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7.1. SR 10-19-2015
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7.1. SR 10-19-2015
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9/14/2015 Public Health Focus > Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA <br />Archived Content <br />The content on this page is provided for reference purposes only. This content has not <br />been altered or updated since it was archived. <br />Search Archive <br />Home News ft Events Public Health Focus <br />News & Events <br />Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA <br />• FDA conducted a preliminary analysis on some samples of electronic cigarettes and components <br />from two leading brands. Due to the variability among products, this analysis should not be used to <br />draw conclusions about what substances are or are not present in particular electronic cigarettes or <br />brands of electronic cigarettes. <br />• FDA's Center for Drug Evaluation, Office of Compliance purchased two samples of electronic <br />cigarettes and components from two leading brands. These samples included 18 of the various <br />flavored, nicotine, and no -nicotine cartridges offered for use with these products. These cartridges <br />were obtained in order to test some of the ingredients contained in them and inhaled by users of <br />electronic cigarettes. <br />• FDA's Center for Drug Evaluation, Division of Pharmaceutical Analysis (DPA) analyzed the cartridges <br />from these electronic cigarettes for nicotine content and for the presence of other tobacco <br />constituents, some of which are known to be harmful to humans, including those that are potentially <br />carcinogenic or mutagenic. <br />• DPA's analysis of the electronic cigarette samples showed that the product contained detectable <br />levels of known carcinogens and toxic chemicals to which users could potentially be exposed. <br />• DPA's testing also suggested that quality control processes used to manufacture these products are <br />inconsistent or non-existent. <br />• Specifically, DPA's analysis of the electronic cigarette cartridges from the two leading brands <br />revealed the following: <br />• Diethylene glycol was detected in one cartridge at approximately 1%. Diethylene glycol, an <br />ingredient used in antifreeze, is toxic to humans. <br />o Certain tobacco -specific nitrosamines which are human carcinogens were detected in half of the <br />samples tested. <br />• Tobacco -specific impurities suspected of being harmful to humans—anabasine, myosmine, and <br />R-nicotyrine—were detected in a majority of the samples tested. <br />• The electronic cigarette cartridges that were labeled as containing no nicotine had low levels of <br />nicotine present in all cartridges tested, except one. <br />• Three different electronic cigarette cartridges with the same label were tested and each <br />cartridge emitted a markedly different amount of nicotine with each puff. The nicotine levels <br />per puff ranged from 26.8 to 43.2 mcg nicotine/100 mL puff. <br />• One high -nicotine cartridge delivered twice as much nicotine to users when the vapor from that <br />electronic cigarette brand was inhaled than was delivered by a sample of the nicotine inhalatior <br />product (used as a control) approved by FDA for use as a smoking cessation aid. <br />Page Last Updated: 04/22/2014 <br />Note: If you need help accessing information in different file formats, see Instructions for Downloading <br />Viewers and Players. <br />Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website <br />Policies <br />hftp://www.fda.gov/NewsEvents/PublicHealthFocus/ucml73146.htm 1/2 <br />
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