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Hastings Women’s Law Journal

Abstract

This article explores dietary supplement regulation and the belief systems and legal rules that shape it. Part I discusses the key provisions of the federal Dietary Supplement Health and Education Act (DSHEA). Part II examines how DSHEA, philosophically, represents a compromise between extreme medical paternalism (the orthodox view that the FDA should dictate consumer access to dietary supplements) and radical patient autonomy (the liberal view that patients should have unlimited consumer access to dietary supplements). Part II frames the debate in terms of regulatory proposal, policy, values, and belief system. Strong controls in regulation (FDA's paternalistic viewpoint) and weak controls in regulation (the industry's autonomous approach) are contrasted. Two models of healing are compared. Additionally, the influence of belief systems behind the strong and weak regulatory controls are contrasted and defined by who determines what is 'healthy'/dangerous, what is the ultimate authority in health care choices, how consumer choices should be understood and what the nature of the body is. The D.C. Circuit has rejected the FDA's paternalistic approach of suppressing health claims on dietary supplements that do not meet the FDA standard. Instead, the court's decision respects consumer autonomy, and its regulatory approach encourages information, rather than restricts access. Lastly, the author concludes that examining the core beliefs and values surrounding the debate helps clarify the debate.

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