The oversight provided by the Food and Drug Administration affects directly such businesses as agriculture, tobacco, meat processing and packing, pharmaceuticals, the cosmetics industry, and the makers of much of the biomedical hardware commonly found in modern medical facilities.
The creation of a federal agency to oversee the food and drug industries is largely a product of the twentieth century.
Nevertheless, in the last quarter of the nineteenth century, one influential scientist, Harvey Wiley, attached to the United States Department of Agriculture as its chief chemist, was vitally concerned with the safety of the nation’s food supply. During his term in office, which ran from 1883 to 1912, Wiley created “poison squads” to test foods that were suspected of causing illnesses.
Wiley’s efforts were bolstered substantially in 1906 with the publication of Upton
Among the most influential readers of The Jungle was President Theodore Roosevelt, whose reaction was immediate. He goaded Congress, many of whose members read Sinclair’s novel, into passing the
This act also demanded that food and drugs be labeled accurately and honestly, which was a blow to many charlatans who had been selling magical cures–things like snake oil–to an unsuspecting public. Between 1906 and 1927, the enforcement of the Pure Food and Drug Act fell to the Bureau of Chemistry, an agency within the United States Department of Agriculture. In 1927, the Bureau of Chemistry was renamed the Food, Drug, and Insecticide Administration, and in 1930, the name was shortened to the Food and Drug Administration.
In 1928, Congress, through the passage of the Food, Drug, and Insecticide Act, authorized the federal government to establish a separate agency to carry out research relevant to the Pure Food and Drug Act. This agency was concerned not only with food and drugs but also with biomedical devices used in the treatment of various conditions.
In 1931, during Herbert Hoover’s presidency, Congress passed the Agricultural Appropriation Act, which changed the agency’s name to the Food and Drug Administration (FDA). During the presidency of Franklin D. Roosevelt, Congress passed the Food, Drug, and Cosmetics Act of 1938, which increased the types and number of commodities that fell under the jurisdiction of the federal government. This act increased the penalties that could be exacted against those who violated its provisions.
Special interest groups attempted to apply pressure to the agency and to encourage it to overlook some of their infractions of clear-cut rules, the enforcement of which would cost them dearly. In 1940, to circumvent such pressure, the agency became a part of the Federal Security Agency, where it remained until 1953, when it became officially attached to the Department of Health, Education, and Welfare. It remained attached to this cabinet-level department until 1980, when it became an adjunct of the Department of Health and Human Services, also a cabinet-level department, to which it remains attached.
Through the years, the federal Food and Drug Administration has undergone a great deal of public scrutiny and criticism. Because its findings affect the lives and welfare of millions of people, the public demands high standards of this agency. Sometimes, to maintain such standards, the FDA is forced to take actions that cost various affected industries millions of dollars.
In the first half of 2008, for example, two major criticisms were leveled against the FDA. In the first instance, an epidemic of human salmonella poisoning afflicted 1,294 people in forty-three states as well as in Canada and the District of Columbia. The FDA undertook an immediate investigation and initially proclaimed that tainted tomatoes might be the source of this epidemic.
Only two years earlier, the agency had cast a similar suspicion on the $180-million-a-year spinach crop from California’s Salinas Valley, resulting in an embargo that led to the bankruptcy of many of those involved in the production and distribution of spinach. The outbreak of illness caused by e-coli was traced to spinach from California’s Salinas Valley and destroyed the businesses of many farmers dependent on the spinach crop for their economic survival. Their losses were estimated by some to exceed $1 million for each day the embargo was in effect.
In 2008, as a result of the suspicion cast on tomatoes, several varieties of tomatoes were withdrawn from markets and restaurants in many areas. The tomato industry lost millions of dollars because of these recalls. After several weeks, it was determined that tomatoes were probably not the cause of the epidemic and suspicion then fell on two other possible sources, jalapeño peppers and cilantro, both ingredients in the salsa that is a frequent accompaniment of Mexican food.
Finally the FDA pinpointed jalapeño peppers and cilantro imported from Mexico, to which contaminated irrigation water was traced, as the probable culprits, but there was no conclusive evidence that such was the case. The FDA declined to exclude tomatoes categorically from its list of suspects. Importers and those involved in Mexican agriculture took an enormous financial hit because of the FDA’s investigation. Meanwhile, the FDA declared that jalapeños and cilantro grown in the United States were safe to eat.
By this time, however, the damage had been done, and the financial losses to farmers were substantial. Given the ambiguity of the FDA’s investigation, many people avoided altogether the vegetables that had been mentioned as possible sources of the epidemic. Rather then trying to check the origins of vegetables on the list of suspects, many shoppers played it safe by not buying any of the suspected vegetables.
Critics have pointed out that many illnesses and even deaths occur every year when drugs are prescribed by physicians to treat conditions for which the prescribed drugs were not intended and for which they have not been field tested. This is a grave problem with extremely dangerous consequences for many people who receive these off-label drugs. Despite the dangers involved, the FDA has been powerless to take action against physicians who prescribe drugs for unintended uses because the agency is not legally authorized to question the authority of physicians in prescribing legal medications. Also, with the growth of the pharmaceutical industry, the agency has been severely understaffed, so it has had to cut back on many of its investigative efforts.
Field testing is a long and, at times, unwieldy process. Although some side effects are apparent almost immediately when a person has taken a drug, in many cases it takes months or even years for side effects to occur. In matters of health, the public often expects immediate results, but the FDA should not hasten field testing to produce such results nor should it be pressured into doing so.
Of additional concern to the FDA has been a suspected correlation between the regular use of cell phones and brain cancer. Millions of people use cell phones and the cell phone industry generates many hundreds of million dollars in profits for both the manufacturers and service providers of cell phones and cell phone service. The public has become dependent on cell phones for much of its communication. In this matter, the FDA has the responsibility of trying to assess the hazards that cell phones might pose, but such an assessment would involve broad longitudinal studies tracing the health records of cell phone users over periods of time that might extend to decades. Meanwhile, the FDA cannot ban cell phones even though it cannot give its categorical approval to their use.
One must remember that the links between the use of tobacco products and certain types of cancer took decades to be established. As a result, many Americans found fault with the FDA for not acting more aggressively to discourage the use of tobacco products, but a thriving tobacco industry lobbied strenuously to thwart the kind of ban that some people thought was necessary. Lawsuits relating to the use of tobacco and cancer often involved histories of tobacco use that went back forty or fifty years. In cases of this sort, it is difficult to isolate a single cause of an illness that occurs in one’s later life.
With dramatic increases in research, the FDA frequently has had to reverse some of its earlier advisories. For many years, it recommended that women have diets high in calcium and that they take calcium supplements to strengthen their bones and to forestall such conditions as osteoporosis. It was assumed that men could also benefit from such a recommendation.
After several years, however, a link was discovered between high calcium intake among men and the incidence of prostate cancer. Presumably, high calcium intake in men can result in inhibiting their absorption of vitamin D. Reductions in the absorption of this vitamin are thought to increase the occurrence of prostate cancer in men. The FDA, therefore, cautions all men nineteen or older to control their intake of foods high in calcium–mostly dairy products–and not to take calcium supplements. Such reversals raise serious public concerns, but they are quite understandable in the light of continuing research.
Although the FDA’s reversals of some of its long-standing edicts shake public confidence in the agency, there is no justification for suppressing recent research findings merely to save face. If the agency is to function effectively and is to have the full confidence of the public it serves, it must admit previous errors that have sometimes resulted in its need to countermand some of its earlier recommendations and edicts.
Johnson, Cathy Marie. The Dynamics of Conflict Between Bureaucrats and Legislators. Armonk, N.Y.: M. E. Sharpe, 1996. Chapter 4 focuses on the Food and Drug Administration. It is interesting to compare Johnson’s account with the later account of Richard Rettig noted below. King, Paul H., and Richard Fries. Design of Biomedical Devices and Systems. New York: Marcel Dekker, 2003. Chapter 14 is devoted to the role of the FDA in its oversight of biomedical devices. Rettig, Richard A. The Food and Drug Administration Confronts Homeland and National Security. Santa Monica, Calif.: RAND, 2003. A spirited discussion of how the FDA sometimes is thought to intrude on the responsibilities of other governmental agencies. Wannisky, Kathleen E. Department of Health and Human Services, Food and Drug Administration, Bar Code Label Requirement for Human Drug Products, and Biological Products. Washington, D.C.: U.S. General Accounting Office, 2004. A forthright presentation of how bar code labeling of drugs reduces the danger that prescriptions will be filled inaccurately, resulting in the wrong drugs being administered to patients. Warner, John W., and Beverly Sweatman. Federal Jobs in Law Enforcement. 2d ed. Lawrenceville, N.J.: Arco/Thomson Learning, 2002. A comprehensive listing of government jobs in law enforcement with a full listing of such jobs available in the Food and Drug Administration
Health care industry