With the establishment of the Food and Drug Administration, the U.S. government undertook the task of protecting consumers.

The establishment of the U.S. Food and Drug Administration (FDA) grew out of a need to enforce regulations intended to protect the nation’s food and drug supplies. The push for regulating food and drugs began soon after the United States was founded, when Massachusetts enacted a general food law in 1785. The first federal protection legislation came in 1848, when Congress passed the Drug Importation Act, Drug Importation Act (1848) which enabled U.S. customs inspectors to stop adulterated drugs from entering the country. During the second half of the nineteenth century, many new drugs appeared on the market containing unknown and questionable substances, including highly addicting ones such as morphine, heroin, and cocaine. Congress tried, unsuccessfully, to respond to the problem by introducing more than 190 bills between 1879 and 1906 to regulate food and drugs. [kw]U.S. Food and Drug Administration Is Established (1927)
[kw]Food and Drug Administration Is Established, U.S. (1927)
[kw]Drug Administration Is Established, U.S. Food and (1927)
Food and Drug Administration, U.S.
Consumer protection
[g]United States;1927: U.S. Food and Drug Administration Is Established[06810]
[c]Agriculture;1927: U.S. Food and Drug Administration Is Established[06810]
[c]Health and medicine;1927: U.S. Food and Drug Administration Is Established[06810]
[c]Organizations and institutions;1927: U.S. Food and Drug Administration Is Established[06810]
Campbell, Walter Gilbert
Larrick, George P.
Wiley, Harvey W.

At the turn of the century, however, came renewed public interest in the conditions under which food was produced. As a result of Upton Sinclair’s The Jungle (1906), Jungle, The (Sinclair, U.) which exposed conditions in the meatpacking industry, Congress passed the Pure Food and Drug Act in June, 1906. Pure Food and Drug Act (1906) Enforced by the Bureau of Chemistry Bureau of Chemistry, U.S. within the U.S. Department of Agriculture (USDA), the act made the interstate commerce of mislabeled or adulterated food, drinks, and drugs a federal crime. The act defined food as all substances used for food, drink, or seasoning for human or animal consumption; adulteration was defined as adding substances to reduce the quality or strength, hiding damaged conditions, or using filthy or diseased animals in production. Harvey W. Wiley, the USDA chief chemist who was also known as the father of the pure food movement, led the Bureau of Chemistry’s efforts to enforce the 1906 act, although the act gave him no power to invoke fines or penalties.

Frustrated with the limitations of the 1906 act, Wiley retired from the Bureau of Chemistry in 1912 and was succeeded by Carl Alsberg. During the 1910’s, the bureau struggled to enforce the law. Several cases reached the U.S. Supreme Court, including one in 1914 in which the Court ruled that the government needed merely to show that a substance might affect public health in order to declare it illegal. In 1921, attorney Walter Gilbert Campbell, who had been chief inspector of the Bureau of Chemistry since 1907, took over as the bureau’s head.

Aware of the bureau’s struggles to enforce the 1906 law, Congress began to consider creating a separate law-enforcement agency charged with administering the country’s food and drug laws. With the creation of the Food, Drug, and Insecticide Administration (FDIA) in 1927, the country had its first regulatory agency dedicated to enforcing public health laws specifically related to food and drugs. Established as a separate agency under the Department of Agriculture, the FDIA became the Food and Drug Administration in 1930. Under Campbell’s direction, the agency addressed many problems in the food and drug industries and began to educate the public on nutrition and health.

In 1933, the New Deal policies of President Franklin D. Roosevelt Roosevelt, Franklin D.
[p]Roosevelt, Franklin D.;Food and Drug Administration led the FDA to recommend a complete revision of the 1906 law. Roosevelt demanded consumer protection for the millions of Americans struggling during the Depression and looked to the FDA to end questionable practices within the food and drug industries. Unfortunately, it took a major public health threat to prompt Congress to enact a revised food and drug law. In 1937, the S. E. Massengill Company manufactured, without proper testing, a product called Elixir of Sulfanilamide Elixir of Sulfanilamide for the treatment of sore throats. Almost twelve gallons were distributed before the FDA received notice of deaths attributed to the elixir. Upon testing, the FDA found the product to contain a highly toxic solvent related to radiator antifreeze. Under the 1906 law, the FDA could do little, and more than one hundred people, mostly children, died.

This incident dramatized the desperate need for change, and strong prompting by the FDA led Congress to pass the Federal Food, Drug, and Cosmetic Act in 1938. Federal Food, Drug, and Cosmetic Act (1938) With more than forty provisions, this act served as the nation’s basic food law and as the basis for the FDA’s actions. The law set food standards, placed cosmetics under regulation for the first time, and required that all new drugs be tested for safety. Moreover, the law gave the FDA the power to inspect factories and to seek the penalty of court injunctions. (The power to inspect without prior consent was added in 1953.) It was on the basis of this law and future amendments that the FDA established firm regulations to protect the country’s consumers.

In 1940, the FDA moved from the Department of Agriculture to the Federal Security Agency, and Walter Campbell was named the first commissioner of the Food and Drug Administration. The FDA made two other moves over the next thirty years—to the Department of Health, Education, and Welfare in 1953 and to the Public Health Service under the Department of Health and Human Services in 1968. By the early 2000’s, the agency had nine thousand employees working at offices or inspection posts in nearly 170 cities. FDA personnel conducted about sixteen thousand visits annually to facilities under its oversight.

In 1988, the Food and Drug Administration Act Food and Drug Administration Act (1988) officially established the FDA as an agency of the Department of Health and Human Services, with a commissioner appointed by the president with the advice and consent of the Senate. This act also broadly listed the responsibilities for the commissioner in four major areas: research, enforcement, education, and information. All responsibilities were related to the primary goal of protecting the country’s food and drug supplies.

The FDA’s multitude of responsibilities were geared toward protecting the food, drugs, and cosmetics available to U.S. consumers. By establishing quality standards and conducting periodic inspections, the agency helped companies comply with the complicated regulations governing food, drug, and cosmetic production. Every substance that went into a product—from pesticides used to control insect problems in the food industry to color additives in cosmetics—came under FDA control. The FDA also worked to ensure that foreign products sold in the United States were produced under sanitary conditions. In addition, the FDA served as an information resource for American consumers regarding the quality of thousands of products. Through consumer consultants and publications such as FDA Consumer and FDA Drug Bulletin, the agency brought information as well as warnings to the public’s attention. The FDA also used the media to prevent illness from widespread contaminations such as those that often follow natural disasters.

Even after the 1938 law provided increased options for the FDA, the agency continued to be hampered by limitations. FDA regulation applied only to interstate commerce; food prices, advertising, and mailed food products did not fall under FDA control, and meat and poultry were controlled by another agency. After 1938, once a violation was determined to have been committed, several options were available to the agency, including recalls, seizures, fines, and injunctions. Until 1985, the maximum fine was $1,000 for misdemeanor violations and $10,000 for felony violations. After federal revisions, the maximum fine was raised to $100,000 per offense and $250,000 for a felonious offense or one that resulted in death. Corporations faced fines twice as high. Noting an increase in criminal violations in the late 1980’s, the FDA opened the Office of Criminal Investigations to deal with criminal offenses.

Passage of the 1938 Food and Drug Act received little public attention. After World War II brought several technological advances that companies wanted to carry over into consumer use, however, many products and substances needed FDA approval. Under Commissioner George P. Larrick, the FDA worked to set strict regulations and research guidelines to protect consumers. In the 1950’s, the agency increased its regulation of food production. In 1954, Congress passed the Pesticide Amendment, which gave the FDA the power to set and enforce pesticide tolerances in foods. (The newly created Environmental Protection Agency took over this area in 1970.) The Food Additives Amendment in 1958 charged the FDA with establishing the proven safety of all chemical additives before they were used in food. One year later, the “Generally Recognized as Safe,” or GRAS, list appeared, which included the most common substances used in food production—including salt, pepper, sugar, and vinegar—that were permissible and excluded from testing. That same year, the Delaney Clause to the 1938 act prohibited the use of substances if they were proven to be carcinogenic in animals. With the addition of the Color Additives Amendment in 1960, no substance could be put into the U.S. food supply without first being determined safe. The responsibility to prove safety fell on the producers, and the responsibility for policing the producers fell on the FDA. During the 1960’s, several problems with the manufacture of baby food and infant formula showed that companies could not be relied upon to police themselves. As a result of these problems, the FDA pushed for the 1980 Infant Formula Act and its 1986 amendment, which strengthened quality standards and established recall procedures.

In addition to developing strict guidelines for approving substances for use in food, the FDA also recalled some products after they had been approved. In response to new medical information regarding cancer, the FDA removed such products as cyclamates and saccharin from the food supply. When necessary, the agency also responded to concerns about contaminated seafood and other products.

The FDA also worked to educate the public about good nutrition. The labeling of food proved to be an integral part of raising public awareness. Food labels Food;labeling had been under federal control since 1906, but they became more important in the 1980’s. Increased public attention to fitness caused the FDA to lower the recommended diet to 2,000 calories per day in 1980. In addition, the FDA and the Department of Agriculture revised the recommended diet from the “basic four” food groups to the “food pyramid” of the 1990’s. The 1990’s also brought new FDA guidelines that required uniform labels on all food products and defined such food-related terms as “lower,” “light,” and “free.”

The FDA provided consumers and doctors with the security that drugs were safe and uniform. With the emergence of a number of chemicals during World War II, pharmacology Pharmaceuticals, FDA regulation became a vital field of medicine and one that relied on the resources of the FDA. Antibiotics appeared as a direct result of World War II, and the FDA responded by requiring the certification of five different antibiotics by 1949, including penicillin and streptomycin. Manufacturers were required to test for efficacy and to keep distribution records so that entire batches could be recalled if necessary. Soon after, companies were required to keep distribution records of all drugs. The importance of this policy was demonstrated in 1982, when the pain reliever Tylenol was linked to several poisoning cases and had to be recalled. Safety also came into play in the early 1960’s when the drug thalidomide, which had been widely used in Europe throughout the 1950’s as a supposedly safe sedative and antinausea treatment for pregnant women, came to the FDA for approval. Frances Kelsey, who was assigned to review the drug, learned of an association between the use of thalidomide and deformed babies and was instrumental in keeping the drug off the U.S. market.

The FDA also controlled the distribution of drugs by determining which products would be available by prescription only—after 1952, these carried the warning “Caution: Federal law prohibits dispensing without prescription”—and which would be available over the counter. Several drugs previously available only by prescription started appearing in over-the-counter versions when the FDA established new guidelines in the 1970’s. The 1980’s also saw a dramatic increase in the availability of generic drugs, for which the FDA provided strict guidelines.

Despite all the FDA’s efforts to monitor the drug industry, problems throughout the 1940’s and 1950’s pointed to a loophole in the 1938 law. Although manufacturers were required to prove safety, they were not required to prove effectiveness. Many “safe” products were consequently approved even though they were not effective. Congress investigated the issue in the early 1960’s, and in 1962, reforms were passed that required all new drugs to prove both safety and effectiveness. The reforms also called for manufacturers to report the benefits and risks of their products to the FDA and medical professionals, and the FDA was charged with evaluating the drugs approved between 1938 and 1962 for effectiveness.

In the 1980’s and early 1990’s, two unrelated issues, acquired immunodeficiency syndrome (AIDS) and breast implants, brought increased pressures on the FDA. Throughout the 1980’s, critics and AIDS activists charged the FDA with being too slow to test and release drugs. The FDA did not approve an AIDS test for blood until 1985. Frustrated with the delayed approvals, AIDS sufferers often turned to fraudulent “cures” and highly unpredictable experimental procedures available in other countries. The FDA also came under fire for problems with silicone breast implants. The Medical Device Amendments of 1976 had provided the same guidelines for these devices as for drugs; another measure in 1990 compelled hospitals and other medical facilities to report any problems with medical devices that resulted in serious illness, injury, or death. These amendments came under heavy criticism when silicone breast implants were found to be dangerous in the early 1990’s. Many again thought that the FDA had moved too slowly in response to the issue.

The FDA has unquestionably had a tremendous effect on American life. Protecting the products that account for more than 25 percent of a consumer’s budget, the FDA has worked to ensure that those products are safe and of the highest quality. Once it had been given power to enforce the country’s food and drug laws, the agency made significant advances in ending questionable practices that could harm public health. Food and Drug Administration, U.S.
Consumer protection

• Hawthorne, Fran. Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat. New York: John Wiley & Sons, 2005. Examines the inner workings of the powerful agency, including how it makes decisions while under pressure from industry, agriculture, politicians, and consumers. Features notes, bibliography, and index.
• Hilts, Philip J. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation. New York: Alfred A. Knopf, 2003. Documents the history of the U.S. Food and Drug Administration from its establishment during Theodore Roosevelt’s presidency to the beginning of the twenty-first century. Emphasizes the FDA’s regulatory role and its battles against entrenched business interests.
• Mintz, Morton. By Prescription Only. Boston: Beacon Press, 1967. Covers the role of the FDA in regulating the drug industry. Discusses the problems of drug testing and regulation as well as the role of advertising and the media in promoting new drugs.
• Patrick, Bill. The Food and Drug Administration. New York: Chelsea House, 1988. Covers the history and influence of the FDA on the food and drug industries. Also discusses the societal impact of the agency’s work.
• Young, James Harvey. American Health Quackery: Collected Essays. Princeton, N.J.: Princeton University Press, 1992. Discusses the scams that have pervaded medical practice in the United States and how the FDA has responded to false claims and misinformation.

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