To protect and improve their health, many people purchase dietary supplements and herbal medicines over the counter—often assuming they’re regulated like drugs. While the law requires pharmaceuticals to meet specific quality standards set by USP, the same requirements don’t apply to supplements. That’s why we’ve created quality standards and a verification process specifically for these health products, giving manufacturers the tools they need to safeguard the health of their consumers. Brands that display the USP Verified Mark signal to the public that what’s on their label is what’s in the bottle, allowing their vetted product to stand apart from a majority of the competition.
In response to the COVID-19 pandemic, demand for certain products, including some dietary supplements has increased. During this pandemic, regulatory agencies are facing challenges in conducting GMP inspections, and normal regulatory operations have been impacted. At the same time, many suppliers of dietary ingredients are located abroad, often in places extensively affected by the pandemic with similar challenges. These factors can contribute to increased risk of substandard quality ingredients and manufacturing practices, as well as an increased opportunity for economically motivated bad actors to manufacture adulterated dietary supplements. As a standard setting organization committed to promoting public health, USP supports manufacturers of dietary supplements as they continue their production of quality products to meet consumer needs.
USP is committed during these extraordinary times to provide support to manufacturers to help ensure the quality of dietary supplements. The USP Dietary Supplements Compendium (DSC) is one stop shop for all your DS quality needs including the necessary analytical tools such as monographs, general chapters and chemical reference standards, to conduct the necessary identity testing, strength, purity and performance. USP DSC also includes GMP associated general chapters for manufacturers to use to help ensure that their supplements are made using safe, sanitary and well controlled manufacturing practices.
Manufacturers can use these documentary standards to verify the identity of the ingredients used to produce dietary supplements. USP documentary standards for dietary supplements are supported by chemical Reference Standards, which are highly characterized specimens of dietary ingredients, impurities, and degradation products, as well as USP compendial reagents and performance calibrators that are specified for use when conducting official USP–NF tests and assays.
USP invites stakeholder inputs to prioritize development of quality standards for commonly used ingredients for which public quality standards are lacking (https://www.usp.org/dietary-supplements-herbal-medicines/development-process). Please contact us at DietarySciStaff@usp.org to provide your inputs so that USP can better address your needs.
USP is playing a critical role in the public health response to COVID-19. To learn more, visit https://www.usp.org/covid-19.
