February 7, 2020

Stanton A. Glantz, PhD

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.

22nd 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 22nd Century’s Modified Risk Tobacco Product (MRTP) application requesting exposure modification orders for its VLN King and VLN Menthol King cigarettes. 22nd 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”

 

  1. “Helps reduce your nicotine consumption”

 

  1. “… 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 22nd Century’s MRTP application for VLN cigarettes should be denied.

 

            As part of the application, 22nd 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.