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Supplements are now being performed by the Office of Nutritional Products, Labeling, and Dietary Supplements’ Division of Dietary Supplement Programs, which comprises a regulations and review team, a compliance and enforcement team, and a clinical review team. Led by Dr. Susan Walker, the division creates policies, regulations, and guidance documents to ensure the safe manufacture and labeling of dietary supplements and reviews safety information submitted by dietary supplement manufacturers 75 days before the marketing of a product to ensure that it is reasonably expected to be safe.
The DSHEA also called for the creation of the Office of Dietary Supplements (ODS), which is housed within the National Institutes of Health and is responsible for facilitating research into the role of dietary supplements in disease prevention and health promotion. The mission of ODS is to strengthen knowledge about dietary supplements by evaluating available research and stimulating and supporting more scientific trials, as well as by educating people about the cur- rent state of knowledge. As part of their mission, ODS hosted the 2000 National Nutrition Summit and created numerous resources, including Computer Access to Research on Dietary Supplements, International Bibliographic Information on Dietary Supplements, Annual Bibliographies of Significant Advances in Dietary Supplement Research, and Dietary Supplement Ingredient and Labeling databases. The ODS’s 2004–2009 strategic plan comprises five major goals: (1) expanding the evaluation of dietary supplements in reducing the risk for chronic disease; (2) fostering research on dietary supplements for optimal health and performance; (3) enhancing understanding of the basic effects of dietary supplements on biological systems; (4) improving methodologies; and (5) expanding outreach and education.

The DSHEA gave the FDA the authority to establish special good manufacturing practices for dietary supplements. In March 2003 the FDA released its “Proposed Rule for Dietary Supplement Current Good Manufacturing Practices,” which addresses important components of dietary supplement manufacture, including design and construction of manufacturing facilities, quality-control procedures, testing of the final product(s) or incoming and in-process materials, management of consumer complaints, and record keeping and filing of compliance with these standards. The basic tenets of the current good manufacturing practices require that dietary supplement manufacturers use current industry standards in the processing of dietary supplements to avoid contamination (by pesticides, heavy metals, or other impurities) and improper labeling and to ensure that product labels accurately reflect the identity, purity, quality, strength, and composition of dietary supplements. The following are some examples of product quality problems that these rules are meant to address:
• contains more of the active or inactive ingredients than listed on the label;
• contains less active ingredients than listed on the label;
• contains the wrong ingredient(s);
• contains a drug contaminant;
• contains other contaminant(s), such as bacteria, mold, pesticide, or lead;
• package contains foreign material, such as glass;
• improper packaging and/or mislabeled product.
The “Proposed Rule for Dietary Supplement Current Good Manufacturing Practices” was open to public comment for a year before it was to be considered final. After approval, dietary supplement companies would have 36 months to implement the changes necessary to comply with the rule. Until then, dietary supplement manufacturers were to follow good manufacturing practices for foods. During the comment period, however, the FDA received more than 1600 pages from consumers and members of the dietary supplement industry. A final rule therefore has been delayed and is expected in late 2006 (for current information, see http://www.cfsan.fda.gov/dms/ds-ind.html#GMPS).
Creation of New Government Entities
Appointed in 1995, the Commission on Dietary Supplements directs the labeling of dietary supplements, essentially to determine how to provide scientifically valid information about them. The first commission comprised scientists from various U.S. universities with expertise in dietary supplements, a member of the Council for Responsible Nutrition, a Seton Hall University School of Law professor, a public relations specialist, and a representative from the Herb Research Foundation.