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U.S. Department of Health and Human Services

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This Week In FDA History - May 29, 1911

Photo of the various products declaring false therapeutic claims
Several early 20th-century epilepsy "remedies." The maker of Dr. Lindley's Epilepsy Remedy, top left, pleaded guilty to misbranding in violation of the Pure Food and Drugs Act, just days before the U.S. v. Johnson ruling.
May 29, 1911:
In U.S. v. Johnson, the Supreme Court ruled that the 1906 Pure Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug.

FDA in 2006

In 1912, Congress issued corrective legislation. The Sherley Amendment brought therapeutic claims within the jurisdiction of the Pure Food and Drugs Act but required the agency to prove those claims to be false and fraudulent before they would be judged as illegal. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) required drug manufacturers to prove to the FDA that their products were both safe and effective prior to marketing. They also gave the FDA control over prescription drug advertising. In addition, the FD&C Act prohibits marketers of dietary supplements to make false claims, and a dietary supplement that is promoted to treat, prevent, or cure a disease or condition is considered an unapproved, and therefore illegal, new drug.