Elixir sulfanilamide was an improperly prepared sulfanilamide

Sulfonamide (medicine)

Sulfonamide or sulphonamide is the basis of several groups of drugs. The original antibacterial sulfonamides are synthetic antimicrobial agents that contain the sulfonamide group. Some sulfonamides are also devoid of antibacterial activity, e.g., the anticonvulsant sultiame...

 medicine that caused mass poison

Poison

In the context of biology, poisons are substances that can cause disturbances to organisms, usually by chemical reaction or other activity on the molecular scale, when a sufficient quantity is absorbed by an organism....

ing in the United States in 1937. It caused the deaths of more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act

Federal Food, Drug, and Cosmetic Act

The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...

.

History

Aside from the Pure Food and Drug Act

Pure Food and Drug Act

The Pure Food and Drug Act of June 30, 1906, is a United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines...

 of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisoning crisis.

In 1937, S. E. Massengill Company

S. E. Massengill Company

S. E. Massengill Company was a pharmaceutical company started in 1898. It was founded by Samuel Evans Massengill, who graduated from the University of Nashville Medical School, but decided to manufacture drugs rather than practice medicine himself...

, a pharmaceutical manufacturer, created a preparation of sulfanilamide

Sulfonamide (medicine)

Sulfonamide or sulphonamide is the basis of several groups of drugs. The original antibacterial sulfonamides are synthetic antimicrobial agents that contain the sulfonamide group. Some sulfonamides are also devoid of antibacterial activity, e.g., the anticonvulsant sultiame...

 using diethylene glycol

Diethylene glycol

Diethylene glycol is an organic compound with the formula 2O. It is a colorless, practically odorless, poisonous, and hygroscopic liquid with a sweetish taste. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used solvent...

 (DEG) as a solvent

Solvent

A solvent is a liquid, solid, or gas that dissolves another solid, liquid, or gaseous solute, resulting in a solution that is soluble in a certain volume of solvent at a specified temperature...

, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to humans, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this (although it was known at the time). Watkins simply added raspberry flavoring to the sulfa drug which he had dissolved in DEG and the company then marketed the product. Although animal testing

Animal testing

Animal testing, also known as animal experimentation, animal research, and in vivo testing, is the use of non-human animals in experiments. Worldwide it is estimated that the number of vertebrate animals—from zebrafish to non-human primates—ranges from the tens of millions to more than 100 million...

 should have been routine in most drug company operations, Massengill performed none and there were no regulations requiring premarket safety testing of new drugs.

The company started selling and distributing the medication in September 1937. By October 11, the American Medical Association

American Medical Association

The American Medical Association , founded in 1847 and incorporated in 1897, is the largest association of medical doctors and medical students in the United States.-Scope and operations:...

 received a report of several deaths caused by the medication. The Food and Drug Administration

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 was notified, and an extensive search was conducted to recover the distributed medicine. Frances Oldham Kelsey

Frances Oldham Kelsey

Frances Kathleen Oldham Kelsey, Ph.D., M.D., is a pharmacologist, most famous as the reviewer for the U.S. Food and Drug Administration who refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns proved to be justified when it was proven that...

 assisted on a research project that verified that the excipient

Excipient

An excipient is generally a pharmacologically inactive substance used as a carrier for the active ingredients of a medication. In many cases, an "active" substance may not be easily administered and absorbed by the human body; in such cases the substance in question may be dissolved into or...

 DEG was responsible for the fatal adverse effect

Adverse effect (medicine)

In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...

s. At least 100 deaths were blamed on the medication.

The owner of the company, when pressed to admit some measure of culpability, famously answered, "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." Watkins, the chemist, committed suicide while awaiting trial.

Congress responded to public outrage by passing the 1938 Food, Drug, and Cosmetic Act, which required companies to perform animal safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their products. The Massengill Company paid a minimum fine under provisions of the 1906 Pure Food and Drugs Act, which prohibited labeling the preparation an "elixir

Elixir

An elixir is a clear, sweet-flavored liquid used for medicinal purposes, to be taken orally and intended to cure one's ills. When used as a pharmaceutical preparation, an elixir contains at least one active ingredient designed to be taken orally....

" if it had no alcohol in it.

See also

• List of medicine contamination incidents
• Human subject research legislation in the United States
  Human subject research legislation in the United States
  Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations...