11.01.03
Also in late October, Representatives Susan Davis (D-CA), Henry Waxman (D-CA) and John Dingell (D-MI) unveiled bill HR. 3377, the “Dietary Supplement Access and Awareness Act.” This legislation, according to the Representatives, would increase the FDA’s authority over dietary supplements. Specifically, the legislation enables FDA to monitor the health risks of dietary supplements and take appropriate action if problems develop. However, legislation will not have any impact on the regulation of vitamins and minerals, which are specifically excluded from the bill. In addition, for dietary supplements that contain herbs, amino acids and other botanicals, the bill will ensure that FDA has basic information about who makes them and the products’ ingredients. The bill also requires dietary supplement manufacturers to provide FDA with information about all adverse events, so that the agency can spot warning signs and investigate if necessary. The bill further allows FDA to prohibit sales to minors of supplements that may cause significant harm to children. Finally, the bill allows FDA to demand safety information from a manufacturer if FDA has evidence that a particular supplement may pose serious risks. The Representatives that introduced the bill feel that this legislation will both protect consumers from those few dietary supplements that pose a real risk to health and preserve access to safe dietary supplements.