U.S. Food and Drug Administration history

Johnson (1911), the Supreme Court ruled that therapeutic claims were essentially subjective and hence beyond the reach of this law.

After a failed attempt at prosecuting a product that claimed to treat cancer, the government passed the Sherley Amendment in 1912, which prohibited labeling medicines with phony therapeutic claims with the intent of defrauding the purchaser.

Winslow's Soothing Syrup (1916). Source: https://fdanj.nlm.nih.gov/catalog/fdnj04110

The Bureau of Chemistry was renamed the Food, Drug, and Insecticide Administration in 1927.

28). Similarly, under the Seafood Amendment of 1934, Gulf coast shrimp packaged under FDA supervision was required to be stamped with a label stating “Production supervised by the United States Food and Drug Administration” as a mechanism for ensuring quality and freshness.

In 1937, Massengill, a Tennessee drug company, began to market a liquid sulfa drug called Elixir Sulfanilamide.

These efforts were successfully challenged by the patent medicine industry and its Congressional allies until 1938, when the so-called “Elixir Sulfanilamide tragedy” made it impossible for Congress to continue to ignore demands for tighter regulation.

FDA publishes first Red Book (successor to 1949 "black book"), officially known as Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food.

In 1951, Congress passed the Durham-Humphrey Amendment, which required that some drugs be labeled as for sale only with a prescription.

Companies can produce and sell generic versions of animal drugs approved after October 1962 without duplicating research done to prove them safe and effective.

The 1966 Fair Packaging & Labeling Act required that all consumer products on the market in interstate commerce be labeled accurately and informatively.

As Akerlof (1970) demonstrates, when consumers have less information about product quality than producers, lower quality products (which are generally cheaper to produce) may drive out higher quality products.

For instance, the 1976 Medical Device Amendments required medical device manufacturers to register with the FDA and to follow quality control guideline.

Revising a policy from 1977 that excluded women of childbearing potential from early drug studies, FDA issues guidelines calling for improved assessments of medication responses as a function of gender.

In the hours following the Three Mile Island nuclear emergency of March 28, 1979, FDA contracted with firms in Missouri, Michigan, and New Jersey to prepare and package enough doses of potassium iodide to protect those threatened with thyroid cancer if exposed to radiation.

Consumers can “punish” firms that cheat on quality by taking their business elsewhere (Klein and Leffler 1981). Hence, as long as consumers are able to identify whether or not they have been cheated, regulation may not be needed to solve the asymmetric information problem.

In 1983 such control was found no longer needed and was abolished.

Hutt, Peter Barton and Peter Barton Hutt II. “A History of Government Regulation of Adulteration and Misbranding of Food.” Food, Drug and Cosmetic Law Journal 39 (1984): 2-73.

While these forces increased the variety of foods available, it also increased uncertainty about quality, since the more specialized and urbanized consumers became, the less they knew about the quality of products purchased from others (Wallis and North 1986).

By 1990 the Centers for Disease Control and Prevention confirm over 1,500 cases of EMS, including 38 deaths, and FDA prohibits the importation of l-tryptophan.

Concerns that mandatory pre-market approval of new drugs may have reduced the rate at which new pharmaceuticals become available to consumers prompted the FDA to issue new rules in 1991 to accelerate the review of drugs for life-threatening diseases.

Indeed, the association between thalidomide and birth defects was discovered by researchers in Europe, not by drug investigators at the FDA. Hence, the FDA may not in fact have deserved the credit it was given in preventing the thalidomide tragedy from spreading to the United States (Harris 1992).

To help consumers choose heart-healthy foods, the Department of Health and Human Services announces that FDA will require food labels to include trans fat content, the first substantive change to the nutrition facts panel on foods since the label was changed in 1993.

Similarly, the 1994 Dietary Supplements and Nutritional Labeling Act weakened the FDA’s ability to regulate dietary supplements by classifying them as foods rather than drugs.

The FDA Modernization Act of 1997 was a major legislative act meant to reform the regulation of food, medical products, and cosmetics in more nuanced ways.

Coppin and High (1999) argue that rent-seeking on the part of bureaucrats within the government – specifically, Doctor Harvey Wiley, chief of the Bureau of Chemistry – was a critical factor in the emergence of this law.

French and Phillips (2000) discuss the development of food regulation in the United Kingdom.

Project BioShield Act of 2004 authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the U. S., among other provisions.

Background: The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world.

Additionally, in 2009, FDA was charged with implementing the Family Smoking Prevention and Tobacco Control Act.