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HomeMy WebLinkAboutTC Agd Pkt 2014-08-20 (4)LATE MAIL# rHO"F Scott Anderson From: sally warren Isaw74 @att.netj Sent: Wednesday, August 13, 2014 4:03 PM To: Scott Anderson Cc: Tina Warren Subject: elcigaretts -vapor cigarettsanother year Scott, Thank you for hearing my concerns about adding a cigaretts to the no smoking ordinance. For my son who is 53 and been a smoker for 30 years the no smoking ordinance was as you can imagine a blow but he started on his owns to try many different quitting procedures including the patch which all made him sick. He is disabled with Chrons, Ankllosing Spondylitis, and depression. Also last year went to the emergency room 4 times with kidney stones and prostrate enlargement. Since being moved from CMSP health program and being given Medical he has joined Kaiser for his medical needs and this includes joining a smoking secession programs and counselor who encouraged him to continue with the vapor cigarette since the other options made him so very sick. Now that that option might be taken away when he is making such progress is a disaster. He lives in low income housing in Tiburon and they are sticklers for rules and laws so this would be the end of his housing options if you can't make some exceptions in your proposed law for ill and disabled persons that have had this prescribed as medication. He doesnt smoke outside at all and this product only makes a very small emission that has absolutey no odder. His goal is to completely be free of the a cigg but it will take more time with help from Kaiser and his determination. This doesn't happen overnight and I hope you can be compassionate and understanding and add something to your proposal to give disabled people more time at least another year or more for the secession plan to work. Thank you and please present this to your board. Sally Warren 42 Neds WAY, TIBURON, CA AUG 13 'N 14 415- 290 -1091 PLANNJJ\1G DIVISION 1 To: From: TOWN OF TIBURON 1505 Tiburon Boulevard Tiburon, CA 94920 Mayor and Members of Town Council Community Development Department Town Council Meeting August 20, 2014 Agenda Item: PN Subject: Consider Amendments to Title VI, Chapter 28 (Smoking and Tobacco Regulations) of the Tiburon Municipal Code for the Purpose of Adding the Use of Electronic Smoking Devices to the Definition of Smoking (Ordinance — Introduction) Reviewed By: BACKGROUND Earlier this year, the Town Council directed staff to develop draft an ordinance for Council consideration that would add the use of electronic smoking devices, commonly known as "e- cigarettes" to the definition of "smoking" as regulated in Chapter 28 of the Tiburon Municipal Code. The purpose of the ordinance would be for e- cigarettes to come under the same Town smoking regulations as traditional cigarettes. A draft ordinance (Exhibit 1) has been properly noticed for public hearing and comes before the Town Council for review and consideration. ANALYSIS Electronic smoking devices are a relatively new phenomenon, reportedly invented by a pharmacist on the early 2000's as a smoking cessation aid. They are hand -held nicotine vaporizers that deliver an aerosol made up of nicotine, flavorings and other chemicals to users from a nicotine -laced liquid inside the device. These chemicals include formaldehyde, propylene glycol, and acetaldehyde, among others. E- cigarettes are meant to look and feel like a traditional cigarette, right down to a small light at the tip that lights up, similar to a burning cigarette. E- cigarettes produce a vapor from a heating element that boils the liquid contents, hence the term «vaping,> The use of e- cigarettes has gained significant popularity over the past five years, with a reported doubling of sales each year. As the popularity of the devices grows, policy makers are faced with the question of whether e- cigarettes should be considered in the same way as traditional cigarettes when it comes to their use in public and semi - public places. Studies are not yet conclusive as to the long -term health effects of e- cigarettes. Some studies indicate the vapor may be releasing harmful substances, including nicotine, but the trend is still too new to be able to cite longitudinal effects of direct usage and second hand inhalation. TOWN OF TIBURON PAGE 1 OF 3 Town Council Meeting August 20,2014 Electronic smoking devices have not been approved by the Food and Drug Administration, although it has been determined that they fall under the purview of that agency and regulation may be forthcoming. At the present time, e- cigarettes remain essentially unregulated at the federal or state level. There is, however, recent evidence that e- cigarettes have adverse effects on both users and bystanders. E- cigarettes have caused major injuries, including severe burns and nicotine poisoning. E- cigarette aerosol contains as much nicotine as conventional tobacco cigarettes, together with other chemicals known to be carcinogenic and cause asthma. They also emit a high level of fine and ultrafine particles, which may exacerbate respiratory problems and constrict arteries. In an abundance of caution, the cities of San Francisco, Los Angeles, Chicago, and New York have implemented regulations treating e- cigarettes as another form of smoking, and the reported number of other municipalities enacting similar regulations is at least at 172. In California, the cities of Walnut Creek, Richmond, Carlsbad, and Davis (among others) have passed regulations on e- cigarettes. Common reasons cited for enacting regulations include the following: • Concern about second -hand health effects from the vapors • Confusion about where smoking is allowed/prohibited, since e- cigarettes and their vapor closely resemble traditional cigarettes • Concern that acceptance of e- cigarettes may increase the social acceptability of smoking, particularly among minors and youth • Concern that vapors violate smoke -free air laws, or the intent of those laws Additionally, recent research indicates that second -hand vapor from e- cigarettes could be harmful for a number of reasons. Based on the combined weight of recent research, University of California San Francisco researchers very recently released policy recommendations including banning e- cigarettes wherever cigarettes are banned. See Exhibit 2, p. 14. Additional written materials regarding e- cigarettes that have been received by the Town are attached as Exhibit 3. RECOMMENDATION Staff recommends that the Town Council: 1. Hold a public hearing on the draft ordinance. 2. Review and consider introduction of the ordinance. Should the Council desire to move forward with the ordinance, the procedure would be to move to read the ordinance by title only, waiving any additional reading, and introduce the Ordinance amending Title VI, Chapter 28 (Smoking and Tobacco Regulations) of the Tiburon Municipal Code. Pass the first reading by roll call vote. If first reading is passed, the Ordinance will return for final adoption on a future consent calendar. The ordinance would take effect 30 days after adoption. TOWN OF TIBURON PAGE 2 OF 3 Town Council Meeting August 20, 2014 EXHIBITS 1. Draft ordinance amending Chapter 28. 2. Americans for Nonsmoker's Rights publication, 2014. 3. American Heart Association Journal article, 2014. 4. Materials Regarding E- cigarettes (letters, news reports, etc). Prepared By: Scott Anderson, Director of Community Development m Ann Danforth, Town Attorney TOWN OF TIBURON PAGE 3 OF 3 ORDINANCE NO. _ N. S. DRAFT AN ORDINANCE OF THE TOWN COUNCIL OF THE TOWN OF TIBURON AMENDING PROVISIONS OF TITLE VI, CHAPTER 28 OF THE TIBURON MUNICIPAL CODE (SMOKING AND TOBACCO REGULATIONS) The Town Council of the Town of Tiburon does ordain as follows: Section 1. Findings, A. The popularity of e- cigarettes has grown and continues to grow across the nation; and B. E- cigarettes are not currently regulated by the Food and Drug Administration, unless they are used for therapeutic purposes; and C. Although e- cigarettes are too new for longitudinal studies on their health effects, current research indicates that chemicals contained in e- cigarettes may be harmful and that vaping (i.e., use of e- cigarettes) does release contents of e- cigarettes into the air; and D. Recent scientific studies have found that the aerosol emitted from e- cigarettes contains harmful elements including, without limitation, nicotine, fine and ultrafine particles, at least 10 chemicals on California's Proposition 65 list of carcinogens and reproductive toxins, and propylene glycol. D. E- cigarettes are made to mimic conventional cigarettes, making enforcement of no- smoking rules difficult and confusing if e- cigarettes are allowed; and E. Numerous cities, counties, and organizations are putting into place laws or policies that treat e- cigarettes the same as conventional cigarettes when it comes to acceptable locations for usage in public and semi - public places; and F. The Town of Tiburon has for over two decades enforced strict local smoking control laws, defining where smoking conventional tobacco products is prohibited; and G. The Town Council of the Town of Tiburon desires to include e- cigarettes in the smoking controls and treat them in a manner similar to conventional cigarettes; and H. The Town Council has held a public hearing on August 20, 2014, and has heard and considered any and all public testimony on this matter. EMU= NO. I Town of Tiburon Ordinance No. — N. S. Effective -4- -12014 DRAFT 8/5/2014 Page I The Town Council finds that all notices and procedures required by law attendant to the adoption of this Ordinance have been followed. J. The Town Council finds that the amendments made by this Ordinance are necessary for the protection of the public health, safety, and welfare. K. The Town Council has found that the amendments made by this Ordinance are consistent with the goals and policies of the Tiburon General Plan and other adopted ordinances and regulations of the Town of Tiburon. L. WHEREAS, the Town Council finds that that these amendments are covered by the general rule that the California Environmental Quality Act (CEQA) applies only to projects that have the potential for causing a significant effect on the environment pursuant to CEQA Guidelines Section 15061(b)(3), and further finds that if the amendments were not covered by the above section, the amendments would be categorically exempt pursuant to Sections 15305, 15307 and /or 15308 of the CEQA Guidelines. Section 2. Amendment to Title VI Chapter 28, Section 28_2. Title VI, Chapter 28, Section 28 -2 of the Tiburon Municipal Code is amended as follows: (A) The definition of "Electronic Smoking Device" is added to read as follows: "Electronic Smoking Device" means an electronic or battery- operated device that delivers vapors for inhalation. This term shall include every variation and type of such devices whether they are manufactured, distributed, marketed or sold as an electronic cigarette, an electronic cigar, and electronic cigarillo, an electronic pipe, an electronic hookah or any other product name or descriptor. (B) The definition of "Smoking" is amended to read as follows: "Smoking" means engaging in an act that produces gas, particles, vapor or smoke by means of means of combustion, electrical ignition or vaporization, where the apparent or usual purpose of said act is the human inhalation of the byproducts. "Smoking" does not include acts where (a) the combustion or vaporization material contains no tobacco, nicotine and (b) the purpose is solely olfactory, such as producing smoke from incense. "Smoking" does include the use of a lighted pipe, lighted cigar, or lighted cigarette, lighted hookah, Electronic Smoking Device or other device of any kind containing tobacco, tobacco product, tobacco -like product, spices, or any other plant or herbal materials to the extent that local regulation of such lighted device, product or material is allowed by law. Town of Tiburon Ordinance No. — N. S. Effective -4- 42014 DRAFT 8/5/2014 Page 2 Section 3. Severability. If any section, subsection, clause, sentence, or phrase of this Ordinance is for any reason held to be invalid or unconstitutional by a decision of a Court of competent jurisdiction, such decision shall not affect the validity of the remaining portions of the Ordinance. The Town Council of the Town of Tiburon hereby declares that it would have passed this Ordinance, any section, subsection, sentence, clause or phrase thereof, irrespective of the fact that any one or more sections, subsections, sentences, clauses, or phrases may be declared invalid or unconstitutional. Section 4. Effective Date. This Ordinance shall take effect and be in force thirty days after the date of passage, and before the expiration of fifteen (15) days after passage by the Town Council, a copy of the ordinance shall be published with the names of the members voting for and against it at least once in a newspaper of general circulation published in the Town of Tiburon. This ordinance was introduced at a regular meeting of the Town Council of the Town of Tiburon on , 2014, and was adopted at a regular meeting of the Town Council of the Town of Tiburon on 2014, which was noticed pursuant to relevant sections of the California Government Code, by the following vote: AYES: COUNCILMEMBERS: NAYS: COUNCILMEMBERS: ABSENT: COUNCILMEMBERS: ALICE FREDERICKS, MAYOR TOWN OF TIBURON ATTEST: DIANE CRANE IACOPI, TOWN CLERK Town of Tiburon Ordinance No. — N. S. Effective - -/- -/2014 DRAFT 8/52014 Page 3 AMERICANS FOR NONSMOKERS' RIGHTS Defending your right to breathe smokefree air since 1976 Electronic (e -) Cigarettes and Secondhand Aerosol "If you are around somebody who is using e- cigarettes, you are breathing an aerosol of exhaled nicotine, ultra -fine particles, volatile organic compounds, and other toxins, "Dr. Stanton Glantz, Director for the Center for Tobacco Control Research and Education at the University of California, San Francisco. Current Legislative Landscape • As of January 2, 2014, 108 municipalities and three states include e- cigarettes as products that are prohibited from use in smokefree environments. Constituents of Secondhand Aerosol E- cigarettes do not just emit "harmless water vapor." Secondhand e- cigarette aerosol (incorrectly called vapor by the industry) contains nicotine, ultrafine particles and low levels of toxins that are known to cause cancer. • E- cigarette aerosol is made up of a high concentration of ultrafine particles, and the particle concentration is higher than in conventional tobacco cigarette smoke.' • Exposure to fine and ultrafine particles may exacerbate respiratory ailments like asthma, and constrict arteries which could trigger a heart attack.' At least 10 chemicals identified in e- cigarette aerosol are on California's Proposition 65 list of carcinogens and reproductive toxins, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986. The compounds that have already been identified in mainstream (MS) or secondhand (SS) e- cigarette aerosol include: Acetaldehyde (MS), Benzene (SS), Cadmium (MS), Formaldehyde (MS,SS), Isoprene (SS), Lead (MS), Nickel (MS), Nicotine (MS, SS), N- Nitrosonornicotine (MS, SS), Toluene (MS, SS). 3,4 • E- cigarettes contain and emit propylene glycol, a chemical that is used as a base in e- cigarette solution and is one of the primary components in the aerosol emitted by e- cigarettes. • Short tern exposure causes eye, throat, and airway irritation.5 • Long term inhalation exposure can result in children developing asthma .6 • Even though propylene glycol is FDA approved for use in some products, the inhalation of vaporized nicotine in propylene glycol is not. Some studies show that heating propylene glycol changes its chemical composition, producing small amounts of propylene oxide, a known carcinogen.' • There are metals in e- cigarette aerosol, including chromium, nickel, and tin nanoparticles 8 • FDA scientists found detectable levels of carcinogenic tobacco - specific nitrosamines in e- cigarette aerosol .9 2530 San Pablo Avenue, Suite J • Berkeley, California 94702 • (510) 841 -30321 FAX (510) 841 -3071 www.no- smoke.org . am @no - smoke.org L� MiTIBZT NO. C2 • People exposed to e- cigarette aerosol absorb nicotine (measured as cotinine), with one study showing levels comparable to passive smokers.10 • Diethylene Glycol, a poisonous organic compound, was also detected in e- cigarette aerosol." • Exhaled e- cigarette aerosol contained propylene glycol, glycerol, flavorings, and nicotine, along with acetone, formaldehyde, acetaldehyde, propanal, diacetin, and triacitine.12 • Many of the elements identified in the aerosol are known to cause respiratory distress and disease. The aerosol contained particles >1 pm comprised of tin, silver, iron, nickel, aluminum, and silicate and nanoparticles ( <100 nm) of tin, chromium and nickel. The concentrations of nine of eleven elements in e- cigarette aerosol were higher than or equal to the corresponding concentrations in conventional cigarette smoke .13 • E- cigarettes cause exposure to different chemicals than found in conventional cigarettes and there is a need for risk evaluation for both primary and passive exposure to the aerosol in smokers and nonsmokers .14 • Short term use of e- cigarettes has been shown to increase respiratory resistance and impair lung function, which may result in difficulty breathing.15 • Overall, e- cigarettes are a new source of Volatile Organic Compounds (VOCs) and ultrafine /fine particles in the indoor environment, thus resulting in "passive vaping. "" E- cigarette aerosol is a new source of pollution and toxins being emitted into the environment. We do not know the long -term health effects of e- cigarette use and although the industry marketing of the product implies that these products are harmless, the aerosol that e- cigarettes emit is not purely water vapor. May be reprinted with appropriate attribution to Americans for Nonsmokers' Rights, © 2014 REFERENCES 1 Fuoco, F.C.; Buonanno, G.; Stabile, L.; Vigo, P., "Influential parameters on particle concentration and size distribution in the mainstream of e- cigarettes." Environmental Pollution 184: 523 -529, January 2014. z Grana, R; Benowitz, N; Glantz, S. "Background Paper on E- cigarettes," Center for Tobacco Control Research and Education, University of California, San Francisco and WHO Collaborating Center on Tobacco Control. December 2013. 3 Goniewicz, M.L.; Knysak, J.; Gawron, M.; Kosmider, L.; Sobczak, A.; Kurek, J.; Prokopowicz, A.; Jablonska- Czapla, M.; Rosik- Dulewska, C.; Havel, C.; Jacob, P.; Benowitz, N., "Levels of selected carcinogens and toxicants in vapour from electronic cigarettes." Tobacco Control [Epub ahead of print], March 6, 2013. " Williams, M.; Villarreal, A.; Bozhilov, K.; Lin, S.; Talbot, P., "Metal and silicate particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol," PLoS ONE 8(3): e57987, March 20, 2013. 5 Wieslander, G; Norback, D; Lindgren, T. "Experimental exposure to propylene glycol mist in aviation emergency training: acute ocular and respiratory effects." Occupational and Environmental Medicine 58:10 649 -655, 2001. 6 Choi, H; Schmidbauer,N; Spengler,J; Bornehag, C., "Sources of Propylene Glycol and Glycol Ethers in Air at Home;' International Journal of Environmental Research and Public Health 7(12): 4213 -4237, December 2010. 7 Henderson, TR; Clark, CR; Marshall, TC; Hanson, RL; & Hobbs, CH. "Heat degradation studies of solar heat transfer fluids," Solar Energy, 27, 121 -128. 1981. 2 a Williams, M.; Villarreal, A.; Bozhilov, K.; Lin, 5.; Talbot, P., "Metal and silicate particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol." PLoS ONE 8(3): e57987, March 20, 2013. 9 Westenberger, B.J., "Evaluation of e- cigarettes," St. Louis, MO: U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, May 4,2009. 10 Flouris, A.D.; Chorti, M.S.; Poulianiti, K.P.; Jamurtas, A.Z.; Kostikas, K.; Tzatzarakis, M.N.; Wallace, H.A.; Tsatsaki, A.M.; Koutedakis, Y., "Acute impact of active and passive electronic cigarette smoking on serum cotinine and lung function." Inhalation Toxicology 25(2): 91 -101, February 2013. 11 Westenberger, B.J., "Evaluation of e- cigarettes." St. Louis, MO: U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, May 4, 2009. lz Schripp, T.; Markewitz, D.; Uhde, E.; Salthammer, T., "Does e- cigarette consumption cause passive vaping7." Indoor Air 23(1): 25 -31, February 2013. v Williams, M.; Villarreal, A.; Bozhilov, K.; Lin, S.; Talbot, P., "Metal and silicate particles including nanoparticles are present In electronic cigarette cartomizer fluid and aerosol." PLoS ONE 8(3): e57987, March 20, 2013. 14 Pellegrino, R.M.; Tinghino, B.; Mangiaracina, G.; Marani, A.; Vitali, M.; Protano, C.; Osborn,l.F.; Cattaruzza, M.S., "Electronic cigarettes: an evaluation of exposure to chemicals and fine particulate matter (PM)." Annali Dl Igiene 24(4):279 -88, July- August 2012. is Vardavas, C.I.; Anagnostopoulos, N.; Kougias, M.; Evangelopoulou, V.; Connolly, G.N.; Behrakis, P.K., "Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance impedance and exhaled nitric oxide Chest 141(6): 1400 -1406, June 2012. lc Schripp, T.; Markewitz, D.; Uhde, E.; Salthammer, T., "Does e- cigarette consumption cause passive vaping7." Indoor Air 23(1): 25 -31, February 2013. 1402 [FS -39] E- Cigarettes Circulation circ.ahajournals.org Circulation. 2014;129:1972 -1986 doi: 10.1161 fCIRCULATIONAHAA 14.007667 sMa o 11 j- }Crss _ j .r Contemporary Reviews in Cardiovascular Medicine E•Cigarettes A Scientific Review Rachel Grana, PhD, MPH; Neal Benowitz, MD; Stanton A. Glantz, PhD Author Affiliations Correspondence to Stanton A. Glantz, PhD, Center for Tobacco Control Research and Education, University of California, San Francisco, 530 Parnassus Ave, No. 366, San Francisco, CA 94143 -1390. E -mail glantz @medicine.ucsf.edu Key Words: adolescent particulate matter public policy smoking Introduction Electronic cigarettes (e- cigarettes) are products that deliver a nicotine - containing aerosol (commonly called vapor) to users by heating a solution typically made up of propylene glycol or glycerol (glycerin), nicotine, and Flavoring agents (Figure 1� invented in their current form by Chinese pharmacist Hon Lik in the early 2000s. The US patent application describes the e- clgarette device as 'an electronic atemization cigarette that functions as substitutes [sic] for quitting smoking and cigarette substitutes *(patent No. 8,490,628 82). By 2013, the major multinational tobacco companies had entered the e- cigarette market. E- cigarettes are marketed via television, the Internet, and print advertisements (that often feature celebrities)2 as healthier alternatives to tobacco smoking, as useful for quitting smoking and reducing cigarette consumption, and as a way to circumvent smoke -free laws by enabling users to "smoke anywh ere. '3 There has been rapid market penetration of e- cigarettes despite many unanswered questions about their safety, efficacy for harm reduction and cessation, and total Impact on public health. E- cigarette products are changing quickly, and many of the findings from studies of older products may not be relevant to the assessment of newer products that could be safer and more effective as nicotine delivery devices. In addition, marketing and other environmental Influences may vary from country to country, so patterns of use and the ultimate impact on public health may differ. The Individual risks and benefits and the total Impact of these products occur in the context of the widespread and continuing availability of conventional cigarettes and other tobacco products, with high levels of d„al use of e- ciearettes and conventional cigarettes at the same time among adults 4-8 and youth. 9 11 It is Important to assess e- cigarette toxicant exposure and individual risk, as well as the health effects, of e- cigarettes as they are actually used to ensure safety and to develop an evidence -based regulatory scheme that protects the entire population http://circ.ahajoumals.org/content/129/19/1972.full F�rI_I I i N ®. 1 of 21 7/28/2014 4:57 PM Figure 1. - — -- Examples of different electronic cigarette (e- cigarette) products. '- - -• Reproduced from Grana et al.l View larger versbn: In this page Ina new window Download as PowerPdnt Slide There has been rapid market penetration of e- cigarettes despite many unanswered questions about their safety, efficacy for harm reduction and cessation, and total Impact on public health. E- cigarette products are changing quickly, and many of the findings from studies of older products may not be relevant to the assessment of newer products that could be safer and more effective as nicotine delivery devices. In addition, marketing and other environmental Influences may vary from country to country, so patterns of use and the ultimate impact on public health may differ. The Individual risks and benefits and the total Impact of these products occur in the context of the widespread and continuing availability of conventional cigarettes and other tobacco products, with high levels of d„al use of e- ciearettes and conventional cigarettes at the same time among adults 4-8 and youth. 9 11 It is Important to assess e- cigarette toxicant exposure and individual risk, as well as the health effects, of e- cigarettes as they are actually used to ensure safety and to develop an evidence -based regulatory scheme that protects the entire population http://circ.ahajoumals.org/content/129/19/1972.full F�rI_I I i N ®. 1 of 21 7/28/2014 4:57 PM E- Cigarettes http: // circ. ahajoumals .org /content/129 /19/1972.full — children and adults, smokers and nonsmokers —In the context of how the tobacco Industry Is marketing and promoting these products. Health claims and claims of efficacy, for quitting smoking are unsupported by the scientific evidence to date. To minimize the potential negative Impacts on prevention and cessation and the undermining of existing tobacco control measures, e- cigarette use should be prohibited where tobacco cigarette use is prohibited, and the products should be subject to the same marketing restrictions as tobacco cigarettes. Methods Initial searches conducted via PubMed using the key words electronic cigarette, e- cigarette, and electronic nicotine delivery systems yielded 151 studies (Figure 2). Seventy-one articles presented original data and were Included. Eighty articles were excluded because they were not relevant, were not in English, or were reviews or commentaries that did not provide original data, although some are cited for background and context. Searches using the same search terms were conducted using World Health Organization regional databases; only BIBLIOTECA Virtual em Salude Latin America and Caribbean Included relevant papers, all of which had already been located with PubMed. Working with the World Health Organization, we also contacted Investigators to locate other studies, some of which had not yet been published (submitted or In press). We also reviewed technical reports prepared by health organizations, 12 -15 news articles, and relevant Web sites. The results of these searches were used to prepare a report commissioned by the World Health Organization Tobacco Free Initiative, which provides details of Individual studies, including some studies that are not discussed in this article because of length constrains.) After the manuscript was submitted for peer review, 5 more articles became available, resulting in a total of 82 articles forming the basis for this review. The Product E- cigarette devices are manufactured mainly in China. As of late 2013, there was wide variability In e- cigarette product engineering, Including varying nicotine concentrations in the solution used to generate the nicotine aerosol (also called e- liquid), varying volumes of solution in the product, different carder compounds (most commonly propylene glycol with or without glycerol [glycerin]), a wide range of additives and flavors, and battery voltage. Quality control Is variable, 16 and users can modify manv of the products, Including using them to deliver other drugs such as marijuana. 17,18 These engineering differences result in variability In how e- cigarettes heat and convert the nicotine solution to an aerosol and consequently the levels of nicotine and other ch-.mlcals delivered to users and the air pollution generated by the exhaled aerosol. 19 E- liquids are flavored, Including tobacco, menthol, coffee, fruit, candy, and alcohol flavors, as well as unusual flavors such as cola and Belgian waffle.3 Flavored (conventinna0 tobacco products are used disproportionately by youth and Initiators, 20 and cigarettes with characterizing flavors (except menthol) have been banned in the United States Marketing and Media Research Consumer perceptions of the risks and benefits and decisions to use e- cigarettes are heavily Influenced by how they are marketed. Celebrities have been used to market e- cigarettes since at least 2009.21 Grana and Ling3 reviewed 59 single -brand e- cigarette retail Web sites In 2012 and found that the most popular claims were that the products are healthier (95 %). cheaper (9396), and cleaner (95 %) than cigarettes; can be smoked anywhere (88 %); can be used to circumvent smoke -free policies (71 %); do not produce secondhand smoke (76 %); and are 2 of 21 7/28/2014 4:57 PM Figure 2. Studies screened and selected '— _ -- --' '� - - -- for inclusion. PRISMA Indicates I— Preferred Reporting Items for - I—" Systematic Reviews and - =- Meta - Analyses. View larger versbn: In this page Ina new window Download as PowerPoint Slide The Product E- cigarette devices are manufactured mainly in China. As of late 2013, there was wide variability In e- cigarette product engineering, Including varying nicotine concentrations in the solution used to generate the nicotine aerosol (also called e- liquid), varying volumes of solution in the product, different carder compounds (most commonly propylene glycol with or without glycerol [glycerin]), a wide range of additives and flavors, and battery voltage. Quality control Is variable, 16 and users can modify manv of the products, Including using them to deliver other drugs such as marijuana. 17,18 These engineering differences result in variability In how e- cigarettes heat and convert the nicotine solution to an aerosol and consequently the levels of nicotine and other ch-.mlcals delivered to users and the air pollution generated by the exhaled aerosol. 19 E- liquids are flavored, Including tobacco, menthol, coffee, fruit, candy, and alcohol flavors, as well as unusual flavors such as cola and Belgian waffle.3 Flavored (conventinna0 tobacco products are used disproportionately by youth and Initiators, 20 and cigarettes with characterizing flavors (except menthol) have been banned in the United States Marketing and Media Research Consumer perceptions of the risks and benefits and decisions to use e- cigarettes are heavily Influenced by how they are marketed. Celebrities have been used to market e- cigarettes since at least 2009.21 Grana and Ling3 reviewed 59 single -brand e- cigarette retail Web sites In 2012 and found that the most popular claims were that the products are healthier (95 %). cheaper (9396), and cleaner (95 %) than cigarettes; can be smoked anywhere (88 %); can be used to circumvent smoke -free policies (71 %); do not produce secondhand smoke (76 %); and are 2 of 21 7/28/2014 4:57 PM E- Cigarettes http: / /circ. ahajoumals .org /contentl129 /19/1972.ful single -brand e- cigarette retail Web sites In 2012 and found that the most popular claims were that the products are healthier (95%), cheaper (93 %). and cleaner (9590 than cigarettes; can be smoked anywhere (8890; can be used to circumvent smoke -free policies (71 %); do not produce secondhand smoke (769); and are modern (7390. Health claims made through text and pictorial and video representations of doctors were present on 22% of sites. Cessation- related claims (direct and Indirect statements) were found on 64% of sites. Marketing on the sites commonly stated that e- cigarettes produce only "harmless 22ater vapor." Similar messaging strategies were being used in the United Kingdom. These marketing messages have been repeated in the media. A thematic analysis of newspaper and online media coverage about e- cigarettes In the United Kingdom and Scotland from July 2007 to June 2012 found 5 themes: healthier choice, circumventing smoke -free restrictions, celebrity use, price, and risk and uncertainty. 23 Coverage often Included anecdotes about having tried nicotine replacement therapies (NRTs), failing to quit, and then trying the e- cigarette (such as the celebrity endnrsement by actress Katherine Heigl an the US David Letterman television program 21), Implying that e- cigarettes are a more effective form of NRT. E- cigarette companies also have a strong presence in social media, which reinforces their marketing messages, including repeating the use of celebrity endorsements (eg, Heigi) and spreading images of the UK musical group Girls Aloud "puffing an e- cigarettes to cope with the stress of their 10th anniversary tour.' 22 Cigarette and other tobacco companies have been unable to market their products on television and radio since the 1970s. E- cigarette advertising on television and radio is mass marketing of an addictive nicotine product for use in a recreational manner to new generations who have never experienced such marketing. In an online convenience sample of 519 adult smokers and recent quitters who viewed a television commercial for Blu e- cigarettes, 76% of current smokers reported that the ad made them think about smoking cigarettes, 74% reported It made them think ahout quitting, and 66% said It made them likely to try an e- cigarette in the future. 24 The 34% of participants who had used e- cigarettes were significantly more likely to think about smoking cigarettes after viewing the ad than nonusers (83% and 72%, respectively), suggesting that viewing an e- cloarette commercial may Induce thoughts about smoking and cue the urge to smoke. Prevalence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......... . . . . . . . . . . . . . ................................. . . . . . . . ....... . . . . . . . . . . . . . ........... Awareness of e- cigarettes and e- cigarette trial have at least doubled among both adults and adolescents in several countries from 2008 to 2012. In the United States, awareness is more prevalent among men, but trying e- cigarettes is more prevalent among women. Almost the same percent of European Union and US adult respondents to national surveys rennrted having tried e- cigarettes (7% in 2012 versus 6.2% in 2011, respectively).5 25 All population -based studies of adult use show the highest rate of e- cigarette use among current smokers, followed by former smokers, with little use amnnq nonsmokers, although e- cigarette trial and use rose In all of these categories. 4-6 Etter and Bullen26 followed up a sample of e- cigarette users recruited from Web sites dedicated to e- cigarettes and smoking cessation, most (72%) of whom were former smokers at baseline. At the 1 -year follow up, 6% of former smokers who were dally e- cigarette users at baseline relapsed to smoking cigarettes, and almost all (9290 of the farmer smokers using e- cigarettes daily at baseline were still using e- cigarettes dally at follow -up. Among 36 dual users at baseline, 16 (44%) had stopped smoking after 1 year. The epidemiological, population -based studies indicate that, across countries, e- cigarettes are most commonly being used concurrently with conventional tobacco cigarettes (dual use). Consistent with marketing messages, the most common reasons given for trying e- cigarettes are for use in places where <m-king Is restricted, to cut down on smoking, and for help with quitting smoking. 6.27-30 Choi and Forster 31 followed up a cohort of Midwestern young adults (mean age, 24.1 years) who had never used e- cigarettes from 2010 to 2011 and found that 21.6% of baseline current smokers, 11.9% of baseline former smokers, and 2.9% of baseline nonsmokers reported having ever used e- cigarettes at follow -up. Those who believed at baseline that e- cigarettes could help with quitting smoking and perceived e- cigarettes to be less harmful than cigarettes were more likely to report experimenting with e- cigarettes at follow -up (adjusted odds ratio [OR), 1.98; 95% confidence Interval [CII, 1.29 -3.04; and adjusted OR, 2.34; 95% Cl, 1.49 -3.69, respectively). 3 of 22 7/28/2014 4:57 PI E- Cigarettes http:// circ. ahajoLimals .orgleontent/129 /19/1972.ful Data on e- clgarette use among adolescents are more limited but, like for adults, show rapid Increases in awareness and use in 5 countries (United States, Poland, Latvia, Finland, and Korea), with higher rates of trial and current use in European countries than the United States or Korea. 9' 10' 32, 33 In Korea, youth ever use of e- cigarettes rose from 0.5% in 2008 to 9 4% in 2011,10 and In the United States, it rose from 3.3% in 2011 to 6.8% in 2012.9 As with adult population -based studies, data suggest that e- cigarette use is most appealing and prevalent among youth who are also experimenting with or are current users of tobacco cigarettes. Dual use with conventional cigarettes is the predominant pattern of e- cigarette use: 6194 In US middle school students and 80% among US high school students in 2011. These results indicate rapid market penetration of e- cigarettes among youth, with trial among US high school students (10.090 in 2012 even higher than the 2011 rate for adults (6.290.5 Despite a law prohibiting e- cigarette sales to minors, e- cigarette use among Utah youth (grades 8, 10, and 12) tripled between 2011 and 2013, with youth 3 times more likely to report current e- cigarette use than adults. 34 Although dual use with cigarettes is high, some youth experimenting with e- cigarettes have never tried a tobacco cigarette, which indicates that some youth are initiating use of nicotine, an addictive drug, with e- cigarettes. In 2012, 20.3% of middle school and 7.2% of high school ever e- cigarette users reported never smoking conventional cigarettes.9 Similarly, in 2011 in Korea, 15% of students in grades 7 through 12 who had ever used e- cigarettes had never smoked a cigarette. 10 The Utah Department of Health found that 32% of aver e- cigarette users reported that they had never smoked conventional cigarettes. E- Cigarette E -Fluid and Vapor ........................... ......... -..... Chemical Constituents The nicotine content of the cartridge e- liquid from <. me brands revealed poor concordance of labeled and actual nicotine content. 35-39 Simulated e- cigarette u =e revealed that individual puffs contained from 0 to 35 Vg nicotine per puff. 37 Assuming a high nicotine delivery of 30 pg per puff, it would take -30 puffs to deliver the 1 mg nicotine typically delivered by smoking a conventional cigarette. A puff of the e- cigarette with the highest nicotine content contained 20% of the nicotine contained In a puff of a conventional cigarette. 37 Actual nicotine delivery from an e- cigarette would likely be affected by users' smoking behavior. An analysis of UK brand e- clgarettes and the resulting aerosol demonstrated that, across brands, nicotine content of the e- liquid in the cartridges was not significantly correlated with the amount found in the resulting aerosol, indicating differences in the engineering characteristics of the de%ire that strongly influence nicotine delivery even with a consistent puffing protocol. 40 Goniewicz et al 41 analyzed the aerosol from 12 brands of e- cigarettes, a conventional cigarette, and a nicotine inhaler for toxic and carcinogenic compounds. The levels of toxicants in the aerosol were 1 to 2 orders of magnitude lower than In cigarette smoke but higher than with a nicotine inhaler (Table 1). Table 1. View this table: Levels of Toxicants in In this window Ina new window '.. E- Clgarette Aerosol Compared With Nicotine Inhaler and Cigarette Smoke Kim and Shin 42 analyzed the tobacco - specific nitrosamines NNN, NNK, and NAT and total tobacco- specific nitrosamines In 105 refill fluids from 11 companies in the Korean market and found nearly a 3- order -of- magnitude variation in tobacco- specific nitrosamine concentrations, with total tobacco - specific nitrosamine concentration ranging from 330 to 8600 pg /mL cytototdeity Bahl et a143 screened 41 e- cigarette refill fluids from 4 companies for cytotoxlcity using 3 cell types: human pulmonary fibroblasts, human embryonic stem cells, and mouse neural stem cells. Cytotoxicity varied among products from highly toxic to low or no cytotoxiclty. The authors determined that nicotine did not cause cytotoxicity, that some products were noncytotoxic to pulmonary fibroblasts but 4 of 22 7/28/2014 4:57 P: E- Cigarettes http: // circ. ahajoumals .orgtcontenV129 /19/1972.ful cytotoxic to both types of stem cells, and that cytotoxicity was related to the concentration and number of flavorings used. The finding that the stem cells are more sensitive than the differentiated adult pulmonary fibroblasts cells suggests that adult lungs are probably not the most sensitive system to assess the effects of exposure to e- cigarette aerosol. These findings also raise concerns about pregnant women who use e- cigarettes or are exposed to secondhand e- cigarette aerosol. In a study funded by the FlavarArt e- cigarette liquid manufacturers, Romagna et al 44 compared the cytotoxicity of aerosol produced from 21 nicotine- containing, flavored (12 tobacco Flavored and 9 fruit or candied flavored) brands of e- cigarette liquid with smoke from a conventional cigarette using embryonic mouse fibroblast cells. Only aerosol from coffee - flavared e- liquid produced a cytotoxic effect (average, 51% viability at 100% concentration of solution). Farsalinos et al 45 tested cytotoxicity in cultured rat cardiac myoblasts of exposure to aerosol generated from 20 refill solutions from 5 manufacturers containing 6 to 24 mg /mL nicotine In various flavors, a "base" -only solution (50% propylene glycol and 50% glycerol), and conventional cigarette smoke. The aerosol from 3 fluids was cytotoxic at 100% and 50% dilution: 2 were tobacco flavored and 1 was cinnamon cookie flavored. Cigarette smoke was cytotoxic at 100% and all dilutions except 6.25 %. Secondhand Exposure ....... ....... ............................... E- cigarettes do not burn or smolder the way conventional cigarettes do, so they do not emit side- stream smoke; however, bystanders are exposed to aerosol exhaled by the user. Schripp et al 46 conducted chamber studies In which subjects used 3 e- liquids (0 mg nicotine, apple flavor; 18 mg nicotine, apple flavor: 18 mg nicotine, tobacco flavor) and I tobacco cigarette and measured levels of several toxins and nicotine in the resulting aerosol. Three e- cigarette devices were used for these experiments: 2 that used a tank system that is directly filled with e- liquid and one that used a cartridge with a cotton fiber on which to drip the liquid. They found low levels of formaldehyde, acetaldehyde, isoprene, acetic acid, 2- butanodione, acetone, propanol, propylene glycol, and diacetin (from flavoring), traces of apple all (3- methylbutyl -3- methylbutanoate), and nicotine (with differing levels depending on the specific protocols) emitted Into the air. Toxins in the e- cigarette aerosol were at much lower levels compared with the conventional cigarette emissions. 46 in another chamber study, Flourls et al 47 compared emissions of conventional cigarettes and e- clgarettes in conditions designed to approximate a smoky bar (target air CO of 23 ppm) using machine- smoked e- cigarettes and cigarettes. E- cigarette aerosol (using a single brand of e- cigarette made in Greece and a single e- liquid with at least 60% propylene glycol, 11 mg /mL nicotine) was generated with a pump that operated for the same duration as the cigarette smoking, and aerosol was released into the rnom. (A person Inhaling a nicotine aerosol usually absorbs 80% of the nicotine, a8 whereas the pump discharges all nicotine Into the environment, so the nicotine exposure may be higher in this study than would be the case with actual secondhand aerosol exposure.) Serum cotinine In nonsmokers sitting In the chamber was similar for cigarette smoke and e- cigarette aerosol exposure (average, 0.8 ng /mLfor tobacco cigarette and 0.5 ng /mL for e- cigarette). Schober et al 39 measured Indoor pollution from 3 people using e- cigarettes over a 2 -hour period in a realistic environment modeled on a cafe. They found elevated nicotine, 1,2- propanediol, glycerin, aluminum, and 7 polycyclic aromatic hydrocarbons classified as probable carcinogens by the International Agency for Research on Cancer in the room air. Czogala et a149 conducted a chamber study of secondhand exposure to e- cigarette aerosol compared with cigarette smoke, finding that, on average, bystanders would be exposed to nicotine b,,t at levels 1110th that of cigarette smoke (e- cigarette aerosol, 3.32 ±2.49 pg /m3; cigarette smoke, 31.60 ±6.91 pg /m3; r= 0.008). Both e- cigarette aerosol and cigarette smoke contained fine particles (PM25), with e- cigarette aerosol particle concentrations ranging from 6.6 to 85.0 pg /m . E- cigarette aerosol was not a source of exposure to carbon monoxide, a key combustion element of conventional cigarette smoke. Particulate Matter ................................................................................................. ............................... E- cigarettes deliver nicotine by creating an aerosol of ultrafine particles. Fine 5 of 22 7/28/2014 4:57 Pi E- Cigarettes http: / /sirs. ahajoumals .org /contenV129 /19/1972.ful particles can be variable and chemically complex, and the specific components responsible for toxicity and the relative importance of particle size and particle composition are generally not known. 50 Given these uncertainties, it is not clear whether the ultrafine particles delivered by e- clgarettes have health effects and toxicity similar to the ambient fine particles generated by conventional cigarette smoke or secondhand smoke. There is strong evidence, however, that frequent low or short-term levels of exposure to fine and ultrafine particles from tobacco smoke or air pollution can contribute to pulmonary and systemic Inflammatory nrnresses and Increase the risk of cardiovascular and respiratory disease and death. 51-54 Fuoco et al 55 examined particle number concentration and distribution and performed a volatility analysis of the e- cigarette aerosol generated from 3 devices (2 rechargeable and I disposable) using 4 refill e- liquids with varying levels of nicotine and flavorants. They found that higher e- liquid nicotine content was associated with higher particle numbers in the resulting aerosol., with little effect on the particle size distribution. Longer puffing time resulted in more particles. Flavor was not associated with dlfferonrea in particle number or size distribution. Consistent with other studies, 46,56-58 the particle size distribution (range of modes, =120 -165 nm) was similar to that of conventional cigarettes, with some e- clgarettes delivering more particles than conventional cigarettes (Figure 3). ',. Figure 3. Particle number distribution t^ • from (A) mainstream aerosol in e- liquid 1 and from (B) - — - conventional cigarette. _ Reproduced from Fuoco et a155 with permission from the }^ publishes Copyright ®2013 "- Elsevier Ltd. View larger version: In this page Ina new window '.. Download as PowerPoint Slide !. Zhang et a157 examined the size of e- cigarette aerosol particles and likely deposition in the human body (using a single brand, BloogMaxXFusion) with both propylene glycol and vegetable glycerin -based liquids. Using particle size and lung ventilation rates (1 for a "reference worker' and 1 for a "heavy worker ": 1.2 and 1.688 m3 /h, respectively), their human deposition model estimated that 73% to 80% of particles would be distributed into the exhaled aerosol, whereas 9% to 18% of particles would be deposited in alveoli resulting in arterial delivery, and 9% to 17% would be deposited in the head and airways, resulting in venous delivery. As expected, the heavy worker model showed more alveolar delivery across puffs compared with the reference worker, who would have more head and airway delivery. In total, .20% to 27% of particles are estimated to be deposited In the circulatory system and Into organs from e- cigarette aerosol, which Is comparable to the 25% to 35 %for conventional cigarette smoke. In their study of passive exposure to exhaled e- cigarette aerosol in a simulated cafe. Schober et al 39 found that concentrations of fine particles in the air increased from a median of 400 particles per 1 cm with people simply sitting in the room for 2 hours to medians of 49 000 to 88 000 particles per 1 cm (depending on the e- cigarette fluid used) after 2 hours of e- cigarette use In the same room Both the e- liquid and the Poly -fll fibers that are used to absorb the e- liquid for heating and conversion to an aerosol come into contact with heating elements that contain heavy metals (tin, nickel, copper, lead, chromium). Williams et al 58 found heavy metals in samples of e- cigarette liquids and aerosol. Tin, which appeared to originate from solder joints, was found as both particles and tin whiskers in the fluid and Poly -fil, and e- cigarette fluid containing tin was cytotoxic to human pulmonary fibroblasts. E- cigarette aerosol also contained other metals, including nickel, 2 to 100 times higher than found in Marlboro cigarette smoke. The nickel and chromium nanoparticles (<100 nm) possibly originated from the heating element. It is likely that engineering features, including the nature of the battery, the heating temperature of the liquid, and the type of heating element and 6 of 22 7/28/2014 4:57 Pl E- Cigarettes http:// circ. ahajoumals .org /content/129 /19/1972.ful reservoir, will Influence the nature, number, and size of particles produced. These metal nanoparticles can deposit into alveolar sacs in the lungs, potentially causing local respiratory toxicity and entering the bloodstream. In summary, the particle size distribution and number of particles delivered by e- cigarettes are similar to those of conventional cigarettes, with most particles In the ultraflne range (modes, =100 -200 nm). Particle delivery appears to depend on the nicotine level in the e- cigarette fluid but not the presence of flavors. Smokers exhale some of these particles, which exposes bystanders to "passive vaping " Like cigarettes, e- cigarette particles are small enough to reach deep Into the lungs and cross Into the systemic circulation. At a minimum, these studies show that e- cigarette aerosol Is not merely "water vapor" as is often claimed in the marketing for these products. Tests on e- cigarettes show much lower levels of most toxicants, but not particles, than conventional cigarettes. The thresholds for human toxicity of potential toxicants in e- cigarette vapor are not known, and the possibility of health risks to primary users of the products and those exposed passively to their emissions must be considered. Nicotine Absorption - ....................I....... _ ......................................... ............................... ...... Early studies of nicotine absorption in 2010 found that e- cigarettes delivered much lower levels of plasma nicotine than conventional cigarettes, 59,60 whereas a more recent study demonstrated that more experienced users using their own product who engaged in more puff Intervals have nicotine absorption similar to that with conventional cigarettes, 61-63 perhaps as a re�ill[ of a combination of characteristics of the devices and user vaping topography. 63 Another study of smokers smoking e- cigarettes using a specified protocol found a �im)lar rise in serum cotinine immediately after use (mean increase, =20 ng /mL) 47 Several studies reported that regardless of nicotine delivery, e- cigarettes can modestly alleviate some symntoms of withdrawal, and participants positively appraised the use of e- cigarettes.62 -65 In a study comparing the nicotine inhalator and e- cigarettes, 60 the nicotine inhalator delivered an amount of nicotine similar to that in the 16 -mg e- cigarette; however, the authors noted that the e- cigarette malfunctioned and did not deliver any nicotine In a third of participants. These results highlight the need for product regulation In terms of drug delivery and effects, as well as device functioning and labeling. Health Effects ................................................................................................. ............................... Propylene glycol and glycerin are the main base ingredients of the e- liquid. Exposure to propylene glycol can cause eye and respiratory Irritation, and prolonged or repeated inhalation in Indu, trial settings may affect the central nervous system, behavior, and the spleen. 66 In Its product safety materials, Dow Chemical Company states that "Inhalation exposure to [propylene glycol] mists should be avoided," 67 and the American Chemistry Council warns against irs use in theater fogs because of the potential for eye and respiratory irritation. 8 When heated and vaporized, propylene glycol can form propylene oxide, an International Agency for Research on Cancer class 2B carcinooen 69 and glycerol forms acroleln, which can cause upper respiratory tract irritation. 70.71 Major injuries and illness have resulted from e- cigarette use, 72 including explosions and fires. 73,74 Less serious adverse events Include throat and mouth Irritation, cough, nausea, and vomiting. A study 75 of healthy smokers' pulmonary function after acute ad lib puffing of an e- cigarette ( Nobacco, medium, 11 mg) for 5 minutes (after refraining from smoking tobacco cigarettes for 4 hours) found no effect on spirometry but did find significantly increased dynamic almay resistance (18 %) and decreased expired nitric oxide (16%). Sham e- cigarette use had no significant effect. This study is limited by the small sample size, the short period of tobacco use abstinence before protocol execution, the short length of exposure to e- cigarette aerosol, and the lack of comparison with smoking conventional cigarettes. In addition, smokers in general have high airway resistance with dynamic testing and lower expired nitric oxide, likely as a result of oxidant stress. Despite these limitations, this study suggests that e- cigarette use constricts peripheral airways, possibly as a result of the irritant effects of propylene glycol, which could be of particular concern in people with chronic lung disease such as asthma, emphysema, or chronic bronchitis. Flouris at al 47 assessed the short-term effects of e- cigarette use on pulmonary function in 15 cigarette smokers who puffed an e- cigarette (>60% propylene glycol, 7 of 22 7/28/2014 4:57 P1 E- Cigarettes http: // circ. ahajoumals .org /content/129 /19/1972.ful 11 mg /mL nicotine) and a conventional cigarette according to a specified protocol, and passive exposure to e- cigarette aerosol and conventional cigarette smoke with 15 never smokers. Active cigarette smoking resulted in a significant decrease In expired lung volume (forced expiratory volume In the first second of expiration (forced inspiratory vital capacity) that was not seen with active e- cigarette use or with passive tobacco cigarette or e- cigarette exposure. Additional analysis of the data collected in this study 76 found that white cell count Increased after cigarette smoking, reflecting inflammatory process - associated risk for acute cardiovascular events. Active e- cigarette use and passive exposure to e- cigarette vapor did not result in a significant increase In these biomarkers over 1 hour of exposure. Schober at al 39 found elevated levels of exhaled nitric oxide in people using a nicotine e- cigarette (but not a nicotine -free e- cigarette), which the authors attributed to pulmonary Inflammation. National Vaper's Club, a pro -e- cigarette advocacy group, published a "risk assessment" of e- clgarette and cigarette use that concluded that "neither vapor from e- liquids or cigarette smoke analytes posed a condition of 'significant risk' of harm to human health via the Inhalation route of exposure." 77 The authors failed to detect benzo(a)pyrene in conventional cigarette smoke despite the fact that it is an established carcinogen in cigarette smoke, and their assessment of conventional cigarettes concluded that they did not pose significant risk, both �f which point to fatal errors in the data, data analysis, or both. Another reportlS funded by the Consumer Advocates for Smoke -free Alternatives Association and published on the Internet used occupational threshold limit values to evaluate the potential risk posed by several toxins In e- cigarettes, concluding that "there is no evidence that vaping produces inhalable exposures to contaminants of the aerosol that would warrant health concerns by the standards that are used to ensure safety of workplaces." Threshold limit values are an approach to assessing health effects for occupational chemical exposures that are generally much higher (often orders of magnitude higher) than levels considered acceptable for ambient or population -level exposures. Occupational exposures also do not consider exposure to sensitive subgroups such as people with medical conditions, children, and infants who might be exposed to secondhand e- cigarette emissions, mast notably nicotine. In summary, only a few studies have directly investigated the health effects of exposure to e- cigarette aerosol, but some demonstrate the ability of e- cigarette aerosol exposure to result in biological effects. Long -term biological effects are unknown at this time because e- cigarettes have not been In widespread use long enough for assessment Effects on Cessation of Conventional Cigarettes ............. ........... ................ .... ......... ................ .................... ........... ............ I ............ ... E- cigarettes are promoted as smoking cessation aids, and many individuals who use e- cigarettp. believe that they will help them quit smoking conventional cigarettes. 7.29,30 The assumption that e- cigarettes will be as effective as or more effective than pharmaceutical NRTS has also motivated support for e- cigarettes among some public health researchers and policy makers 78 and (as discussed later) formed the basis for some public policies on the regulation of e- cigarettes Population -Based Studies There are 4 longitudinal studies 4.79-81 and 1 cross - sectional study 82 of the association between e- cigarette use and quitting conventional cigarettes (Table 2). Table 2. — Population Studies of the view this table: Association Between j In this window in a new windew E- Cigarette Use and Cessation of Conventional Cigarette Smoking Adkison at al studied current and former smokers in the In terns tto na/ ro6acco cpnrror study in the United States, Canada, the United Kingdom, and Australia at baseline and 1 year later and found that e- cigarette users had a statistically significant greater reduction in cigarettes per day (e- cigarette users, 20.1 to 16.3 cigarettes per day; nonusers, 16.9 to 15.0 cigarettes per day). Although 85% of 8 of 22 7/28/2014 4:57 Pl E- Cigarettes http:// cire. ahajoumals .org/content1129 /19/1972.ful e- cigarette users reported they were using the product to quit smoking at the initial wave, e- cigarette users were no more likely to have quit 1 year later than nonusers (OR, 0.81; 95% Cl, 0.43 -1.53; a= 0.52). Vickerman et al 80 found that =31% of quit -line callers surveyed 7 months after enrollment reported that they had ever tried e- cigarettes. The majority used them for <1 month (67.1%1, and 9.2% were using them at the 7 -month survey. The main reason for e- cigarette use was tobacco cessation (51.390, but it is not known whether ever use occurred as part of a quit attempt in the preceding 7 months. Although quit -line callers represent a small population of smokers motivated to quit, these data present a real -world estimate of the potential effectiveness of using e- cigarettes for cessation in a population of smokers motivated to quit. Although this study had a low response rate (34.6%) and may be subject to recall bias because e- cigarette use and perceptions were assessed only at the 7 -month follow -up, those who reported using e- cigarettes were statistically significantly less likely to quit than those who had not used e- cigarettes (21.7% among callers who used for it month, 16.6% among those who used for <1 month, and 31.4% among never users; a<0.001). The unadjusted adds of quitting were statistically significantly lower for e- cigarette users compared with nonusers (OR, 0.50; 95% Cl. 0.40 - 0.63). Grana et al 79 explored predictors of quitting among a national sample of smokers who participated in a study in 2011 and follow -up in 2012. Current e- clgarette use (past 30 days) at baseline did not predict a greater likelihood of having quit at the follow -up (OR, 0.71; 9S% Cl, 0.35- 1.46). In a second logistic regression model that Included baseline cigarettes per day, time to first cigarette, and intention to quit, in addition to baseline current e- cigarette use, only Intention to quit (OR, 5.59; 95% Cl, 2.41 - 12.98) and cigarettes per day (OR, 0.97; 95% Cl. 0.94 -0.99) were significant predictors of having quit at follow -up; current e- cigarette use remained nonsignificant (OR, 0.76; 95% Cl, 0.36 - 1.60). Choi and Forster 81 followed up a cohort of young adults in Midwestern (recruited October 2010 -March 2011 and followed up for 1 year). Among those who were smoking cigarettes at baseline, 11% of those who used e- cigarettes at least 1 day in the past 30 days at baseline quit smoking at follow -up compared with 17% of smokers who never used e- cigarettes. In a logistic regression controlling for demographics and baseline cigarettes per day, baseline past 30 -day e- cigarette use was not a significant predictor of having quit at follow -up (OR, 0.93; 95% CI, 0.19 -4.63; r= 0.93). There was also no significant change In the number of conventional cigarettes smoked per day between those who did and did not use e- cigarettes (difference, 0.2 cigarettes per day; 95% Cl. -3.72 to 4.18; a= 0.91). In a national cross - sectional sample, Popova and LIng62 found that adult smokers who ever used e- cigarettes were significantly less likely to be former smokers compared to those who never used e- cigarettes (OR, 0.69; 95% Cl. 0.52 - 0.94), controlling for demographics (Lucy Popova, personal communication). In an examination of only those who tried to quit, those who ever used e- cigarettes were significantly less likely to be former smokers than never users (adjusted OR, 0.61; 95% Cl, 0.45 - 0.83). Combining these results in a random - effects meta - analysis (Table 2) yields a pooled OR of 0.61 (95% Cl, 0.50 - 0.75), indicating that e- cigarette use In the real world is associated with significanriv Inwer odds of quitting smoking cigarettes. A limitation of 3 of these studies 4,80,87 Is that they did not control for level of nicotine dependence. It is possible that more dependent smokers, who would have more difficulty quitting in general, would be the ones who would be more likely to experiment with e- cigarettes, which could contribute to the finding that e- cigarette use is associated with a lower quit rate. Clinical Trials Four clinical trials (2 with vory small sampled examined the efficacy of e- cigarettes for smoking cessation. 83-86 Three trials 83-85 did not have a control group who were not using e- cigarettes. The other study 86 compared e- cigarette efficacy to a standard -of -care regimen with a 21 -mg nicotine patch. None of the trials were conducted with the level of behavioral support that accompanies most pharmaceutical trials for smoking cessation. Polosa et a183 conducted a proof -of- concept study in Italy in 2010 with smokersl8 to 60 years of age not intending to quit in the next 30 days. Subjects were offered 9 of 22 7/28/2014 4:57 PI E- Cigarettes http: // tiro. ahajoumals .org /contentl129 /19/1972.ful Categorla e- cigarettes and Instructed to use up to 4 cartridges (7.4 -mg nicotine content) per day as desired to reduce smoking and to keep a log of cigarettes per day, cartridges per day, and adverse events. Six -month follow -up was completed with 68% of participants (27 of 40): 13 were using both e- cigarettes and tobacco cigarettes, 5 maintained exclusive tobacco cigarette smoking, and 9 stopped using tobacco cigarettes while continuing to use e- cigarettes. Cigarette consumption was reduced by at least 50% in the 13 dual users (25 cigarettes per day at baseline to 6 cigarettes per day at 6 months; P<0.001). Polosa et al 87 continued follow -up of this sample at 18 and 24 months with 23 subjects (58% of the original 40 enrolled). Among the 23 participants who completed a 24 -month visit, 18 continued to smoke, and 11 had reduced cigarette consumption by aS0% with a statistically significant reduction from an average of 24 to 4 cigarettes per day (P= 0.003). Five participants had quit tobacco cigarettes at 24 months. Study limitations included the use of a poor - quality product and the lack of a comparison or control group, which could make It difficult to determine Whether quit rates achieved were not due to chance. Capannetto et al 85 conducted a similar study with 14 smokers with schizophrenia not intending to quit in the next 30 days. Participants were provided the same Categoria e- cigarette, and carbon monoxide, product use, number of cigarettes smoked, and positive and negative symptoms of schizophrenia were assessed at baseline and 4, 8, 12, 24, and 52 weeks. Seven of 14 participants (50Y) sustained a 50% reduction in the number of cigarettes per day smoked at week 52, and the median of 30 cigarettes per day decreased to 15 cigarettes per day (P= 0.018). Sustained abstinence from smoking occurred with 2 participants (14.3%) by week 52. Positive and negative aspects of schizophrenia were not increased after smoking cessation. The most common outcome was dual use of e- cigarettes with conventional cigarettes. Study findings are not generalizable to smokers with mental illness because of the very small sample size and lack of a control group. Caponnetto et al B4 also conducted a randomized, quasi - controlled trial to examine the efficacy of e- cigarettes of different strengths for smoking cessation and reduction in 3 study arms: 12 weeks of treatment with the 7.2 -mg nicotine e- cigarette, a 12 -week nicotine- tapering regimen (6 weeks of treatment with a 7.2 -mg e- cigarette and 6 weeks with a 5.4 -mg e- cigarette), and a 12 -week treatment with a nonnicotine e- cigarette. Similar reductions in the median cigarettes per day were seen at all study visits for all 3 treatment arms (7 -10 cigarettes per day at 1 year). There was no statistically significant difference in 6 -month or 1 -year quit rate among the 3 conditions (1 -year rates: 4% for placebo e- cigarette users, 9% for law - nicotine e- cigarette users, and 13% for high- nicotine e- cigarette users). The authors noted that those who Initiated quitting in the first few weeks of the study stayed quitters, whereas those who did not remained dual users throughout the study. Twenty-six percent of quitters continued to use e- cigarettes at 1 year. Problems with the study include the lack of a control group not using e- cigarettes and noted lack of product quality (the devices malfunctioned often, and new ones had to be sent frequently). An author on all of these studies, R. Polosa, served as a consultant for the Arbl Group SRL, the manufacturer of the Categoria e- cigarette used in the study, beginning in February 2011. Rullen et a1S6 conducted a randomized, controlled, clinical trial of e- cigarettes compared with medicinal NRT in Auckland, New Zealand. Adult smokers motivated to quit were randomized to the 3 study arms (16 -mg e- cigarette, 21 -mg NRT patch, no- nicotine e- cigarette). Voluntary telephone counseling was offered to all subjects. Subjects were observed at baseline, 1 week (quit day), 12 weeks, and 6 months. Fifty-seven percent of participants in the nicotine e- cigarettes group reduced their cigarettes per day by ?50% at 6 months compared with 41% in the patch group (P= 0.002) and 45% In the nonnicotine e- cigarette group (P= 0.08). Those randomized to the nicotine patch group were less adherent to the treatment (46%) than the 16 -mg e- cigarette group (78901 and the no- nicotine e- cigarette group (82 %). Of note, the study methodology may have introduced bias against success in the nicotine patch group because e- cigarettes were mailed for free directly to participants randomized to either the nicotine or no- nicotine e- cigarette group, whereas participants in the patch group were mailed cards redeemable for nicotine patches at a pharmacy and vouchers to cover the modest fee. Therefore, although the protocol for providing the patches represented "usual care' for New Zealand quit -line callers, this procedure may have introduced bias against NRT, making it difficult to view the study as a head -to -head comparison of e- cigarettes and NRT for cessation. There were no statistically significant differences In biochemically confirmed (breath CO) self- reported continuous abstinence from quit 10 of 22 7128/2014 4:57 PI E- Cigarettes http://circ.ahajoumals.org/content/129/19/1972.ftil day to the 6 -month follow -up between the nicotine e- cigarette (7.3%), nicotine patch (S.8%), and nonnlcotine e- cigarette (4.190. Neither Capponnetto at a184 nor Bullen et al 86 found effects of e- cigarette use on quitting beyond what is seen in unassisted or low- assistance studies of smokers using NRT to quit 8s In determining the effectiveness of smoking cessation therapy, active drug Is considered efficacious when It outperforms placebo; therefore, the evidence to date from clinical trials does not demonstrate that e- cigarettes are efficacious for cessation. However, It is possible that e- cigarettes even without nicotine act as substitutes for the sensory and behavioral effects of conventional cigarettes. If this is the case, the nonnicotine placebo e- cigarette would be considered an active treatment condition and ac discussed previously, has been shown to reduce withdrawal symptoms. 59,60,63,89 Important limitations of the current research Include the use of e- cigarettes that deliver relatively low levels of nicotine and the provision of minimal behavioral counseling. Another important limitation of studies assessing the effectiveness of e- cigarettes for smoking cessation is that, because they are not approved as cessation therapy, there are no therapeutic instructions for using them as replacements or to quit smoking (eg, dosage tapering, duration of use, how to combine them with behavioral strategies, guidance for discontinuation). In contrast to the assumption that e- cigarettes would function as a better form of NRT, population -based studies that reflect real -world e- cigarpttp „sp found that e- cigarette use Is not associated with successful quitting; all 4,79,80,82 had point estimates of the odds of quitting of <1.0. The 1 clinical trial examining the effectiveness of e- cigarettes (both with and without nicotine) compared with the medicinal nicotine patch found that e- cigarettes are no better than the nicotine patch and that all treatments produced very modest quit rates without counseling. S6 Taken together, these studies suggest that e- cigarettes are not associated with successful quitting in general population -based samples of smokers. Health Implications of Cigarette Reduction in the Context of Dual Use Among adults, rad,lnlons In cigarettes per day were nbserved in several of the clinical studies 83,64,86 and In 1 population -based study among those who did not quit. Reduction In cigarettes smoked per day could have benefit if it promotes subsequent cessation, as has been found with NRT, 90 but this pattern has not yet been seen with e- cigarettes. In the cigarette reduction analyses presented in some of the studies, many participants were still smoking about half a pack cigarettes per day at the end of the study. Both duration (years of cigarette use) and intensity (cigarettes per day) determine the negative health effects of smoking. 91 People who stop smoking at younger ages have lower age - adjusted mortality compared with those who continued to smoke later into adulthood. 92 Findings for decreased smoking intensity have been less consistent, with snme studies showing lower mortality with reduced dally cigarette consumption 93 and others not finding a significant overall survival benefit. 94 The 2014 report of the US Surgeon General concluded that "reducing the number of cigarettes smoked per day is much less effective than quitting entirely for avoiriing the risks of premature death from all smoking - related causes of death." 95 Use of electronic cigarettes by cigarette smokers to cut down on the number of cigarettes smoked per day is likely to have much smaller beneficial effects on overall survival compared with quitting smoking completely. This situation Is particularly likely to exist for cardiovascular disease because of the highly nonlinear dose - response relatinnship between exposure to fine particles and the risk of cardiovascular disease. 53.96 Light smoking, even 1 to 4 cigarettes per day, is associated with markedly elevated risk of cardiovascular disease. 97 In addition, e- cigarettes deliver loads of fine particles similar to those of conventional cigarettes. The relative risk nf death from lung cancer Increases with years smoked and cigarettes per day, 98 as well as pancreatic cancer 99 and esophageal cancer. 100 The relative risk of both lung canrpr and bladder cancer levels off after a certain number of cigarettes per day, 101 suggesting that above a certain intensity, the specific levels of exposure may not cause significant differences in risk for these cancers. Doll and Peto 102 found a dose - response relationship between duration of smoking and number of cigarettes smoked per day and risk of lung cancer, with 11 of 22 7/28/2014 4:57 PT E- Cigarettes http:// circ. ahajournals .org/content/129 /19/1972.ful models suggesting the impact of duration to be greater than that of Intensity. Using participants from the Cancer Prevention Study 11, Flanders at a1103 found a greater Increase in lung cancer mortality with a greater duration of cigarette smoking compared with a greater intensity of smoking. Overall, these data suggest that lung cancer mortality Increases more with additional years of smoking than additional cigarettes per day. Thus, If dual use of e- cigarettes and cigarettes results In reductions in the number of cigarettes per day for current smokers, any reduction malignancy risk will be less than proportional to the reduction in cigarette consumption because of the (likely larger) Importance of duration of smoking. What to Tell Patients About E CSgarettes and Cessation .................... -.... ....... ....... First and foremost, clinicians must support a smoker's quit attempt and try to ensure any that advice given does not undermine their motivation to quit. Clinicians should follow the 5 A's of evidence -based treatment: ask, advise, assess, assist, and arrange. 104 They should assess their patient's motivation and readiness to quit and recommend a treatment plan that should include setting a quit date and obtaining cessation counseling and, If appropriate, conventional smoking cessation medications. The safest and most proven smoking cessation pharmacotherapies are the nicotine replacement medications varenicline and bupropion, which have been approved by the US Food and Drug Administration (FDA). Referral to a free telephone quit line leg, 1- 800 -QUIT -NOW) or another counseling support program enhances the effectiveness of smoking cessation medications. If a patient has failed initial treatment, has been intolerant of or refuses to use conventional smoking cessation medication, and Wishes to use e- cigarettes to aid quitting, it is reasonable to support the attempt. However, subjects should be informed that, although e- cigarette aerosol Is likely to be much less toxic than cigarette smoking, the products are unregulated, contain toxic chemicals, and have not been proven as cessation devices. The patient should also be advised not to use the product indoors or around children because studies show that bystanders may be exposed to nicotine and other toxins (at levels much lower than cigarettes) through passive exposure to the e- cigarette aerosol. Because there are no long -term safety studies of e- cigarette use, patients should be urged to set a quit date for their e- cigarette use and not plan to use It Indefinitely. It Is also important to stress that patients should quit smoking cigarettes entirely as soon as possible because continued cigarette smoking, even at reduced levels, continues to impose tobacco - induced health risks (particularly for cardiovascular disease). Tobacco Industry and Involvement .................. ...... ...... .... ...... ..... ..... ..... ............. ......... ................................. - ............ .... By 2013, the major tobacco companies had purchased or developed e- cigarette products (Table 3). Table 3. view this rabic Tobacco Companies That Have Inthiswindow Inanewwindow Acquired or Created E- Cigarette !, Companies and Brands (as of January 2014) There is no evidence that the cigarette companies are acquiring or producing e- cigarettes as part of a strategy to phase out regular cigarettes, even though some claim to want to participate in "harm reduction.' Lorillard CEO Murray Kessler stated in an interview with the Wali srr..Uownel that e- cigarettes will provide smokers an unprecedented chance to reduce their risk from cigarettes. 105 He also published an op -ed in u54 Today on September 23, 2013, stating: 'E- cigarettes might be rho most significant harm - reduction option ever made available to smokers." 106 Shortly before this op -ed was published, however, Lorillard won approval from the US FDA to market new nonmentholated Newport conventional cigarettes, expanding their cigarette line while touting their ability to offer a product they claim reduces harm from cigarettes. This allows the cigarette companies to have it both ways. (Likewise, after evaluating the cigarette companies' Internal documents and public positions on sous [a form of moist snuff tobarro In a pouch popular In Sweden) as "harm reduction" in Europe, Gilmore et al 107 found that they were entering the snus market 107 and adopting "harm reduction" rhetoric 109 to protect their cigarette business as long as possible.) As noted in the 2010 Surgeon 12 of 22 7/28/2014 4:57 P1 E- Cigarettes http: / /circ. ahajouma ls.org /contentl129 /19/1972.ful General's report,'vv the tobacco industry has used every iteration of cigarette design to undermine cessation and prevention. - The tobacco companies address e- rinarette issues as part of their policy agenda. As they did beginning in the 1980s,110.111 they continue to engage In creating and supporting "smokers' rights" groups, seemingly Independent groups that interan with consumers directly on political involvement In support of their agenda. ]it Altria and R,4 Reynolds Tobacco Company maintain Web sites called Citizens for Tobacco Rights and Transform Tobacco. E- cigarette news and action alerts are featured on the home pages of these websites and Include instructions for taking action against bills designed to Include e- cigarette use in smoke -free laws. E- cigarette companies engage in similar tactics, using the same political and public relations strategies as the tobacco companies (most notably featuring organtzed "vapers" like the organized smokers). They also use social media that is tigh *Iv Integrated with their product marketing campaigns to press their policy agenda. 22 These strategies were successfully deployed in Europe to convince the European Parliament to CL,hstantially weaken the proposed EU Tobacco Product Directive in October 2013.112 Current State of Global Regulation (Mar oi (March s4) ....................................................... ............................... _.......................... _.. _.. Like e- cigarette products, the policy environment related to e- cigarettes is rapidly developing despite the fact that the science is Just emerging. Policy makers in many countries are under considerable pressure to provide regulatory guidance regarding e- clgarettes, often on the basis of the assumption that e- cigarettes will contribute to reducing the harms of smoking either by serving as a smoking cessation aid or by replacing combusted cigarettes. The data reviewed here, together with evidence of dual use and youth Initiation of e- cigarette use, do not demonstrate any hypothesized harm - reducing effectL Some countries (including Brazil, Singapore, Canada, the Seychelles, and Uruguay) have prohibited the sale of e- cigarettes, and many others are developing pol Ides. 1 The United States, European Union, and United Kingdom illustrate the range of regulatory approaches being developed. The United States In the United States, as of March 2014, e- clgarette products remained unregulated by any federal authority, particularly the US FDA. The Sottera Inc case ruling that was upheld on appeal In the US court found that e- cigarettes could be regulated a< tobacco products unless they are marketed with health and therapeutic claims. 113 The US FDA has stated Its Intent to assert Cdeem ") authority over e- cigarettes but has yet to act. The US FDA does not have the authority to regulate where e- cigarettes are used; that is the domain of state and local governments, where almost all activity on smoke -free laws has occurred. Since e- cigarettes entered the US market in 2008, there has been a rapid increase in the number of municipalities and states that have adopted legislation regulating where e- cigarettes can be used and laws restricting sales to minors. As of March 2014, 27 states had laws restricting sales to minors, 1 state (Minnesota) taxed e- cigarettes as tobacco products, and 3 states (New Jersey, North Dakota, and Utah) and >100 municipalities (including New York, Los Angeles, San Francisco, and Chicago) nrohibited the use of e- cigarettes in 100% smoke -free Indoor environments. 114 An additional 9 states restricted e- cigarettes In other venues such as school district property, Department of Corrections / prisons, public educational facilities and grounds, and commuter transit systems. 114 Some local and statewide smoke -free laws enacted before the Introduction of e- cigarettes Include language that could be Interpreted as including e- cigarettes. Eturopmr, Union Tobacco Product Directive In February 2014, the European Parliament approved a revised European Union Tobacco Product Directive that regulates e- cigarettes with nicotine concentrations up to 20 mg /mL (an amount equal to that in a pack of cigarettes) as tobacco products. IS E- cigarettes with higher nicotine concentrations or intended therapeutic uses will be regulated as medical devices. 116 The directive stipulates that e- cigarettes must be childproof and that packaginn must Include Information about Ingredients, adverse effects, and health warnings. its Refillable cartridges are allowed as long as their volume does not exceed 2 mL (but could be banned by the European Commission If at least 3 member states prohibit them on the basis of 13 of 22 7128/2014 4:57 PI E- Cigarettes http://circ.ahajoumals.org/content/129/19/1972.fW risks to human healthl "' Marketing and advertising restrictions will mirror those of tobacco products. n 5 The United riingdotn In the United Kingdom, the Medicines and Healthcare Products Regulatory Agency announced a plan to regulate e- cigarettes as medicines on the basis of the assumptinn that e- cigarettes function like NRTs for smokers wishing to cut down or quit. 79 As of January 2014, Medicines and Healthcare Products Ren,uatory Agency policies did not Include any restrictions on e- cigarette marketing. 117 The antismoking advocacy group Action on Smoking and Health UK has announced that it "does not ronsider it appropriate to Include e- cigarettes under smokefree regulations," 318 supporting one of the e- cigarette companies' key marketing messages that e- clgarettec ran be used everywhere without the restrictions and social stigma of smoking. 3,119 Policy Recommendations ........ ..—... .............. .................... -- ... .................. ...... ....... ...................... ................. .,. E- cigarettes deliver lower levels of some of the toxins found in cigarette smoke. Main concerns about the potential of e- cigarettes to make a contribution to reducing the harm caused by cigarette smoking arise from effects on youth, dual use with cigarettes resulting in delayed or deferred quitting (among both adults and youth), and renormalization of smoking behavior. The ultimate effect of e- cigarettes on public health will depend on what happens In the polity environment. These policies should be implemented to protect public health: Prohibit the use of e- cigarettes anywhere that use of conventional cigarettes Is prohibited. Prohibit the sale of e- cigarettes to anyone who cannot legally buy cigarettes or In any venues where sale of conventional cigarettes is prohibited. Subject e- cigarette marketing to the same level of restrictions that apply to conventional cigarettes (including no television or radio advertising). Prohibit cobranding e- cigarettes with cigarettes or marketing In a way that promotes dual use. Prohlbit the use of characterizing flavors in e- cigarettes, particularly candy and alcohol flavors. Prohibit claims that e- cigarettes are effective smoking cessation aids until e- cigarette manufacturers and companies provide sufficient evidence that e- cigarettes can be used effectively for smoking cessation. Prohibit any health claims for e- cigarette products until and unless approved by regulatory agencies to scientific and regulatory standards. Establish standards for regulating product ingredients and functioning. In addition to being important in their own right, should these pollcles be put in place together with polices designed to make combustible tobacco products (eg, cigarettes, cigars, cigarillos) less desirable and available, it is possible that current conventional cigarette smokers who will not quit nicotine would shift to e- cigarettes without major dual use or youth initiation to nicotine addiction with e- cigarettes. Absent this change In the policy environment, it is reasonable to assume that the behavior patterns that have been observed for e- cigarettes will persist, which makes it unlikely that they will contribute to reducing the harm of tobacco use and could increase harm by perpetuating the life of conventional cigarettes. Conclusions ........... ...................................................................................... ............................... Although most of the discussion of e- cigarettes among health authorities has concentrated on the product Itself, its potential toxicity, and use of e- cigarettes to help people quit smoking, the e- cigarette companies have been rapidly expanding using aggressive marketing messages similar to those used to promote cigarettes In the 1950s and 1960s. E- cigarette advertising is on television and radio in many countries that have long banned similar advertising for cigarettes and other 14 of 22 7/28/2014 4:57 P] E- Cigarettes http: // circ. ahajoumals .org /content/129 /19/1972.ful tobacco products and may be Indirectly promoting smoking conventional cigarettes. Although It Is reasonable to assume that, if existing smokers switched completely from conventional cigarettes (with no other changes in use patterns) to e- cigarettes, there would be a lower disease burden caused by nicotine addiction, the evidence available at this time, although limited, points to high levels of dual use of e- cigarettes with conventional cigarettes, no proven cessation benefits, and rapidly Increasing youth initiation with e- cigarettes. Although some cite a desire to quit smoking by using the e- cigarette, other common reasons for using the products are to circumvent smoke -free laws and to cut down on conventional cigarettes, which may reinforce dual use patterns and delay or deter quitting. The trajectory of the dual use pattern among adults or children is unclear, but studies of youth find that as many as one third of youth who use e- cigarettes have never smoked a conventional cigarette. Nicotine is a highly addictive substance with negative effects on animal and human brain development, which is still ongoing in adolescence. 120 -723 Furthermore, high rates of dual use may result in greater total public health burden and possibly Increased individual risk if a smoker maintains an even low -level tobacco cigarette addiction for many years instead of quitting. Although data are limited, it is clear that e- cigarette emissions are not merely "harmless water vapor," as is frequently claimed, and can be a source of Indoor air pollution. Smoke -free policies nrotect nonsmokers from exposure to toxins and encourage smoking cessation. 124 One hundred percent smnke -free policies have larger effects on consumption and smoking prevalence, 125 as well as hospital admissions for myocardial infarction, stroke, and other cardiovascular and pulmonary emergencies, 126 than weaker policies. Introducing e- cigarettes Into clean air environments may result in population harm if use of the product reinforces the act of smoking as socially acceptable or if use undermines the benefits of smoke -free policies. Aclmowledgments ................................................................................................. ............................... We thank the following Individuals for their advice and feedback: Cott Anastasio, PhD; John Balmes, MD; Cynthia Hallett, MPH; Sara Kalkhoran, MD; Lauren Lempert, JD, MPH; C. Arden Pope III, PhD; Martina Pdtschke- Langer, MD, MA; Prudence Talbot, PhD; Michael Thun, MD; Gemma Vestal, JD, MPH, MBA; and the reviewers solicited by the World Health Organization Tobacco Free Initiative of the longer report prepared for it. Sources of Funding ............................................................................................... ............................... This article is a greatly condensed version of a report prepared for (and supported by) the World Health Organization Tobacco Free Initiative. Additional support came from the University of California Tobacco Related Disease Research Program 21 FT -0040 and grant 1 P50CAl 80890 from the National Cancer Institute and Food and Drug Administration Center for Tobacco Products. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, the US FDA, or the World Health Organization. Dr Glantz Is an American Legacy Foundation Distinguished Professor in Tobacco Control. Disclosures ................................................................................................. ............................... Or Benowitz is a consultant to several pharmaceutical companies that market smoking cessation medications and has been a paid expert witness In litigation against tobacco companies. Drs Grana and Glantz report no conflicts. ® 2014 The Authors. crrcvraa.n is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution Non - Commercial- NODervis License, which permits use, distribution, and reproduction in any medium, provided that the Contribution is properly cited, the use Is non - commercial, and no modifications or adaptations are made. References nicotine delivery systems). Center for Tobacco Control Research and Education, 15 of 22 7/28/2014 4:57 P1 Daily Journal - California's Largest Legal News Provider Pagel of 3 pailypoUrnal Classifieds /Jobs /Office Space : Experts /Senices : MCLE : Search LOS out TUESDAY WEDNESDAY THURSDAY FRIDAY TODAY SEARCHIBACK to soarch results Bookmark Renfro; m.nm.ww+�reu. oyvasw:.arasm aawr w= v�tizanx+ � ,.,.w...;.worvmnvrk.w.�o-.�na.,a QavYCmwtlapvmL! »�ml^W„M W � lN#9'a1vu6mrtlAtuJ V mfmW v,Pnlm,bmvr,®q�. GkwvtlG pyympVnb6aa @,bm6enlvu,ebmme,tlYmt4vym¢�N6a bpmaYmep,m� �mYe. MOrMey. Mwch 3.2014 Municipalities face cloudy a -cig issues G. Ross Trindle, 111 is a partner at Best Best & Kneger LLP in the municipal law practice group and Is head of the firm —s public safety group. Based in me Ontario office, his practice focuses on public safety servkes and public liability defense In state and federal court. He can be reached at ms xtdndle@bbklaw.cem.. Andrew "Andy" Malorano is an associate at BB&K in the municipal law and special dlsmcisprectice groups. Based In the firm —s Ontario office, he represents several water districts, fire districts and departments, andpolke departments across Southern California on issues involving public safety regulations, the Brawn Act, public official condkts ofinterest, document privacy, gun confiswNon actions, and land use and planning approvals. He can be reached at andrewmaiomno @bbWew.cem. tobacco product and the new electronic versions. A hot new product on the market has become a source of confusion for some cites and counties: electronic cigarettes. Similarto, but distinctly different from, traditional tobacco cigarettes, much remains unknown abort the casual and long -term use of electronic cigarettes. That has local governments concerned about public health and safety risks. Some California cities have even banned the establishment of new retail stores selling e- cigarettes while continuing to evaluate the health and public safety risks. Electronic cigarettes - ecigs or ecigarettes - are battery- powered devices that typically look similar to traditional tobacco cigarettes or cigars. E-cigs simulate smoking by vaporizing a liquid solution as the user inhales. The user exhales a vapor cloud that resembles the smoke from a traditional cigarette. The similarity in design and use can make it difficult to distinguish between a traditional This liquid solution that goes Into the a -cig -juice, e-juice or e- liquid - contains various amounts of nicotine, a few other chemicals, and can have concentrated flavors mixed in to provide flavor. Flavors range from classic tobacco to sweeter flavors like pine colada and hard candies. The juice often is sold in a bottle or in pre - filled disposable cartridges for easier use. Given the mechanics of e-cigarettes, many users of the devices claim that they are not "snaking" but Instead are taping" (short for vaporizing) the e- Juice. Indeed, no material is combusted when the device is used as advertised. Although the long -term health effects and dsks of continued use of a- cigarettes are uncertain, their increased popularity is rot. Currently, the U.S. Food and Drug Administration's Center for Drug Evaluation and Research only regulates e- cigarettes that are marketed for therapeutic purposes. The FDA, however, expressed Its Intent to seek to have its regulatory capabilities for "tobacco products" broadened to include e- cigarettes and other similar novel products included within its regulatory purview. Similarly, California Health and Safety Code Section 119405 only prohibits the sale of e - cigarettes to minors, while expressly referencing that California law is subject to any federal regulation of the devices, Including the regulations of the FDA. This current state of the law does not provide much guidance for loot governments as they seek to deal with the growing popularity of vaping. Some municipalities in Calffomia have taken a more conservatve approach to the Issue by placing a moratorium on the establishment of new retail stores selling ecigs pending further scientific study of the Issue. Others have chosen more aggressive https: / /www.dailyj oumal.com/ subscriber /SubMain.cfm ?shCenFileName= SEARCH &shNe... 114 E`2-1 -IIBI� NO• - 3/3/2014 03 -11 -14 City Council Meeting Daily Journal - California's Largest Legal News Provider approaches involving the regulation or prohibition of the sale or use of e- cigarettes under certain conditions or in certain locations. California Government Code Section 65856 allows cities and counties to adopt an interim urgency ordinance (moratorium), In order to protect the public safety, health and welfare of residents from a current and immediate threat. These prohibitions extend to any use that may conflict with a cVs or wunlys general mnmg plan, any specific plan, or zoning proposal that the legislative body is studying within a reasonable time. Given their urgent nature, the moratorium measures become effective immediately upon adoption, but require a four -fifths vote of the legislative body and are only valid for a 45-day period. This period can, under certain circumstances, be extended by the legislative body for up to a year or longer (including the original 45 days) should further study be required. In the last year alone, several cities including Alhambra, Norwalk, Cerritos, Seal Beach and Bellflower have passed moratoria relating to the establishment of certain new retailers selling a -cigs. For example, Norwalk's city council noted that its moratorium was passed due to the possible effects of a -cig sales. Including the devices' promotion of illegal tlmg use, the negative Impacts on the welfare of children and minors due to Increased exposure to illegal drug-related paraphernalia, and the high concentration of Illegal drug use in neighborhoods. Bellflowees moratorium, by contrast, is broader and not only places a moratorium an the establishment of e- cigaretle retailers, but on e- cigarefie manufacturers as well. Regardless ofswpe, the important takeaway is that these cities are taking the time to study the Impact of a -dgs before deciding on what action, if any, to take to regulate or ban these devices. Other municipalities, however, are taking mom aggressive positions. Poway, for example, recently chose to broaden the definition of "smoking- in Its municipal code to include e- cigarettes, and to extend its existing prohibition on *smoking" to Include public buildings, grounds, parks and trolls. The practical result of such action appears to be a ban on the use of e-dgs in these public areas. In justification of the ban, Poway cited the unknown health risks associated with extended use of e-dgs, the increasing popularity of the devices with minors who may then turn to using traditional cigarettes, and concerns about enforcing smoke -free ordinances due to the difficulty In distinguishing between regular cigarettes and a -dgs. Poway's ban also referenced a limited study by the FDA finding that ecigs contain carcinogens and toxic chemicals, giving further support to the belief that the FDA Is studying a -clgs In preparation for regulating the devices. Similarly, Beverly Hills recently decided to regulate the sale and use of ecigarettes within city limits. The city's staff report chronicled how the city council first addressed this issue in November 2013, directing its Health & Safety Commission to review and provide policy recommendations on the sale and use of e- cigarettes in the city. After studying the issue, the commission recommended that e- cigarettes be regulated similarly to tobacco products, Specifically, the recommendations of the commission that were adapted by the city council included: prohibiting the use of e- cigarettes In all open air dining areas, in all city buildings and parks, and in enclosed places of employment and day care facilities where state law prohibits the smoking of tobacco products. Other regulations include prohibiting the sale of e- cigarettes in self -serve vending machines and requiring all e, cigarette retailers in the city to obtain a permit prior to selling e- cigarette products. The Beverly Hills ordinance adopting these regulations referenced certain initial studies into e- cigarettes which, according to the ordinance, revealed that certain e4iquids contained toxic ingredients and carcinogens and that all but one tested cartridge labeled as containing no niwtine did in fad contain low levels of nicotine. Critics of the decision to ban or regulate ecigareltes point to the perceived lack of evidence proving that mere are health hazards associated with the use of the devices. These critics also stress the Importance that the devices may have on those seeking relief from an addiction to traditional tobacco cigarettes. While the long -term impacts of the use of ecigarenes am still being evaluated, the federal and state governments have yet to pass comprehensive regulations concerning the devices. In the meantime, local governments in California do have options, ranging from taking no action until the state and federal government issue mom guidance and - regulations for the industry, to an outright ban on the sale and manufacture. The question does not appear to be whether the popularity, of e- cigarettes will continue to grow, but instead it is where and how such growth will occur. And at least for now, the answer rests with local governments. G. Ross Trindle, III is a partner at Best Best & Krieger UP in the municipal law practice group and is head of the firm's public safety group. Based In the Ontario office, his practice focuses on public safety services and public liability defense in state and federal court. He can be reached at r0w.tdndle@bbk1awwm.. Page 2 of 3 https: / /www.dailyj oumal.com/ subscriber /SubMain.cfm ?shCenFileName= SEARCH &sbNe... 313/2014 03 -11 -14 City Council Meeting 11 - 16 q1SA x7 .p SMOKE -FREE MARIN COALITION American Cancer Society /Cancer Action Network American Lung Association Marin County Tobacco Related Disease Control Program Bay Area Community Resources Marin Pharmacists Association Marin County Office of Education Marin Link Asian Advocacy/ Community Action Marin American Heart Association Smoke -Free Marin C/O 899 Northgate Ave. Suite 400 San Rafael, C:4 94903 w yv.smokefreemarinxom Date: May 7, 2015 To: City Councils in Marin From: Jennie Cook, Chair of the Smoke -Free Marin Coalition Attachments Included: Policy support letters; Definitions Re: Smoke- Free Marin Coalition requests that your city council amend yoursmoke- free ordinance to prohibit the use of electronic vaping in the same areas where smoking is restricted, similar to actions taken by San Francisco, San Diego, New York, Chicago, and Marin jurisdictions including Marin Unincorporated, Mill Valley and Corte Madera. To prohibit vaping or use of ENDS (Electronic Nicotine Delivery Systems) in areas that regular cigarettes are restricted the County Tobacco Related Disease Control Program has sample language that would only require changing a couple of definitions (see attached) in your current ordinance. For these simple ordinance updates that are used by other Marin communities you may contact Bob Curry (415) 473 -3020. The Situation: The tobacco industry has taken over the electronic cigarette industry and launched misleading campaigns, promoting these as health products that would help smokers quit smoking. However, researchers found health risks and safety dangers of e- cigarettes, e- hookahs, and other electronic vaping products that have not been disclosed by this nicotine addiction industry, which targets youth through on -line social media and youth dominated channels. Youth are attracted to these electronic vaping nicotine delivery toys, which come in candy flavors and have a "techno appeal" as they plug into computers just like their cell phones and iPods. High doses of nicotine very quickly addict youth and discourage current smokers from quitting. There are health consequences from nicotine in people of all ages. Marin School counselors in Marin have reported high use among teens. These "e- liquids;' the key ingredients in e- cigarettes, are powerful neurotoxins. Tiny amounts, ingested or absorbed through the skin by children can cause vomiting and seizures and even be lethal. Exposure to ultrafine particles may exacerbate respiratory ailments like asthma, and constrict arteries which could trigger a heart attack. ➢ E- cigarettes are easily available: Many Marin stores sell E- cigarettes. These unhealthy products are located next to candy in gas stations and convenience stores. One Marin gas station employee said, "Any child can grab and chew on a nicotine filled e- hookah pen filled with liquid nicotine, which could be fatal." ➢ ENDS- Vaping Products Can Cause Fires: Fires have been caused by explosions of these products when batteries get over - heated, injuring their users and others nearby, as when a four year old was burned in a car. According to Chief Christopher Gray, San Rafael Fire Chief, "Fire fighters across the country are deeply concerned about the explosive nature of E- Cigarettes and will support their local governments in any policies that prohibit their use. " ➢ Tobacco industry's dream come true: e- cigarettes undermine smoke -free ordinances, make enforcement confusing, and make smoking seem socially normal again. The Smoke -Free Marin Coalition asks every city council in Marin to take action quickly to prevent reversal of the progress we made together during the last two decades when we finally lowered nicotine addiction. April 24, 2014 Committee Chair Jennie Cook Smoke -Free Marin Coalition C/O Marin County Tobacco Related Disease Control Program 899 Northgate Ave., Suite 400 San Rafael, CA 94903 Dear Ms. Cook: The American Cancer Society Cancer Action Network is committed to protecting the health and well -being of the residents of Marin County. As such, we support the efforts of Smoke -Free Marin to expand existing smoking regulations to include e- cigarettes and other electronic smoking devices. The health effects of e- cigarettes — especially the longer -term effects — are scientifically uncertain. Currently, only a limited number of studies have examined the contents of e- cigarette vapor. Some of the studies have found the vapor to contain only propylene glycol, nicotine, and flavorings, and other studies found them to contain heavy metals, volatile organic compounds and tobacco - specific nitrosamines, among other ingredients. A 2009 study done by the FDA found cancer - causing substances in several of the e- cigarette samples tested. Additionally, Food and Drug Administration (FDA) tests found nicotine in some e- cigarettes that claimed to contain no nicotine. There is general agreement among scientists in the field that, in the short run, at least, e- cigarettes are almost certainly less harmful than combusted cigarettes. But there are still serious questions about the safety of inhaling the substances in some e- cigarette vapor. E- cigarettes have not been subject to thorough, independent testing, so users cannot be sure of what they are actually inhaling. Some studies have shown that some e- cigarettes can cause short-term lung changes and irritations and the long -term health effects, as noted above, are unknown. Additionally, the effects of secondhand vapor from e- cigarettes require further study, especially to determine differences among the many brands and types of e- cigarettes. In addition, allowing the use of electronic smoking devices in public places where smoking is otherwise prohibited can create confusion with enforcement issues as well, as there are concerns that they may create new tobacco users and reverse efforts that have made smoking socially unacceptable. The appeal of e- cigarettes to youth is a new and rapidly growing problem, as e- cigarettes are sold in an assortment of flavors that appeal to youth, and CDC data shows that the marketing of these products is enticing to this population. The CDC reported that the use of e- cigarettes by youth, among both high school and middle school students, doubled from 2011 to 2012. Eliminating public use of e- cigarettes will help to prevent the tobacco industry from using these devices to create a new smoking norm, while luring the next generation of young people to a deadly addiction. The American Cancer Society Cancer Action Network encourages that the same public protections applied to tobacco products be expanded to include electronic smoking devices. Countless jurisdictions across the country, from New York to San Francisco, have chosen to protect their citizens by taking the important step of redefining smoking to include these electronic devices. We applaud Smoke -Free Marin for increasing public awareness about the dangers of these products, and we support their efforts to protect the residents of this community. Sincerely, Cassie Ray, Government Relations Director American Cancer Society Cancer Action Network American Cancer Society Cancer Anion Network 980 9" Street, Suite 2200 • Sacramento, CA 95814 . 707,290.0003 AMERICAN LUNG ASSOCIATION. IN CALIFORNIA 1531 [Street Suite 201 Sacramento, CA 95814 916 -554 -5864 phone 916- 442 -8585 fax lung.org /california April 18, 2014 Coalition Chair Jennie Cook Smoke -Free Merin Coalition C/0 Morin County Tobacco Related Disease Control Program 899 Northgate Ave. Suite 400 San Rafael, CA 94903 Dear Chair Jennie Cook: The American Lung Association in California supports action taken by Merin City Councils and School Boards to protect the public health of Merin residents by including electronic cigarettes in tobacco retailer permit and smokefree air laws. The American Lung Association is concerned that very little is known about the health effects of electronic cigarettes and of the vapors that they release, or what the health consequences of them might be. Two initial studies have found formaldehyde, benzene and tobacco - specific nitrosamines (a cancer - causing chemical) coming from the secondhand emissions from e- cigarettes. While we have a lot more to learn about these products, it's clearthat there is much to be concerned about and there's a lot more than just "water vapor" in these products. In addition, it is important to note that e- cigarettes have not been approved by the U.S. Food and Drug Administration (FDA) to be safe and effective in helping smokers quit cigarettes. And finally, it's worth highlighting that the e- cigarette industry appears to be using the same playbook as the cigarette companies did a generation ago. We are deeply concerned that these products are starting kids on a lifetime addiction to nicotine. According to one researcher, there are more than 250 e- cigarette brands for sale today, over half of which offered fruit or candy - flavors. We've seen candy - flavors including Captain Crunch, gummy bear, cotton candy, Atomic Fireball and fruit loops. It is critical for communities to remain on the cutting edge in protecting their residents from new and emerging tobacco products. We support the Smoke -Free Merin Coalition for making this advocacy project a priority to protect public health. Sincerely, Kimberly Amazeen Vice President, Programs & Advocacy UNIVERSITY OF CALIFORNIA SAN FRANCISCO l BERKELEY • DAVLS •IRVINE •LOS ANGELES •MERGED ' RIVERSIDE •SAN DIEGO • SAN FRANC15C0 SANTA BARBARA • SANTA CRUZ STANTON A. GLANTZ, PhD 530 Parnassus Suite 366 Professor of Medicine (Cardiology) San Francisco, CA 94143 -1390 American Legacy Foundation Distinguished Professor of Tobacco Control Phone: (415) 476 -3893 Director, Center for Tobacco Control Research and Education Fax: (415) 514 -9345 glantz@medicine.ucsf.edu April 30, 2014 Jennie Cook Smoke -Free Marin Coalition Via email Dear Jennie, I am writing to support pending legislation you are considering that would include e- cigarettes in current smoke -free ordinances throughout all of the City Councils in Marin and policies of local Mann School Boards. This is a sensible piece of legislation that mirrors what cities large and small are doing all over the country (and the world). Last December two colleagues at UCSF and I prepared an extensive review of the scientific evidence at the request of the World Health Organization, 'Background Paper on E- cigarettes (Electronic Nicotine Delivery Systems)" (copy attached, as well as two peer reviewed papers we published on use of e- cigarettes by youth). While the scientific evidence is still accumulating, there is no question that e- cigarettes pollute the air breathed by bystanders with nicotine, ultrafine particles, volatile organic compounds, and other pollutants and that bystanders take these chemicals into their bodies. Having spent decades cleaning up the indoor air, there is no reason to reintroduce a new form of indoor air pollution. In particular, it is my understanding that you have been provided with a technical report prepared for the e- cigarette advocacy group CASAA by Igor Burstyn entitled "Peering through the mist" that concludes that "there is no evidence that vaping produces inhalable exposures to contaminants of the aerosol that would warrant health concerns by the standards that are used to ensure safety of workplaces." The problem with this study is that it employs occupational threshold limit values (TLVs) to evaluate the potential risks posed by various toxins in e- cigarettes. TLVs are used to assess health effects for occupational chemical exposures that are generally much higher (often orders of magnitude higher) than levels considered acceptable for ambient or population -level exposures. (Employing an occupational standard to evaluate risk to the general population is the same approach to risk assessment as those conducted for secondhand smoke by those affiliated with the tobacco industry decades ago, which also concluded that secondhand tobacco smoke could not produce any adverse health effects.) TLVs also do not consider exposure to sensitive subgroups, such as people with medical conditions, children and infants, who might be exposed to secondhand e- cigarette emissions, most notably nicotine. You should not rely on this study as justification for allowing the citizens of Los Angeles to be involuntarily exposed to e- cigarette pollution. Another common claim is that e- cigarettes are helping people quit smoking and any restriction on where people can use e- cigarettes would undermine this benefit. The evidence from large population -based studies is just the opposite: overall e- cigarette use is associated with less quitting cigarettes. Moreover, even if the claims that e- cigarettes help people quit smoking were true, there is absolutely no evidence that creating e- cigarette zones would interfere with quitting smoking. I am also very concerned about two exceptions in the legislation, one for theatrical productions and another for vaping lounges. The seemingly minor amendment to exempt theatrical productions will have big effects given the fact that CA is a center for producing television programs and motion pictures, because it will make it legal to use ecigarettes in these venues, which could end up influencing youth all over the world to start using e- cigarettes and begin a life of nicotine addiction. And the e- cigarette companies have been very aggressive in using Hollywood to promote their products. In terms of vaping lounges, it is important to ensure that all they are selling is e- cigarettes and associated paraphernalia and that they not be allowed to sell food or drinks so as to prevent opening up a serious loophole in the law. Even better, I suggest that you consider grandfathering existing vaping lounges (as long as they only sell e- cigarettes) and prohibit opening new such businesses. I had the privilege of appearing before several legislative bodies in Marin decades ago when they were considering legislation to limit and, eventually, prohibit smoking in workplaces and public places. I have to say that the current debate over e- cigarettes makes me feel like I have got in a time machine and returned to the 1980s. The fact is that Marin jurisdictions, like hundreds of other places, saw past the controversy that pro - tobacco forces generated (and today the e- cigarette companies are being taken over by the tobacco industry) and passed its smokefree legislation. And the public loved it. Now is the time to do the same thing and take the simple step of adding e- cigarettes to your smokefree ordinance without any exceptions. If I can provide any additional information, feel free to contact me. As always, Stanton A. Glantz, PbD Professor of Medicine American Legacy Foundation Distinguished Professor of Medicine Director, Center for Tobacco Control Research and Education MARIN GENERAL HOSPITAL April 24, 2014 Dear Smoke -Free Marin Coalition, 250 Bon Air Road. Green6rae, CA 94904 t)) 475 - 925 -7000 At Marin General Hospital, we have enjoyed our long term collaboration with you that also helped develop our own tobacco free campus. We are pleased that so many communities in Marin have enacted new smoking ordinances to protect non - smokers in multi -unit housing, outdoor areas and other places where people share breathing space. However, we are concerned that these ordinances are not keeping up with the pace of the new e- cigarette (vaping) trends that are so popular with young people. If communities don't act soon, vaping lounges (with their youth - friendly flavor varieties), will start opening up and we will see more and more people addicted to tobacco. We understand between September 2010 -2014, there were a total of 2,405 calls to the nation's 55 poison control centers, as described in this article - http://www.tobaccofreekids.orci/press releases /post /2014 04 03 ecigarettes Additionally, e- cigarettes have caused explosions that destroyed users' faces and mouths, and caused fires in cars and homes. Recently, it left a youth in Utah with first and second degree burns when the child's mother charged her e- cigarette in her car. Marin General Hospital urges the Smoke -Free Coalition to work with all city councils and school boards to update their policies to restrict the use of e- cigarettes and other vaping products. Please keep us informed on the progress of this campaign. Sincerely, Joel Sklar, MD Chief Medical Officer www.maringeneral.org OUR HOME. OUR HEALTH. OUR HOSPITAL. 5 Important Lessons From The Biggest E- Cigarette Study The Huffington Post I by Anna Almendrala (/Anna Uusertfau tF Follow Like 830 Aimendralal /login /index.php ?author -anna- Posted: 05/14/2014 8:03 am EDT I Updated: 05/14/2014 8:59 am EDT almendraia) 7155 Share 117 Tweet ht a lin ffln comlcwsl share ?url= http7 //www huffinotonoost com /2014 /05 /14 /ecigarcette- studies n 5319225.htmll Email Comment m MORE: E Cigarette Vapors E Cigarettes Vapino E Cigarette Studies Electronic Cigarettes. Ucsf E Cigarettes Vaping Laws Electronic Cigarette Restrictions, E cigarette Safety Those colorfully lit e- cigarettes are giving off way more than just "harmless water vapor," according to a comprehensive new study review by UC San Francisco's Center for Tobacco Control Research and Education. Users could also be inhaling and exhaling low levels of chemicals such as formaldehyde, propylene glycol and acetaldehyde (to name a few), and this secondhand vapor could be a potentially toxic source of indoor air pollution. While the levels of the toxins were still much lower compared to conventional cigarette emissions, the findings fly in the face of the e- cigarette industries' claims that the handheld devices are just as safe as any other smoking cessation tool a=://vaperanks com/ new - studies - suggest -e- cigarette - vapor -is- considerably- safer- than- tobacco -smoke /). E- cigarettes as we know them today were invented by a Chinese pharmacist, Hon Lik in the early 20oos as a smoking cessation aid. They are handheld nicotine vaporizers that deliver an aerosol made up of nicotine, flavorings and other chemicals to users. It's the chemicals in those vapors that are moving municipalities like Los Angeles, New York City Washington D C Chicago (hM: / /www huffingtonpost.com /2oia /o3 /oF /la bans a cigarettes - public- places n 400S7n51i trial and Boston to restrict "vaping" in some way. Formaldehyde, for instance, is a carcinogen G=:Z1www.c—dp—h.ca.gov/programs 1 of 4 5 Important Lessons From The Biggest E- Cigarette Study http: / /www.huffingtoni Thesis/ Documents /formaldehyde.ndfl that also irritates the eyes, nose and throat. Propylene glycol can also cause eye and respiratory irritation, and prolonged exposure can affect the nervous system and the spleen. Acetaldehyde, also known as the "hangover chemical (hn://www.sciencedaily.com/releasest2ooc)/­o.ti /090:119102419.htm)," is also a possible carcinogen. The secondhand vapor finding is just one of several that UCSF researchers highlighted in the broadest review to date of peer - reviewed e- cigarette - studies. The findings, which were published Monday in the American Heart Association's journal Circulation (h=://circ.ahaiournals.org/content/129/19/1972.fUM, include: i. Some youth have their first taste of nicotine via e- cigarettes. Twenty percent of middle schoolers and 7.2 percent of high schooler e- cigarette users in the U.S. report never smoking cigarettes. 2. Nicotine absorption varies too much between brands. Early 2010 studies found that users got much lower levels of nicotine from e- cigarettes than from conventional cigarettes, but more recent studies show that experienced e- cigarette users can draw levels of nicotine from an e- cigarette that are similar to conventional cigarettes. Yet another study noted that the chosen e- cigarettes for the research malfunctioned for a third of participants. UCSF researchers say this indicates the need for stronger product standards and regulations. 3. Just because particulate matter from e- cigarettes isn't well studied, doesn't mean it's safe. To deliver nicotine, e- cigarettes create a spray of very fine particles that have yet to be studied in depth. "It is not clear whether the ultra -fine Tartirlr_c delivered by e- cigarettes have health effects and toxicity similar to the ambient fine particles generated by conventional cigarette smoke or secondhand smoke," wrote the researchers. But we do know that fine particulate matter from cigarettes and from air pollution are associated with an increased risk of cardiovascular and respiratory disease. And some research has found that the size and spray of fine particulate matter from e- cigarettes is just as great or greater than conventional cigarettes. 4. So far, e- cigarette use is not associated with the successful quitting of conventional cigarettes. One clinical trial found that e- cigarettes was no more effective than the nicotine patch at helping people quit, and both cessation methods "produced very modest quit rates without counseling." 5. Major tobacco companies have acquired or produced their own e- cigarette products. They're promoting the products as "harm reduction" for smokers, which allows them to protect their cigarette market while promoting a new product. Companies also using "grassroots" tactics to form seemingly independent smokers' rights groups, just like they did for cigarettes in the 198os. Based on the weight of the combined research, UCSF researchers end with several policy recommendations, which include banning e- cigarettes wherever cigarettes are banned, subjecting e- cigarettes to the same advertising restrictions that constrict cigarette marketing and banning fruit, candy and alcohol flavors, which are attractive to younger customers. While its rare, ovemeated batteries have exploded Users inhale chemicals that make airway cans resistant to antibiotics Briefing E- cig-related calls to poison- --- - control centers rose 219% from 2012 to 2013 The vapor contains the carcinogen formaldehyde, propylene glycol and nicotine The Vapor Trail Tracking the conflicting claims about e- cigarette safety BY ALICE PARK A LOOK AT THE NUMBERS shows thatvaping is catching on as quickly as smoking did in the 1950s. In just two years, the percentage of smokers who have tried e- cigarettes, which vaporize a liquid solu- tion rather than burn tobacco, jumped from 2%in 2oro to 30% in 2012. Fueling that trend are claims that e-cigs are a health- ier way for people to use nico- tine and that they can help smokers kick the habit. The latest report from the U.K. found that the devices were 6o% more likely than nico- tine patches or gum to help smokers give up cigarettes. That seems like good news, but as with most data on e -cigs, which are not yet regu- lated by the Food and Drug Administration, those mm- 20 hers maybe a smokescreen. E-cigs still contain nicotine, the stuff that keeps smokers comingback forpuff after Puff—and according to the U.K. report, just 2o% of people who used e-cigs as a cessation tool actually stopped smoking cigarettes. And this is among people who are motivated to quit It doesn't mean that smokers who switch to e-cigs either because they think they are safer or so they can smoke where cigarettes are banned are more likely to stop smok- ing. When these people are included, e- cigarettes are actually less likely to lead to quitting. And that's espe- cially true among teens: high school students who smoke tend to use both. "Some people likely do quit smoking on e-cigs, but more people are being deterred from quitting or having their quit effort undermined," says Stanton Glantz ofthe Univer- sity of California, San Francis- co. The people who quit may be outnumberedby new smokers who start because of e -cigs and former smokers who light up again when their nicotine cravings are reignit- ed by ads for the devices. And while e-cig vapor doesn't con- tain all the toxic by- products ofhuming tobacco, e-cigs do emit other harmful agents, in- cluding carcinogens. Most experts agree that e -cigs are the lesser oftwo evils when compared with tradi- tional tobacco, but they're still a delivery system fora highly addictive drug ---and there is still so much we don't know. The Checkup HEALTH NEWS EXAMINED Headline says: "Paleo Diets Don't Help You Lose Weight" Science says: Researchers Put the diet under a microscope and found that the foods our Paleolithic ancestors ate did not trigger the production of hormones that suppress appetite. That "I'm full" feeling comes from soluble fiber; they grazed on Insoluble fiber. Modem cavemen eat the soluble kind too, though. Not quite right Headline sap: "Pancreatic Cancer Will Soon Be Second Deadliest" Sctencesays: By 2030, more people with pancreatic cancer will dle of the disease than those with any other kind of cancer except lung. That's because it's become more common and is hard to detect and other cancers have become more treatable. Jury's out Headline sayst "Airplanes Are Full of Dangerous Germs" Sclerres says: Scientists ex- posed airplane surfaces to E. coil and MRSA to see how long the germs could last and which surfaces were best at transmitting them. Their findings? Some lasted eight days, and nonporous surfaces passed them on most readily. wash your handsl TIME June x6,2014 Scott Anderson From: sally warren [saw74 @att.net] Sent: Wednesday, August 13, 2014 4:03 PM To: Scott Anderson Cc: Tina Warren Subject: a /cigaretts -vapor cigarettsanother year LATE MAIL# PH° yr Scott, Thank you for hearing my concerns about adding a cigaretts to the no smoking ordinance. For my son who is 53 and been a smoker for 30 years the no smoking ordinance was as you can imagine a blow but he started on his owns to try many different quitting procedures including the patch which all made him sick. He is disabled with Chrons, Ankllosing Spondylitis, and depression. Also last year went to the emergency room 4 times with kidney stones and prostrate enlargement. Since being moved from CMSP health program and being given Medical he has joined Kaiser for his medical needs and this includes joining a smoking secession programs and counselor who encouraged him to continue with the vapor cigarette since the other options made him so very sick. Now that that option might be taken away when he is making such progress is a disaster. He lives in low income housing in Tiburon and they are sticklers for rules and laws so this would be the end of his housing options if you can't make some exceptions in your proposed law for ill and disabled persons that have had this prescribed as medication. He doesnt smoke outside at all and this product only makes a very small emission that has absolutey no odder. His goal is to completely be free of the a cigg but it will take more time with help from Kaiser and his determination. This doesn't happen overnight and I hope you can be compassionate and understanding and add something to your proposal to give disabled people more time at least another year or more for the secession plan to work. Thank you and please present this to your board. Slr Sally Warren 42 Neds WAY, TIBURON, CA AUG 13 n 14 415- 290 -1091 PL NNING DIVISION TOWN OF TIBURON 1505 Tiburon Boulevard Tiburon, CA 94920 To: From: Subject: Reviewed By: BACKGROUND Mayor and Members of the Town Council Office of the Town Attorney Town Council Meeting August 20, 2014 Agenda Item: P// Recommendation to Introduce and Pass First Reading of an Amendment to the Town's Contract Ordinance Chapter 3A of the Municipal Code contains the Town's procedure for entering into valid and binding contracts. The ordinance establishes maximum contract authorization amounts for the town manager and department heads and procedures for the bidding, award and execution of authorized contracts. The Town Council adopted a major revision of Chapter 3A in 2008. Staff has identified several sections that warrant updating. ANALYSIS State law requires formal competitive bidding for large public works projects, but allows for more streamlined procedures for small and medium projects. The three types of projects are distinguished by estimated project cost; the state changes the dollar amount for each type from time to time. The 2008 Chapter 3A provides that, in most cases, the threshold amounts that determine the required bidding process shall be automatically increased to reflect changes at the State level. Because the amounts have increased significantly, staff believes that the Municipal Code would be more helpful if the Town updates the threshold amounts as follows. • Chapter 3A currently establishes a $125,000 threshold between major and minor public works contracts. Since 2008, the State has raised this amount to $175,000 and staff proposes that the Town revise the Municipal Code amounts to reflect this change (Sections 3A -1, 3A -11). • Chapter 3A allows a simplified procedure for minor public works contracts under $30,000. The statutory threshold is now $45,000. Staff recommends amending the ordinance to reflect this increase and add an automatic escalator clause for future increases (Section 3A -10). Staff also recommends the following changes: • The current ordinance authorizes the town manager to execute contracts of up to $40,000 The Town should increase the town manager's authority for all such contracts to $60,000. This increase will significantly streamline the Town's process for mid -sized agreements. Town Council Niectinr August 20, 2014 Please note that this authorization applies only when the Town Council has previously appropriated the expenditure through the budget process (Section 3A -3). • The current ordinance also authorizes the town manager to settle a claim or litigation against the town for up to ten thousand dollars, after consultation with the mayor. Staff recommends increasing this amount to fifteen thousand dollars (Section 3A -3). • The current ordinance requires the Town to public a notice inviting bids twice, the first time at least ten days before bid opening. The proposed amendment would require 14 days notice, published once and advertised in appropriate trade journals. FINANCIAL IMPACT None. RECOMMENDATION Staff recommends that the Town Council: Hold a public hearing and take testimony on the proposed ordinance; and 2. Introduce the draft ordinance, as follows: Move to read by title only, waiving any additional reading, and introduce the ordinance amending Title I, Chapter 3A (Town Contracts) of the Tiburon Municipal Code. Pass the reading by roll call vote. If the first reading is passed, the ordinance will return for final adoption on a future consent calendar. I X01 1. Draft Ordinance amending Chapter 3A. 2. Current Chapter 3A. Prepared By: Ann R. Danforth, Town Attorney RO )N _.. Page 1 ni , ORDINANCE NO. N.S. AN ORDINANCE OF THE TOWN COUNCIL OF THE TOWN OF TIBURON AMENDING CHAPTER 3A OF THE TOWN'S MUNICIPAL CODE REGARDING CONTRACT AWARD PROCEDURES The Town Council of the Town of Tiburon does ordain as follows: SECTION 1. Title 1, Chapter 3A, Section 3A -1 of the Tiburon Municipal Code is hereby amended to read as follows: 3A -1 Definitions. The following definitions shall apply to this chapter: "Contract" means any binding agreement between the town and any individual, public agency, corporation, partnership or other entity. Contract shall also mean, without limitation, any document which purports to transfer liability to the town or in which purportedly obliges the town to indemnify, defend and/or hold harmless any individual, public agency, corporation, partnership or other entity. "Formal bidding" means a contractor selection procedure that substantially complies with the process set forth in Article V of this chapter for public works projects. "Informal bidding" means any non -formal contractor selection procedure authorized by this chapter. A "major public works contract" means a contract for a public works project whose value exceeds one hundred seventy five thousand dollars ($175,000). A "minor public works contract" means a contract for a public works project whose value is equal to or does not exceed one hundred seventy five thousand dollars ($175,000). This threshold of $175,000 that distinguishes major from minor public works projects shall be automatically adjusted to conform to the maximum set by Section 22032(b) of the Public Contracts Code or its successor statute for projects that may be let by informal bidding. Except where otherwise indicated, "public works project" means any project meeting the definition of a "public project" under section 22002 of the Public Contracts Code, as amended, or any successor statute. SECTION 2. Title I, Chapter 3A, Section 3A -3 of the Tiburon Municipal Code is hereby amended to read as follows: 3A -3 Contract authority of the town manager. The town manager is authorized to negotiate and execute on the behalf of the town, without prior approval of the town council, any contract: �'ITIDIT NO. (a) For purchases, general services, public works, professional services or employment, or community, social or recreational services, and the total expenditure does not exceed sixty thousand dollars, provided that such monies have been appropriated or budgeted for such purpose and there is an unexpended and unencumbered balance of such appropriation sufficient to pay the expense of the contract; (c) For the lease of town property for a period of less than six months, or for the use of town property or facilities for a period not to exceed five days, in accordance with town policy, which require no payment of money by the town; (d) For settlement of a claim or litigation against the town, after consultation with the mayor, where the total expenditure does not exceed fifteen thousand dollars; (e) Allowing the right of entry onto town property. SECTION 3. Title I, Chapter 3A, Section 3A -10 of the Tiburon Municipal Code is hereby amended to read as follows: 3A -10 Minor public works contracts which do not exceed forty -five thousand dollars. Minor public works contracts which do not exceed forty-five thousand dollars may be performed by the employees of a public agency by force account, by negotiated contract, or by purchase order. The dollar amounts set forth in this section shall be automatically adjusted to conform to the maximum set by Section 22032 (a) of the Public Contracts Code or its successor statute regarding informal bidding ordinances. SECTION 4. Title I, Chapter 3A, Section 3A -11 of the Tiburon Municipal Code is hereby amended to read as follows: 3A -11 Minor public works contracts of one hundred seventy five thousand or less. Minor public works contracts of one hundred seventy five thousand or less may be let according to this section. Said dollar maximum shall be automatically adjusted to conform to the maximum set by Section 22032 (b) of the Public Contracts Code or its successor statute regarding informal bidding ordinances. (a) The town shall maintain a list of qualified contractors, identified according to categories of work. This list shall comply will all criteria established by the California Uniform Construction Cost Accounting Commission. (b) All contractors on the list for the category of work being bid or all construction trade journals specified in section 22036 of the California Public Contracts Code, or both all contractors on the list for the category of work being bid and all construction trade journals specified in section 22036 of the California Public Contracts Code, shall be mailed a notice inviting informal bids unless the product or service is proprietary. (c) All mailing of notices to contractors and construction trade journals pursuant to subsection (b) of this section shall be completed not less than ten calendar days before bids are due. (d) The notice inviting informal bids shall describe the project in general terms, state how to obtain more detailed information about the project and state the time and place for the submission of bids. (e) The town manager shall have the authority to award informal contracts to contractors selected pursuant to this section. (f) If all bids received are in excess of one hundred seventy -five thousand dollars ($175,000), the Town Council may, by adoption of a resolution by a four -fifths vote, award the contract, at one hundred eighty -seven thousand five hundred dollars ($187,500) or less, to the lowest responsible bidder, if it determines the cost estimate of the public agency was reasonable. If the lowest responsible bidder's bid exceeds one hundred eighty -seven thousand five hundred dollars ($187,500), or if the Council does not adopt the necessary award resolution by four - fifths vote, the Town shall re -bid the project using the formal bidding procedure. (g) The dollar amounts set forth in subsection (f) shall be automatically adjusted to conform to the maximum set by Sections 22032 and 22034(f) of the Public Contracts Code or its successor statute regarding informal bidding ordinances. SECTION 5. Title I, Chapter 3A, Section 3A -13 of the Tiburon Municipal Code is hereby amended to read as follows: 3A -13 General. Major public works contracts shall be let by formal competitive bidding as required by Uniform Public Construction Cost Accounting Act, California Public Contracts Code sections 22000 et seq. SECTION 6. Title I, Chapter 3A, Section 3A -14 of the Tiburon Municipal Code is hereby amended to read as follows: 3A -14 Notice inviting bids. Notice inviting formal bids shall state the time and place for the receiving and opening of sealed bids and distinctly describe the project. The notice shall be published at least 14 calendar days before the date of opening the bids in a newspaper of general circulation, printed and published in the Town's jurisdiction of the public agency; or, if there is no newspaper printed and published within the Town's jurisdiction, in a newspaper of general circulation that is circulated within the Town. The notice inviting formal bids shall also be sent electronically, if available, by either facsimile or electronic mail and mailed to all construction trade journals specified in California Public Contracts Code Section 22036. The notice shall be sent at least 15 calendar days before the date of opening the bids. In addition to notice required by this section, the public agency may give such other notice as it deems proper. SECTION 7 SEVERABILITY. If any section, subsection, clause, sentence, or phrase of this Ordinance is for any reason held to be invalid or unconstitutional by a decision of a Court of competent jurisdiction, such decision shall not affect the validity of the remaining portions of the Ordinance. The Town Council of the Town of Tiburon hereby declares that it would have passed this Ordinance, any section, subsection, sentence, clause or phrase thereof, irrespective of the fact that anyone or more sections, subsections, sentences, clauses, or phrases may be declared invalid or unconstitutional. SECTION 8. EFFECTIVE DATE. This Ordinance shall take effect and be in force thirty days after the date of passage, and before the expiration of fifteen (15) days after passage by the Town Council, a copy of the ordinance shall be published with the names of the members voting for and against it at least once in a newspaper of general circulation published in the Town of Tiburon. This ordinance was introduced at a regular meeting of the Town Council of the Town of Tiburon on , 2014, and was adopted at a regular meeting of the Town Council of the Town of Tiburon on 2014, by the following vote: AYES: COUNCILMEMBERS: NOES: COUNCILMEMBERS: ABSENT: COUNCILMEMBERS: ATTEST: DIANE CRANE, TOWN CLERK ALICE FREDERICKS, MAYOR Town of Tiburon C! 3A -1 Sections: Chapter 3A TOWN CONTRACTS Article I. General Provisions 3A -1 Definitions. 3A -2 General requirements. 3A -3 Contract authority of the town 3A -16 manager. 3A -4 Contract authority of department heads. 3A -5 Emergency contract procedures. 3A -6 Rejection of price quotations and bids. Article II. Purchase Contracts for Supplies, Materials and Equipment 3A -7 Purchasing procedures. 3A -8 Optional alternative procedure for purchases which exceed twenty -five thousand dollars. Article III. Contracts for Services 3A -9 Service contract procedures. Article IV. Minor Public Works Contracts 3A -10 Minor public works contracts which do not exceed thirty thousand dollars. 3A -11 Informal bidding for minor public works contracts which exceed thirty thousand dollars. 3A -12 Alternative procedure —Minor public works contracts. Article V. Major Public Works Contracts 3A -13 General. 3A -14 Notice inviting bids. 3A -15 Bids — Rejection and re- advertisement. 3A -16 Choice of identical bids. 3A -17 No bids received. (Tiburon Supp. No. 9, 9 -08) 3A -18 Bidders — Presentation and security. Article I. General Provisions 3A -1 Definitions. As used in this chapter, the following terms are defined in this section: "Contract" means any binding agreement between the town and any individual, public agency, corpora- tion, partnership or other entity. Contract shall also mean, without limitation, any document which pur- ports to transfer liability to the town or in which pur- portedly obliges the town to indemnify, defend and /or hold harmless any individual, public agency, corporation, partnership or other entity. "Formal bidding" means a contractor selection procedure that substantially complies with the proc- ess set forth in article V of this chapter for public works projects. "Informal bidding" means any nonformal contrac- tor selection procedure authorized by this chapter. A "major public works contract" means a contract for a public works project whose value exceeds one hundred twenty-five thousand dollars. A "minor public works contract" means a contract for a public works project whose value does not ex- ceed one hundred twenty-five thousand dollars. This threshold of one hundred twenty-five thou- sand dollars that distinguishes major from minor pub- lic works projects shall be automatically adjusted to conform to the maximum set by section 22032(b) of the Public Contracts Code or its successor statute for projects that may be let by informal bidding. Except where otherwise indicated, "public works project" means any project meeting the definition of a "public project" under section 22002 of the Public Contracts Code, as amended, or any successor statute. (Ord. No. 510 N.S., § 2 (part)) 3A -2 General requirements. (a) No contract shall be valid or binding upon the town unless it is entered into and executed in ac- cordance with this chapter. 14 EKHIBIT NO. I (b) Notwithstanding anything in this chapter to the contrary, no contract shall be valid or binding upon the town unless it has been approved as to form by the town attorney prior to execution on behalf of the town or unless, in the town manager's judgment, there are special circumstances such that the town's interest in entering into the contract on an expedited basis render it impracticable to obtain the town attor- ney's approval. (c) The town need not use formal or informal bidding to award a contractor except as expressly required by this chapter. (Ord. No. 510 N.S., § 2 (part)) 3A -3 Contract authority of the town manager. The town manager is authorized to negotiate and execute on the behalf of the town, without prior ap- proval of the town council, any contract: (a) For purchases, general services, public works, professional services or employment, or community, social or recreational services, and the total expenditure does not exceed forty thousand dol- lars, provided that such monies have been appropri- ated or budgeted for such purpose and there is an un- expended and unencumbered balance of such appro- priation sufficient to pay the expense of the contract; (b) For the lease oftown property for a period of less than six months, or for the use of town property or facilities for a period not to exceed five days, in accordance with town policy, which require no pay- ment of money by the town; (c) For settlement of a claim or litigation against the town, after consultation with the mayor, where the total expenditure does not exceed ten thousand dollars; (d) Allowing the right of entry onto town prop- erty. (Ord. No. 510 N.S., § 2 (part)) 3A -4 Contract authority of department heads. (a) The director of public works shall be author- ized to negotiate and execute contracts for the town for budgeted services, public works, supplies, materi- als and equipment required by his department up to a 3A -2 maximum of ten thousand dollars, provided that such monies have been appropriated or budgeted for such purpose and there is an unexpended and unencum- bered balance of such appropriation sufficient to pay the expense of the contract. (b) The chief of police, director of administrative services, town attorney and community development director shall be authorized to negotiate and execute contracts for the town for budgeted services, sup- plies, materials and equipment required by their re- spective departments up to a maximum of five thou- sand dollars, provided that such monies have been appropriated or budgeted for such purpose and there is an unexpended and unencumbered balance of such appropriation sufficient to pay the expense of the contract. (c) The town manager shall have discretion to lower the contract authority maximums in this sec- tion by written to the town official or officials in- volved, with a copy of said notice to the director of administrative services and the town attorney. (Ord. No. 510 N.S., § 2 (part)) 3A -5 Emergency contract procedures. (a) Except as set forth in subsections (b) and (c) of this section, the town manager is authorized to negotiate and execute on the behalf of the town, without prior approval of the town council, any con- tract for emergency purchases, services or public works projects, where the amounts are greater than set forth in section 3A -3(a) of this chapter. If the emergency requires letting a contract before the council can be convened, the town manager shall have the authority to let the contract notwithstanding the procedures set forth in subsections (b) and (c) of this section. In an emergency situation, this authority shall extend beyond appropriated or budgeted funds to the extent necessary to protect the health and safety of persons or property. (b) In the event of any emergency, the town council may proceed to enter into a contract for a minor public works project without giving notice for bids to let contracts. (c) In case of an emergency, the council may pass a resolution by a four -fifths vote of its members 15 (rihman Supp. No. 9, 9 -08) 3A -5 declaring that the public interest and necessity de- mand the immediate expenditure of public money to safeguard life, health or property. Upon adoption- of the resolution, it may expend any sum required in the emergency without complying with this chapter. (Ord. No. 510 N.S., § 2 (part)) 3A -6 Rejection of price quotations and bids. The town manager shall have discretion to reject any or all price quotations or bids presented for any contract for purchase of supplies, materials and equipment or for services. If the town manager re- jects all price quotations or bids, the town manager may, in his discretion, re- advertise for new price quo- tations or bids. If the town manager determines that the amount of price quotations or bids was excessive, he may enter into a contract at a lower price without re- advertising for price quotations or bids within his contract authority. In the event that such lower price exceeds the contract authority of the town manager, the manager may refer the contract at such lower price to the town council for award or take such al- ternate action with respect to the purchase as he de- termines to be in the town's best interests. (Ord. No. 510 N.S., § 2 (part)) Article H. Purchase Contracts for Supplies, Materials and Equipment 3A -7 Purchasing procedures. (a) Purchases of supplies, materials and equip- ment that exceed thirty thousand dollars shall, when- ever practicable, be based on at least three price quo- tations and shall be awarded on the basis of the price quotation most advantageous to the town. Price quo- tations may be solicited by direct mail requests to prospective vendors or by telephone. (b) The town may consider factors other than price in determining the most advantageous price quotation. These factors shall include, without limita- tion, the quality and performance of the subject sup- plies, materials and equipment; the ability of the ven- dor to complete the transaction in a timely fashion; quality of the vendor's performance in past transac- (Tiburon Supp. No. 9, 9 -08) 16 tions with the town or others; and the ability of the vendor to provide future maintenance, repairs, parts and service. (c) Price quotations shall not be required in any of the following circumstances: (1) In the judgment of the town manager, the solicitation of price quotations would for any reason be an idle act; (2) The purchase is for supplies, materials or equipment that can only be obtained from one vendor or manufacturer; (3) In the judgment of the town manager, there exist particular time considerations such that it ap- pears likely that the solicitation of price quotations would be contrary to the interests of the town. (Ord. No. 510 N.S., § 2 (part)) 3A -8 Optional alternative procedure for purchases which exceed twenty- five thousand dollars. For purchases of supplies, materials and equip- ment that exceed twenty-five thousand dollars, the town manager shall have the discretion to select a vendor pursuant to a formal bidding process, if the town manager determines that such a process is likely to be to the advantage to be in the town's inter- est. Such procedure shall incorporate the methods used for selecting a contractor for a public works pro- ject by formal competitive bidding, as determined to be applicable by the town attorney. (Ord. No. 510 N.S., § 2 (per)) Article III. Contracts for Services 3A -9 Service contract procedures. (a) Service contracts that exceed thirty thousand dollars shall, whenever practicable, be based on at least three price quotations and shall be awarded on the basis of the price quotation most advantageous to the town. Notwithstanding the foregoing, contracts for environmental review services may be let on the basis of two price quotations. Price quotations may be solicited by direct mail requests to prospective service providers or by telephone. (b) The town may consider factors other than price in determining the most advantageous price quotation. These factors shall include, without limita- tion, the quality and performance of the subject ser- vices, the ability of the provider to provide the ser- vices in a timely fashion; the quality of the provider's performance in past transactions with the town or others; and the ability of the provider to provide fu- ture related services that the town may require. (c) Price quotations shall not be required in any of the following circumstances: (1) In the judgment of the town manager, the solicitation of price quotations would for any reason be an idle act; (2) The contract is for services that can only be obtained from one provider; (3) In the judgment of the town manager, there exist particular time considerations such that it ap- pears likely that the solicitation of price quotations would be contrary to the interests of the town. (Ord. No. 510 N.S., § 2 (part)) Article IV. Minor Public Works Contracts 3A -10 Minor public works contracts which do not exceed thirty thousand dollars. Minor public works contracts that do not exceed thirty thousand dollars may be performed by the em- ployees of a public agency by force account, by ne- gotiated contract, or by purchase order. (Ord. No. 510 N.S., § 2 (part)) 3A -11 Informal bidding for minor public works contracts which exceed thirty thousand dollars. Minor public works contracts that exceed thirty thousand dollars shall be let according to this section. (a) The town shall maintain a list of qualified contractors, identified according to categories of work. This list shall comply with all criteria estab- lished by the California Uniform Construction Cost Accounting Commission. (b) All contractors on the list for the category of work being bid or all construction trade journals 3A -9 specified in section 22036 of the California Public Contracts Code, or both all contractors on the list for the category of work being bid and all construction trade journals specified in section 22036 of the Cali- fornia Public Contracts Code shall be mailed anotice inviting informal bids unless the product or service is proprietary. (c) All mailing of notices to contractors and con- struction tradejournals pursuant to subsection (b) of this section shall be completed not less than ten cal- endar days before bids are due. (d) The notice inviting informal bids shall de- scribe the project in general terms, how to obtain more detailed information about the project and state the time and place for the submission of bids. (e) The town manager shall have the authority to award informal contracts to contractors selected pur- suant to this section. (f) If all bids received are in excess of one hun- dred twenty-five thousand dollars, the town council may, by adoption of a resolution by a four -fifths vote, award the contract, at one hundred thirty -seven thou- sand five hundred dollars or less, to the lowest re- sponsible bidder, if it determines the cost estimate of the public agency was reasonable. If the lowest re- sponsible bidder's bid exceeds one hundred thirty- seven thousand five hundred dollars, or if the council does not adopt the necessary award resolution by four - fifths vote, the town shall re -bid the project us- ing the formal bidding procedure. The dollar amounts set forth in this subsection shall be automatically ad- justed to conform to the maximum set by section 22034(f) of the Public Contracts Code or its succes- sor statute regarding informal bidding ordinances. (Ord. No. 510 N.S., § 2 (part)) 3A -12 Alternative procedure —Minor public works contracts. Notwithstanding anything in this article to the con- trary, the town manager shall have discretion to let any public works contract by formal bidding as de- scribed in article V of this chapter. (Ord. No. 510 N.S., § 2 (per)) 17 (Tiburon Supp. No. 9.9-08) 3A -13 Article V. Major Public Works Contracts 3A -13 General. Major public works contracts shall be let by for- mal competitive bidding as required by the Local Agency Public Construction Act, Public Contracts Code sections 20100 et seq. (Ord. No. 510 N.S., § 2 (part)) 3A -14 Notice inviting bids. The notice inviting bids shall set a date for the opening of bids and shall be published at least twice, not less than five days apart, in a newspaper of gen- eral circulation, as required by statute. The fast no- tice shall be published at least ten days prior to the date of opening of bids. In addition to the foregoing, the notice shall be published in such other newspa- pers and journals as the town engineer determines are likely to solicit the most favorable bids. (Ord. No. 510 N.S., § 2 (part)) 3A -15 Bids — Rejection and re- advertisement. The council shall have the discretion to reject any bids presented and re- advertise- After rejecting bids, the council may pass a resolution by a four -fifths vote of its members declaring that the project can be performed more economically by the town's own forces, day labor, or the materials or supplies fur- nished at a lower price in the open market. Upon adoption of the resolution, the council need not re- advertise and may have the project done in the man- ner stated without further compliance with this chap- ter. (Ord. No. 510 N.S., § 2 (part)) 3A -16 Choice of identical bids. If two or more bids are the same and the lowest, the council may accept the one that it chooses. (Ord. No. 510 N.S., § 2 (part)) 3A -17 No bids received. If no bids are received, the council may have the project done without further compliance with this chapter. (Ord. No. 510 N.S., § 2 (part)) Cribmon Supp. No. 9,9-08) 18 3A -18 Bidders — Presentation and security. (a) All bids shall be presented under sealed cover. (b) All bids shall be accompanied by bidder's security in an amount equal to at least ten percent of the amount bid. The security shall be in the form of cash, a cashier's check payable to the town, a certi- fied check payable to the town or a bidder's bond executed by an admitted surety insurer, payable to the town. A bid will not be considered unless accom- panied by the required security. (c) If the successful bidder fails to execute the contract, the amount of bidder's security shall be for- feit to the town except as otherwise may be provided by law. (Ord. No. 510 N.S., § 2 (part))