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FOLLOWING LEGISLATIVE ACTS
U.S v. Johnson (1911)
"An article shall also be deemed to be misbranded: In case of drugs: First. If it be an imitation of, or offered for sale under the name of, another article. Second. [In case of a substitution of contents] . . . or if the package fail to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilid, or any derivative or preparation of any such substances contained therein."
-Justia, U.S. Supreme Court.
U.S. Reports: United States v. Johnson, 221 U.S. 488 (1911), Library of Congress.
The Sherley Amendment (1912)
"The Sherley Amendment provided language that prohibited the intentional labeling of medication bottles or packaging with false therapeutic claims. "
-Weill Cornell Medicine.
Public Health Reports, JSTOR, (Jan. 21, 1916)
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Summary of the misbranding charges brought about by the FDA for fraudulent claims made by the manufacturer's of Mrs. Winslow's Soothing Syrup (1916),
Weill Cornell Medicine.
Food, Drug, and Cosmetic Act (1938)
U.S. Food And Drug Administration.
"The new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use. Moreover, it mandated pre-market approval of all new drugs, such that a manufacturer would have to prove to FDA that a drug were safe before it could be sold."
-U.S. Food & Drug Administration.
The FDA Modernization Act (1997)
"For example, the 1997 Act increased patient access to promising experimental drugs and medical devices and provided for a rapid review process for important new medications."
-Weill Cornell Medicine.
"The FDA has served America well. Today, with a bill I'm about to sign into law, we can ensure that it will serve America well into the 21 century, and I hope serve as a model again for how we can maintain our goals of pursuing the public interest and adjust our means to the possibilities and the challenges of a dramatically new era."
-President Clinton, November 21, 1997, National Archives.
Food and Drug Administration Modernization Act of 1997 - The Provisions, EveryCRSReport.
Family Smoking Prevention and Tobacco Control Act (2009)
President Barack Obama, surrounded by members of Congress, and others, signs the Family Smoking Prevention and Tobacco Control Act in 2009, Counter Tools
"This Act, amending the Comprehensive Smokeless Tobacco Health Education Act, as well as the Food, Drug, and Cosmetics Act and the Federal Cigarette Labeling and Advertising Act, provides the Department of Health and Human Services with authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors."
-Federal Trade Commision.
Drug Quality and Security Act (2013)
"Title I: Drug Compounding - Compounding Quality Act - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements."
-Congress.Gov.
"Title II: Drug Supply Chain Security - Drug Supply Chain Security Act - (Sec. 202) Establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain."
-Congress.Gov.