Swedish Match’s Consumer Perception Study Provides No Evidence for the Population-Level Effects of Modified Snus Labels

We just submitted this comment to FDA.  The tracking number is 1jy-8fp2-y90f.
 
Swedish Match’s Consumer Perception Study Provides No Evidence for the Population-Level Effects of Modified Snus Labels
 
Docket ID: FDA-2014-N-1051
 
Lucy Popova, PhD & Stanton A. Glantz, PhD
Center for Tobacco Control Research and Education
University of California San Francisco
 
November 24, 2014
 
 
According to the Modified Risk Tobacco Product Applications Guidance for the Industry, “FDA shall issue an order under section 911(g)(1) of the FD&C Act (risk modification order) only if it determines the applicant has demonstrated that the product, as it is actually used by consumers, will:
 

  • Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and
  • Benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products” (p. 3)

 
The Swedish Match’s MRTP application attempts to demonstrate the benefit to the population by presenting the results of an online experiment (section 6.4.2 and appendices). Their “Consumer Perception Study” evaluated the effects of the proposed labels compared to existing labels on adults’ perceptions of harm and willingness to purchase or use the product.  Contrary to Swedish Match’s the claims, this study does not evaluate the effects of the proposed label on “subjects’ tobacco use behavior” (p. 689) nor can it evaluate the effects of “removal” of current warnings (p. 689).
 
An online experimental study with a brief exposure to the picture of the products with the new warning labels is hardly equivalent to evaluating how the product is actually used by consumers.
 
The selection of the proposed label is problematic. As the Swedish Match’s own study reports, significantly lower proportion of participants exposed to modified labels found them easy or very easy to understand, compared to those who saw current labels. This could be due to the longer text on the proposed label or the smaller size of the font to fit the longer label. Why not select a different label, such as “This product may not be as dangerous as smoking”? Or something even simpler?  There is no information provided on why this label was chosen and what other alternatives were researched.
 
Recently, Popova and Ling conducted a study with a national US sample of non-users of tobacco, smokers, and dual users, exposing them to advertisements for moist snuff, snus, and e-cigarettes with different warning labels. The data from non-users of tobacco have been published in BMC Public Health (see Popova and Ling, Nonsmokers’ responses to new warning labels on smokeless tobacco and electronic cigarettes: an experimental study, BMC Public Health 2014, 14:997 http://www.biomedcentral.com/1471-2458/14/997) and the data from smokers have been presented at the National Conference on Health Communication, Marketing and Media. In brief, we found that the proposed warning label (“WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes”):
 

  1. significantly lowered perceptions of harm of snus among exclusive smokers
  2. significantly increased positive attitudes towards moist snuff among dual snuff/cigarette users
  3. significantly lowered perceptions of harm of moist snuff among non-users of tobacco

 
These results demonstrate that while the modified label might benefit current exclusive smokers, the effects might not be beneficial for dual users (by promoting continued dual use) and would not be beneficial to non-users of tobacco (by encouraging them to start using snus).
 
This result, combined with the many problems with the Swedish Match study demonstrate that the evidence submitted by Swedish Match  is not sufficient to demonstrate the proposed new warning labels would benefit the health of the population as a whole.   
 
For these reasons, the FDA should deny the requested petition to change the warning labels.
 
 
 

Comments

Please read the Popova and Ling study

I urge everyone to follow the link and read the Popova and Ling study.  The reasoning and scientific rigor of this study is crucial to cite when opposing Swedish Match's application. The more people know about it and talk about it the better.

Dual use

Dual users smoke fewer cigarettes than exclusive cigarette smokers. See Frost-Pineda et al., 2010. Are you arguing that duel users, for their own good, should be given incorrect warnings that overstate the harms of snus, as current warnings do? If they are unwilling or unable to quit should they only smoke cigarettes? Your logic escapes me.

Any smoking brings most of the risk

The dose-response for the effects of smoking on cardiovascular disease are highly nonlinear, with most of the risk accruing at smoking a few cigarettes a day.  While there may be lower cancer risk, both duration and intensity of smoking appear to contribute to the risk.  Add the risk of snus to that and so it is unlikely that dual use will lower risk even if someone smokes fewer cigarettes.  The total risk might even be higher.

How does total risk get higher with dual use?

You seem to be saying that a dual user would lower their cancer risk, but leave their cardiovascular risk unchanged by still smoking a few cigarettes a day.  That sounds like decreased overall health risk.  If using snus lowers cancer risk, what added "risk of snus" are we talking about?  I'm still trying to understand how a dual user who gets half their nicotine from snus and half from cigarette smoking is worse off than someone who gets the same amount of nictoine exclusively from smoking. How does the "total risk" of the former get higher?

Not necessarily

To the extent that duration of smoking matters, the effect of smoking a few less cigarettes a day would not have much effect on cancer risk.  Total risk could be higher because of synergist effects of smoking and snus use and the fact that snus use has a different cancer profile than cigarettes.
 
The typical patterns do not show much drop in the number of cigarettes smoked per day.
 
In addition, if snus use deters cessation, as smokeless use does in military recruits, there will be a big increase in risk.

Synergistic effects of smoking and snus

Please explain, in layman's terms, how the cancer profiles between smoking and snus are different and what the synergistic effects are when using both. This is the first I've heard that combining snus and smoking makes for greater harm than simply adding the risks of each.  Seems like this is the more important aspect of your argument. 

Cigarettes and snus are exposing users to different toxins...

... that can interact, resulting in a more toxic mix or different effects.  If you want to know more about this, look in toxicology textbooks.
 
Also, the cancer profiles of cigarettes and snus are different, so the risks will at least add.

toxicology of snus and cigarettes

I'd like to learn more. Any particular toxicology book about the synergistic effects of snus and cigarettes you reccomend?  I'm surprised this isn't more prominent in your argument for the harm of dual use.  It's much more persuasive than your other points.  Thanks for responding.

Not particularly

The possiblility of synergism between different toxins is well established and depends on the specifics of the situation.  For example breathing asbestos is bad, smoking is bad, but smoking and breathing asbestos is much worse  than the sum of the two effects.