• Source: United States v. Johnson (1911)

      • In United States v. Johnson, 221 U.S. 488 (1911), the United States Supreme Court ruled that the misbranding provisions of the Pure Food and Drug Act of 1906 did not pertain to false curative or therapeutic statements but only false statements as to the identity of the drug.
      In 1912, Congress responded with the Sherley Amendments, which addressed the perceived lack of enforcement of fraud related to therapeutic claims. The Act was amended to prohibit false and fraudulent claims of health benefits but enforcement under the amendment required proof of fraudulent intent, a difficult standard. The misbranding amendment required a curative or therapeutic product to bear a label with a quantity or proportion statement for specified narcotic substances:

      any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide or any derivative or preparation of any such substances


      References




      External links


      Text of United States v. Johnson, 221 U.S. 488 (1911) is available from: CourtListener Justia Library of Congress
      "May 29, 1911 - U.S. v. Johnson". This Week in FDA History. U.S. Food and Drug Administration.

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