In response to growing concern about the inadequacy of regulations on food and drugs, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act, which required premarket safety clearance for certain products.

The Federal Food, Drug, and Cosmetic Act was passed in 1938 in response to growing concern that many parts of earlier legislation, such as the Pure Food and Drug Act of 1906, were either inadequate or outdated. A basic weakness of the regulative framework in the 1930’s was the absence of proper public protection against food and drug products or advertisements that made fraudulent therapeutic claims. Furthermore, fraudulent claims were often made for cosmetic products, a category not addressed in the 1906 act or its subsequent amendments. [kw]Federal Food, Drug, and Cosmetic Act (June 25, 1938)
[kw]Food, Drug, and Cosmetic Act, Federal (June 25, 1938)
[kw]Drug, and Cosmetic Act, Federal Food, (June 25, 1938)
[kw]Cosmetic Act, Federal Food, Drug, and (June 25, 1938)
[kw]Act, Federal Food, Drug, and Cosmetic (June 25, 1938)
Federal Food, Drug, and Cosmetic Act (1938)
Consumer protection
[g]United States;June 25, 1938: Federal Food, Drug, and Cosmetic Act[09800]
[c]Laws, acts, and legal history;June 25, 1938: Federal Food, Drug, and Cosmetic Act[09800]
[c]Trade and commerce;June 25, 1938: Federal Food, Drug, and Cosmetic Act[09800]
Copeland, Royal S.
Campbell, Walter Gilbert
Tugwell, Rexford Guy
Roosevelt, Franklin D.
[p]Roosevelt, Franklin D.;Federal Food, Drug, and Cosmetic Act

Following discussions between Walter Gilbert Campbell, chief of the Food and Drug Administration Food and Drug Administration, U.S. (FDA), and Rexford Guy Tugwell, the assistant secretary of agriculture, the FDA initiated a move to tighten the federal regulation of food, drugs, and cosmetics. When this legislative effort was later introduced in Congress by Senator Royal S. Copeland as Senate Resolution 1944 on June 12, 1933, it met with bitter opposition from business and advertising circles. This was partly because the bill’s original sponsor, Tugwell, inspired suspicion and fear with his openly expressed belief in a planned economy.

To help assuage such resistance and to forestall passage of competing congressional measures introduced by powerful trade groups, Copeland modified several aspects of his earlier bill during 1934 and 1935. Nevertheless, business groups remained opposed to key parts of the Copeland bill such as the provision that the FDA would be responsible for regulating food, drug, and cosmetic advertising. Because the advertising regulation Advertising;regulation framework of the Federal Trade Commission Federal Trade Commission (FTC) was relatively lenient, the business lobbyists wanted the FTC, rather than the FDA, to have such authority.

The likelihood of congressional passage of the modified Copeland bill appeared remote until two important developments occurred. First, the 1938 Wheeler-Lea Act reinforced FTC authority over food and drug products. Second, a drug tragedy emphasized the need for greater control over labeling and testing of products intended for public consumption: More than one hundred people died after consuming the drug Elixir of Sulfanilamide, Elixir of Sulfanilamide which contained sulfanilamide dissolved in a potent poison called diethylene glycol. Apparently, this product was tested for flavor, appearance, and fragrance, but its safety was not evaluated before its market introduction. Clearly, if there had been stringent regulations to ensure safety tests of products intended for public consumption, this tragedy could have been averted.

These events created a political climate conducive to enactment of the Copeland bill. It was passed by the Senate on May 5, 1938, and by the House of Representatives on June 1, 1938. Finally, after more than five years of bitter legislative history since it was introduced in Congress, the Federal Food, Drug, and Cosmetic Act was signed into law by President Franklin D. Roosevelt on June 25, 1938.

The key provisions of the 1938 act were as follows: It prohibited traffic in new drugs unless they had been adequately tested for safe use under conditions prescribed on their labels. Drugs were required to carry warnings against habit formation (if any), to provide adequate directions for use, to bear warnings against unsafe use, and to have precautionary labeling if subject to deterioration over time. The Federal Food, Drug, and Cosmetic Act also prohibited traffic in foods and cosmetics that were injurious to health. The addition of any poison or other adulterant to food was prohibited; further, coal-tar dye products for hair were required to bear a warning label regarding use and preliminary testing.

The act contained several key innovations not offered by the amended version of its predecessor, the 1906 Pure Food and Drug Act. Pure Food and Drug Act (1906) First, the 1938 act prohibited the production of food under unsanitary conditions that might contaminate it or render it injurious to public health. Second, foods considered harmful because of naturally contained poisons were subject to regulation. Third, the 1938 act empowered the imposition of emergency license restrictions whenever the dangers of bacterial food contamination could not be addressed effectively by other statutory means. Fourth, label disclosure of artificial coloring, flavoring, or preservatives was specifically required, as was information on vitamin and mineral content and other characteristics of special dietary foods. Finally, greater authority and power were envisaged for agencies responsible for enforcing the law. Injunctive powers were added to other methods of enforcement previously available, and the penalties for noncompliance were increased. Furthermore, the 1938 act specifically allowed for factory inspections. It also provided for automatic premarket testing and approval of new drugs and coal-tar dyes.

Compared to the 1906 act, the 1938 act was more comprehensive in scope and was better oriented to serving the public interest. It established the principle that food and drugs that were dangerous to the public should be prohibited, no matter what the source of the danger represented (for example, whether or not a poisonous agent was added artificially or occurred naturally). On the other hand, the act was criticized because, although it required drug manufacturers to establish that their products were safe, it did not mandate the establishment of product efficacy. Moreover, the act allowed for automatic clearance of drugs through time lapse if the FDA did not take any action. Both of these defects would be addressed in future legislation.

Additional aspects of the 1938 act merit special attention. Section 201 carefully defined what constituted a food or a drug. The statutory term “food” included all products that could be used as a food or drink by either humans or animals as well as all raw materials that do not have food value but enter into food products during manufacture. The term “drug” encompassed all substances that are recognized in the current official U.S. pharmacopoeia, recommended for use in a disease condition, or capable of affecting bodily structure or function.

Two aspects are worth noting. First, the statutory requirements that apply for a food are somewhat different from those that apply for a drug. Second, the definitions of what constitutes a “food” or a “drug” need not be mutually exclusive. That is, a given substance could satisfy the definition of both a food and a drug. Unless there is a clear statement concerning intended use as either a food or a drug, such a substance has to satisfy the statutory provisions that apply to both types of products. As one example, the manufacturer of a laxative in the form of a medicated candy or chewing gum could bring the product within the definition of the term “drug” and escape the rules concerning food. On the other hand, medicated foods (food products with added medicines) are considered to be adulterated foods. Unless such products can be justified as special dietary foods, as was done for the addition of iodine to table salt, the 1938 act banned the marketing of such products.

Another aspect of the 1938 act that led to some controversy was the congressional intent to allocate supervision of food advertising to the FTC and supervision of food labels and labeling to the FDA. This distinction remains unclear and has generated conflicting precedents. For example, the FTC has launched several proceedings on the basis of food labels. Although these proceedings appear legitimate given the agency’s mandate to control unfair or deceptive acts in commerce, they may also be characterized as an encroachment on the FDA’s authority. Moreover, the FDA and FTC decisions have not been consistent with regard to enforcing drug labeling requirements. A further complication is that some courts have ruled that the FDA’s authority to proceed against a firm that misbrands products is not diminished by a prior proceeding against the same firm by the FTC, whereas other court decisions have implied just the opposite. Federal Food, Drug, and Cosmetic Act (1938)
Consumer protection

• Anderson, Oscar E. The Health of a Nation: Harvey W. Wiley and the Fight for Pure Food. Chicago: University of Chicago Press, 1958. Wiley’s biography; presents him as a crusader with a flair for publicity. An interesting look at the relationship between science and politics.
• Curtis, Patricia A. Guide to Food Laws and Regulations. Ames, Iowa: Blackwell, 2005. Overview of all U.S. federal laws and regulations regarding the preparation, sale, and marketing of foodstuffs. Bibliographic references and index.
• Herrick, Arthur D. Food Regulation and Compliance. 2 vols. New York: Revere, 1944-1947. Authoritative source on early food and drug laws in the United States. The 1906 act is compared with the 1938 act. Also reviews other federal food statutes. Despite being dated, this book offers a useful summary interpretation of the intent and scope of key sections of the 1938 act.
• Hinich, Melvin J., and Richard Staelin. Consumer Protection Legislation and the U.S. Food Industry. New York: Pergamon Press, 1980. Examines enforcement procedures of the Food and Drug Administration, the Federal Trade Commission, and the Department of Agriculture. Explains the conflicts between federal, state, and local governmental food regulations.
• Kay, Gwen. Dying to Be Beautiful: The Fight for Safe Cosmetics. Columbus: Ohio State University Press, 2005. Study of the history of safety regulation in the U.S. cosmetics industry. Part of the Women, Gender, and Health series. Bibliographic references and index.
• Kleinfeld, Vincent A., and Alan H. Kaplan. Federal Food, Drug, and Cosmetic Act: Judicial and Administrative Record, 1961-1964. Chicago: Commerce Clearing House, 1965. This book belongs to the Food Law Institute Series and is a useful source of information on food, drug, and related laws. It contains details of the legislative and judicial activities initiated in connection with the Federal Food, Drug, and Cosmetic Act for the period 1961 through 1964. Several types of cases are described in detail.
• Quirk, Paul J. “Food and Drug Administration.” In The Politics of Regulation, edited by James Q. Wilson. New York: Basic Books, 1980. Focuses on the social and economic effects of drug regulation. Analyzes problems created by the food and drug laws and suggests various reforms. There is also a chapter in the book on the relationship between politics and government regulation.
• Skinner, Karen. “Scientific Change and the Evolution of Regulation.” In Chemical Safety Regulation and Compliance, edited by Freddy Homburger and Judith K. Marquis. Basel, Switzerland: S. Karger, 1985. Provides a good overview of the passage of the 1938 act and discusses its implications concerning food safety and food additives.
• Temin, Peter. Taking Your Medicine: Drug Regulation in the United States. Cambridge, Mass.: Harvard University Press, 1980. A detailed history of food and drug regulation and its relationship to the development of new drugs and the therapeutic revolution. Relates this to economic behavior and the role of government in the drug market.

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