Sunday, April 20, 2014 12:17:01 PM
First, Happy Easter to everyone!
Here are a few off-the-cuff reactions to the (abstract of the) study Sagitar linked to, which I remember seeing a couple of months ago. Three results I found interesting:
(1) "Smokers rated the “very low” nicotine cigarette as less risky overall than the “average” nicotine cigarette (p=0.001); this effect held true for specific diseases including lung cancer, heart disease, emphysema, stroke, chronic bronchitis, and other cancers (p’s <0.001)."
I can imagine this result giving the FDA pause when it comes to the issue of labeling cigarettes as VLN. Just as the FDA (for good reason) decided to ban labeling cigarettes as "Light," partly because of the false conclusions that smokers drew about Light cigs being healthier, so can I imagine that the false beliefs participants in this study formed (e.g. that cigs with very low nicotine are less risky in terms of their connection with lung cancer, emphysema, etc.) on the basis of the label 'VLN' might incline the FDA not to allow such labeling. Lower levels of nicotine don't directly reduce the health risks of the other materials in such cigs. (But see below for another thought on this matter.)
(2) "Additionally, smokers rated the “very low” nicotine cigarette as having less desirable subjective effects than the “average” nicotine cigarette, including reduced satisfaction, psychological reward, and enjoyment of respiratory sensations (p’s<0.05)."
This result suggests that potential VLN smokers might have some subjective reason NOT to switch from regular to VLN cigs, if they form the (false!) belief that VLN cigs don't taste or feel or affect them in the same way. That could be some impediment to XXII sales.
I say only some impediment for several reasons: if VLN were mandatory, then of course it wouldn't matter. Second, it might be possible to change smokers' beliefs about the subjective effects of VLN vs. normal cigs - e.g. by publicizing these sorts of "blind taste test" results. And third, there might be other reasons - and perhaps, on balance, stronger reasons - for smokers to choose VLN cigs over normal ones, even given their (false) expectation of less satisfaction. Those reasons are captured in the next bit:
(3) "Moreover, smokers predicted having greater interest in quitting smoking in 1 month, 6 months, and 1 year (p’s <0.02) when considering exclusive availability of the “very low” nicotine cigarette. Similarly, more smokers predicted being abstinent in 5 years when considering exclusive availability of the “very low” nicotine cigarette (p=0.04)."
Since this effect seems robust, I can imagine the FDA thinking that, on balance, it is preferable to allow VLN labeling (and/or to mandate VLN for all cigs), even given the first result noted - that people will falsely think they are "healthier" in a direct sense - because of this last result, that people believe themselves more likely to quit with a VLN cig. Moreover, smokers might be willing to purchase VLNs even if they think they won't be as satisfying, if they have a greater motivation to quit (and falsely believe they are directly healthier) than they have a motivation for a more satisfying normal cig.
I would be very curious to see research that measures these competing preferences: the preference for what they take to be a more satisfying cig, and the preference for a healthier cig that will help them quit. (Just ask them which of the two cigs they would be likelier actually to purchase and smoke!)
This might tell us both something about what the FDA is likely to do, and how XXII's product is likely to fare in the market. Secondly, it would be important not only to study smokers' predictions about what they (think they) would buy (given these competing subjective preferences), but also to study their actual behavior. Would they simply resort to non-VLN cigs, even if they thought that they wouldn't?
Looks like there's plenty more research to be done - and the FDA should think carefully about how to approach the public messaging related to VLN cigs.
Here are a few off-the-cuff reactions to the (abstract of the) study Sagitar linked to, which I remember seeing a couple of months ago. Three results I found interesting:
(1) "Smokers rated the “very low” nicotine cigarette as less risky overall than the “average” nicotine cigarette (p=0.001); this effect held true for specific diseases including lung cancer, heart disease, emphysema, stroke, chronic bronchitis, and other cancers (p’s <0.001)."
I can imagine this result giving the FDA pause when it comes to the issue of labeling cigarettes as VLN. Just as the FDA (for good reason) decided to ban labeling cigarettes as "Light," partly because of the false conclusions that smokers drew about Light cigs being healthier, so can I imagine that the false beliefs participants in this study formed (e.g. that cigs with very low nicotine are less risky in terms of their connection with lung cancer, emphysema, etc.) on the basis of the label 'VLN' might incline the FDA not to allow such labeling. Lower levels of nicotine don't directly reduce the health risks of the other materials in such cigs. (But see below for another thought on this matter.)
(2) "Additionally, smokers rated the “very low” nicotine cigarette as having less desirable subjective effects than the “average” nicotine cigarette, including reduced satisfaction, psychological reward, and enjoyment of respiratory sensations (p’s<0.05)."
This result suggests that potential VLN smokers might have some subjective reason NOT to switch from regular to VLN cigs, if they form the (false!) belief that VLN cigs don't taste or feel or affect them in the same way. That could be some impediment to XXII sales.
I say only some impediment for several reasons: if VLN were mandatory, then of course it wouldn't matter. Second, it might be possible to change smokers' beliefs about the subjective effects of VLN vs. normal cigs - e.g. by publicizing these sorts of "blind taste test" results. And third, there might be other reasons - and perhaps, on balance, stronger reasons - for smokers to choose VLN cigs over normal ones, even given their (false) expectation of less satisfaction. Those reasons are captured in the next bit:
(3) "Moreover, smokers predicted having greater interest in quitting smoking in 1 month, 6 months, and 1 year (p’s <0.02) when considering exclusive availability of the “very low” nicotine cigarette. Similarly, more smokers predicted being abstinent in 5 years when considering exclusive availability of the “very low” nicotine cigarette (p=0.04)."
Since this effect seems robust, I can imagine the FDA thinking that, on balance, it is preferable to allow VLN labeling (and/or to mandate VLN for all cigs), even given the first result noted - that people will falsely think they are "healthier" in a direct sense - because of this last result, that people believe themselves more likely to quit with a VLN cig. Moreover, smokers might be willing to purchase VLNs even if they think they won't be as satisfying, if they have a greater motivation to quit (and falsely believe they are directly healthier) than they have a motivation for a more satisfying normal cig.
I would be very curious to see research that measures these competing preferences: the preference for what they take to be a more satisfying cig, and the preference for a healthier cig that will help them quit. (Just ask them which of the two cigs they would be likelier actually to purchase and smoke!)
This might tell us both something about what the FDA is likely to do, and how XXII's product is likely to fare in the market. Secondly, it would be important not only to study smokers' predictions about what they (think they) would buy (given these competing subjective preferences), but also to study their actual behavior. Would they simply resort to non-VLN cigs, even if they thought that they wouldn't?
Looks like there's plenty more research to be done - and the FDA should think carefully about how to approach the public messaging related to VLN cigs.
Recent XXII News
- 22nd Century Group (Nasdaq: XXII) Launches Pinnacle VLN® Trial in California, Opening Another Major New State for Reduced-Nicotine Cigarettes • GlobeNewswire Inc. • 05/21/2026 11:00:00 AM
- 22nd Century Group (Nasdaq: XXII) Expands High-Margin Pinnacle Platform With Launch of Pinnacle Pure at Major U.S. Retailers • GlobeNewswire Inc. • 05/18/2026 01:00:00 PM
- 22nd Century Group (Nasdaq: XXII) Ignites Major VLN® Retail Expansion in Metro New York and Northern New Jersey Under Pinnacle Brand • GlobeNewswire Inc. • 05/15/2026 12:37:00 PM
- 22nd Century Group, Inc. Highlights FDA Filing of VLN® MRTP Renewal Applications for Scientific Review • GlobeNewswire Inc. • 05/12/2026 05:50:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/07/2026 10:30:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/07/2026 10:06:10 AM
- 22nd Century Group Reports First Quarter 2026 Financial Results • GlobeNewswire Inc. • 05/07/2026 10:00:00 AM
- 22nd Century Group to Announce First Quarter 2026 Results on May 7, 2026 • GlobeNewswire Inc. • 05/04/2026 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/01/2026 09:20:20 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 05/01/2026 09:15:15 PM
- 22nd Century Group Shares 2026 Vision for VLN® Product Growth and Tobacco Harm Reduction Leadership • GlobeNewswire Inc. • 04/29/2026 08:35:00 PM
- 22nd Century Group Expands Reduced Nicotine Platform Through New Testing Services Agreement with North Carolina State University • GlobeNewswire Inc. • 04/23/2026 11:50:00 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 04/13/2026 04:15:24 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 04/10/2026 08:35:13 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 04/10/2026 08:30:36 PM
- 22nd Century Advances Reduced Nicotine Product to Target Approximately Half of the ~$82 Billion U.S. Cigarette Market with 100mm VLN® Product Initiative • GlobeNewswire Inc. • 04/07/2026 12:00:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 03/31/2026 09:00:54 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 03/27/2026 08:30:40 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/26/2026 12:02:51 PM
- 22nd Century Group Reports Fourth Quarter and Full Year 2025 Financial Results • GlobeNewswire Inc. • 03/26/2026 10:00:00 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 03/24/2026 05:57:09 PM
- 22nd Century Group to Announce Fourth Quarter and Full Year 2025 Results on March 26, 2026 • GlobeNewswire Inc. • 03/23/2026 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/20/2026 09:14:20 PM
- 22nd Century Group Reports Continued Early Sales Momentum for VLN® Cigarette Products • GlobeNewswire Inc. • 02/23/2026 10:07:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2026 09:15:28 PM
