Companies across the value chain face growing pressure to demonstrate quality, consistency and transparency, while consumers expect products they can trust, and retailers and brand owners need confidence in their supply chains. Manufacturers must manage diverse ingredients, evolving testing expectations and increasingly global sourcing networks.
Public standards can help create alignment in this environment. The United States Pharmacopeia (USP), a private, nonprofit scientific organization, works with stakeholders around the world to develop public standards and science-based solutions that support quality across the development, manufacture and delivery of regulated health products.
USP’s mission is to improve health through public standards and solutions that help ensure the quality of medicines, dietary supplements and food ingredients. Used in more than 150 countries, USP standards and resources help provide a shared scientific framework for industry, regulators and other stakeholders.
For the dietary supplement and nutritional ingredient sectors, that framework is especially important. Quality expectations must be communicated clearly across ingredient suppliers, finished product manufacturers, contract manufacturers, brands and retailers. USP standards help establish a common language for evaluating identity, purity, strength, composition and performance.
USP publishes these standards and related information in several compendia, including the USP–NF, the Dietary Supplements Compendium, the Food Chemicals Codex and the Herbal Medicines Compendium. Together, these resources give companies access to scientifically developed standards, methods and supporting information that can be used throughout the product life cycle.
The Dietary Supplements Compendium includes quality standards as well as supplementary information such as chromatograms, botanical illustrations, chemical structures and safety evaluations. The Herbal Medicines Compendium contains monographs for herbal medicines that appear in at least one compendium outside the United States; because FDA does not recognize a separate herbal medicine regulatory category for traditionally used botanicals, this resource is not intended for use in the United States.
The origins of USP
USP was founded in 1820 by 11 physicians who were frustrated by the lack of consistent products not only between states but within cities.
These physicians went to Congress to request formation of the Unites States Pharmacopeia. Congress chartered USP but did not (and still does not) provide any funding. USP was run entirely by volunteer experts between 1820 and 1949. There was one paid employee in 1949.
Currently about 800 experts volunteer for USP and there are over 1,200 USP employees across 22 countries.
Supporting quality: Standards, methods and materials
USP develops tools that help companies understand requirements for producing high-quality, consistent dietary ingredients and supplement products. These tools are created through a collaborative process involving USP Expert Volunteers, USP scientific staff, regulatory authorities, ingredient and finished product manufacturers, and other external stakeholders.
Within USP’s Dietary Supplements and Herbal Medicines program, three Expert Committees contribute scientific expertise: Non-Botanical Dietary Supplements, Botanical Dietary Supplements and Herbal Medicines, and Dietary Supplement Admission Evaluation and Labeling. Their work helps ensure that standards reflect relevant scientific knowledge and practical industry considerations.
USP’s written quality standards, including General Chapters and monographs, work together with reference standards and other reference materials to support product development, testing and ongoing quality management. For B2B stakeholders, these resources can help reduce ambiguity and support more efficient communication across the supply chain.
General Chapters may describe how to conduct specific types of tests, provide information about a topic or analytical technique, or address issues that are particularly relevant to dietary supplements. They can serve as practical technical resources for companies developing specifications, comparing methods or evaluating product quality requirements.
Useful chapters for dietary supplements
Useful General Chapters for dietary supplements include <64> Probiotic Tests, <561> Articles of Botanical Origin, <621> Chromatography, <2021> Microbial Enumeration Tests for Dietary Ingredients and Dietary Supplements, <2740> and <2750> Manufacturing Practices for Dietary Ingredients and Dietary Supplements, and <2800> Multi-ingredient Dietary Supplement Products—Product Quality Tests.
Depending on the product type, companies may find relevant information in as many as 20 different General Chapters.
Monographs provide another core tool by providing validated methods, analytical procedures and acceptance criteria that define key quality attributes, including identity, purity, content, strength, composition and performance. For companies, this helps translate broad quality expectations into specific, testable criteria.
Reference standards and other reference materials help support appropriate identification and quantification of materials tested using compendial methods and help demonstrate that an analytical system is functioning properly. They can be used for both qualitative and quantitative tests and may also support product development activities.
Together, monographs, General Chapters and reference standards help companies characterize materials more consistently. They also support supply chain transparency by giving ingredient manufacturers, finished product manufacturers and retailers a shared technical vocabulary.
How USP develops monographs for dietary ingredients and supplements
USP prioritizes products for monograph development based on public health needs and current or expected widespread use. The process is designed to draw on available industry expertise while maintaining an independent scientific foundation.
When developing monographs, USP reaches out to industry for validated test methods, specifications and samples. Where possible, USP works with multiple manufacturers and obtains commercial samples to develop appropriate acceptance criteria. Methods submitted by manufacturers are verified by USP laboratories as part of this process.
When an industry donor is not available, USP may develop and validate its own methods and test a broad range of samples to establish relevant acceptance criteria. Today, USP has monographs for over 600 dietary ingredients and supplement products, along with more than 400 Dietary Supplement Reference Standards.
Safety evaluation is also part of the process. USP’s Dietary Supplement Admission Evaluation and Labeling Expert Committee (DSAEL EC) evaluates safety and toxicological information to determine whether an ingredient is suitable for monograph development. This review helps ensure that USP does not create monographs for unsafe ingredients and helps address cases that fall into a gray area between old and new dietary ingredients.
The safety reviews include evaluation of safety and toxicological information, determination of suitability for monograph development, and, in the interest of public health, development of a precautionary statement if the EC feels it is necessary.
Summaries of the Admission Evaluations, which are published in the DSC, can be quite useful during product development for determining appropriate levels of ingredients for the dosage, identifying potential interactions, and providing proposed wording for precautionary labels.
Engaging with USP
For companies developing, manufacturing, testing or selling dietary supplements, USP can serve as a scientific resource and a forum for collaboration. The Dietary Supplements and Herbal Medicines Science Team responds to approximately 300 inquiries each year, including questions about monographs and General Chapters, suggestions for new monograph topics, proposed improvements to existing methods or acceptance criteria, and requests for conference speakers. Industry stakeholders can contact the team at DietarySciStaff@usp.org.