Americans are avid consumers, and the Federal Food, Drug, and Cosmetic Act (FDCA) (52 stat. 1040) covers products that represent nearly a quarter out of every dollar spent. The FDCA and the agency that administers it, the Food and Drug Administration (FDA), govern the safety and accurate labeling of a trillion dollars worth of products annually, including prescription and over-the-counter drugs, cosmetics, medical devices, blood and tissue products, and the nation's entire food supply except for meat and poultry.
Despite frequent amendments since the statute's inception in 1938, two longstanding and complementary regulatory goals remain at the core of the FDCA. The first is to protect the public's safety—the FDCA mandates the safety, purity, and in some cases the "effectiveness" of the products within its scope. For most food products, the FDA ensures safety through inspections of products already on the market, controls the manufacturing practices of companies, and possesses recall and seizure authority. For new drugs, medical devices, and food additives, the FDA has even more robust authority. Unlike most goods sold in the United States, new drugs, medical devices, and food additives must obtain the FDA's stamp of approval as "safe" before being marketed to the public, and drugs and devices must satisfy the added standard of "effectiveness." In a process that often takes years, FDA scientists review extensive empirical research submitted by manufacturers to assess the safety and effectiveness of each new drug or device. Once a product is on the market, the FDCA directs the FDA to monitor emerging information and authorizes it to withdraw approval of products in light of new safety concerns.
The FDCA's second major goal is to disclose information—the statute requires truthfulness and completeness in product labeling and other marketing communications. The act and related FDA regulations contain both prohibitions and affirmative requirements in this area. The act forbids "misbranding," and provides a range of civil and criminal enforcement mechanisms against inaccurate product labeling. It also grants FDA authority to require certain information on product labels, such as the standardized nutritional content box that appears on almost every food label and listing possible side effects and drug interactions on pharmaceutical labels.
Systematic federal regulation of the nation's food and drug supply dates back almost a century, and various public health crises have been instrumental in congressional decisions to implement or strengthen the federal regulatory regime. Upton Sinclair's widely-read book, The Jungle portrayed extremely unsanitary conditions in the meat packing industry and created wide public support for the precursor to the FDCA, the Pure Food and Drug Act of 1906. Numerous deaths from a popular consumer medicine (elixir of sulfanilamide) in the 1930s led Congress to enact the FDCA in 1938. The FDCA significantly expanded federal regulatory authority, most notably by requiring premarket safety approval for new drugs, adding cosmetics to the statutory scheme, and providing express authority for factory inspections.
Congress further strengthened the FDCA in 1958 with the Food Additives Amendment (also called the "Delaney Clause" after its House sponsor), precluding FDA approval of any food additive found to cause cancer in humans or animals; and in 1962 Congress required that drug manufacturers produce scientific evidence not just that their products were "safe" before marketing them, but also that they were "effective" in their intended use. In 1976 the FDCA's scope was expanded to cover all medical devices used in the United States.
Throughout its long history the FDCA has been relatively secure from serious constitutional challenge, primarily because the statute regulates only products that are "in interstate commerce" and thus comfortably within Congress's Commerce Clause authority. Courts have also upheld the FDCA against a different sort of constitutional challenge brought by terminally ill patients claiming a fundamental privacy right to use whatever substances they and their doctors think will relieve their suffering despite the FDA's failure to approve its "safety" or "effectiveness," as in Rutherford v. United States (1980) (which holds that "[t]he premarketing requirement of the [FDCA] is a [valid] exercise of Congressional authority to limit the patient's choice of medication."
More significant than any serious constitutional questions are some important limitations on the scope of the FDCA's coverage. The act does not regulate the "practice of medicine" by individual physicians, meaning that once a drug is on the market, doctors can prescribe it in doses, in combinations with other drugs, or in patient populations (such as children or pregnant women) that differ significantly from the terms upon which the drug was tested and approved, and physicians are free to use a drug approved for one disease to treat a different medical condition. Such medical use of approved drugs for unapproved uses (termed "off-label" use) is widespread in certain specialties such as cancer, AIDS treatment, and pediatric medicine. A U.S. Supreme Court decision in FDA v. Brown and Williamson Tobacco Corp. (2000) upheld another key limitation on the FDCA's coverage by placing cigarettes and other tobacco products outside of the statute's scope. Despite these limitations at the margins, the FDCA remains one of the nation's most important consumer protection statutes.
Bibliography
Dunn, James Harvey. Federal Food, Drug, and Cosmetic Act Chicago: Clearinghouse Press, 1938.
Hutt, Peter Barton and Richard A. Merrill. Food and Drug Law: Cases and Materials 2d ed. New York: Foundation Press, 1991.
Young, James Harvey. Pure Food: Securing the Federal Food and Drugs Act of 1906 Princeton, NJ: Princeton University Press, 1989.
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