Summary
The Dietary Supplement Health and Education Act was enacted with the goal of facilitating the use of dietary supplements by minimizing their regulation. Here, Cohen argues that DSHEA's definition of supplement is not based on scientific findings or foundations.
Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerine and limburger cheese . . . [T]his historical experience does suggest why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of self-styled panaceas that inventive minds can devise. [Individuals have] the right to be treated by a health care practitioner with any medical treatment (including a treatment that is not approved, certified, or licensed by the Secretary of Health and Human Services) that such individual desires or the legal representative of such individual desires. The makers of our Constitution undertook to secure conditions favorable to the pursuit of happiness. They recognized the significance of man's spiritual nature, of his feelings and of his intellect. They knew that only a part of the pain, pleasure and satisfactions of life are to be found in material things. They sought to protect Americans in their beliefs, their thoughts, their emotions and their sensations. They conferred, as against the Government, the right to be left alone--the most comprehensive of rights and the right most valued by civilized men.See the full content of this document
Extract
Science, Politics, and the Regulation of Dietary Supplements: It's Time to Repeal Dshea
I. INTRODUCTION
Conflict between the orthodox medical community and practitioners of alternative therapies has been a recurring motif throughout the history of medicine. It is not surprising that in today's media and Internet society, where medicine has become as much an industry as a healing art, that many people wish to "take charge" of their bodies, through the latest "blockbuster" medications, whether they be alternative medicines or the more traditional type.Dietary supplements, a major component of complementary and alternative medicine ("CAM"), have become extraordinarily popular in recent years.4 The Dietary Supplement Health and Education Act ("DSHEA")5 was enacted with the goal of facilitating the use of dietary supplements by minimizing their regulation.6 DSHEA raises three major questions concerning policy and politics:(1) Are there essential differences between pharmaceuticals and supplements?7(2) If so, do these differences justify the radically different approach under which drugs and supplements are regulated today?(3) To what extent should the government regulate any substance used to treat, ameliorate or prevent disease?DSHEA has several critical weaknesses, three of which are of critical importance for this article. First, DSHEA classifies compounds as dietary supplements based on their source, rather than their pharmacologic and physiologic properties.8 This article will argue that DSHEA's definition of supplement is not based on scientific findings or foundations. Second, DSHEA assumes that components of foods cannot cause harm, even when ingested in large amounts, and that therefore supplements should be subject only to regulations dealing with foods rather than with the more stringent regulations applied to drugs.9 DSHEA also assumes that since herbs and botanicals are "natural," they warrant regulation only to the same extent as food components, regardless of their pharmacologic, physiologic, or pathologic attributes, and irrespective of whether they are foods at all.10 This article will maintain that both of these assumptions are erroneous. Third, the marketing of dietary supplements must be accompanied by a statement indicating that these substances are not intended to treat diseased but rather to maintain normal bodily function. This article will claim that this is a meaningless distinction to most consumers, who consider that failure of normal bodily function is a form of disease. This article will conclude that these and other deficiencies inherent in DSHEA render current dietary supplement regulations inherently misleading.This article will analyze the problem of DSHEA from four perspectives. Part II will review the genesis of the Food, Drug, and Cosmetic Act ("FD&C Act")12 and DSHEA, compare their approaches to regulation, and question whether purported differences between pharmaceuticals and supplements are sufficient to have warranted the development of such radically different laws governing each. This discussion will include a look at the role of statutorily imposed semantic distinctions. The section will conclude that the supposed differences between "drugs" and "supplements" that have been written into DSHEA are ephemeral, and that they should not determine the scope of a state's regulatory power.Part III will propose that DSHEA ignores biological findings crucial to the distinction between drugs and supplements. This section will focus on the toxic effects resulting from ingestion of vitamins, amino acids, and botanicals that were documented in the medical literature long before DSHEA was enacted. This section will briefly discuss the issue of establishment hubris, a phenomenon that has existed throughout medical history and has arguably been an impediment to the acceptance of what have become some of today's most important medical therapies.Part IV will examine the role of public health with regard to supplements and drugs. This section will examine contrasting philosophies concerning the role of government in regulating an individual's use of drugs. The focus here will be on the Rutherford case and the Access to Medical Treatment Act.13 This section will argue that regulation of both drugs and supplements requires a knowledge base adequate to evaluate their pharmacologic and physiologic effects as well as their risks and benefits. Since most consumers lack this knowledge base, a state has an obligation to act in parens patria...See the full content of this document
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