Paper: ENDS use and awareness in the USA [Tobacco Control]

[Tom09]

AK Regan, G Promoff, SR Dube, R Arrazola: Electronic nicotine delivery systems: adult use and awareness of the ‘e-cigarette’ in the USA. Tobacco Control, online first, October 27, 2011.

Background: Electronic nicotine delivery systems (ENDS), also referred to as electronic cigarettes or e-cigarettes, were introduced into the US market in 2007. Despite concerns regarding the long-term health impact of this product, there is little known about awareness and use of ENDS among adults in the USA.

Methods: A consumer-based mail-in survey (ConsumerStyles) was completed by 10 587 adults ($18 years) in 2009 and 10 328 adults in 2010. Data from these surveys were used to monitor awareness, ever use and past month use of ENDS from 2009 to 2010 and to assess demographic characteristics and tobacco use of ENDS users.

Results: In this US sample, awareness of ENDS doubled from 16.4% in 2009 to 32.2% in 2010 and ever use more than quadrupled from 2009 (0.6%) to 2010 (2.7%). Ever use of ENDS was most common among women and those with lower education, although these were not the groups who had heard of ENDS most often. Current smokers and tobacco users were most likely to try ENDS. However, current smokers who had tried ENDS did not say they planned to quit smoking more often than smokers who had never tried them.

Conclusions: Given the large increase in awareness and ever use of ENDS during this 1-year period and the unknown impact of ENDS use on cigarette smoking behaviours and long-term health, continued monitoring of these products is needed.

What this paper adds?
Besides US population data on awareness and use,
showing off how staffers of a federal agency (CDC) frame the e-cig issue.

 

[rothenbj]

"Ever use of ENDS was most common among women and those with lower education, although these were not the groups who had heard of ENDS most often."

Ima postugating that I are one of dem lowly edumacated thet stumbled inder thar classamaction.

 

[Placebo Effect]

In trying to find the full text to no avail, I found the results of a survey done by Legacy that they presented at the 2011 SRNT Conference.

http://www.legacyforhealth.org/Ecigs.pdf

This seems to be a study of only former and current smokers, thus maybe explaining the differences in conclusions.

CONCLUSIONS

• While e-cigarette awareness is relatively widespread, e-cigarette use is concentrated among Whites, males, and those with a college degree.

• Women are less aware and less likely to use e-cigarettes than men, but their perception of harm from e-cigarettes does not differ.

• Compared to non-Hispanic Whites, awareness and use among non-Hispanic Blacks is low. Risk perception data demonstrates that non-Hispanics Blacks are more likely to have negative harm perceptions attached to e-cigarettes than non-Hispanic Whites.

• This data suggests that as many as 4 million former and current smokers may be using a device with unknown health risk impact. We recommend inclusion of of awareness, use, and harm perception items in national datasets to follow the potential public health impact of e-cigarettes on initiation and interest in cessation, especially among young adults.

Of the various categories, only 3 categories of people had 50% thinking that e-cigs were less harmful than cigarettes: whites, those aged 18-24, and those with 'Some college.' Current smokers and former smokers were nearly identical at 46% and 44.9%.

What percent of smokers / former smokers think smokeless tobacco is less harmful than cigarettes? I know I've seen the numbers before, and they're a heck a lot lower than 50%.

 

[rothenbj]

The study appears to grow the body of evidence that there is a boogie man in the closet and we just don't know how dangerous these ENDS might be, but studies like Prue Talbot and the FDA's study as well as every other TC freak indicate we need to keep including legislation wherever we can get away with it to treat them just like cigarettes. The only thing I saw that they missed was NJ's public e cig ban. After reading this, I'm getting the feeling we'll be hearing something from the SG next year addressing the eminent danger posed by this product.

The one thing I didn't see, unless I totally missed it, was a breakdown of their stratification of survey population. They went through the task of defining smokers and tobacco users and dual users. They went through defining ever smokers and never smokers (the magic 100 cigarettes in a lifetime).

However, I saw no breakdown of the actual number of people that they surveyed in each of these categories. What good are statistics if they don't represent a working population. If I have 1m apples in the world and 250k oranges and decide to study the condition of my various fruit so have 1,000 pieces pulled based on the age of the fruit and where it was grown, and state the apples were twice as insect infested, what does that mean? Were 4 times more apples in the sample or were an equal number of apples and oranges picked. What do any comparative numbers mean?

Current cigarette smokers were 2.5 times as likely as never-cigarette smokers to have heard of ENDS and were almost six times as likely to have tried and three times as likely to have used ENDS in the past month.

emphasis mine

Does this mean that nearly the same proportion of never smokers to smokers that heard of ENDS had tried them in the past month? My anecdotal evidence indicates that not one never smoker that I introduced to my PV has ever been overcome with curiosity to try one in the last month. After all, that might eventually be considered one of those equal to or more than 100 "cigarettes" that moves you from never, never land into the ex-smoker category that increases your chance of dying from a smoking related disease by 10-35%. Who would take such a risk?

Since they didn't give any breakdown on the smokers to ever and never smokers, you can't even get a feel for overall E cig prevalence in the smoker community and it would have been great to see a question 4. "Have you used any of the smokeless products to refrain from smoking cigarettes for over six months"

Incidentally hookah users were considered tobacco users regardless of what they're smoking. According to Erin L. Sutfin, Ph.D., an assistant professor in the Department of Social Sciences and Health Policy in his 2011 study, 40.3 percent of college and university students surveyed had smoked tobacco from a hookah.*

*Wake Forest Baptist Medical Center (2011, April 5). Hookah use widespread among college students; Study reveals mistaken perception of safety in potential gateway drug.

Boy is that going to start throwing some TC stats into a spiral.

 

[Placebo Effect]

Another good bit

However, our results revealed inconsistent demographic patterns between awareness and use of ENDS; although men and young adults were more aware of ENDS, they did not try this product more often. These inconsistencies may indicate that ENDS do not necessarily appeal to the demographic groups who are more aware of ENDS somehow, perhaps by exposure to ENDS advertising.

ENDS may also impact the initiation of tobacco use. One in 28 never-smokers in our sample had tried ENDS.

Ohhhh no.

It is too soon to determine the long-term health effects of ENDS; however, preliminary studies have observed the presence of glycerin, genotoxins, known carcinogens13 and diethylene glycol14 in some ENDS, which can be harmful to humans. Specifically, diethylene glycol, which has been found in a few batches of ENDS manufactured in China, has caused mass poisonings and deaths in the past when substituted for propylene glycol.

Ummm ... This is false and they should issue a retraction.

The US Department of Transportation has proposed banning the use of ENDS on airplanes, and although some states, including New York, have considered banning the use of ENDS in public places, no state or locality has yet enacted such a policy.

Wow, really?

 

[rothenbj]

"Specifically, diethylene glycol, which has been found in a few batches of ENDS manufactured in China"

I meant to point that out and forgot. I tracked down their reference and it was a general reference to DEG. Somehow they managed to go from 1 cartridge out of 18 tested by the FDA researchers that found 1% DEG in the liquid only, to a few batches. As I said, this study does little to identify who the real boogie men are.

 

[Vocalek]

Current smokers were defined as adults who reported smoking $100 cigarettes in their lifetime and currently smoke
everyday or some days;

Some days? I'm sorry, but anyone who can go for an entire day (or more) without smoking isn't a "current smoker" in my book.

Anyone who smokes "some days" is a chipper. Word Spy - chipper


Lumping "chippers" together with daily smokers and calling them "current smokers' skews interpretation of results. For example, folks who smoke once a week only when they go to a bar might be more inclined to have no intention of ever quitting than someone who is feeling the health effects of daily smoking.

 

[tommy2bad]

For example, folks who smoke once a week only when they go to a bar might be more inclined to have no intention of ever quitting than someone who is feeling the health effects of daily smoking.

Social Smokers, I know them. They only smoke 'lights' they never have a lighter and haven't bought any cigs since packs of 10 went off the shelves.
Haven't come across the term chipper before, well I have but over here its a take away fries shop. We call them mooches.

 

[Placebo Effect]

I spoke to the CDC's Gabbi Promoff, who is listed as an author and the contact person on the article.

She apparently wasn't the lead author. I told her that the false claim about diethylene glycol needed to be retracted, and noted that the line that "a few batches" were found to be contaminated with DEG would be reproduced in model legislation and used in local bans across the country. I told her that if this wasn't corrected for the print version, the end result would likely me a variety of people on the Internet (excluding myself, of course) calling her a liar, and that information being publicly available by anyone searching her name on Google.

She said she'd look at the FDA report and then contact the lead author in the next couple of days to see about changing it in the version that will be published in Tobacco Control.

 

[Vocalek]

Gee. The New York Times has fact checkers, but Tobacco Control can't afford them? Perhaps they believe that their unpaid peer reviewers will get the job done.

 

[Tom09]

A remark concerning the "specifically, diethylene glycol, which has been found in a few batches of ENDS manufactured in China", discussed as a sidetrack in this thread:
Regan et al. 2011 are actually accurate on this factoid, as presented. One sample has been documented in FDA’s 2009 lab report („Diethylene Glycol was detected in one sample (Smoking Everywhere 555 High cartridge) at approximately 1%“ (Westenberger 2009), additional sample reported in FDA’s 2010 warning letter to Cixi E-Cig („presence of DEG in the Vitamin C E-liquid„ „fivefold in excess of the USP upper limit for DEG in Propylene Glycol and Glycerin“ [i.e > 5 x 0.1%], Levy 2010). Regan et al. may have missed to add specific references to their „a few batches“ sentence. However, authors have cited the related FDA press releases (2009 & 2010) at various places in their paper, showing that they are fully aware of this preliminary, not formally published data.
We should, therefore, not argue against CDC authors‘ 2011-ish sample count.

 

[MattZuke]

I spoke to the CDC's Gabbi Promoff, who is listed as an author and the contact person on the article.
....
She said she'd look at the FDA report and then contact the lead author in the next couple of days to see about changing it in the version that will be published in Tobacco Control.

I tossed her a link to the FDA study, which only included the "about 1%" claim for S.E. 555. I don't have the source for the actual figure, but suggested she do a lab study to see if 2% nicotine, 1% DEG, 97% PG would even vaporize at 60C.

 

[MattZuke]

http://tobaccocontrol.bmj.com/conte...44.full.pdf?keytype=ref&ijkey=vBfoTedk2pcAB1I

gabbi.promoff (gabbi.promoff@cdc.hhs.gov) has asked for fact checking.

 

[MattZuke]

Matt,

Thank you for sending this to me and for such a fast response.

Would you mind taking a look at the article and the statement in question and let me know your thoughts on its accuracy? I pasted the specific statement in question below...

http://tobaccocontrol.bmj.com/cgi/r...2011-050044?ijkey=vBfoTedk2pcAB1I&keytype=ref

Specifically:

Specifically, diethylene glycol, which has been found in a few batches of ENDS manufactured in China, has caused mass poisonings and deaths in the past when substituted for propylene glycol.15

Which is found in the paragraph that reads:

It is too soon to determine the long-term health effects of ENDS; however, preliminary studies have observed the presence of glycerin, genotoxins, known carcinogens13 and diethylene glycol14 in some ENDS, which can be harmful to humans. Specifically, diethylene glycol, which has been found in a few batches of ENDS manufactured in China, has caused mass poisonings and deaths in the past when substituted for propylene glycol.15 Other studies have shown that ENDS brands vary in terms of chemical delivery and their ability to suppress nicotine withdrawal symptoms,14 16 and many ENDS users are concerned with the toxicity of these products.9 Additional studies have shown that ENDS require more suction than traditional cigarettes to deliver product, which makes dosing non-uniform over time and may also be harmful to the user's health.17 Considering the increasing awareness and ever use highlighted in our study, research is warranted to establish the health consequences and population impact of ENDS; findings from this research would be used to better inform the public of any identified health consequences. Unless they make therapeutic claims (eg, cessation), ENDS are considered tobacco products. Although current FDA jurisdiction over tobacco products is limited to cigarettes, smokeless tobacco products and roll your own tobacco, FDA has stated its intent to assert jurisdiction over all tobacco products.
Gabbi Promoff
Issues Management Team Lead, Policy Unit
CDC Office on Smoking and Health

E-mail: GPromoff@cdc.gov with corrections

 

[MattZuke]

Oh, it looks like Gabbi didn't actually want to fact check her contribution.

These two people are
"Tynan, Michael (CDC/ONDIEH/NCCDPHP)" <gby1@cdc.gov>,
"Ross, Ashley M. (FDA/CTP/OP)" <ashley.ross@fda.hhs.gov>

 

[Vocalek]

This is worded awkwardly. Makes it sound as if e-cigarettes caused massive poisonings.

Specifically, diethylene glycol, which has been found in a few batches of ENDS manufactured in China, has caused mass poisonings and deaths in the past when substituted for propylene glycol.15

One of the references to this article is the FDA's press release.

14. Food and Drug Administration. FDA and public health experts warn about electronic cigarettes. 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm

Given the fact that the press release was a "spin job" on a scientific paper, this is an extremely inappropriate reference. Any discussion of the FDA's testing should cite the actual lab report as the reference and stick to the facts as reported in the scientific report.

14. U.S. Food and Drug Administration. Final Report "Evaluation of e-cigarettes". May 4, 2009. http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf (accessed June 2011)

Imagine if instead of this reference,

16. Vansickel AR, Cobb CO, Weaver MF, et al. A clinical laboratory model for evaluating the acute effects of electronic “cigarettes”: nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiol Biomarkers Prev 2010;19:1945e53.

The authors had listed this as the reference for their discussion of nicotine delivery:

16. Sathya Achia Abraham. Study Reveals a Need to Evaluate and Regulate 'Electronic Cigarettes'. Virginia Commonwealth University News Center. Feb. 2, 2010. http://www.news.vcu.edu/news/Study_reveals_a_need_to_evaluate_and_regulate_electronic_cigarettes (accessed November 2011)

 

[MattZuke]

This is worded awkwardly. Makes it sound as if e-cigarettes caused massive poisonings.



One of the references to this article is the FDA's press release.



Given the fact that the press release was a "spin job" on a scientific paper, this is an extremely inappropriate reference. Any discussion of the FDA's testing should cite the actual lab report as the reference and stick to the facts as reported in the scientific report.



Imagine if instead of this reference,



The authors had listed this as the reference for their discussion of nicotine delivery:

I sent them a link to I believe the actual report, which is missing the actual figures of DEG tested in the liquid.

Anyhow she's looking into it, but if you want to address this on your own

Promoff, Gabbi (CDC/ONDIEH/NCCDPHP)" <era6@cdc.gov>
"Tynan, Michael (CDC/ONDIEH/NCCDPHP)" <gby1@cdc.gov>,
"Ross, Ashley M. (FDA/CTP/OP)" <ashley.ross@fda.hhs.gov>

And yeah, I read it as if they were trying to link e-cigarettes to massive poisonings. I made it clear to Gabbi

In simple terms, a 100 pound person is not at risk at poisoning themselves if ENDS used 100% DEG because they're consuming .9% the toxic dose per hour. This is impossible because ENDs operate at 60C, DEG boils at 250C, which is why it's used in Sterno Fuel. I'm sure you'll find someone at the CDC who's a better reference for me. Ask about 1ml heated to 60C over 16 hours, that's the base ENDs specification.

 

[Vocalek]

It is too soon to determine the long-term health effects of ENDS; however, preliminary studies have observed the presence of glycerin, genotoxins, known carcinogens13 and diethylene glycol14 in some ENDS, which can be harmful to humans.

This sentence is confusing. Is the parenthetical phrase, "which can be harmful to humans," meant to apply to every item listed? If so, since when is glycerin harmful to humans? Glycerin, when pure, is Generally Recognized as Safe (GRAS).

We have already discussed the fact that reference #14 points to a press release. What about reference #13? Given the text quoted, you'd assume that this reference is to a toxicology report, right? You would think that most, if not all, the authors are experienced in toxicology testing, right?

You'd be wrong. In the Journal, this article is clearly labeled "Editorial".

13. Cobb NK, Byron J, Abrams DB, et al. Novel nicotine delivery systems and public health: the rise of the ‘e-cigarette’. Am J Public Health 2010;100:2340e2.

This description of the authors is included with the article:

Nathan K. Cobb, M. Justin Byron, and David B. Abrams are with the Schroeder Institute for Tobacco Research and Policy Studies, Legacy Foundation, Washington, DC, and the Department of Health, Behavior, and Society, the Johns Hopkins Bloomberg School of Public Health, Baltimore, MD. Nathan K. Cobb and Peter G. Shields are with the Lombardi Comprehensive Cancer Center, Georgetown University School of Medicine, Washington, DC.

What expertise do they have?

• Nathan C. Cobb is a practicing physician, and expert in the field of behavioral informatics.
• M. Justin Byron completed his Field Placement in the Schroeder Institute as part of the requirements for a Master’s in Behavioral Science and Health Education at the Johns Hopkins Bloomberg School of Public Health, which he completed in 2009. He is currently a doctoral student in the department of Health, Behavior and Society at the Johns Hopkins Bloomberg School of Public Health.
• David B. Abrams is Professor in the Department of Health, Behavior and Society at The Johns Hopkins Bloomberg School of Public Health, and Professor (Adjunct) at Georgetown University Medical Center/Lombardi Comprehensive Cancer Center.
• Dr. Peter G. Shields is a full professor in the Departments of Oncology and Medicine. He is the Deputy Director of the Lombardi Comprehensive Cancer Center.

All appear to be well educated, but there is not a toxicologist among them.

It is unlikely that any of the aurthors went into a lab to perform qualitative and quantitative analyses on e-cigarette liquid and vapor. At best, this article is a secondary, rather than a primary source.

The reason that primary sources are preferable to secondary sources is that meaning can become garbled across too many sources, just like the game of "telephone" where a secret is whispered into the ear of the first person, who passes it on to next person, and by the time the last person relates what she heard, the original message is unrecognizable.

Cobb, et al. might have consulted some editorial-type source or press release that stated, "we fear that e-cigarettes contain blah, blah, and blah." They might have slightly revised this idea to read, "It's very likely that e-cigarettes contain blah, blah, and blah." And by the time Regan, et al. get their hands on it the idea, it morphed into "blah, blah, and blah have been observed."

I was unable to find the word "genotoxic" or the word "carcinogen" in the primary source, the FDA's "Final Report": http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

It seems that this highly charged verbiage lives within the world of editorials and press releases, but not within the world of scientific reports.

It would be most helpful if Regan, et al. would name the chemicals that are genotoxic and/or "known carcinogens" and specify both the quantity observed and the quantity at which each of these chemicals endangers human health. They would, of course, also need to name the study in which this data were published and list it among the references.

Last Question:

Cahn and Siegel reviewed 16 studies "that have characterized, quite extensively, the components contained in electronic cigarette liquid and vapor using gas chromatography mass spectrometry (GC-MS)."

Cahn Z, Siegel M. Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes? Journal of Public Health Policy advance online publication 9 December 2010; doi: 10.1057/jphp.2010.41. http://www.hsph.harvard.edu/centers-institutes/population-development/files/article.jphp.pdf

They concluded, "a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventionalnicotine replacement products."

Why was this reference not included? Was it because the authors failed to paint a picture of a highly dangerous product, the way that the Cobb, et al. editorial and the FDA press release did?

 

[Bill Godshall]

The most important findings of the survey are that:
- 1.2% (2.5 million) of US adults reported past-month use of e-cigarettes in 2010,
- ever-use of e-cigarettes quadrupled from .6% in 2009 to 2.7% in 2010, and
- awareness of products doubled from 16.4% in 2009 to 32.2% in 2010.

Although the survey also found current cigarette smokers and tobacco users were significantly more likely (than non current smokers and non tobacco users) to have ever-used an e-cigarette, and to have used them in the past month, it is almost certain that ever cigarette smokers and ever tobacco users are exponentially more likely to have ever-used an e-cigarette and to have used them in the past month (than current smokers and current tobacco users) because many/most e-cigarette users have completely quit smoking (and thus, are no longer a current smoker) and because many folks who use e-cigarettes don't consider themselves to be tobacco users.

 

[Vocalek]

A remark concerning the "specifically, diethylene glycol, which has been found in a few batches of ENDS manufactured in China", discussed as a sidetrack in this thread:
Regan et al. 2011 are actually accurate on this factoid, as presented. One sample has been documented in FDA’s 2009 lab report („Diethylene Glycol was detected in one sample (Smoking Everywhere 555 High cartridge) at approximately 1%“ (Westenberger 2009), additional sample reported in FDA’s 2010 warning letter to Cixi E-Cig („presence of DEG in the Vitamin C E-liquid„ „fivefold in excess of the USP upper limit for DEG in Propylene Glycol and Glycerin“ [i.e > 5 x 0.1%], Levy 2010). Regan et al. may have missed to add specific references to their „a few batches“ sentence. However, authors have cited the related FDA press releases (2009 & 2010) at various places in their paper, showing that they are fully aware of this preliminary, not formally published data.
We should, therefore, not argue against CDC authors‘ 2011-ish sample count.

I guess we missed the Cixi reference because few, if any, of the readers of this forum would be idiotic enough to order anything from a site that obviously uses English as a second language and that purports to increase our sexual prowess via the use of ......-fortified e-cigarette cartridges. I am very surprised that the FDA takes them seriously.