The 1938 FD&C Act

Soon after assuming office in 1933, President Franklin Roosevelt announced his support of new legislation to strengthen the regulatory provisions of the 1906 Pure Food and Drug Act. Agitation for change had been brewing for several years, particularly at the state level. A series of highly publicized books, most notably 100,000,000 Guinea Pigs (1933) and American Chamber of Horrors (1936), severely criticized the practices of the food, drug, and cosmetic industries, sparking controversy over the safety of cosmetics.

In June 1933, Senator Royal S. Copeland of New York introduced legis-lation to strengthen the 1906 Act. During subsequent Senate debate on the bill, attention was focused on a sensational photograph of a woman who reportedly was blinded by an eyelash dye.

Although the factual basis of the story was disputed by the industry and never confirmed, the so-called "Lash Lure" incident provided the smoking gun the legislation needed for passage.

For Senator Copeland, the eventual passage of the Copeland-Lea Food, Drug, and Cosmetic Bill in 1938 was the crowning achievement of his three-term Senate career.

The American Manufacturers of Toilet Articles (AMTA) supported the basic tenets of Copeland's legislation. The prospect of a patchwork of state laws greatly concerned the membership and provided the basis for their support of this federal legislation.

During a speech at the Association's 1937 annual meeting, Copeland pointed out that "unless we establish a Federal standard . . . there would be an individual standard for each state and those of you engaged in manufacturing and shipping in interstate commerce would have to conform to 46 or 48 different standards."

The 1938 Food, Drug and Cosmetic (FD&C) Act contained both adulteration and misbranding provisions. A cosmetic was deemed to be adulterated if it "contains any poisonous or deleterious substance that may render it injurious to users under customary conditions of use." The misbranding provisions prohibited labeling that is "false or misleading in any particular."

The provisions also required that a package's quantity of contents and name and address of manufacturer, packer or distributor be conspicuously included on the label. To enforce the statute, the Food and Drug Administration was given search and seizure and prosecution powers.