USP Dietary Supplement Standards
To help manufacturers, suppliers, and regulators safeguard the dietary supplement supply, USP provides documentary standards and reference materials for determining product and ingredient identity, strength, quality, and purity. These standards help limit the introduction of potential adulterants and contaminants, and serve as a widely acknowledged quality benchmark in the buying and selling of dietary supplement products and their ingredients in the global marketplace. In addition to its standards, USP offers third-party, independent verification services for dietary supplement finished products and dietary ingredients.
USP's Relationship with Dietary Supplements
Since its beginning in 1820, USP has been concerned with the standardization of botanicals and minerals, evidenced by the content of the first USP, which contained mostly botanicals and other natural drugs. In 1930, USP formed the Vitamin Advisory Board, which established the first pharmacopeial assays and Reference Standards for Vitamin A and D, and by 1942, USP had established monographs for all vitamins recognized at that time. In 1975, USP acquired the National Formulary (NF), which primarily features specifications for excipients commonly used in pharmaceuticals and dietary supplements. Read More.
In 1990, the USP Convention adopted a resolution calling for standards on dosage forms containing combinations of vitamins and minerals, leading to the development of a separate "Nutritional Supplements" section in the USP–NF. After the passage of the Dietary Supplements and Health and Education Act in 1994, this section was expanded significantly and renamed "Dietary Supplements" with the addition of many new monographs for botanical and non-botanical dietary ingredients and dietary supplement articles.
With the purchase of the Food Chemicals Codex (FCC) in 2006, USP once again added to its portfolio of standards relevant to dietary supplements. Considering the changing needs of a growing global dietary supplement industry, USP published the USP Dietary Supplements Compendium (DSC) in 2009, with the intention of providing a comprehensive resource for dietary supplement manufacturers, suppliers, and regulators. The DSC combines the "Dietary Supplements" section and other relevant monographs from USP–NF with monographs from the FCC.
Today, USP offers nearly 800 monographs in the DSC and more than 200 Reference Standards for use in the development and testing of dietary supplements. In addition, the USP Verified Mark, the symbol awarded by USP to dietary supplement products that meet the stringent criteria of its voluntary Dietary Supplement Verification program, has appeared on more than 400 million supplement labels.