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Home My WebLink About01-28-2014 pc HansenJAN 2 8 2014 I January 28, 2014 Dear Council Member, The attached three pages are samples of recently published material from disparate sources on the burgeoning threat to public health from non - FDA - approved nicotine delivery devices such as e- cigarettes. Briefly, an amendment is needed which would clarify that these devices are covered in our current tobacco use laws the same as regular such products. We have good model language for this sensible tweak. Thank you for your consideration. We stand ready to assist in any way. imp Stephen L. Hansen, M.D. San Luis Obispo County Medical Association San Luis Obispo County Tobacco Control Coalition 805 -544 -2737 hansens2@)pacbell.net AGENDA CORRESPONDENCE Date " *41tem# THE WALL STREET JOURNAL. CORPORATE NEWS r States.UrgeE CigfaretteRules Attorneys General Press FDA to Move Quickly to Keep Devices Away From Minors BY MIKE ESTM Attorneys general from 40 states urged the rood and Drug Administration on Tuesday to regulate the advertising, ingredi- ents and sale of electronic ciga- rettes to keep them out of the hands of minors. The call for action comes less than three weeks after a govern- ment survey showed that the percentage of high - school stu- dents who have tried a -ciga- rettes —which turn nicotine -laced liquid into vapor —rose to 106 last year from 4.7% in 2011. . The battery- powered devices aren't regulated by federal au- thorities, but the FDA is aiming to propose regulations by Oct. 31 for the relatively young but fast - growing alternative to tradi- tional cigarettes. Federal rules ban the sale of cigarettes to any- one under 18 and more than two dozen states have moved to bar e- cigarette sales to minors. Most researchers say a -ciga- rettes are less harmful than-tra ditional smokes, which release tar and other toxins through combustion Proponents say e- cigarettes are an effective way to wean smokers off of traditional cigarettes. But public -health officials say e- cigarettes could get more peo- ple hooked on nicotine and serve as a new gateway to smoking. Retail sales of e- cigarettes are expected to top $1 billion this year, a bit more than 1% of the overall U.S. tobacco market. Unlike regular smokes, a -ciga- rettes are sold on the Internet, and marketed on television They also come in a dizzying array of flavors, including chocolate and cherry. The FDA banned the sale of flavored cigarettes, with the exception of menthol, in 2009. in a letter to FDA Conunis- sioner Margaret Hamburg, attor- neys general from New York, Cal ifornia, Ohio and 37 other states asked the agency "to take all possible measures" to meet its stated Oct. 31 deadline for pro- posing regulations. The attorneys general ex- pressed concern that e-cigarettes are marketed on prime -time TV, "making it easier for those ad- vertisements to reach. children." They noted that some makers pitch e- cigarettes with the help of cartoon characters like mon- keys, years after makers of tradi- tional cigarettes were banned from using cartoons in their ads. The officials said e- cigarette flavors, such as gurnmy bear and 'manufacturers including Lorll- bubble grunt, appeal to youth. The lard Inc., maker of blu. and cost of e- cigarettes also has NJOY Inc. have come out in sup- Wien, snaking them more afford- able and attractive to teenagers, they added. Minnesota is the only state with a special a -ciga- rette tax, in contrast to tradi- tional cigarettes, which are taxed heavily at the state and federal level. Rechargeable e-cigarette kits require a larger initial invest- ment than a pack of regular ciga- rettes but typically are cheaper over time. Disposable a -ciga- rettes are often priced similarly to traditional cigarettes. Several leading , e- cigarette port of age limits and say they don't market their products to youth but advertise on TV. Loril- lard has defended the use of fla- vors and says it requires age ver- ification for online sales. The attorneys general noted that nicotine is "highly addic- tive" with "immediate biu -them- ica1 effects on the brain and body," citing a U.S. Surgeon Gen- eral report- Public- health author- ities say nicotine can affect the neurological development of ml- nors and recommend that preg- nant women abstain. News & Analysis Medical News & Perspectives ........ p123 Lab, Field, & Clinic ...........................p127 Experts Call for Research Plus Regulation of e- Clgarettes CDC: Use of Emerging Tobacco Products Increasing Among US Youths Researchers Describe Novel Interventions to Improve Healthy. Lifestyle Choicer in Diverse Settings US Views Shift on End -of -Life Care news @JAMA: From JAMA's Daily News Site New Compound Inhibits Eluslve Proteln Behind Many Cancers Capitol Health Call ..........................pl28 GAO: Better Coordination Needed to Avoid, Duplicate Autism Research GAO: VA Peer Review Process After Adverse:. Events Not Working - -, Preemles, Pediatric Research, Retired Chimps to Benefit From New Law . The Drug Quality and Security Act Becomes Law News From the CDC ........................p129 -. Epilepsy Linked Wlth Comorbidlties Cyclosporlasis Outbreaks Traced to Salad Mix, and Cilantro in Salsa Medical News & Perspectives Experts Call for Research Plus Regulation of e- Cigarettes Tracy Hampton, PhD ecause using a product that can cause addiction to nicotine is gen- erally a bad idea, it stands to reason that people should steer clear of electronic cigarettes, which provide doses of nicotine and other additives in an aerosol form. On the other hand, for current smokers, the bat- tery- powered devices that contain notarand fewer toxins might offer a less unhealthy al- ternative to traditional cigarettes. Regulators, public health officials, and clinicians are struggling with these and other complexities associated with e- cigarettes as they work to regulate the products and ad- vise individuals concerning their use. "I started out agnostic on these Issues: said Stanton Glantz, PhD, director of the Center for Tobacco Control Research and Education at the University of California, San Francisco. Based on what he knows now, he says, "the bottom line is that e- cigarettes seem like a good idea but probably aren't" Glantz and others are gathering impor- tant data on the potential risks and ben- efits of e- cigarettes to help inform the dis- cussion about these products and to determine whether e- cigarettes deliver promise or peril —or perhaps a bit of both. (See also Viewpoint on e- cigarettes in this is- sue.) Less Toxic but Still Dangerous No one questions whether e- cigarettes are less toxicthan tobacco -based cigarettes. "It's a reasonable assumption that if smokers switch completely, it would benefit their health;' said Tim McAfee, MD, MPH, who is the director of the office on smoking and health at the Centers for Disease Control and Prevention (CDC). But studies consistently reveal that most people who use e- cigarettes are so- called dual users, meaning that they use e- cigarettes as well as paper- and -tar ciga- rettes (Regan AK et al. Tob Control. 2013; 22[1]:19 -23; Vickerman KA et al. Nicotine Tob Res. 2013;15[10]:1787 -1791; Pearson JL et al. Am J Public Health. 2012;102[9]:1758 - 1766). And because smoking - related cardio- vascular and cancer risks depend more on how long people smoke than on how much they smoke, dual users are unlikely to gain health benefits from smoking a few less tra- ditional cigarettes each day (Bjartveit K, Tver- dal A. Tob Control. 2005;14[5]:315 -320). It's also questionable whether e- cigarettes can be a more effective smoking cessation aid than other nicotine cessation products for smokers who want to quit.. The only randomized clinical trial that com- pared e- cigarettes with conventional nico- tine patches found no statistically signifi- cant difference in the ability of smokers to quit when they used e- cigarettes or nico tine patches (Bullen C et al. Lancet. 2013; 382[99051:1629- 1637). Even if e- cigarettes could provide ben- efits to some adult smokers, officials say that the biggest problem with e- cigarettes per- tains to adolescents, in whom nicotine use can have harmful effects on brain develop- ment. A recent CDC report revealed that the proportion of middle and high school stu- dents who have used e- cigarettes doubled to nearly 7 %, or almost 2 million, between 2011 and 2012 (CDC. MMWR Morb Mortal The use of e- cigarettes has increased sharply in recent years, with revenues doubling every year since 2008. lama.com JAMA January 8, 2014 Volume 311, Number 2 123 E- Cigarettes: What are You Smoking? Electronic (e -) cigarette proponents now appear to be behind the "harm reduction" agenda, a push to promote e- cigarettes and other smokeless tobacco products as safer alternatives for smokers. The concept of "reduced harm "to the smoker is misleading given the limited amount of research on the potentially negative health effects of e- cigarettes and their efficacy as a cessation tool. Recent research on the constituents of e- cigarettes shows that the product contains lead, chromium, nickel, and other metals, as well as silicate particles, so while some may believe the product is "safer," use of the product certainly isn't risk -free. "Harm reduction" also does not address ANR's concerns about the impact of "secondhand vapor" on public health. What are workers and bystanders exposed to in the "vapor mist "when one or more people are smoking e- cigarettes? Also, if the product is designed simply to provide current smokers with an alternative to tobacco cigarettes, then why is it offered in flavors like bubble gum, fruit punch, and green apple? Science and internal tobacco industry documents tell us that kids dis- like the taste of tobacco and love sweet flavors. Flavorings, except for Menthol, are now banned in tobacco cigarettes; e- cigarettes also should not be allowed to contain flavorings that are preferred by young people and entice them to experiment with the product. The perception of reduced harm leads to greater experimentation, which can lead to nicotine addiction and resultant morbidity and mortality. Our youth have been educated about the health risks of smoking and exposure to secondhand smoke, but given the recent emergence of e- cigarettes and the virtually unchallenged online media marketing campaigns and promotions (via Twitter, YouTube, and Facebook), neither youth nor adults are being properly educated about the product itself or about the tobacco industry's involvement in the e- cigarette market. There are hundreds of e- cigarette manufacturers, and tobacco companies are quickly getting into the business; including Lorillard, which bought Blu•e;-cigarettes, RJ Reynolds, which is developing ' Vuse, and Altria, which recently announced its plans to introduce an e- cigarette by the end of 2013. Some e- cigarette companies are also using old tobacco industry tactics to legitimize the product: such as NJOY has hired former Surgeon General Richard Carmona to serve on its Board of Directors. Determining the safety of e- cigarettes is further complicated by the fact that no two e- cigarettes are alike. E- cigarettes are an unregulated product designed to deliver nicotine to the user. Nicotine cartridges are heated via a lithium battery and there have been several instances of Reducing Thirdhand Smoke's Health Risks, Brick by Brick New York's Grand Central Terminal can boast two "landmark" mile- stones in 2013. First, it turned 100. Second, it quit smoking a decade ago. On this, the centennial anniversary of its opening, and decennial anniversary of New York City's Smoke -free Air Act, Grand Central stands restored to its former grandeur. Generations of accumulated black grime have been stripped to expose a beautifully, elaborately painted ceiling. Only a small dark patch of bricks remains as an intentional reminder of what was obscured for so long. Grand Central's black- bricked ceiling was thought to have resulted from the accumulation of coal and diesel smoke. In fact, spectroscopic examination revealed the grime to be highly toxic tar and nicotine residue from tobacco smoke. This clingy "thirdhand smoke" residue remained, decades after the smoke that created it dissipated. Thirdhand smoke brings with it a new set of previously uncontemplated health risks. In the 1980s, tobacco tar was discovered to harm aircraft comput- ers and safety equipment mechanisms. More recent research shows that as smoke residue ages, its carcinogenic nitrosamines, benzene- deriva- tives, and nicotine react with ozone in the air to transform these already carcinogenic chemicals into new toxic substances. We may not all live to Grand Central's age of 100, but since New York City adopted its smokefree law 10 years ago, life expectancy has reached an all -time high, with 400,000 fewer smokers and 1,500 fewer tobacco - related deaths per year. As the City is flourishes, with 10,000 more restaurants, we are only beginning to uncover the obscured layers of health benefits attributable to the elimination of thirdhand smoke. Smoking Strikes Out The Maryland Stadium Authority announced in February that smoking would be prohibited at Camden Yards, the home of the Baltimore Orioles, thus continuing a recent trend whereby smoking has either been eliminated altogether or severely restricted at every Major League Baseball stadium. Twenty -one of the thirty stadiums are completely smokefree within the entrance gates and no stadium allows smoking in the seating areas. Among the better known ballparks that are 100% smokefree are Fenway Park in Boston, Wrigley Field in Chicago, Dodger Stadium in Los Angeles, Yankee Stadium in New York, and AT &T Park in San Francisco. Comerica Park in Detroit would qualify as a smokefree stadium but for its cigar bar. Moreover, in recognition of the potential dangers of electronic cigarettes and the confusion they create when used in areas where smoking is prohibited, ten stadiums restrict the use of electronic cigarettes to the same extent as the use of the battery exploding in the users mouth. In recognition of the poten- tobacco products. In addition to whatever penalties may be prescribed tial dangers of e- cigarettes, their use is prohibited on most airlines, and for violations under city and state laws, several stadium policies call for many cities and states are now including e- cigarettes in the definition ejection of violators, fines, and in one case, even revocation of season of "smoking" in their smokefree laws. Some communities are prohibiting tickets. Clearly, nonsmokers have hit a home run when it comes to their sale to minors and considering excise taxes on the product as well. breathing easy at the ballpark. ANR UPDATE Volume 32, Number 2 — Summer 2013