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[1] of 1906 did not pertain to false curative or therapeutic statements but only false statements as to the identity of the drug.
| United States v. Johnson | |
|---|---|
 | |
| Argued April 13, 1911 Decided May 29, 1911 | |
| Full case name | United States v. Johnson |
| Citations | 221 U.S. 488 (more) 31 S. Ct. 627; 55 L. Ed. 823 |
| Holding | |
| 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. | |
| Court membership | |
| |
| Case opinions | |
| Majority | Holmes, joined by White, McKenna, Lurton, Van Devanter, Lamar |
| Dissent | Hughes, joined by Harlan, Day |
| Laws applied | |
| Pure Food and Drug Act | |
In 1912, Congress responded with the Sherley Amendments, which addressed the perceived lack of enforcement of fraud related to therapeutic claims.[2] 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:[2]
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
edit- ^ 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).
- ^ a b "Pure Food and Drug Act Amendment of 1912 ~ P.L. 62-301" (PDF). 37 Stat. 416 ~ House Bill 11877. Legis★Works. August 23, 1912. Archived from the original (PDF) on October 17, 2015. Retrieved November 4, 2017.
External links
edit- 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.