Surveillance of Dietary Botanical Supplements

been raised regarding the safety and postmarketing surveillance of dietary sup-plements and dietary botanical supple-ments (DBSs) in particular.1,2 DSHEA sig-nificantly modified the regulatory appa-ratus for these supplements, defining these products as a separate regulatory cat-egory3 that includes, among other ingredi-ents, vitamins, minerals, herbs or other botanicals, and amino acids.4 Dietary sup-plements and DBSs in particular are wide-ly used in the US; in 2002, 18 % of the population reported use of “natural herbs” in the previous 12 months, and sales of DBSs topped $4 billion.5,6 Under DSHEA, premarket safety ap-proval for dietary supplements is not mandated.7 Registration with the Food and Drug Administration (FDA) is not required for ingredients marketed before October 1994, and the safety of these in-gredients is presumed.8,9 Manufacturers are required to notify and provide safety data to the FDA 75 days in advance of initiating marketing of a dietary supple-ment containing a new dietary ingredient (marketed after October 1994), although the standards employed to establish the safety of these ingredients have been questioned.8,10,11 Once dietary supplements are marketed, the FDA, rather than dietary supplement manufacturers, is responsible for ensuring their safety. Specifically, the FDA is responsible for detecting adverse events associated with dietary supplement use and is charged with taking remedi-al actions to protect public health.11 Until recently, under DSHEA, dietary supplement manufacturers were not re