FDA GMPs (good manufacturing practices) are intended to promote dietary supplement quality and consistency. However, a steady stream of reports of adulterated, tainted and/or poor quality dietary and herbal supplements, as well as state enforcement efforts and multi-agency federal enforcement actions, have made everyone—regulators, retailers, health providers and consumers—wary of the quality of dietary supplements. In response, many are seeking reassurance that the products they buy, recommend or use are of high quality.
At USP, we agree with Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), who wrote “A uniform standard will help consumers make informed decisions and support products that are making investments in quality that the (FDA) GMP regulations were designed to incentivize" in the INSIDER article “Uniform Standards Needed for Third-Party GMP Audits."
Public standards developed through an open, transparent process can help create this uniform standard of GMPs, and they provide the dietary supplement industry with consistent tests and validated analytical test procedures in support of public health. One of the benefits of standards developed through an open, transparent and rigorous expert committee decision-making process is that the standards reflect input, not just from industry, but also from academia, health practitioners and regulators (including the FDA.) Another benefit of public standards, rather than private industry standards, is that these standards are available for anyone to use to test the quality of a product at any point in the supply chain. Wider use of public quality standards, such as those developed by USP—which are used in its USP Verified Program—in conjunction with cGMP compliance can help ensure the quality and consistency of dietary supplements in the marketplace, and thereby protect public health.
Dietary Supplement Standards
According to FDA statistics, the most cited FDA Form 483 observation given to manufacturing facilities is failing to verify that finished batches of dietary supplements meet product specifications, or even worse, failing to have specifications for ingredients or finished products. Quality standards for excipients, dietary ingredients and finished products for dietary supplements, established on science can help address this issue.
To support the dietary supplement industry the Dietary Supplement Compendium (DSC), published by USP, is intended to be a comprehensive resource for supplement manufacturers. In this single compendium, manufacturers can find specifications for dietary supplement components and finished products needed to qualify and test supplement components as well as develop, manufacture, and test finished products. The DSC also contains information to help prepare for cGMP audits, develop and validate test procedures. The DSC contains close to 500 monographs for dietary ingredients (e.g., ginkgo, powdered ginkgo extract) and finished products (e.g., ginkgo tablets). These monographs set forth an ingredient or product’s name, definition, test specification and other requirements related to packaging, storage and labeling of the article. The specification consists of tests, test procedures and corresponding acceptance criteria that help ensure the identity, strength, quality, purity and performance of the ingredient or product.
Protecting public health is a shared responsibility involving industry, regulators and health practitioners.
Christine Feaster is vice president, head of strategic marketing and program operations, dietary supplements and herbal medicines at USP.