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1.
J Public Health Manag Pract ; 7(3): 1-10, 2001 May.
Article in English | MEDLINE | ID: mdl-11338081

ABSTRACT

The nation's largest tobacco age-restriction enforcement program is described. Between 1997 and 2000, the U.S. Food and Drug Administration--working with state agencies--conducted nearly 200,000 compliance checks in 123,000 establishments in 44 states, 1 territory, and Washington, D.C. The overall violation rate was 26 percent (more than 40,000 violations), ranging from 9 percent in Maine to 54 percent in the Virgin Islands. Due to the recent Supreme Court ruling, the FDA has stopped conducting these checks and is shutting down its tobacco program. The protocol described in this article will prove useful to others conducting compliance checks and seeking to keep tobacco out of the hands of children.


Subject(s)
Commerce/legislation & jurisprudence , Drug and Narcotic Control , Nicotiana , Plants, Toxic , United States Food and Drug Administration , Adolescent , Age Factors , Child , Commerce/standards , Guideline Adherence , Humans , United States
2.
JAMA ; 277(5): 405-9, 1997 Feb 05.
Article in English | MEDLINE | ID: mdl-9010173

ABSTRACT

On August 28, 1996, the US Food and Drug Administration (FDA) asserted jurisdiction over cigarettes and smokeless tobacco under the Federal Food, Drug, and Cosmetic Act. Under this Act, a product is a "drug" or "device" subject to FDA jurisdiction if it is "intended to affect the structure or any function of the body." The FDA determined that nicotine in cigarettes and smokeless tobacco does "affect the structure or any function of the body" because nicotine causes addiction and other pharmacological effects. The FDA then determined that these pharmacological effects are "intended" because (1) a scientific consensus has emerged that nicotine is addictive; (2) recent studies have shown that most consumers use cigarettes and smokeless tobacco for pharmacological purposes, including satisfying their addiction to nicotine; and (3) newly disclosed evidence from the tobacco manufacturers has revealed that the manufacturers know that nicotine causes pharmacological effects, including addiction, and design their products to provide pharmacologically active doses of nicotine. The FDA thus concluded that cigarettes and smokeless tobacco are subject to FDA jurisdiction because they contain a "drug," nicotine, and a "device" for delivering this drug to the body.


Subject(s)
Ganglionic Stimulants/pharmacology , Legislation, Drug , Nicotine/pharmacology , Tobacco Industry , United States Food and Drug Administration , Humans , Plants, Toxic , Policy Making , Smoking Prevention , Tobacco Industry/legislation & jurisprudence , Tobacco Use Disorder/prevention & control , Tobacco, Smokeless , United States , United States Food and Drug Administration/legislation & jurisprudence
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