fied by FDA that their products were considered adulterated as the agency had determined that their ingredients were new dietary ingredients about which FDA had not been notified 75 days in advance of sale, and that failure to cease distribution of the product could result in enforcement action (CFSAN, 2004).

Consumer and health care advisory letters from FDA cautioning use have occasionally led to voluntary product recalls by manufacturers (East Earth Herb, 2000; FDA, 2000; Vital Nutrients, 2001). In addition, warnings about specific dietary supplement ingredients issued in response to a variety of potential health problems identified by FDA as possible concerns have been posted on FDA MedWatch website (FDA, 2004).

As dietary supplements, like foods, can be contaminated with foreign toxic substances, FDA must consider more than the “inherent” safety of specific dietary supplement ingredients to adequately evaluate the potential for public health concerns. Supplement products vary in their quality and composition, which impacts the safety of specific products. Dietary supplement products tainted by improper raw materials, heavy metals, pesticides, or microorganisms, for example, can be unsafe due to these contaminants. DSHEA provides that FDA may define current GMPs for dietary supplement production. Proposed GMPs for the dietary supplement industry were published in early 2003 (FDA, 2003). While GMPs are designed to enhance safety, they are focused on purity and consistency rather than whether a dietary supplement ingredient itself is safe. As requested by FDA, this report focuses on evaluating the inherent safety of a dietary supplement ingredient in the absence of such contamination.

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