Letter by Dr. A. S. Calhoun to Franklin D. Roosevelt

Food, Drug, and Cosmetic Act of 1938

Letter excerpt

By: Archie S. Calhoun

Date: October 22, 1937

Source: "Letter by Dr. A. S. Calhoun to Franklin D. Roosevelt." Available online at U.S. Food and Drug Administration. Ballantine, Carol. "Taste of Raspberries, Taste of Death." 〈http://www.fda.gov/oc/history/elixer.html〉 (accessed January 30, 2006).

About the Author: Archie S. Calhoun was a medical doctor who practiced family medicine in the early decades of the twentieth century.

INTRODUCTION

Beginning in the first decade of the twentieth century the United States Food and Drug Administration (FDA) enacted a series of legislations and acts that have imposed measures to control the quality of food items and medicine. For example, in 1906, the FDA (which at that time was known as the Bureau of Chemistry) passed the Food and Drugs Act. Under this act, certain food items as well as drugs were determined to be unsafe and their use was illegal. However, within a few decades, the shortcomings of the act became apparent. Some drugs were found to have no therapeutic value. One example is a diabetes drug marketed as Banbur. Even more ominously, some cosmetics were found to be harmful. A then-popular eyelash dye known as Lash-Lure caused blindness in some users.

By the early 1930s, it was apparent that the Food and Drugs Act needed to be revamped in order to provide more current, forceful, and stable legislation pertaining to the use of food, cosmetics, and drugs. A new bill proposing to completely revise this law was introduced into the Senate in the year 1933. At first, the proposal was not regarded as urgent by the Senate and after four years, action had yet to be taken.

In 1937, more than one hundred Americans, many of them children, died after taking a medicine intended to treat streptococcal infections and marketed as Elixir Sulfanilamide. The active ingredient in the preparation was dissolved in diethylene glycol in order to make a liquid form of the drug. The diethylene glycol in the mixture was toxic to humans. However, because the drug was not illegal under the existing Food and Drugs Act, its use was permitted. Furthermore, at that time there was no requirement for drug testing prior to marketing.

The physician Archie Calhoun was motivated in 1937 to write to then President Franklin D. Roosevelt to recount the deaths of patients under his care due to the use of medicines that were at that time not subject to legislated quality control. At that time the Food, Drug, and Cosmetic Act was being formulated. The letter was influential in convincing Roosevelt of the need for the legislation.

PRIMARY SOURCE

Nobody but Almighty God and I can know what I have been through these past few days. I have been familiar with death in the years since I received my M.D. from Tulane University School of Medicine with the rest of my class of 1911. Covington County has been my home. I have practiced here for years. Any doctor who has practiced more than a quarter of a century has seen his share of death.

But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently, and to realize that that medicine which I had used for years in such cases suddenly had become a deadly poison in its newest and most modern form, as recommended by a great and reputable pharmaceutical firm in Tennessee: well, that realization has given me such days and nights of mental and spiritual agony as I did not believe a human being could undergo and survive. I have known hours when death for me would be a welcome relief from this agony. (Letter by Dr. A. S. Calhoun, October 22, 1937)

SIGNIFICANCE

Not surprisingly, the public outcry was resounding. In response, the Food, Drug, and Cosmetic Act of 1938 was singed into law on June 25 of that year. This act required drug manufacturers to test and demonstrate to the FDA (who, then as now, administer the act) the safety of any new drug prior to its sale. The act also included a more comprehensive list of drugs that were unsafe, and so illegal for sale.

Another aspect of the act that has proven to be important was the requirement for labeling of ingredients and safe dosage levels. This legislation formed the foundation for modern-day food and drug regulation. Over the years, there have been periodic amendments to the Food, Drug, and Cosmetics Act of 1938. However, the FDA still uses the rigorous provisions of this act to ensure food and drug safety.

Aspects of the act such as labeling and safe dose guidelines have proven to be important and paved the way for labeling of other consumer products. As well, the mandated requirement for the demonstration of product safety prior to marketing has been fundamentally important in protecting consumers. This safety-first approach has been adopted by other countries and is a vital part of health protection legislation.

In 2005, the FDA announced the creation of a new and independent Drug Safety Oversight Board to oversee the management of drug safety issues, and to provide new information in an easily accessible format to health care providers and patients about the risks and benefits of medicines.

FURTHER RESOURCES

Periodicals

Wax, P. M. "Elixir sulfanilamide-Massengill revisited." Veterinary and Human Toxicology (December 1994): 36(6):561-2.

Web sites

U.S. Food and Drug Administration. "Consumer Education: What You Should Know About Buying and Using Drug Products." 〈http://www.fda.gov/cder/consumerinfo/DPAdefault.htm〉 (accessed January 29, 2006).

U.S. Food and Drug Administration. "The 1938 Food, Drug, and Cosmetic Act." 〈http://www.fda.gov/oc/history/historyoffda/section2.html〉 (accessed May 5, 2005).