For almost a century, the Food and Drug Administration (FDA) has regulated nutrients and other dietary supplement ingredients and products under the food provisions initially of the Federal Food and Drugs Act of 1906 and now of the Federal Food, Drug and Cosmetic Act of 1938 (“FD&C Act”), as amended. Congress amended the FD&C Act through the Food Additives Amendment of 1958 and the Color Additive Amendments of 1960 to strengthen FDA authority over food ingredient safety. In 1976, Congress enacted the Vitamin-Mineral Amendments which provides that FDA may limit the contents of dietary supplements only for safety reasons. In 1994, Congress enacted the Dietary Supplement Health and Education Act (“DSHEA”) to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary supplements and dietary ingredients.

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 selfstyled 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.

There exists increasing concern that the Dietary Supplements Health and Education Act (“DSHEA”) has proven ineffective and perhaps counterproductive. Most illustratively, consider a recent and remarkably candid remark from Tommy Thompson, then Secretary of Health and Human Services: “I really think Congress should take a look at the food supplement law again. It doesn't make any sense to me.”

A health law that makes no sense to the Secretary of Health of Health and Human Services should certainly draw the attention of academics and policy-makers alike. Much of the debate concerning DSHEA regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Specifically, while pharmaceutical drugs must undergo years of costly pre-market testing, most dietary supplements—like most foods—can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (“FDA”) remove them.

In response to the increasing attention to the link between health and nutrition, a wealth of information—and misinformation—is becoming available, especially via the Internet. Consumers are advised to carefully assess the reliability of information they use to determine whether a product is safe. Meanwhile, regulators are sorting out the facts themselves, but despite the ever-increasing availability of scientific research, our evolving understanding of nutrition is still supplemented by our perceptions about risk.

The primary framework for the regulation of dietary supplements is the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). Underlying DSHEA is the congressional intent to support two goals: “(1) to facilitate consumer access to dietary supplements, given that many dietary supplements are used by consumers to help them maintain and improve their health; and (2) to give the Food and Drug Administration (“FDA”) the authority to step in where safety problems arise and to ensure proper labeling.”

In the ten years since the passage of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), dietary supplements have become a widely available and important element of individualized preventative healthcare. Congress created DSHEA in response to great consumer demand, thereby embracing the dietary supplement category and opening the door for the growth of the dietary supplement industry. DSHEA introduced an expansive definition of dietary supplements and laid out available claims and strict safety standards for such products.

While the statute has remained unchanged since its passage in 1994, the Food and Drug Administration (“FDA”) appears to be in the process of re-interpreting sections of DSHEA in ways that could fundamentally limit the availability of dietary supplements. Specifically, FDA has been utilizing DSHEA's “new dietary ingredient” (“NDI”) safety provision to narrow the scope of ingredients that can be considered, even before addressing their safety, for use in dietary supplements.

Scientific studies continue to establish a strong relationship between constituents in foods and dietary supplements and certain diseases. The general population is inundated on a seemingly daily basis by media reports of new studies showing that a food or dietary supplement is useful in treating particular diseases or reducing the likelihood that a consumer will develop particular diseases. With increasing frequency, consumers are looking for foods and supplements to help manage and prevent the onset of disease.

Not surprisingly, the food and dietary supplement industries are responding by developing new products and repositioning old products efforts to help consumers manage their health. For example, yogurt used to be positioned only as a delicious component of a meal but now is also promoted for use in weight loss programs after a study showed that the calcium in dairy products is effective in weight loss.

The Dietary Supplement Health and Education Act of 1994 (“DSHEA” or “the Act”) was a seminal event in the world of food and drug law. The Act took a controversial category of product traditionally regulated by FDA as either a food or a drug, depending upon the product claims and formulation, and created a new regulatory category called “dietary supplement” that was placed within the “food” definition. As such, products meeting the “dietary supplement” definition benefited in two significant ways, (1) dietary supplements could make “structure/function” claims traditionally within the realm of drug products; and (2) unlike food ingredients, dietary ingredients could be used in dietary supplements without being either approved food additives or generally recognized as safe (“GRAS”) ingredients. These legislative provisions significantly changed the legal, corporate, and consumer landscape, allowing products to enter the marketplace with broadbased claims without FDA premarket review or approval of the ingredients, formulation, or product claims.

Everyone condemns medical quackery. Government regulators seek to protect us from it. Alternative providers strive to distance themselves from it. Orthodox medicine wants to stamp it out.

The question is: What constitutes “quackery”? How do we distinguish quacks from mainstream practitioners? Even more problematic, how do we distinguish between quackery, which everyone agrees is beyond the pale and therefore should be fair game for sanction, and practices that, while unorthodox, should be tolerated in the interests of promoting medical progress and patient choice? These are particularly challenging questions now, when a number of factors are combining to undermine the hegemony of mainstream medicine, when some of the same forces that spurred the growth of quackery in the 19th century are remerging, and when neo-conservatives are clamoring for greater freedom of choice for health care consumers.

This article begins with a brief history of quackery in America and the factors that encourage its growth. The article then attempts to distinguish between quackery and acceptable medical practice.

To overcome the unattractiveness of small markets, the United States government provides financial aid and incentives for drug manufacturers to create cures for rare diseases under the Orphan Drug Act (“the Act”). Recent research integrating genetic information and pharmacology holds promise for creating more effective drugs targeted at smaller populations than ever before. In the near future, it seems that a flood of new drugs targeted at small disease populations could take advantage of the government benefits under the Act. Drug applicants will include true orphan drugs along with “Trojan” applicants that seek to co-opt the benefits for drugs that should not qualify as orphans. Currently, the FDA appears ill prepared to discern between the two types of applicants and prevent abuse of the system.

In 1983, the federal government passed the Act. Congress designed the Act and subsequent modifications to provide incentives for companies to bring drugs for rare diseases to market.