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United States v. Johnson (1911)
In ''United States v. Johnson'' , the United States Supreme Court ruled that the misbranding provisions of the Pure Food and Drug Act〔Pure Food and Drug Act, ch. 3915, 34 Stat. 768 (1906) (current version as amended at 21 U.S.C.S. §§ 301-392 (1985)). The regulation has been amended in part by Pub. L. 101-629, 104 Stat. 4511 (1990).〕 of 1906 did not pertain to false curative or therapeutic statements; rather, it only prohibited 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;:〔37 Stat. 416 (1912)〕 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.
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