October 26, 2014
Stanton A. Glantz, PhD
American Industrial Hygiene Association recommends e-cigs be included in clean indoor air laws and policies
The American Industrial Hygiene Association just published a white paper, Electronic Cigarettes in the Indoor Environment, that contains an excellent review of the current state of the science on -cigarette emissions.
Here is the executive summary:
Executive Summary
Electronic-cigarettes (e-cigarettes) are battery-powered devices of many different configurations that deliver vaporized nicotine and other chemicals or flavorings to users, but that do not contain tobacco or require combustion. E-cigarettes have an internal, rechargeable, battery-operated heat source that converts liquid nicotine and/or flavorings into a mist or vapor that the user inhales. These devices are frequently promoted as a healthier or safer alternative to traditional cigarettes for users and bystanders. Consequently, there has been growing interest among manufacturers and others to allow e-cigarettes to be used indoors and in other settings where traditional cigarettes have previously been banned. There has, however, been conflicting and at times confusing information presented to the public regarding the public health risks and benefits associated with e-cigarettes. This white paper attempts to present the best available science on the subject today.
The use of e-cigarettes (or “vaping”) has seen an unprecedented increase worldwide. Vaping has been promoted as a beneficial smoking cessation tool and/or an alternative nicotine delivery device that contains no combustion byproducts. However, nicotine is highly addictive. Furthermore, available research indicates that vaping solutions and their emissions may contain much more than just nicotine, including aerosolized flavorings, propylene glycol, and other intentional and unintentional contaminants. These ingredients could present an as-yet undefined health hazard to both users and bystanders.
Whereas e-cigarette use and exposure may lower some or most risks associated with conventional cigarette use, the health effects of nicotine and aerosol exposures from e-cigarettes are not well-understood at this time. Current research indicates that vaping aerosols are not without risk, especially for nearby persons in areas with limited ventilation and persons with compromised health conditions. Limited published studies that evaluated the potential hazardous effects of the natural and/or synthetic chemicals used in e-cigarettes indicate that there are potential health effects reported for both users and those exposed secondhand.
Multiple scientific reports express the need for more research. There are several key data gaps and areas of uncertainty that hinder a more quantitative assessment of health risks related to e-cigarettes at this time. These include:
• Quality control of these products is lacking for both product constituents and labeling.
• Laboratory studies may not reflect actual exposures during use because of the variability in types of devices, user vaping habits and duration, and because many users mix their own vaping solutions.
• There is limited data on chemical emissions/thermal degradation products/exposures (especially among bystanders and in confined indoor settings).
• There is little information on the dynamics of pre and post respiration aerosols and their fate in the environment.
• There is limited information on dose-response relationships for many constituents, such as short- or long-term health effects associated with low-level exposures, including those for vulnerable populations.
• There is little or no information about the health effects of flavorings that are inhaled rather than ingested.
• There is little information about the synergistic effects from e-cigarette contents and other environmental contaminants.
Note that these issues are related only to an assessment of human health risks. They do not incorporate other potentially important factors, such as public risk perceptions, risk management options/control measures (e.g., ventilation), and nicotine dependence. In addition, serious safety issues have been reported and need to be addressed, including child safety and poisonings, battery explosions, and the potential for the vapor to set off smoke alarms.
Given this review of available information, the existing research does not appear to warrant the conclusion that e-cigarettes are “safe” in absolute terms. Although they may provide a “safer” alternative to tobacco cigarettes for the user, these products emit airborne contaminants that may be inhaled by both the user and those in the vicinity of vaping. Many of the data sources reviewed confirm that e-cigarettes are not emission-free and that their pollutants could be of health concern for users and those who are exposed secondhand. Clearly, e-cigarettes lack the combustion products produced by smoking tobacco, many of which are associated with cancer development. Although nicotine may not cause cancer, it is associated with other adverse physiological effects. In addition, the other components in e-cigarettes may not be without risk, particularly when they are inhaled rather than ingested. Therefore, e-cigarettes should be considered a source of volatile organic compounds (VOCs) and particulates in the indoor environment that have not been thoroughly characterized or evaluated for safety.
The Food & Drug Administration (FDA) currently regulates only e-cigarettes that are marketed for therapeutic purposes. However, the FDA has proposed a rule extending its tobacco product authorities to include other products like e-cigarettes and the World Health Organization (WHO) has recommended that consumers be strongly advised not to use electronic nicotine delivery systems, including e-cigarettes, until they are deemed safe and effective and of acceptable quality by a competent national regulatory body. Although several agencies and organizations have adopted restrictions on the use of e-cigarettes in public places, there is currently no U.S. federal law or regulation that explicitly bans the use of e-cigarettes on airplanes, railroads, buses, or other modes of transportation.
Because of concerns about primary and secondary exposure to e-cigarette vapors and liquids (also called “e-juices”), AIHA supports risk-based regulation of e-cigarettes using reliable safety, health, and emissions data. Four areas of risk based regulation relating to the safety of primary users and people exposed to secondhand vapors or e-juices should be considered:
1. Physical/Electrical Hazards - All e-cigarette devices, whether they are being used for therapeutic or recreational purposes, should be evaluated for potential physical and/or electrical hazards by applicable regulatory agencies.
2. Accidental Exposure - The health risks and economic consequences of accidental exposure to e-juice liquids by children, adults, and pets should be addressed, including proper labeling and child-resistant packaging requirements.
3. New Product/New Chemical Use - All future e-juice components that may be used by consumers should be fully evaluated for any potential hazards (e.g., toxicity, flammability, safety hazards, and secondary exposures) prior to introduction into the marketplace.
4. Relationship to Current Smoking Bans - Because e-cigarettes are a potential source of pollutants (such as airborne nicotine, flavorings, and thermal degradation products), their use in the indoor environment should be restricted, consistent with current smoking bans, until and unless research documents that they will not significantly increase the risk of adverse health effects to room occupants. [emphasis added]
Comments
I.Burnstyn Review . . . .
Thank you for posting http://tobacco.ucsf.edu/american-industrial-hygiene-association-recommen... : it appears to totally justify why here:
http://www.itv.com/news/london/2014-10-22/e-cigarettes-are-banned-on-all...
and here
http://metro.co.uk/2014/10/19/starbucks-has-banned-e-cigarettes-after-he...
Companies in the UK are banning the use of electronic cigarettes in “Indoor Areas”. However, here:
http://www.thegrocer.co.uk/fmcg/tobacco/o2-academies-to-sell-blu-e-cigs-...
it appears that not all are behaving in accordance with the most recent, evidence-based Reviews. Maybe the 02 Academies will Review the new interpretations.
It might be that they are still erroneously being guided by “Reviews” such as this
http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08.... by I. Burnstyn: a “Technical” Report from July/August 2013, which the AIHA Statement mentions early on.
Unfortunately, the Burnstyn paper is still cited by influential Organisations, such as ASH England here http://www.ash.org.uk/files/documents/ASH_715.pdf";http://www.ash.org.uk... who use the paper (and others) to justify the claim that the toxins found in electronic cigarettes:
“. . .are at levels much lower than those found in cigarettes and not at levels which would generally cause concern.”
Ardent electronic cigarette advocates such as Clive Bates here http://nicotinepolicy.net/clive-bates/2523-who-position-on-ends-a-critiq... also still cite this as the key paper. Here, Bates claims that:
“ . . . [The WHO] has no science to justify an indoor vaping ban” and, specifically with regard to the Burnstyn paper, he states that:
“Without any justifiable reason, WHO has not cited the most authoritative overall assessment of vapour toxicity to date, which concluded that active vaping was low risk, and that exposure to bystanders would be “orders of magnitude less”.
As has been previously identified here http://www.tobacco.ucsf.edu/glantz-letter-la-city-council-supporting-the... , the Burnstyn paper utilises an erroneous outcome measure.
“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.”
<STRONG;This analysis has been clearly supported by the new AIHA Statement. It states that (p7/8):</strong;
“OSHA regulates exposure to nicotine in the workplace to less than 0.5 mg/m3 (500 μg/m3) for the industrial workplace, and the American Conference of Governmental Industrial Hygienists publishes a Threshold Limit Value for nicotine at the same level for an eight-hour time-weighted average (TWA).[37] However, ANSI/ASHRAE Standard 62.1-2013 <EM;– Ventilation for Acceptable Indoor Air Quality (IAQ)</em;, applicable to office buildings, schools, larger multifamily housing, and many other spaces, cautions that the OSHA standards and ACGIH guidelines are intended to limit worker exposure to injurious substances at levels that do not interfere with the industrial work process and do not risk the workers’ health and safety. These standards and guidelines do not attempt to eliminate all effects, such as unpleasant smells or mild irritation.[38] Therefore, the target population and use of these standards and guidelines are different from those for the populations of many public and commercial buildings.[38] . . . . . . “OSHA standards are based on working with nicotine occupationally, so they are not entirely applicable or appropriate for IAQ irritation, nuisance, and exposure purposes.”
I moreover note, at the end of the Burnstyn Review, it states that:
“Funding for this work was provided by The Consumer Advocates for Smoke-free Alternatives Association (CASAA) Research Fund. CASAA is an all-volunteer, donation-funded, non-profit organization devoted to defending consumer access to and promoting tobacco harm reduction; for more information, see http://casaa.org/" title="http://casaa.org/";http://casaa.org/. CASAA exercised no editorial control over the author’s writing or analysis: the author, not the funder, had full control of the content. The author is thankful to Dr Carl V Phillips, the CASAA Scientific Director, for frank discussion of relevant scientific matters . . . . “.
It is interesting to reflect, therefore, that in this very recent Review http://www.sciencedirect.com/science/article/pii/S0091743514003739";http... the authors highlight that:
“A substantial number of studies were published by authors with a conflict of interest and we must exercise the utmost caution in trusting their conclusions.”
David Bareham
connections
CASAA loves to portray itself as a grassroots organization. It may once have been that. However it accepts and receives funding from the smoking device industry:
http://www.theverge.com/2013/3/11/4079010/vaporware-why-we-still-dont-kn... title="http://www.theverge.com/2013/3/11/4079010/vaporware-why-we-still-dont-kn......
It provides materials and organization for lobbying by device trade groups:
http://sfata.org/fdaguidance/" title="http://sfata.org/fdaguidance/";http://sfata.org/fdaguidance/
And it has ties to the tobacco industry, e.g. its board members Rodu and Phillips.
Burstyn's "review" was not only funded by CASAA. CASAA created the project ("commissioned our own paper") and chose the scientist:
http://vaping.com/blog/casaa-funded-research-finds-electronic-cigarettes... title="http://vaping.com/blog/casaa-funded-research-finds-electronic-cigarettes......
http://casaa.org/uploads/About_CASAA_Flyer.pdf" title="http://casaa.org/uploads/About_CASAA_Flyer.pdf";http://casaa.org/uploads...
http://www.aviatorclub.com/exclusive-interview-with-founding-member-of-c... title="http://www.aviatorclub.com/exclusive-interview-with-founding-member-of-c......
Burstyn admits CASAA had input into the review: "CASAA was asked to review the retrieved bibliography to identify any reports or articles that were missed"
http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08....
http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08.pdf
Burstyn admits more input came from CASAA "Scientific Director" Carl V. Philips:
http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08.... http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08.pdf
Phillips has a long history of ties to the tobacco industry:
http://www.tobaccotactics.org/index.php/Carl_V_Phillips" title="http://www.tobaccotactics.org/index.php/Carl_V_Phillips";http://www.toba...
Burstyn was subsequenly given a board seat by CASAA:
http://blog.casaa.org/2014/10/casaa-welcomes-brad-rodu-and-igor.html" title="http://blog.casaa.org/2014/10/casaa-welcomes-brad-rodu-and-igor.html";ht...
along with Brad Rodu, a major recipient tobacco industry "science" funding.
Funding "science" that creates the appearance of scientific controversy is SOP for tobacco industry. When it was convicted of racketeering, a key part of the case against it was its funding of "science" that misled the public:
http://publichealthlawcenter.org/sites/default/files/resources/doj-final... title="http://publichealthlawcenter.org/sites/default/files/resources/doj-final......
The tobacco industry has a long history of blowing smoke. I suggest the smoking device industry is equally capable of blowing fog.
So when I hear Burstyn's "review" chose TLVs, a metric that made his sponsor's product look OK, I am not surprised.
And when I see Burstyn cited over and over, usually by parties with clear interests, as if it were an independent scientific work to be given equal weight with any other, I remember 50 years of CTR and CIAR and the ETS Consultants Program. Scientists disagree! Look here's this scientist who says otherwise. Endless "studies" cited with implausible conclusions, and when you looked at them, you found industry money. For decades, on and on.
And my hope is we cut to the chase a little faster this time.
conflicts of interest
CASAA accepts and receives funding from the smoking device industry:
http://www.theverge.com/2013/3/11/4079010/vaporware-why-we-still-dont-kn... title="http://www.theverge.com/2013/3/11/4079010/vaporware-why-we-still-dont-kn......
CASAA provides materials and organization for lobbying by device industry trade groups:
http://sfata.org/fdaguidance" title="http://sfata.org/fdaguidance";http://sfata.org/fdaguidance
Burstyn's "review" was not only funded by CASAA. CASAA created the project ("commissioned our own paper") and chose the scientist:
http://vaping.com/blog/casaa-funded-research-finds-electronic-cigarettes... title="http://vaping.com/blog/casaa-funded-research-finds-electronic-cigarettes......
http://casaa.org/uploads/About_CASAA_Flyer.pdf" title="http://casaa.org/uploads/About_CASAA_Flyer.pdf";http://casaa.org/uploads...
http://www.aviatorclub.com/exclusive-interview-with-founding-member-of-c... title="http://www.aviatorclub.com/exclusive-interview-with-founding-member-of-c......
CASAA had input into the review: "CASAA was asked to review the retrieved bibliography to identify any reports or articles that were missed"
http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08.... title="http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08....
CASAA had more input into the review from its "Scientific Director" Carl V. Philips:
http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08.... title="http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08....
http://www.tobaccotactics.org/index.php/Carl_V_Phillips" title="http://www.tobaccotactics.org/index.php/Carl_V_Phillips";http://www.toba...
Burstyn was subsequently given a board seat by CASAA:
http://blog.casaa.org/2014/10/casaa-welcomes-brad-rodu-and-igor.html" title="http://blog.casaa.org/2014/10/casaa-welcomes-brad-rodu-and-igor.html";ht...
Jon Krueger
Conflict of interests in peer review process?
Regarding Burstyn "systematic review" (BMC Public Health. 2014; 14:18, URL: http://www.biomedcentral.com/1471-2458/14/18" title="http://www.biomedcentral.com/1471-2458/14/18";http://www.biomedcentral.c...), was peer reviewed, as available from its pre-publication history (http://www.biomedcentral.com/1471-2458/14/18/prepub" title="http://www.biomedcentral.com/1471-2458/14/18/prepub";http://www.biomedce...), by Peter Hajek and Konstantinos Farsalinos.
This is an example of what I (and surely other colleagues) have noted in the last months: the publication of papers, notably most of them in favour of e-cigarettes, in journals in which the editors or the scientific reviewers are also positioned in favour of e-cigarettes and have clear links with the authors of the papers or other competing interests. The recent review in "Preventive Medicine" by Pissinger & Dossin, mentioned in David Barehan's previous comment, identifies this topic that needs further investigation.
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