Foreword: Dietary Supplement Regulation in Flux

Abstract:     
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. 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. 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. Congress quickly reacted to these proposed regulatory initiatives. In 1994, it enacted the Dietary Supplement Health and Education Act (DSHEA), which sharply limits the FDA's express authority to regulate covered products. Purporting to balance concerns about the safety of supplements and consumer freedom to purchase them, DSHEA's highly deregulatory approach won effusive praise from commentators who profess strong faith in the ability of consumers to make intelligent choices about supplement use. Other observers remain dubious, however, that the typical consumer will exercise informed skepticism when it comes to claims about the safety and utility of these products.

Keywords: dietary supplements, regulation, food and drug law

Accepted Paper Series