A Brief History of the 1938 Food, Drug and Cosmetic Act*: Part 1

By 1933, serious shortcomings in the US Pure Food and Drug Act of 1906 (the so-called Wiley statute) were evident. First, the old law did not provide for the government regulation of cosmetics (relevant language was dropped from the proposed law in 1900). Second, the law did not adequately cover the regulation of patent medicines. Specifically the definition of dangerous drugs was outdated, given the pharmaceutical innovations of the early 20th century, such as the introduction of barbiturates. Third, language concerning the definition of food adulteration was vague and ambiguous; and fourth, the law provided no control over false advertising.**

Amendments to the 1906 act, such as the 1912 Sherley Amendment, attempted to rectify some of these shortcomings. Congress specifically enacted the amendment to supersede the 1911 Supreme Court decision in US v Johnson, which determined that drug "misbranding" only applied to statements regarding the product's identity and related properties (eg, its strength, purity, etc) and not to statements regarding the product's proposed curative powers (even claims as outrageous as curing cancer). The Sherley Amendment characterized the misbranding of drugs as statements that were both false and fraudulent. However, the wording of the law was unfortunate. The amendment required that the government prove fraudulent intent on the part of the manufacturer—a nearly impossible standard.

Public outcry, from both disinterested parties and dubiously motivated commercial sources*** (as well as muckraking journalists), against the inadequate oversight of food, drugs, and cosmetics led, in 1933, to Congressional hearings and an internal investigation of the Food and Drug Administration. And the FDA, headed by Kentucky lawyer Walter G. Campbell, was only too happy to concede deficiencies in the 1906 law. Perhaps the most important outcome of these events was the spark of interest created in Senator Royal S. Copeland (D-NY), a physician and former New York City health commissioner, to reform the old statute.

In the Spring of 1933, Senator Copeland became the Congressional backer of the so-called Tugwell bill, a measure initially drafted by Rexford G. Tugwell, then Assistant Secretary of Agriculture, with considerable input from the FDA's Campbell. Senate Bill 1944, as it was labeled, would no longer place the burden of proving the manufacturer's fraudulent intent on the government, and misbranding would be defined as any therapeutic claim on the label that was "contrary to general medical opinion." Palliative claims would be distinguished from those that promised cure, and drug manufacturers would have to disclose the ingredients of their products. The charge of adulteration would be applied to any product that was dangerous to health, when used according to the manufacturers directions. Last, provisions relating to drugs would also encompass medical devices.

Support for S. 1944 was mixed. Not surprisingly, most of the drug industry wanted the bill defeated and argued that the measure gave far too much discretionary power to the government. The response from the American Medical Association was curiously lukewarm and the influential Consumers' Research (a frequent critic of the FDA) labeled the bill as too weak. Support for the Tugwell bill was to be found, however, among women's groups—particularly the difficult-to-ignore League of Women Voters.

The FDA engaged in a concerted publicity campaign to promote S. 1944—through favorable press coverage, speaking engagements, the Department of Agricultures' "National Farm and Home Hour," posters, and the agency's notorious "Chamber of Horrors" exhibit. The exhibit was a popular, traveling display of the most worthless, fraudulent, and dangerous drug products on the US market, like Crazy Crystals, Koremlu (a thallium-containing depilatory cream), Marmola, and radioactive Radithor. However, these government-back efforts were ultimately stifled by charges that the FDA was violating the 1919 Deficiency Appropriation Act. The act prevented government agencies from lobbying their causes to Congress. Consequently organized opposition to S. 1944 gained steam, after the FDA's publicity campaign for reform was silenced. Toward the end of 1933, FDA Chief Campbell became convinced that Congressional compromise of the bill was inevitable.

* Not as boring as you think.

** And the Federal Trade Commission was hamstrung in its power to prosecute false advertising given the 1931 Supreme Court decision in the case of the FTC v Raladam Co.

*** Specifically chemist and crude-ergot peddler Howard Ambruster.

Chief source: Jackson, Charles O. Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press; 1970.