Tobacco Product Regulation — A Public Health Approach

Deyton, Lawrence; Sharfstein, Joshua; Hamburg, Margaret A.

doi:10.1056/nejmp1004152

Cited by 61 publications

(40 citation statements)

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“…In the U.S., the enactment of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) (Family Smoking Prevention and Tobacco Control Act, 2009) has empowered the U.S. Food and Drug Administration (FDA) to evaluate and regulate Modified Risk Tobacco Products (MRTPs) (Deyton et al, 2010) and to issue guidance or regulations on the scientific evidence required for the assessment and ongoing review of MRTPs (Food and Drug Administration, 2012). Additional guidance has been developed by the Institute of Medicine (IOM) who have proposed novel testing strategy approaches (Institute of Medicine, 2012).…”

Section: Introductionmentioning

confidence: 99%

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 2: Smoke chemistry and in vitro toxicological evaluation using smoking regimens reflecting human puffing behavior

Zenzen

Diekmann

Gerstenberg

et al. 2012

Regulatory Toxicology and Pharmacology

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Chemical analysis of up to 49 harmful and potentially harmful constituents (HPHC) in mainstream smoke, in vitro cytotoxicity of the particulate and gas/vapor phase of mainstream smoke determined in the Neutral Red Uptake assay, and in vitro bacterial mutagenicity of the particulate phase determined in the Salmonella typhimurium Reverse Mutation (Ames) assay are reported for three Electrically Heated Cigarette Smoking System (EHCSS) series-K cigarettes, the University of Kentucky Reference Cigarette 2R4F, and a number of comparator commercial conventional lit-end cigarettes (CC) under ISO machine-smoking conditions and a total of 25 additional smoking regimens reflecting 'human puffing behavior' (HPB). The smoking machines were set to deliver nicotine yields for the EHCSS and comparator CC derived from the 10th percentile to the 90th percentile of nicotine uptake distributions in smokers determined in two clinical studies. Duplication of the smoking intensity 'per cigarette' on a smoking machine may provide an insight into product performance that is directly relevant to obtaining scientific evidence for reduced exposure substantiation based on mainstream cigarette smoke HPHC-to-nicotine regressions. The reported data support an overall evaluation of reduced exposure to HPHC and biological activity.

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Section: Introductionmentioning

confidence: 99%

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 2: Smoke chemistry and in vitro toxicological evaluation using smoking regimens reflecting human puffing behavior

Zenzen

Diekmann

Gerstenberg

et al. 2012

Regulatory Toxicology and Pharmacology

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“…3,17 The most commonly offered flavors are tobacco and menthol, which are offered by 93% and 92%, respectively, of ENDS brands. 3 Because cigarettes with candy and fruit flavoring encourage youth experimentation, regular use, and addiction, 30 flavorings (other than menthol) have been banned in conventional cigarettes since the Family Smoking Prevention and Tobacco Control Act of 2009. Although the flavoring chemicals used in ENDS solutions have been cited as "food grade" and "generally recognized as safe," under FDA guidelines, this certification relates only to ingestion, not inhalation.…”

Section: Ends Solution Componentsmentioning

confidence: 99%

Electronic Nicotine Delivery Systems

Etzel¹,

Wilson²,

Balk³

et al. 2015

Pediatrics

107

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Electronic nicotine delivery systems (ENDS) are rapidly growing in popularity among youth. ENDS are handheld devices that produce an aerosolized mixture from a solution typically containing concentrated nicotine, flavoring chemicals, and propylene glycol to be inhaled by the user. ENDS are marketed under a variety of names, most commonly electronic cigarettes and e-cigarettes. In 2014, more youth reported using ENDS than any other tobacco product. ENDS pose health risks to both users and nonusers. Nicotine, the major psychoactive ingredient in ENDS solutions, is both highly addictive and toxic. In addition to nicotine, other toxicants, carcinogens, and metal particles have been detected in solutions and aerosols of ENDS. Nonusers are involuntarily exposed to the emissions of these devices with secondhand and thirdhand aerosol. The concentrated and often flavored nicotine in ENDS solutions poses a poisoning risk for young children. Reports of acute nicotine toxicity from US poison control centers have been increasing, with at least 1 child death reported from unintentional exposure to a nicotine-containing ENDS solution. With flavors, design, and marketing that appeal to youth, ENDS threaten to renormalize and glamorize nicotine and tobacco product use. There is a critical need for ENDS regulation, legislative action, and counter promotion to protect youth. ENDS have the potential to addict a new generation of youth to nicotine and reverse more than 50 years of progress in tobacco control. DEFINITIONS• Secondhand aerosol: emissions from electronic nicotine delivery systems (ENDS) that are discharged into the surrounding environment with ENDS use, both directly from the ENDS and exhaled from the lungs of the user.• Thirdhand aerosol: ENDS emissions that remain on surfaces and in dust after ENDS use, which can be reemitted into the gas phase or react with oxidants in the environment to yield secondary pollutants.

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“…21 Under the Family Smoking Prevention and Tobacco Control Act, a ban was implemented in 2009 on cigarettes with characterizing flavors other than menthol and tobacco, including fruit-and candy-flavored cigarettes. 22 Currently, no such ban exists on e-cigarettes and other tobacco products. The plethora of added flavors, colorful packaging, and candylike appearance associated with e-cigarette devices and their liquid refill products, as well as other tobacco products, may make them more attractive to young children.…”

Section: Figurementioning

confidence: 99%

Pediatric Exposure to E-Cigarettes, Nicotine, and Tobacco Products in the United States

et al. 2016

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OBJECTIVES: To investigate the epidemiologic characteristics and outcomes of exposures to electronic cigarettes (e-cigarettes), nicotine, and tobacco products among young children in the United States. METHODS:A retrospective analysis of exposures associated with nicotine and tobacco products among children younger than 6 years old was conducted by using National Poison Data System data. RESULTS:From January 2012 through April 2015, the National Poison Data System received 29 141 calls for nicotine and tobacco product exposures among children younger than 6 years, averaging 729 child exposures per month. Cigarettes accounted for 60.1% of exposures, followed by other tobacco products (16.4%) and e-cigarettes (14.2%). The monthly number of exposures associated with e-cigarettes increased by 1492.9% during the study period. Children <2 years old accounted for 44.1% of e-cigarette exposures, 91.6% of cigarette exposures, and 75.4% of other tobacco exposures. Children exposed to e-cigarettes had 5.2 times higher odds of a health care facility admission and 2.6 times higher odds of having a severe outcome than children exposed to cigarettes. One death occurred in association with a nicotine liquid exposure. CONCLUSIONS:The frequency of exposures to e-cigarettes and nicotine liquid among young children is increasing rapidly and severe outcomes are being reported. Swift government action is needed to regulate these products to help prevent child poisoning. Prevention strategies include public education; appropriate product storage and use away from children; warning labels; and modifications of e-cigarette devices, e-liquid, and e-liquid containers and packaging to make them less appealing and less accessible to children.

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Tobacco Product Regulation — A Public Health Approach

Cited by 61 publications

References 0 publications

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 2: Smoke chemistry and in vitro toxicological evaluation using smoking regimens reflecting human puffing behavior

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 2: Smoke chemistry and in vitro toxicological evaluation using smoking regimens reflecting human puffing behavior

Electronic Nicotine Delivery Systems

Pediatric Exposure to E-Cigarettes, Nicotine, and Tobacco Products in the United States

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