On October 25, 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA),2 passed unanimously by both houses of Congress. This law radically changed the regulatory landscape for the sale and labeling of dietary supplements, restricting the Food and Drug Administration's (FDA's) authority in certain ways, and encouraging the sale of dietary supplements, including vitamins, minerals, herbs, botanicals, and amino acids.
This article examines DSHEA and discusses current FDA attempts to regulate dietary supplements. Part II provides a brief background and discusses FDA's concerns and attitude toward dietary supplements before the passage of DSHEA. Part III discusses recent congressional actions that have influenced FDA's ability to regulate dietary supplements: passage of the Nutrition Labeling and Education Act (NLEA), the moratorium imposed on use of NLEA to restrict dietary supplement labels, and passage of DSHEA in 1994.
Part IV describes the regulatory changes brought about by DSHEA. Part V reviews concerns stemming from the recent growth in the dietary supplement industry and from the regulatory framework currently in place. Concerns about consumer safety and the efficacy of dietary supplements are discussed, and some recent reports of contamination of dietary supplements are reviewed. Part VI chronicles FDA actions since DSHEA, and discusses how FDA is attempting to regulate dietary supplements under DSHEA. The recent Cholestin® decision is analyzed, as is the U.S. Court of Appeals for the D.C. Circuit's ruling that the First Amendment restricts FDA's ability to prevent manufacturers from placing certain health claims on their supplements.
Finally, part VII offers a proposal that would increase consumer knowledge of dietary supplement safety and efficacy.' In the current situation, benign but useless products are shelved beside, and labeled similarly to, both useful products with real health benefits and products that can be harmful. Even the thoughtful consumer is hard-pressed to distinguish one product from another. Unfortunately, there seems little hope that Congress will change the situation, absent some catastrophic public health event.
Laura A.W. Khatcheressian, Regulation of Dietary Supplements: Five Years of DSHEA, 54 Food & Drug L.J. 623 (1999).