Wednesday, September 23, 2015

Premarket Study Positive for Proposed Snus Warning Label Changes

The FDA is considering a request from Swedish Match to modify federally-mandated warnings on the company’s snus packages.  The company wants to remove the current mouth cancer and gum disease/tooth loss warnings; replace the not-safe-alternative warning with the more accurate “this product presents lower [or substantially lower] risks to health than cigarettes”; and retain the current addiction warning.

In support of its application, Swedish Match funded a premarket online survey to measure perceptions of current and proposed labels among 13,200 U.S. participants.  The company’s advisory board asked me and Nantaporn Plurphanswat, my University of Louisville colleague, to analyze the survey, together with University of Vermont psychiatrist John Hughes and Swedish tobacco/nicotine researcher Karl Fagerström.  Our results appear in Nicotine and Tobacco Research (abstract here).

We classified participants according to their tobacco use: smokers, former smokers, ST users, other [combustible] tobacco users and never users.  Participants viewed only one of the current or proposed warnings, after which they were asked if the warning was believable, if snus was harmful, and if they were likely to use snus or motivated to buy snus.  

Most participants, regardless of tobacco use status, found all the current ST warnings believable.  In contrast, they were not as likely to believe the more accurate proposed labels.  The vast majority of respondents also perceived that using snus is harmful.  The perceived odds of harm were mostly lower with the proposed labels, but these differences were not always statistically significant.

These results are not surprising. American health authorities have ignored the substantial body of evidence documenting that ST use is less harmful than smoking and have promoted the message that ST is not a safe alternative to cigarettes (Enter “misinformation” in the search box on this blog for numerous examples).  As a result, most of the population equates the risks of ST use with those of smoking.   

Compared with the current not-safe-alternative warning, smokers viewing the proposed labels were significantly more likely to use or buy snus; the same was true for ST users and other tobacco users viewing the substantially lower risk label. This indicates that the proposed labels could foster a transition from cigarettes and other combustible products to snus, a result that would represent a significant health advantage for individual smokers and public health generally.

Among former tobacco users, no increases in likelihood to use or motivation to buy were seen with the proposed labels. In never users, an increase in motivation to buy snus was noted for the substantially lower risk label; neither proposed label had higher odds for likelihood to use snus.

In summary, our analysis of this pre-marketing survey suggests that tobacco users viewing the proposed relative-risk labels are more likely to perceive snus as less harmful than cigarettes and may be more likely to use and buy snus.

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