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.