Foreword: Dietary Supplement Regulation in Flux

Dietary supplements-vitamins, minerals, herbs, amino acids, and sundry other substances-have soared in popularity over the past decade, resulting in a $20 billion industry with over 1,000 manufacturers marketing 29,000 products.1 A recent survey conducted by the National Center for Complementary and Alternative Medicine ("NCCAM") found that approximately one-fifth of Americans use supplements.2 These products present vexing regulatory challenges for the Food and Drug Administration ("FDA"), and, for many years, the agency struggled to formulate an effective regulatory approach.3 In 1993, the FDA published a notice that summarized its safety concerns associated with various categories of dietary supplements and delineated the rather aggressive regulatory recommendations of an agency task force.4 Congress quickly reacted to these proposed regulatory initiatives.In 1994, it enacted the Dietary Supplement Health and Education Act ("DSHEA"), 5 which sharply limits the FDA's express authority to regulate covered products.Congress apparently acted in response to anxious lobbying from the dietary supplement industry and the public, both of which were concerned that the FDA's notice