Stomaching the Burden of Dietary Supplement Safety: the Need to Shift the Burden of Proof Under the Dietary Supplement Health and Education Act of 1994

• Publication year: 2005

SEATTLE UNIVERSITY LAW REVIEWVolume 28, No. 3SPRING 2005

Stomaching the Burden of Dietary Supplement Safety: The Need to Shift the Burden of Proof Under the Dietary Supplement Health and Education Act of 1994

Morgan J. Wais(fn*)

There are some in the industry that would have us accept the notion that ephedra is only an outlier. That the law is sound and only this single substance needs to be banned. I do not believe that that is the truth, and I believe they know better.(fn1)

-Rep. John D. Dingell

I. Introduction

In the United States, more than half of all Americans consume dietary supplements in some form, be it in a pill, bar, powder, or liquid.(fn2) Americans consume dietary supplements for various reasons-to lose weight, to build muscle, to have more energy, to treat colds, or simply to live a healthier life.(fn3) In the latter half of the twentieth century, "[skyrocketing healthcare costs, longer life expectancy, perceived failure of Western trained doctors to practice preventative medicine, lack of effective communication with patients, and new diseases all contributed" to Americans seeking alternative medical treatments.(fn4) Not wanting the sales of dietary supplements to be wholly unregulated, Congress passed the Dietary Supplement Health and Education Act of 1994 ("DSHEA").(fn5) Although DSHEA made several substantial changes to dietary supplement regulation, it also created a great deal of uncertainty about the scope of the Food and Drug Administration's ("FDA") regulatory power over dietary supplements. Such uncertainty is due in large part to three characteristics: (1) DSHEA contains ambiguous verbiage; (2) DSHEA divested the United States government of a large portion of its regulatory power, and, above all; (3) DSHEA placed the burden of proving dietary supplement safety on the FDA, rather than on the dietary supplement industry.(fn6)

Although this Comment concerns dietary supplements in general, it focuses on ephedra because of its recent rise in popularity and its subsequent fall due to safety concerns.(fn7) Ephedra regulation illustrates many of the deficiencies of supplement regulation under DSHEA. However, simply addressing a single dangerous dietary supplement does not provide a long-term solution for the underlying problems endemic in current supplement regulation.(fn8) Accordingly, changes made to provisions of DSHEA have to be broad and sweeping rather than narrow and limited to ephedra.

In order to best protect consumers, Congress should amend DSHEA so that the burden of proving the safety of dietary supplements rests solely on the dietary supplement industry, rather than on the FDA. Despite countless injuries to supplement users, the current regulatory scheme under DSHEA has not encouraged the FDA to make the safety determinations necessary to meet its burden and properly regulate the dietary supplement industry.(fn9) It has, therefore, become the injured public who has held dietary supplement manufacturers accountable when they produce an unsafe product.(fn10) And it will be the public that will continue to be injured until pre-market approval is required of dietary supplements.

If Congress amends DSHEA and places the burden of proving the safety of dietary supplements on the industry, supplement manufacturers of products that are truly safe will be little more than inconvenienced. To illustrate, manufacturers of vitamin C have little to be concerned about, as there is undeniable evidence proving not only vitamin C's safety, but also its benefits.(fn11) However, ephedra and other dangerous dietary supplements not only lack proven benefits, but have several known deleterious effects. Manufacturers of ephedra would have to establish its safety before marketing their products. As the law currently stands, even products like ephedra that are ultimately banned(fn12) are allowed to remain on the market far too long once their deleterious effects are known, resulting in innumerable unnecessary injuries.(fn13)

Part II of this Comment will give a brief historical perspective on dietary supplement regulation and discuss the evolution of drug regulation by the FDA. Part II will conclude with a discussion of the political environment in which these regulations occur. Part III will give examples and show how the current system has caused injury and harm to consumers of dietary supplements. Part IV will discuss the current burden of proof and how it was applied in the case of ephedra. Part V will discuss how, under the current regulatory structure, consumers cannot be adequately protected, either by the FDA or the tort system. Part VI discusses the benefits that would likely be derived from shifting the burden of proving safety onto the dietary supplement industry. Finally, Part VII concludes this Comment.

II. History of DSHEA, Drug Regulation, Money, and Politics

A. Historical Basis and Formation of the Act

DSHEA was signed into law on October 25, 1994, by President Clinton,(fn14) but the history of regulating dietary supplements extends back much farther.(fn15) Regulation of supplements began when the FDA was created in 1906 by the passage of the Pure Food Act ("PFA").(fn16) The initial goals of Congress were to protect the public and to guard against deceptive labeling practices regarding claims made by the manufacturers.(fn17) PFA was deficient because it gave the FDA only the power to remove dangerous products from the market but did not give it the power to prevent the products from entering the market in the first place.(fn18)

In 1938, Congress amended PFA and enacted the Food, Drug and Cosmetic Act ("FDCA"),(fn19) which gave the FDA the power to not only remove dangerous products from the market, but also to require pre-market approval from the FDA before certain products were placed on the market.(fn20) The FDCA also made the distinction between dietary foods, which were to be regulated as food, and dietary ingredients, which were to be regulated as drugs.(fn21) Dietary foods were presumed safe and the FDA had the burden of proving that the product was not safe, but the burden of proving the safety of dietary ingredients rested upon the manufacturers.(fn22) At that time, most modern dietary supplements were classified as dietary ingredients,(fn23) and thus, like drugs, the burden of proving product safety rested on the manufacturers.(fn24)

Throughout the 1960s and until the early 1990s, there were frequent discussions regarding the regulation and classification of dietary ingredients to allow them to be more easily brought to market.(fn25) Both sides were strong advocates for their positions: One side sought tighter control of dietary ingredients while the other sought a less burdensome approval process.(fn26) Despite the urging of both dietary supplement manufacturers and the public, the classification remained, and the burden of proving the safety of the dietary ingredients remained on the manufacturers.(fn27)

This complex framework-what product falls into which category for the sake of proving its safety-was reworked in 1994 when the FDCA was amended with the passage ofDSHEA.(fn28) In passing DSHEA, Congress sought "to supersede the current ad hoc, patch work regulatory policy on dietary supplements."(fn29) In doing so Congress made several findings, including the following: (1) the availability of dietary supplements improves "the health status of United States citizens[,]"(fn30) (2) the availability of dietary supplements allows consumers to be "empowered to make choices about preventative health care programs based on data from scientific studies of health benefits related to particular dietary supplements,"(fn31) and (3) "the nutritional supplement industry is an integral part of the economy of the United States."(fn32) Most significant was Congress' finding that "although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers."(fn33)

DSHEA changed the regulation of dietary supplements in four main ways. First, the Act defined dietary supplements as products supplementing the diet that contain a vitamin, mineral, herb or other botanical, amino acid, "dietary substance for use by man to supplement the diet by increasing the total dietary intake," or "a concentrate, metabolite, constituent, extract, or combination of any ingredient" described above.(fn34)

The new definition was an attempt to clarify the blurry line between foods, dietary supplements, and pharmaceuticals.(fn35)

Not only did the redefinition of dietary ingredients to dietary supplements place supplements in the same regulatory framework as food, but the new framework did not require supplement manufacturers to keep accurate records of all adverse reactions reported to them from use of a specific supplement.(fn36) Under the new definition, dietary supplement manufacturers could put the product on the market and disregard any complaints or questions regarding the safety of their product.(fn37) Compare this framework to that of pharmaceuticals, where, among other things, companies must keep accurate records of all adverse reactions reported to them.(fn38)

The second primary way in which DSHEA changed regulation of dietary...