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USP and Dietary Supplement Manufacturers

USP provides authoritative standards, guidelines, and independent third-party verification services to help dietary supplement manufacturers meet the demanding requirements of retailers, consumers, and regulatory authorities. USP resources help dietary supplement manufacturers ensure quality in ingredients, products, and manufacturing processes. By following official USP standards and participating in USP's verification programs, manufacturers can meet regulatory requirements and build retailer and consumer confidence in the quality of the supplements they manufacture.

Recommended Resources

USP-verified program for dietary supplements

USP-verified is the number one third-party dietary supplement verification mark. As of 2004, USP-verified dietary supplements constituted 10% of mass-market supplement sales volume. The USP-verified mark is granted to supplements that go through rigorous testing and review processes under a verification program open to voluntary participation by manufacturers.

USP-verified program for ingredients

USP's ingredient verification program verifies active and inactive ingredients used in the manufacture of dietary supplements, 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.

USP–NF

USP's annual publication of official public standards, USP–NF, includes an exclusive section on dietary supplements. This section contains official standards for botanicals and nonbotanicals used in nearly 900 dietary supplement products. USP–NF describes the tests, assays, and acceptance criteria for ingredient and product identification and quantitation as well as physicochemical characterization. It includes packaging, storage, and labeling information. The Dietary Supplement Health and Education Act (DSHEA) designates the USP–NF as official compendia for dietary supplements. Therefore, a dietary supplement represented as conforming to USP–NF standards will be deemed misbranded if it fails to conform.

USP Reference Standards

USP Reference Standards are highly characterized substances that can be used to conduct the QC tests as well as analytical procedures described in the USP–NF. Use of these Reference Standards makes it easier for manufacturers to comply with good manufacturing practices. USP has more than 100 Reference Standards for amino acids, botanicals, vitamins-minerals, and other dietary supplements and ingredients.