Tuesday, June 16, 2015

FDA Call to Action: Submit comments on FDA’s Third Workshop Regarding E-Cigarettes

FDA Call to Action: Submit comments on FDA’s Third Workshop Regarding E-Cigarettes.


The first of three FDA Workshop was held in December 2014, the second in March 2015, and the third in June 2015. You have until July 2nd, 2015 to submit comments on all three workshops.  (Please see: CASAA Call to Action for First FDA Workshop and CASAA Call to Action for Second FDA Workshop for details and instructions for commenting on the first two workshops.) Those workshops offered more critical opportunities for consumer input, so if you have not responded to those CTAs, you might want to start with one or both of them rather than this one.


This Call to Action includes instructions for commenting on the Third Workshop Regarding E-Cigarettes held 1-2 June 2015.





The third workshop focused on issues related to population health. The quality of presenters was substantially improved compared to the previous workshops, with almost half of them presenting useful and honest scientific information. Still, that left about half presenting junk science and anti-ecig propaganda. In addition, for the first time ever at any Center for Tobacco Products public meeting, a consumer representative was given a seat at the table, in the person of CASAA’s Carl V Phillips who was given a slot on the final panel. (Note: This was only a small step. FDA still refused to allow the session presentations by Dr. Phillips and Igor Burstyn that we submitted.) You can read about that at the antiTHRlies blog, here and here, which also links back to Phillips’ live commentaries from the meetings.


Unfortunately, written transcripts of the workshop are not yet available on the FDA website. However, you can view the workshop videos (instructions here if you have problems with the links below -- note that you will have to create a login to access them, but that is easy):


  • For the June 1, 2015 videos, go here for the morning session and here for the afternoon session.
  • For the June 2, 2015 videos, go here for the morning session and here for the afternoon session.


There are three parts to this Call to Action:


  1. If you want to do a fairly quick and simple (but useful) comment, follow the instructions for Part A (“Simple Submission”), then skip down to Part C (“Submission Instructions”) and you’re done.
  2. If you’re feeling more ambitious, you may choose to also follow the instructions for Part B (“Optional Additional Submission”).
  1. Part C provides instructions on how to submit your comment.


You can make as many comments as you wish, so if you’re feeling overwhelmed, just pick something to comment on from Part A or Part B, then skip to Part C for submission instructions . . . and then if you have more time, come back and pick another topic to comment on as a second comment.



PART A (“Simple Submission”)


The most useful role for consumers commenting on this will be to remind the FDA of the importance of including consumer representatives in these meetings.


If you want to make a very simple (but useful) comment, you can simply include the following observations and then skip down to the bottom (PartC) for instructions on how to submit your comment:


  1. Thank the FDA for including a consumer representative at one of their meetings for the first time. Ask them to be sure to include representation from CASAA at all future meetings.
  2. Point out that if they had included presentations from scientific experts who work closely with consumers, rather than people who just study them from a distance, they would have learned a lot more from the sessions on perceptions, motivations, and usage behavior.
  3. Tell them that the reason you and other vapers you know use e-cigarettes is because they replace smoking. (This is something that one might have not learned listening to the junk science that was presented about motivations.) That -- not flavors or marketing -- is the major motivation (although you should feel free to mention, if it is the case, that flavors are an important part of what make e-cigarette use a successful alternative to smoking for you).
  4. Remind them that people who *try* e-cigarettes once or twice should not be confused with the people who are actually using them for tobacco harm reduction.




PART B (“Optional Additional Submission”)


SECOND, IF YOU ARE FEELING INSPIRED, there are various additional points you can choose to comment on. As background, on the second day there were a couple of typically bad presentations about environmental exposure in the presence of someone vaping, but also a couple of excellent bits of new research that used optimal methods and showed that any environmental exposure was at levels that posed no hazard. They showed that typical vapers absorb about 98% of the vapor constituents that they measured, and so very little is exhaled, and found that in a proper test chamber, the levels of environmental contaminants produced by people vaping were trivial. By contrast, on the first day there were a series of presentations of “perceptions” research which were all biased toward calling for more dire warnings; however, the actual data consistently showed that consumers overestimate the risks from e-cigarettes, which means that the proper goal of accurate communication demands encouraging less worry rather than more.


  1. Thank the FDA for allowing presentations that showed just how minimal the “second-hand” exposure is and remind them to consider this information rather than the anti-scientific propaganda about this exposure. Point out that this means that more efforts should be made to encourage smokers -- who produce second-hand smoke -- to switch to vaping.
  2. Point out that the research about public perceptions consistently suggested that the public overestimates the risks from vaping or second-hand exposure, as compared to even the worst-case scientific estimates. Remind them that the proper role of regulators and government in general is to inform the public, not mislead them, and thus warnings that would increase this misperception are inappropriate. If you have personal stories of people you know overestimating the risks from vaping, add one or two of those.
  3. Point out that much of what was claimed by some of the presenters has been thoroughly debunked by good scientific analyses, and just because someone says something does not make it true. Remind the FDA that their obligation is to perform proper scientific analyses -- up to the standards they demand of the companies they regulate -- and not just repeat propaganda. In particular:
    • The claims about gateway effects are not supported by any evidence. (See this article for more information about the lack of legitimate evidence of gateway effects if you are interested.)
    • The claims about high levels of use by minors are based on surveys that ask only whether someone has ever taken a single puff. The data they saw that tried to measure actual use showed a much lower prevalence.
    • Smokers who use e-cigarettes to try to quit are those who find that they cannot just stop unaided. Thus they are self-selected as those who are having the hardest time quitting and so should not be naively compared to people who find it easy to quit smoking. (See this paper for more information about that if you are interested.)


4. The following are some specific questions FDA has posed that you might wish to provide insight about. Following each question (in regular font) we have provided some additional information (in italics) that might help you better understand the information being solicited by FDA.

It’s a long list, and you should not feel compelled to address every single point (or even the more than a few of them), but we’re providing a fairly detailed list of the questions so that you can pick and choose the ones that you feel you wish to respond to. Of course, you won’t necessarily have data to answer these questions fully, but you should feel free to share your personal use patterns and observations. (For those who are interested, you can find the full list of questions posed by FDA here.) Be sure to make clear what question you are responding to with a particular paragraph. You can just quote their question (copy and pasted from the text below--not including the text in italics) and include a phrase like “In your questions for the workshop, you asked ‘xxxxx’...”; connecting your answer to their specific questions will make sure they understand the relevance.

IMPACTS ON THE USE OF CURRENT TOBACCO PRODUCTS:
    • What product features make an e-cigarette more or less appealing to current tobacco users, including cigarette smokers who want to quit? There are, of course, may product features that make e-cigarettes a compelling alternative to smoking. Please share what features appeal to you and WHY. For example, do you value a long battery life, variable wattage/voltage, tank systems and ability to customize flavor choices, etc.?
    • How do flavors affect the appeal and use of e-cigarettes among current tobacco users, including current cigarette smokers? Does the availability of flavors other than tobacco and menthol make vaping a more effective alternative to smoking? Do you find that non-tobacco flavors help you distance yourself from your former smoking habit?
    • Does the presence of flavors have an impact on dual use of e-cigarettes and cigarettes? If you smoke and use e-cigarettes (or have in the past), did you find that non-tobacco flavors make you more or less likely to smoke -- or does it have any impact at all?
    • Does the presence of flavors have an impact on completely switching from cigarettes to e-cigarettes?  If you were at any time a dual user but have now made a complete transition to e-cigarette use, did non-tobacco flavors play a role in that?
    • What proportion of cigarette smokers who use e-cigarettes and who quit smoking continue to use e-cigarettes after quitting (and for how long)? Explain that they are implying the wrong view of e-cigarettes. Smoking cessation products are typically viewed as being used for a finite period of time, with the goal of completely eliminating not only smoking, but also use of the cessation product itself. But e-cigarettes are used as a substitute for smoking. It is worth noting that even the FDA recognizes that long-term use of pharmaceutical nicotine-replacement therapies such as nicotine gum aren’t necessarily problematic.
    • Is there evidence of changes in cigarette smoking frequency among dual e-cigarette and cigarette users? Consider sharing your personal experience in making the transition from smoking to e-cigarette use. For some, the transition is almost immediate, while for others the transition can take days, weeks, months, or even years. Some have no intention of completely giving up smoking, but are simply happy to reduce their smoking habit.
PREVALENCE AND PATTERNS OF USE:
    • What are the reasons individuals try e-cigarettes (and do these reasons differ by subgroups, specifically youth, young adults, or adults)? Let the FDA know why you tried e-cigarettes. For example, was it to reduce or eliminate your smoking habit? Was it to save money?
    • What types of e-cigarette devices are being used (e.g., “cigalike” devices vs. “tank” systems) and by whom? How do patterns of use differ among users of different device types? If you used a cigalike at first and then switched to a more advanced system, did that improve your vaping experience and help you further reduce or eliminate your smoking habit?
    • How do different types of marketing and messages about e-cigarettes influence experimentation with e-cigarettes? If you considered your first usage “experimenting” before you then went on to quit smoking, share that information with them. FDA should not be just categorically discourage all experimenting, because for some smokers, experimenting leads to quitting smoking.
    • Does the use of products with tobacco flavors, menthol or other flavors differ by age group (specifically for youth and young adults versus older adults) and tobacco use history)? Consider sharing information about what kind of flavors you use and your age.
UPTAKE OF E-CIGARETTE USE BY NON-USERS OF TOBACCO PRODUCTS:
    • How does use of e-cigarettes relate to transition to use of other tobacco products, including combustible products? FDA is asking for information about e-cigarettes serving as a “gateway” to other tobacco products (including smoking). Specifically, the concern being expressed is that a non-tobacco user will start using e-cigarettes and then transition to using tobacco products. This is a loaded question in that we know that the risks of smokeless tobacco are far, far less than smoking, and many smokers who start using e-cigarettes will also try low-risk smokeless tobacco (also a tobacco harm reduction (THR) product) to reduce or eliminate their smoking habit. (1) Consider sharing with the FDA information about whether e-cigarette use has led you to use other tobacco products, but please be specific about what types of products those might be, and (2) if e-cigarette use did NOT lead you to transition to other tobacco products, please specifically share that information as well. Also, you can just remind them that if vaping causes a smoker to switch to smokeless tobacco instead (a rare occurrence, but it does happen), that is still a successful example of harm reduction.
    • What factors influence whether experimentation with e-cigarettes leads to regular e-cigarette use? To use of combustible tobacco products? Many adults consider their first use(s) of e-cigarettes as “experimentation.” If this describes you, please consider sharing with the FDA what factors led you to become a regular e-cigarette user. For example, some find that the variety of flavors led them to become vapers (and to reduce or eliminate their smoking habit), while others find that more advanced devices and the inherent customization allowed was a significant factor. Still others moved from experimentation to regular use due to, for example, smoking bans and high taxes on cigarettes.
    • What proportion of former cigarette smokers who initiate e-cigarette use relapse to conventional cigarette smoking? If you are a former smoker who has quit smoking using e-cigarettes, consider sharing details about how long you smoked, how much you smoked, and how long you have remained smoke-free using e-cigarettes. If you have “relapsed,” see the question below.
    • What factors influence whether e-cigarette use causes former smokers to relapse to cigarette smoking? To switch completely to e-cigarette use vs. dual use e-cigarettes and cigarettes? If you have “relapsed” (either currently or in the past), consider sharing information about that with FDA -- you can let them know if changing the device/flavor/nicotine strength helped you “get back on the wagon,” and you can also share information about previous relapses when you were using FDA-approved smoking cessation products. Explain any shortcomings of the e-cigarettes you were using that led you to give up and resume smoking.


ATTITUDES, BELIEFS, AND PRODUCT PERCEPTIONS:


  • What beliefs and perceptions do e-cigarette users and non-users have about the risks of e-cigarettes compared to the risks of other tobacco products (both combustible and noncombustible), NRT, and cessation? How do beliefs and perceptions vary across subgroups by age and by e-cigarette and other tobacco use? This point was touched on in Paragraph 2 of this Part C, but you should feel free to elaborate on the point, including discussing how incorrect beliefs and perceptions of risk of e-cigarettes and smokeless tobacco have been fostered by the government providing misleading information (if you believe this to be the case).
  • What effect, if any, do e-cigarette use and marketing have on social norms related to conventional cigarette smoking? One of the unsubstantiated claims e-cigarette opponents often make is that e-cigarette use somehow “normalizes” smoking. Of course, e-cigarette use is not smoking and they can be quite easily and readily distinguished in public settings (e.g., different aroma, no sidestream smoke, fairly rapid dissipation of vapor, devices often do not resemble traditional cigarettes). Consider explaining to the FDA how your use of e-cigarettes--and the marketing you see about e-cigarettes--actually normalizes a safer alternative to smoking.
  • How do different types of marketing and messages about e-cigarettes impact beliefs and perceptions? Explain some of the sources of good information that you use and point out that they are widely available to anyone. In other words, marketing is useful for introducing someone to the products, but people do not necessarily depend on marketing for substantive information.
  • How does information communicated to consumers via e-cigarette and e-liquid product labels, labeling, and marketing (including advertising) influence attitudes, beliefs, product perceptions, and behaviors? Point out to FDA how much (which probably means how little) of the information you use comes from labels and marketing. However, if there is information on the labels and in marketing that you find useful, tell them what it is and tell them that if they restricted provision of that information, it would make you a less informed consumer. If you find that interesting labels and such simply improve your life as a vaper in some small way, point out to them that you would still use the product whatever was on the label, but if labeling were restricted, it would diminish your welfare.



Part C (“Submission Instructions”)


Whether you’re doing Part A, Part B, or both, here are the instructions on how to submit. (You might find it helpful to review FDA's Tips for Submitting Effective Comments.)


1. Make sure that you include the following statement at the very top of your comment because it is required:  
    • I am commenting on Electronic Cigarettes and the Public Health; Third Public Workshop; Docket No. FDA-2014-N-1936-0003..
2. Make sure that somewhere in the comment you describe yourself a bit:
    • Mention if you are an e-cigarette user and how long you have been using e-cigarettes. Go ahead and mention how long ago e-cigarettes allowed you to quit smoking if that describes you.
    • If you are a CASAA member, please mention that to remind them that there is an organized consumer voice they should be listening to. (If you are not, please go HERE and join. It is free and important.)
    • Mention that the material presented at this workshop would have benefited greatly from consumer input.
3. Consider including in your comment something to the effect of, “I am commenting to ask FDA to critically evaluate what was presented at the Third Public Workshop on e-cigarettes, and recognize there was valid science .”
4. Close your comment with a simple, “Thank you.”
5. Submit your comments here. (If you have a long comment, you may get an error message if you try to copy and paste your comment into the comment box. In that case, type "My comment is attached" in the comment box, and then upload the document that contains your comment. To upload your document--immediately beneath the comment box is a button labeled "choose files" for uploading. Click on that box and select the document containing your comment.)

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