Roosevelt Administration, Theodore

The Pure Food and Drug Act of 1906

As the 20th century began, the American public was able to obtain and use virtually any drug in a rapidly growing consumer marketplace. Newspapers advertised patent medicines with undisclosed formulas that offered miracle cures. Manufacturers appealed to consumers' personal and social anxieties, employing marketing strategies that included branding, testimonials, and physician, druggist, or celebrity endorsements. While various states had passed legislation aimed at drug regulation and bills proposing some comprehensive drug legislation had been brought to the U.S. Congress since the late 1870s, these efforts resulted in no appreciable restraint over drug manufacturing, marketing, distribution, or consumption.

Efforts to promote drug regulation reform accelerated in the early 1900s. Harvey Wiley, chief chemist in the Department of Agriculture and longtime reform advocate, investigated food and drug mislabeling by testing commercially available drugs and chemicals on 12 young men he named the “poison squad.” The studies were widely featured in popular magazines and stressed Wiley's concerns that health-threatening products were shipped through interstate commerce and marketed to the public without prior scientific analysis. Samuel Hopkins Adams's The Great American Fraud, a collection of his serialized “muckraking” articles from Collier's Magazine, exposed the harmful ingredients in fraudulently advertised elixirs. In his second term in office, Roosevelt put aside his support of a laissez-faire federal government stance and lobbied Congress to pass a consumer protection bill.

The Pure Food and Drug Act, passed in June 1906, required proper labeling of ingredients that might be dangerous or possibly addictive in over-the-counter medicines. Fraudulently labeled or adulterated drugs transported through interstate or foreign commerce could be seized and penalties could be imposed. The United States Pharmacopeia and the National Formulary became the official standards for drug manufacturers. The Department of Agriculture's Division of Chemistry (later named the Bureau of Chemistry) was assigned to administer the law until the establishment of the Food and Drug Administration in the late 1920s. In response to a 1911 Supreme Court Case ruling that the Pure Food and Drug Act could not stop manufacturers from making false claims about their products' therapeutic efficacy, Congress passed the Sherley Amendment one year later requiring that labels could not contain a statement about a “curative or therapeutic effect” that was “false and fraudulent.” While some public health studies reported less opiate substances appearing in patent medicine products, additional court cases involving consumer deaths from using patent medicines illustrated that the Pure Food and Drug Act did not adequately [Page 703]protect the public since it did not contain specifically “prohibitive” powers. This problem would not be successfully addressed until the passage of the Food Drug and Cosmetic Act of 1938.

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