The actions by the New York attorney general’s office and now a coalition of attorneys general from other states has brought renewed attention to a familiar discussion, how to ensure the quality of herbal products and dietary supplements in the U.S. We believe consumers expect the same level of quality in their dietary supplements as they do for their drugs and drug ingredients.
USP-NF Quality Standards are Required for Drug Ingredients and Over-the-Counter Medicines
Scientifically based, public quality standards, like those published in the U.S. Pharmacopeia-National Formulary (USP-NF), have helped ensure the quality and consistency of drugs and drug ingredients sold in the United States for almost two centuries. The USP-NF is recognized in law as “official compendia”1 in the United States. That means drugs sold in the US must comply with the quality standards established in the USP-NF, regardless of where they are made or by whom and regardless of whether they are labeled “USP.”
USP-NF Quality Standards are Voluntary for Dietary Supplements
The USP-NF also includes public quality standards for vitamins, minerals and botanical ingredients – items that fall into the category of dietary supplements, which is considered a subset of foods. While compliance with these standards is mandatory for prescription and over-the-counter medications, the Dietary Supplement Health and Education Act (DSHEA) made compliance with these standards voluntary for dietary supplements. Supplement manufacturers can adopt USP standards, or, they can select standards from a number of other resources, including other pharmacopeias. Or, the manufacturer can establish its own private standards.
Public Quality Standards Protect Public Health
We believe that public health is best served when both industry and regulators voluntarily utilize the public quality standards of the USP-NF. Uniform public standards would make it clear to everyone what quality is expected and what test methods are appropriate to determine whether that quality exists.
USP, an independent science-based non-profit founded in 1820, is proud of its mission: To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. Our standards are science based and developed using a transparent and public process.
Although our standards are referenced in U.S. law, we are not part of government. Our standards are established by volunteers from industry, regulatory agencies, academia and practitioner groups (e.g., pharmacists) that represent a wide array of scientific expertise and disciplines. USP’s volunteer experts create quality standards that both reflect the input of and provide a uniform point of reference for regulators, manufacturers and consumers.
Who Can Benefit from USP's Official Public Quality Standards
Supplement manufacturers can take advantage of USP’s official designation to help establish compliance with the dietary supplement Good Manufacturing Practices (GMPs)2.
Regulators can take advantage of USP’s official designation and the scientific expertise reflected in our standards to ensure they are conducting appropriate tests.
The public can look for the USP Verified Mark for further reassurance that a product was made in keeping with official quality standards in the United States.
In 2001, in partnership with several manufacturers, USP established a voluntary verification program for manufacturers seeking a more visible way to inform and reassure consumers, health care providers, and retailers that their products consistently meet USP’s high quality standards.
USP works with the participating manufacturers to ensure quality is built into particular products, by conducting good manufacturing practice facility audits and by reviewing product quality control and manufacturing documentation. We also verify that these standards are met by regularly pulling product off store shelves and conducting our own finished product testing. Products that meet these tests are labeled with the USP Verified Mark.
We at USP believe that protecting public health is a shared responsibility involving industry, regulators and health practitioners. That is why, when it comes to medicines and supplements – we believe public health demands public standards.
More information about the USP Verified program and where to find USP Verified dietary supplements is available at www.uspverified.org