumers, find products participating in the Verified program, and complete the Verified application here.
- Education Courses: USP offers a variety of classroom and on–demand, online education courses on topics relevant to dietary supplement manufacturing and quality control. USP Global Education and Training curriculum is developed by the USP experts who set the standards. View and register for the latest course offerings.
- Publications: In addition to USP–NF and DSC, USP offers a variety publications to support the work of dietary supplement manufacturers, including Pharmacopeial Forum, Food Chemicals Codex, and Chromatographic Columns.