22nd Century’s VLN cigarettes marketing with modified exposure claims has not been tested and will likely be appealing to youth and young adults. FDA should reject it.

Today we submitted this public comment to FDA and its Tobacco Products Scientific Advisory Committee.  The regulations.gov tracking number is 1k4-9evp-yi5f. A PDF is available here.

22^nd Century’s VLN cigarettes marketing with modified exposure claims has not been tested and will likely be appealing to youth and young adults

 

Lucy Popova, PhD*; Bonnie Halpern-Felsher, PhD; Benjamin Chaffee, DDS, MPH, PhD; Lauren K. Lempert, JD, MPH; Stanton A. Glantz, PhD

 

University of California San Francisco TCORS

*Georgia State University

 

Docket Number: FDA-2019-N-0001

 

 

February 7, 2020

 

 

On February 14, 2020, TPSAC will convene to discuss 22^nd Century’s Modified Risk Tobacco Product (MRTP) application requesting exposure modification orders for its VLN King and VLN Menthol King cigarettes. 22^nd Century seeks an MRTP order to sell its products with reduced exposure claims, but not reduced harm claims. Its three claims are:

 

1. “95% less nicotine”

 

2. “Helps reduce your nicotine consumption”

 

3. “… greatly reduces your nicotine consumption”

 

While these three claims were tested when shown on the packs, they have not been tested when shown on print or social media advertisements. Because the proposed VLN advertisements with modified exposure claims were not tested and have the potential to attract non-smoking youth and young adults, the 22^nd Century’s MRTP application for VLN cigarettes should be denied.

 

            As part of the application, 22^nd Century submitted VLN Image Library Master_RIF.pdf. These advertising images were not tested in the consumer perception studies. The studies only showed participants packs of the VLN products with the claims on them. On print or online advertisements, where claims of reduced nicotine exposure are combined with aspirational pictures of people enjoying smoking (Figure 1[1]), the same claims might have completely different effects than when shown on the packs.

 

 

Figure 1. Examples of print advertisements for VLNC.

 

 

Furthermore, the images that were submitted as proposed marketing glamorize and normalize smoking and tobacco (Figures 2 and 3[2]). Many feature young adults and are reminiscent of JUUL social media marketing, which has been clearly shown to influence youth initiation and use of Juul.[3] It is possible that seeing these advertisements will make the VLN products appear more appealing to youth and young adults.

Figure 2. An image from VLN image library to be used in advertising for VLN.

 

The effects of these advertisements (especially on youth and young adults) have not been tested and this application did not consider the potential uptake by these groups as a result of these advertisements.[4] This missing aspect of the application is critical, given that we have ample evidence showing the direct influence of ads on youth tobacco uptake.

 

Some proposed advertisements in the application use imagery such as green tobacco plants, sunshine, and words “real tobacco.” (Figure 4[5]) This is similar to “implied” health claims used in Natural American Spirit cigarettes, which make consumers perceive these cigarettes as less harmful in absence of explicit modified risk claims.[6]

 

Figure 3. An image from VLN image library to be used in advertising for VLN.

Figure 4. Example of a print advertisement with a “Real Tobacco” claim.

            Because the advertisements that are proposed to be used with the modified exposure claims have not been tested and because the imagery will likely further mislead consumers into believing this VLN cigarettes are less harmful and might attract youth, the MRTP application should be denied.