United States v. Johnson (1911)
|United States v. Johnson|
|Full case name||United States v. Johnson (1911)|
|Citations||221 U.S. 488 (more)|
|The term "misbranded" and the phrase defining what amounts to misbranding in § 8 of the Pure Food and Drug Act are aimed at false statements as to identity of the article, possibly including strength, quality and purity, dealt with in § 7 of the act, and not at statements as to curative effect. A statement on the labels of bottles of medicine that the contents are effective as a cure for cancer, even if misleading, is not covered by the statute.|
|Majority||Holmes, joined by White, McKenna, Lurton, Van Devanter, Lamar|
|Dissent||Hughes, joined by Harlan, Day|
|Pure Food and Drug Act|
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:
- 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).
- "Pure Food and Drug Act Amendment of 1912 ~ P.L. 62-301" (PDF). 37 Stat. 416 ~ House Bill 11877. Legis★Works. August 23, 1912.
- "May 29, 1911 - U.S. v. Johnson". This Week in FDA History. U.S. Food and Drug Administration.