Manufacturing Practices of Dietary Supplement Companies
According to the Dietary Supplement Health and Education Act of 1994, dietary supplements are considered safe unless they are proven unsafe by FDA. Thus, manufacturers of supplements have largely been free to regulate themselves. The supplement industry follows the good manufacturing practices (GMPs) used for food (although FDA is planning to issue dietary supplement GMPs by 2003). A company may choose -- or not choose -- to operate under pharmaceutical GMPs, which are far more rigorous than food GMPs. Some companies may have internal self-auditing procedures or may undergo voluntary audits by the National Nutritional Foods Association (NNFA). NNFA was established in 1936 and comprises 4000 retailers, manufacturers, and suppliers of the natural products industry. This association tracks regulatory and legislative issues that may have an impact on the industry, and its department of science and quality assurance is responsible for certifying the GMPs of NNFA members and for conducting the "TruLabel Program," begun in 1990. The TruLabel Program seeks to ensure the quality of dietary supplements by conducting annual random tests of NNFA members' products. If a test finds a deficiency in a product's ingredients, the member must correct the problem or be expelled from NNFA. All members will have been audited at least once by 2002.

Another important organization a dietary supplement company may belong to is the Institute for Nutraceutical Advancement (INA). This is an international alliance of 30 dietary supplement companies that sponsor the Methods Validation Program for standardizing the laboratory analysis of raw materials used in manufacturing natural products and the measurement of active ingredients. INA includes committee representatives from the American Botanical Council (ABC), the American Herbal Pharmacopoeia, the American Herbal Products Association (AHPA), the Herb Research Foundation, and FDA.

The purpose of this study was to survey dietary supplement companies to determine their manufacturing practices so that this information could be used in selecting brands for sale at a health system's wellness center and outpatient pharmacies.