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  1. Changes in Science, Law and Regulatory Authorities

Part II: 1938, Food, Drug, Cosmetic Act

With the election of Franklin Roosevelt and the death in 1930 of the embodiment of the 1906 act--Wiley--the FDA now had a receptive ear to petition for needed changes in the law: legally mandated quality and identity standards


 for foods, prohibition of false therapeutic claims for drugs, coverage of cosmetics and medical devices, clarification of the FDA's right to conduct factory inspections, and control of product advertising, among other items. A new generation of muckraking journalists and consumer protection organizations aided in pushing a reluctant Congress to sponsor a bill to replace the old law.

The FDA itself exemplified the state of affairs in the marketplace by assembling a collection of products that illustrated shortcomings in the 1906 law. It included Banbar, a worthless "cure" for diabetes that the old law protected; Lash-Lure, an eyelash dye in which a number of women suffered injuries to their eyes, including one confirmed case of permanent blindness.; numerous examples of foods deceptively packaged or labeled; Radithor, a radium-containing tonic that sentenced users to a slow and painful death; and the Wilhide Exhaler, which falsely promised to cure tuberculosis and other pulmonary diseases. A reporter dubbed this exhibit "The American Chamber of Horrors," a title not far from the truth since all the products exhibited were legal under the existing law.

Languishing in Congress for five years, the bill that would replace the 1906 was ultimately enhanced and passed in the wake of a therapeutic disaster in 1937. A Tennessee drug company marketed a form of the new sulfa wonder drug that would appeal to pediatric patients, Elixir Sulfanilamide. However, the solvent in this untested product was a highly toxic chemical analogue of antifreeze; over 100 people died, many of whom were children. The public outcry not only reshaped the drug provisions of the new law to prevent such an event from happening again, it propelled the bill itself through Congress. FDR signed the Food, Drug, and Cosmetic Act on 25 June 1938.

President Franklin Delano Roosevelt signing the 1938 Food, Drug, and Cosmetic Act

The new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use. Moreover, it mandated pre-market approval of all new drugs, such that a manufacturer would have to prove to FDA that a drug were safe before it could be sold. It irrefutably prohibited false therapeutic claims for drugs, although a separate law granted the Federal Trade Commission jurisdiction over drug advertising. The act also corrected abuses in food packaging and quality, and it mandated legally enforceable food standards. Tolerances for certain poisonous substances were addressed. The law formally authorized factory inspections, and it added injunctions to the enforcement tools at the agency's disposal.

Next: Drugs and Foods Under the 1938 Act and Its Amendments


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