Before passage of the 1938 Food, Drug, and Cosmetic Act, drugs were:

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Before the 1938 Food, Drug, and Cosmetic Act, drugs were not completely unregulated, but the regulations were much less stringent than they are today. The Act significantly increased the regulatory authority of the FDA, requiring new drugs to be proven safe before marketing, among other provisions. Prior to this, there was some regulation, such as the 1906 Pure Food and Drug Act, which prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs, but the 1938 Act greatly expanded the scope of regulation.

Before Passage of the 1938 Food, Drug, and Cosmetic Act