The battle for the FD&C Act (1933-1938)

20. november 2015 at 14:37 | Veronika Valdova, ARETE-ZOE |  Medicine & Pharmacy
The new Federal Food, Drug and Cosmetic Act required drug manufacturers to prove that new drugs were safe before placing them on the market. The FDA was also entrusted with the authority to regulate cosmetics and medical devices.
The origin of the law is an intriguing story in itself. Judge David F Cavers published a very interesting record of the campaign and added his perspective as well.

In 1933, New York Senator Royal S. Copeland introduced the "Tugwell Bill" to protect the consumers from unscrupulous practices of some food and drug manufacturers. Rexford G. Tugwell, then Assistant Secretary of Agriculture, initiated revision of the Act of 1906. It is striking that the public was almost unaware of this important act, which affected the life and health of every citizen. As Judge Cavers pointed out, the "consumer interest is difficult to organize for its own protection".

Back in 1906 the media vigorously supported the new Federal Food, Drug and Cosmetic Act, but this was not the case after 1933. Manufacturers, retailers, and the nation's press formed strong opposition against the bill. The nation's press remained silent on the issue, most likely because the measure was largely seen as a menace to revenues from advertising.

In 1906, Sinclair's book "The Jungle" helped mobilize support for the first Food and Drug bill by describing practices in the meat industry in vivid detail. The awareness of limited protections of consumers increased substantially after the publication of "Your Money's Worth" by Stuart Chase and Fred Schlink in 1927 and "100,000,000 Guinea Pigs" by Kallet and Schlink in 1933.

The 1906 act had already been revised five times. One of the revisions, the 1912 Sherley Amendment, was necessitated by 1911 Supreme Court decision in U.S. v. Johnson. The court held that the original misbranding provision of the act did not cover therapeutic claims.

F&DA officials and members of the Solicitor's office of the Department of Agriculture began drafting the act in March 1933. It soon became obvious that mere amendment to the existing law won't be enough, and that a completely new act is needed. Industry feedback on the new act was sought but the conferences did not provide suggestions of value. The F&DA lobbied for the new law by assembling an array of pictures, labels and advertisements of ineffective, harmful and occasionally lethal nostrums, cosmetic preparations and adulterated or deceptively packaged foodstuffs. The exhibit was soon nicknamed "the American Chamber of Horrors".

FDA Inspector George Larrick and the "American Chamber of Horrors" Exhibit (Wikimedia Commons)

Efforts to regulate advertising claims were not taken well by the drug industry: one complaint stated that the new bill is a calculated attempt to deprive the American public of its right to "self-medication". Astonishingly, the American Medical Association remained silent overall. Senator Copeland, sponsor of the bill, was under constant pressure from various special interest groups. His attempts to conciliate opposition did not result in much desired compromise but in the introduction of a competing bill by the industry, the so-called McCarran-Jenckes Bill.

The bill was reintroduced to Congress several times with numerous amendments every time. Extensive debate concerned the F&DA power to make multiple seizures of adulterated drugs, the definition of "adulteration" and "misbranding" and the division of jurisdiction between the Federal Trade Commission and the F&DA. In 1936, the Tugwell bill lost in the 74th Congress 70:190. Senator Copeland reintroduced the bill in January 1937.

In 1931, the Supreme Court decided case Federal Trade Commission v. Raladam Company, and held that the Commission could not issue a cease and desist order against false advertising unless injury to competition were shown. New provisions defined "false advertisement", "food", "drug", "device" and "cosmetic", and declared the dissemination of false advertising to constitute an "unfair or deceptive practice" under the FTC Act and authorized the Commission to secure a temporary restraining order to enjoin the dissemination of a false advertisement, giving the FTC the same powers as the F&DA.

Then the Elixir sulfanilamide struck. There is no guarantee that any of the previous versions of the bill would have prevented the disaster. The F&DA intervention was based on fact that the drug was misbranded. The solvent used was diethylene glycol rather than alcohol, therefore the product could not be labeled as "Elixir". Moreover, the harmful component - diethylene glycol - was not listed on the label at all. The next version of the bill forbade the introduction into interstate commerce of any drug not generally recognized as safe for use.

Advertising provisions of the Senate bill were eliminated. Otherwise, most of the changes made for a stronger law. The bill was finally signed into law by President Roosevelt on June 25, 1938.

The bill introduced numerous changes:

The definition has changed to include drugs and devices designed to affect bodily structure or function where disease is not involved, and devices used in the diagnosis and treatment of disease. The definition of adulterated product changed, forcing manufacturers either to adopt the USP standard or cease calling their products drugs. Misbranding portion preserved the original definition of labeling that was "false or misleading in any particular". The 1912 Sherley amendment required product labeling to be both "false and fraudulent". This was very difficult to prove even when outrageous claims were made for inefficient nostrums.

The most important amendments included the obligation to include a warning for habit-forming drugs, and to disclose all ingredients, not only those listed in the U.S. Pharmacopeia. Moreover, all drugs had to be equipped with adequate directions for safe use, including limitations and contraindications. New provisions on antiseptics, containers, packaging and labeling were also added. The new law also made new drugs subject to F&DA review and approval.

Applications had to be filed in order to approve a new drug for marketing. An effective application could be suspended if the drug was found to be unsafe or if the application contained untrue material statements.


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