| Abstract: |
In 2004, we published an article in HerbalGram that described a collaboration among the National Institute of Standards and Technology (NIST), the National Institutes of Health, Office of Dietary Supplements (NIH-ODS), and the Food and Drug Administration (FDA) that was then in its infancy [1]. This article provides an update of this program, which is directed at production of Standard Reference Materials (SRMs) that can be used in support of the Dietary Supplement Health and Education Act of 1994 [2] and requirements imposed by the Good Manufacturing Practices (GMPs) published by the FDA. GMPs were issued in June of 2007, with a phase-in period staggered over three years. As of June 2010, all companies, including those with fewer than 20 employees, are required to comply with GMPs. Among other things, the GMPs require dietary supplement manufacturers to establish specifications to evaluate the identity, purity, strength, and composition of ingredients used in their products; set limits on contaminants (e.g., pesticides, bacteria, toxic elements) and adulterants; and evaluate their finished products. The GMPs require that manufacturers follow processes for selection and use of appropriate analytical methods and reference materials. Manufacturers must verify that the methods are appropriate for their intended use, then use those methods to determine whether their specifications are being met. The first SRM developed in this program was issued in 2006. By the end of 2010, there will be 28 dietary supplement-related SRMs available from NIST. |
