The Tobacco Diaries: Lessons Learned and Applied to the Regulation of Dietary Supplements

Abstract

Little is known about adverse reactions to dietary supplements because these events are underreported. The Food and Drug Administration’s ability to regulate dietary supplements has a long and complicated history and the battle over regulation continues. On a simple level, the debate over regulation of dietary supplements boils down to manufacturers’ desire not to be regulated and personal autonomy to make decisions about what supplements to take versus the FDA’s charge to protect the public from harmful drugs and devices. At present, dietary supplements are regulated as food, not drugs. The arguments surrounding this debate fall along a spectrum. These arguments, however, are reminiscent of the debates surrounding the regulation of tobacco. The tobacco companies fought hard to keep the FDA out of regulation, some members of the public argued that they should be allowed to take personal responsibility, and the FDA fought to bring tobacco within its regulatory authority. This article seeks to re-examine the debate over dietary supplement regulation through the lens of lessons learned from the tobacco industry. This article proposes new approaches and concerns regarding the future of the FDA and its role in regulating the dietary supplement industry.