Pure Food And Drug Act Special Interests
Oliverio Gallman
From colonial times until the mid to late nineteenth century, most food and drug regulation in America was enacted at the state and local level. Additionally, these regulations were generally targeted toward specific food products (Hutt and Hutt 1984). For instance, in 1641 Massachusetts introduced its first food adulteration law, which required the official inspection of beef, pork and fish; this was followed in the 1650s with legislation that regulated the quality of bread. Meanwhile, Virginia in the 1600s enacted laws to regulate weights and measures for corn and to outlaw the sale of adulterated wines.
Federal regulation of the food and drug industry was mostly piecemeal until the early 1900s. In 1848, Congress enacted the Drug Importation Act to curb the import of adulterated medicines. The 1886 oleomargarine tax required margarine manufacturers to stamp their product in various ways, imposed an internal revenue tax of 2 cents per pound on all oleomargarine produced in the United States, and levied a fee of $600 per year on oleomargarine producers, $480 per year on oleomargarine wholesalers, and $48 per year on oleomargarine retailers (Lee 1973; Dupré 1999). The 1891 Meat Inspection Act mandated the inspection of all live cattle for export as well as for all live cattle that were to be slaughtered and the meat exported. In 1897 the Tea Importation Act was passed which required Customs inspection of tea imported into the United States. Finally, in 1902 Congress enacted the Biologics Control Act to regulate the safety of vaccinations and serums used to prevent diseases in humans.
Under the 1938 law, the FDA was given considerably greater authority over the food and drug industry. The FDA was granted the power to regulate the therapeutic claims drug manufacturers printed on their product labels; authority over drug advertising, however, rested with the Federal Trade Commission (FTC) under the Wheeler-Lea Act of 1938. Additionally, the new law required that drugs be marketed with adequate directions for safe use, and FDA authority was extended to include medical devices and cosmetics. Perhaps the most striking and novel feature of the 1938 law was that it introduced mandatory pre-market approval for new drugs. Under this new law, drug manufacturers were required to demonstrate to the FDA that a new drug was safe before it could be released to the market. This feature of the legislation was clearly a reaction to the Elixir Sulfanilamide incident; food and drug bills introduced in Congress prior to 1938 did not include provisions requiring mandatory pre-market approval of new drugs.
The federal Government--by nature the highest spokesman for all the people--has a special obligation to be alert to the consumer's needs and to advance the consumer's interests. Ever since legislation was enacted in 1872 to protect the consumer from frauds involving use of the U.S. mail, the Congress and Executive Branch have been increasingly aware of their responsibility to make certain that our Nation's economy fairly and adequately serves consumers' interests.
The march of technology--affecting, for example, the foods we eat, the medicines we take, and the many appliances we use in our homes--has increased the difficulties of the consumer along with his opportunities; and it has outmoded many of the old laws and regulations and made new legislation necessary. The typical supermarket before World War II stocked about 1,500 separate food items--an impressive figure by any standard. But today it carries over 6,000. Ninety percent of the prescriptions written today are for drugs that were unknown 20 years ago. Many of the new products used every day in the home are highly complex. The housewife is called upon to be an amateur electrician, mechanic, chemist, toxicologist, dietitian, and mathematician--but she is rarely furnished the information she needs to perform these tasks proficiently.
Marketing is increasingly impersonal. Consumer choice is influenced by mass advertising utilizing highly developed arts of persuasion. The consumer typically cannot know whether drug preparations meet minimum standards of safety, quality, and efficacy. He usually does not know how much he pays for consumer credit; whether one prepared food has more nutritional value than another; whether the performance of a product will in fact meet his needs; or whether the "large economy size" is really a bargain.
(1) Food and drug protection. Thousands of common household items now available to consumers contain potentially harmful substances. Hundreds of new uses for such products as food additives, food colorings and pesticides are found every year, adding new potential hazards. To provide better protection and law enforcement in this vital area, I have recommended a 2 percent increase in staff for the food and Drug Administration in the budget now pending before the Congress, the largest single increase in the agency's history. In addition, to assure more effective registration of pesticides, a new division has been established in the Department of Agriculture; and increased appropriations have been requested for pesticide regulation and for meat and poultry inspection activities.
--Second, that the head of each federal agency whose activities bear significantly on consumer welfare designate a special assistant in his office to advise and assist him in assuring adequate and effective attention to consumer interests in the work of the agency, to act as liaison with consumer and related organizations, and to place increased emphasis on preparing and making available pertinent research findings for consumers in clear and useable form; and
--Factory inspections now authorized by the pure food and drug laws are seriously hampered by the fact that the law does not clearly require the manufacturer to allow inspection of certain records. An uncooperative small minority of manufacturers can engage in a game of hide-and-seek with the Government in order to avoid adequate inspection. But protection of the public health is not a game. It is of vital importance to each and every citizen.
(1) first, legislation to strengthen and broaden existing laws in the food and drug field to provide consumers with better, safer, and less expensive drugs, by authorizing the Department of Health, Education, and Welfare to:
In 1922, Copeland was nominated (and later elected) as the compromise Democratic candidate for the United States Senate. He was reelected in 1928 and again in 1934. While in the Senate, Copeland demonstrated a special interest in pure food and drug legislation. He is best known for the Copeland-Lea Food, Drug, and Cosmetic Bill that was passed in 1938 after five years of labor. Although a Democrat, Copeland frequently opposed President Roosevelt and his New Deal legislation. Notably, Copeland was a leading opponent of Roosevelt's court reform plan.
President Roosevelt called the conditions revealed in the special commission's report "revolting." In a letter to Congress, he declared, "A law is needed which will enable the inspectors of the [Federal] Government to inspect and supervise from the hoof to the can the preparation of the meat food product."
Passage of the Meat Inspection Act opened the way for Congress to approve a long-blocked law to regulate the sale of most other foods and drugs. For over 20 years, Harvey W. Wiley, chief chemist at the Department of Agriculture, had led a "pure food crusade." He and his "Poison Squad" had tested chemicals added to preserve foods and found many were dangerous to human health. The uproar over The Jungle revived Wiley's lobbying efforts in Congress for federal food and drug regulation.
Roosevelt signed a law regulating foods and drugs on June 30, 1906, the same day he signed the Meat Inspection Act. The Pure Food and Drug Act regulated food additives and prohibited misleading labeling of food and drugs. This law led to the formation of the federal Food and Drug Administration (FDA).
The two 1906 laws ended up increasing consumer confidence in the food and drugs they purchased, which benefitted these businesses. The laws also acted as a wedge to expand federal regulation of other industries, one of the strategies to control big business pursued by the progressives.
From the beginnings of civilization people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848, although the first federal biologics law, which addressed the provision of reliable smallpox vaccine to citizens, was passed in 1813. The following chronology describes some of the milestones in the history of food and drug regulation in the United States.
Congress appropriates $5,000 to the Bureau of Chemistry to study chemical preservatives and colors and their effects on digestion and health. Dr. Wiley's studies draw widespread attention to the problem of food adulteration. Public support for passage of a federal food and drug law grows.
The original Food and Drugs Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs.
Elixir of Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.
Color Additive Amendment enacted, requiring manufacturers to establish the safety of color additives in foods, drugs and cosmetics. The Delaney proviso prohibits the approval of any color additive shown to induce cancer in humans or animals.