tary surveillance system. The premarket risk-benefit analysis is composed of three types of studies: animal toxicology and pharmacological studies, proof-of-principle studies for the disease or condition being addressed, and confirmatory studies of safety and efficacy (FDA, 2007). As a result of this required risk-benefit review, by the time a medication is on the market there are multiple well-conducted studies available that can later be used in support of an alleged association with an adverse event. Under the Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act (DSHEA) of 1994, the law that regulates dietary supplement safety, the FDA does not have the authority to require a premarket safety assessment, yet bears the burden of proof to determine that a dietary supplement is unsafe before or after introduction in the marketplace. Because there are no premarket assessments required for dietary supplements, there is a paucity of laboratory safety studies; hence, postmarket monitoring of adverse events becomes even more significant for ensuring public health. DSHEA provided the FDA with the authority to develop monitoring systems and to take necessary actions when it has sufficient evidence that a product is unsafe (Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 108 Stat 4325, 103rd Congress, October 25, 1994). The FDA has established a program called MedWatch to provide and elicit information on safety issues; reports from either health care professionals or consumers can be submitted voluntarily to the FDA or manufacturers via a standard form, form FDA 3500 (see Appendix E). The Dietary Supplement and Nonprescription Drug Consumer Protection Act made the reporting of life-threatening events to the FDA by manufacturers mandatory after December 2007 (the MedWatch 3500A form is used for this purpose) (Dietary Supplement and Nonprescription Drug Consumer Protection Act, Public Law 109-462, 109th Congress, December 22, 2006). Reports from both consumers and manufacturers are submitted through a passive monitoring system, that is, the FDA does not actively seek the adverse event reports. There are four steps to follow in such a system: (1) detect adverse events, (2) generate signals of public health concerns, (3) assess signals, and (4) take appropriate action.

As with medications and food ingredients, health risks from dietary supplement use are derived mainly from a consumer’s individual susceptibility, or from the dietary supplement’s inherent biological activity or interactions with medications. For the majority of dietary supplements, inherent toxicity might be expected to be less than that of medications because of the lower concentrations and potency per unit. Nevertheless, there are factors (i.e., the lack of composition standardization or a product compendium, multi-ingredient products, biased consumer attitudes, and a potential of overuse by some consumers) that increase the risks to health from the use of dietary supplements. Because dietary supplements are regulated as foods



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