Food and Drug Administration

FOOD AND DRUG ADMINISTRATION

FOOD AND DRUG ADMINISTRATION. The Food and Drug Administration (FDA) was the first regulatory agency established in the United States with consumer protection as its principal mission. Arguably, it is the only federal regulatory agency today whose basic charge has not been substantially altered in nearly one hundred years. Although the agency's responsibilities have grown enormously since Congress first defined food and drug adulterations as a danger to health and as consumer fraud in 1906, FDA remains a science-based regulatory agency responsible for protecting the public health through the regulation of foods, drugs, biological therapeutic products (i.e., vaccines), medical devices, cosmetics, animal feed, and radiation-emitting consumer products.

FDA began as a small, analytical chemistry unit in the U.S. Department of Agriculture, created after the Civil War to promote agriculture and assist farmers. A single chemist, whose job it had been to analyze fertilizers and agricultural chemicals for the Patent Office, was transferred to the new department in 1862 to continue his work on behalf of farmers and state agricultural extension services. In 1880, the chief chemist in the Bureau of Chemistry endorsed passage of a federal food and drug law, and his successor in 1883, Harvey W. Wiley, actively campaigned for the law. When it was finally enacted by Congress in 1906, the Pure Food and Drugs Act was often referred to as the Wiley Act.

Wiley led the bureau in an era in which the transforming trilogy of industrialization, immigration, and urbanization changed America from a nation of farmers into a nation dominated by business. The earliest successful commercial foods were either new altogether—like crackers—or tasty but time-consuming to prepare at home. Condiments such as mustard, catsup, relishes, jams, and jellies, and, later, tinned fruits, meats, and vegetables, were all newly available from a burgeoning prepared foods industry. Likewise, medicines for the inevitable indigestion (dyspepsia) and other ills stemming from a poor diet were some of the most successful patent medicines. Consumers, however, had little way of telling good products from bad. State laws were frequently inconsistent and ineffective. Meanwhile, canned foods exploded, patent medicines and standard drugs were often equally unreliable, catsups fermented, and mustards were often watered down. Even products labeled "pure" were often counterfeits; most "pure Vermont maple syrup," for instance, was made from Iowa corn syrup.

The Bureau of Chemistry found its niche in the Department of Agriculture by using its analytical chemical expertise to improve the U.S. marketplace. Wiley and the bureau chemists turned their attention to the food and drug products on the market, testing them for ingredient substitutions, omissions, or additions that would be defined as "adulteration" and "misbranding," under the 1906 act. Wiley's pioneering work on the safety of food preservatives led Congress to increase his bureau's budget and include special funds for human testing of early food additives (salicylic acid, benzoate of soda, boric acid, copper salts, saccharin). As it became clear that some producers would always take shortcuts to reduce costs (so long as the consumer could not detect the difference), support for a national food and drug law began to emerge and grow, supported by national women's groups, muck-raking journalists, state food and drug officials, and analytic chemists. Wiley's prowess as a "crusading chemist" became legendary. At a convention of hostile canners, for example, he single-handedly changed their minds about regulation by reminding them that what they made they should also be willing to eat.

At the height of Progressive-era politics, during the heyday of analytical chemistry, and in the midst of the bacteriological revolution, Congress transformed the Bureau of Chemistry into a regulatory agency, fully expecting that science would be the arbiter of both health and commercial issues. Signed on 30 June 1906 by Theodore Roosevelt, along with the Meat Inspection Act, which put inspectors into all of the nation's slaughterhouses, the 1906 Pure Food and Drugs Act is still considered by historians to be one of the most significant pieces of Progressive-era legislation. In 1927, the regulatory component of the Bureau of Chemistry became the Food, Drug, and Insecticide Administration, renamed the Food and Drug Administration in 1930.

Within the decade following passage of the 1906 Pure Food and Drugs Act, the consumer marketplace was transformed. Wiley felt strongly about certain issues, and highly contentious and even more highly publicized legal cases were fought over them. But it was the routine enforcement of the simplest adulteration and misbranding portions of the law that transformed the commercial landscape of the country. New federal food and drug inspectors worked with businesses, factories, and trade organizations to update equipment, institute basic sanitary procedures, and apply insights gained from the burgeoning science of bacteriology to safeguarding the nation's food and drug supply. Added to initial concerns about food additives, and in the wake of Pasteur's discovery of the microorganisms responsible for food fermentation as well as some diseases, came increasing concerns about microorganisms in food as a cause of disease. Under Wiley's leadership, the Bureau of Chemistry continued to identify products and pathogens that moved food safety from abstract speculation to concrete action. Wiley began to hire expert microbiologists who, in turn, helped transform the canning and egg industries and shape the new refrigeration industry, helping to insure safer food for all Americans. By the time Wiley left office, in 1912, many known commonplace dangers had been eliminated from interstate commerce, though threats such as botulism, mycotoxins, and e-coli were soon to be discovered. Improvements in the drug trade as well paved the way for extraordinary future advances in therapeutics.

By the 1930s, the 1906 act had become seriously outdated. A new multimillion dollar cosmetic industry, new food products and pesticides, new drugs and new classes of drugs including barbiturates and sulfa drugs, and changes in the field of advertising all made deficiencies in the Wiley Act increasingly apparent. With the active support of consumer advocates such as Consumer's Research and Consumer's Union, so-called "guinea-pig" muckraking journalists, women's organizations, and Eleanor Roosevelt herself, the old law was replaced during the New Deal with the 1938 Food, Drug, and Cosmetic Act. Propelling the new legislation through Congress and onto President Franklin Roosevelt's desk was a 1937 drug disaster. "Elixir sulfanilamide," which contained a poisonous solvent, diethylene glycol, killed over 100 people before the entire field force of the FDA could be dispatched to retrieve every ounce of the product. This episode generated support for an important new provision in the 1938 act requiring companies to perform pre-market safety testing of all new drugs and gain FDA approval before marketing them.

In 1940, the Food and Drug Administration left the Department of Agriculture to become part of a new Federal Security Agency; and in 1953, it was transferred to the Department of Health, Education and Welfare (DHEW). In 1968, FDA became a component of the Public Health Service (PHS). In 1980, education was removed from the DHEW's responsibilities, and it was renamed the Department of Health and Human Services (DHHS). During the 1960s, 1970s, and 1980s, the Drug Enforcement Administration, the Consumer Product Safety Commission, and parts of the Environmental Protection Agency and Federal Trade Commission were all created to extend consumer protection procedures pioneered by the Food and Drug Administration to stop illegal drug sales, recall dangerous consumer durable goods, set tolerances for agricultural chemicals, and control drug advertising.

Significant pieces of legislation broadening and extending FDA's premarket activities were enacted between 1958 and 1976. In the Food Additives Amendment of 1958 and the Color Additives Amendment of 1960, a pre-market approval system was established for food and color additives, requiring that such substances be shown to be safe, suitable, and non-carcinogenic. In 1961, a worldwide scandal erupted over the teratogenic drug thalidomide, responsible for thousands of birth defects in Europe and a few in the United States, where the drug was never approved for sale. In 1962, Congress significantly strengthened FDA's authority over drugs, charging it with assessing both the safety and efficacy of new drugs prior to approval. In 1976, medical devices were subjected to pre-market regulatory assessment, and a system devised to assess such devices in accordance with their perceived risks—three separate risk categories representing high, moderate, and low risks were established. In 1971, the PHS Bureau of Radiological Health was transferred to FDA, bringing with it responsibility for ensuring the safety of radiation-emitting consumer products such as televisions and microwave ovens. In 1972, regulation of biologic products, including serums, vaccines, and blood products, was transferred from the National Institutes of Health (NIH) to FDA.

FDA currently regulates approximately $1 trillion worth of products each year (including both domestic and imported goods), representing about 25 cents of every dollar spent by consumers each year. The agency's fiscal year 2002 budget is $1.553 billion, including $184 million in industry-assessed user fees. The FDA employs about 10,000 personnel in the Washington area and in 167 field offices throughout the United States and Puerto Rico. Included in the fiscal year 2002 budget is an increase of $151.1 million and 832 full-time employees for activities related to bioterrorism and emergency preparedness following the tragic events on 11 September 2001.

BIBLIOGRAPHY

Goodwin, Lorine Swainston. The Pure Food, Drink, and Drug Crusaders, 1879–1914. Jefferson N.C.: McFarland, 1999.

Junod, Suzanne White. "Food Standards in the United States: The Case of the Peanut Butter and Jelly Sandwich." In Food, Science, Policy and Regulation in the Twentieth Century. Edited by David F. Smith and Jim Phillips. London: Rout-ledge, 2000.

Maeder, Thomas. Adverse Reactions. New York: Morrow, 1994.

Marcus, Alan I. Cancer from Beef: DES, Federal Food Regulation, and Consumer Confidence. Baltimore: Johns Hopkins University Press, 1994.

Marks, Harry M. The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900–1990. Cambridge: Cambridge University Press, 1997.

Okun, Mitchell. Fair Play in the Marketplace: The First Battle for Pure Food and Drugs. Dekalb, Ill.: Northern Illinois University Press, 1986.

Swann, John P. "Sure Cure: Public Policy on Drug Efficacy before 1962." In The Inside Story of Medicines: A Symposium, Madison, Wis.: American Institute of the History of Pharmacy, 1997.

White, Suzanne. "The Chemogastric Revolution and the Regulation of Food Chemicals." In Chemical Sciences in the Modern World. Edited by Seymour H. Mauskopf. Philadelphia: University of Pennsylvania Press, 1993.

Young, James Harvey. Pure Food: Securing the Federal Food and Drugs Act of 1906. Princeton, N.J.: Princeton University Press, 1989.

Suzanne White Junod

See also Jungle, The ; Pure Food and Drug Movement .