2018 Feb 1;172(2):181-187. USSTC MRTP Application for Copenhagen Snuff Fine Cut.  Watkins SL, Glantz SA, Chaffee BW. Acc Chem Res. 2.3.: Executive Summary, p. 42, 2.3-executive summary _Redacted.pdf, USSTC MRTP Application for Copenhagen Snuff Fine Cut.
The model only considers mortality, despite the fact that tobacco use (including snus) causes considerable morbidity. Furthermore, USSTC argues that it is necessary to change the risk perceptions because risk perceptions are one of the drivers of behavior. Cigarette and Smokeless Tobacco Perception Differences of Rural Male Youth.
USSTC emphasizes that adult smokers “misperceive” the harm of smokeless tobacco relative to cigarettes, arguing that many US adults, including cigarette smokers, believe that using smokeless tobacco to be equally harmful to smoking cigarettes. Among these current ST users, 52.4% of them concurrently used one or more other tobacco products. PMID: 27107909. Further, there is not sufficient evidence to assure that the proposed marketing will not have a harmful effect on youth by encouraging initiation of moist snuff use, alone or in dual use with combustible tobacco. Fine Cut (overseas military only) However, evidence of such a misperception is insufficient to demonstrate that marketing Copenhagen moist snuff with a reduced harm claim will improve the health of the public overall.
2012. never tobacco users, current cigarette and/or MST users, former cigarette and/or MST users, etc.)
In a study of male baseball athletes at rural high schools in California, cigarettes and smokeless tobacco were perceived to convey different probabilities of risk: participants generally viewed use of both cigarettes and smokeless tobacco as carrying a great risk of oral health problems and great risk of getting into "trouble" (facing discipline) from parents or at school, but smokeless tobacco was viewed, on average, as having less risk of systemic ailments. The applicant must also demonstrate an overall public health benefit to both users and non-users, including youth, and must demonstrate that their proposed labeling and marketing messages will be understood, will not mislead, and will lead to harm reduction.
Further, the USSTC application does not provide any reliable information on whether adolescents would be more interested in using smokeless tobacco, especially after viewing the claims, if adolescents would initiate nicotine use with smokeless tobacco, if adolescents would switch from another tobacco product to smokeless tobacco, or if adolescents would use moist snuff along with other tobacco products.  USSTC MRTP Application for Copenhagen Snuff Fine Cut.
Adolescents’ Perceptions of Health Risks, Social Risks, and Benefits Differ across Tobacco Products.  While this is correct, the modified risk statement may attract more females to use the product, including those who do not currently use tobacco.
There are problems with assumptions 9+and inputs used in the model. Preventive Medicine. Cigarette and Smokeless Tobacco Perception Differences of Rural Male Youth. However, while the high perceived risk might prevent a behavior (as reported in the qualitative study reports: high perceived risks are a barrier to using moist snuff tobacco (MST): “Barriers to situational or exclusive use of MST varied, but initial perceptions of the risk to health were fairly consistent across all audiences”), low perceived risk is not necessarily an incentive to use MST (“Discussions of potential claim statement language took place in the context of health risks not being a key driver for interest in or usage of the product”).
 USSTC has not presented sufficient evidence that the proposed claims will not result in lower tobacco risk perceptions subsequent onset of smokeless tobacco use among youth.
FDA-2016-N-2527. The model is limited to a US native-born male population and considers only mortality outcomes. Long Cut Wintergreen, Bandit Mint FDA should not permit the U.S. Smokeless Tobacco Company to market Copenhagen Snuff with modified risk claims, Benjamin Chaffee, Lucy Popova1, Lauren Lempert, Bonnie Halpern-Felsher2, Wendy Max, Victoria Churchill1, Pamela Ling, Stanton Glantz, University of California San Francisco TCORS. Docket No. Perceptions of Smoking-Related Risks and Benefits as Predictors of Adolescent Smoking Initiation. In analysis of the PATH data, among Wave 1 never-smoking youth, ever-use of smokeless tobacco was associated with 1.7 times greater odds of ever smoking cigarettes and 2.1 times greater odds of past 30-day cigarette smoking after 1 year of follow-up, after adjusting for use of any other form of tobacco, age, sex, race/ethnicity, and several other smoking risk factors. Moist snuff smokeless tobacco contains the known human carcinogens 4-(methylnitrosamino)-1- (3-pyridyl)-1-butanone (NNK) and N’-nitrosonornicotine (NNN).  Altria Client Services LLC.  Chaffee BW, Cheng J. Smokers who report smoking but do not consider themselves smokers: a phenomenon in need of further attention. Modified Risk Tobacco Product Applications. 911. http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf,  International Agency for Research on Cancer.  Kann L, McManus T, Harris WA, Shanklin SL, Flint KH, Queen B, Lowry R, Chyen D, Whittle L, Thornton J, Lim C, Bradford D, Yamakawa Y, Leon M, Brener N, Ethier KA.
USSTC misleadingly claims that the evidence that youth or other non-smokers who use moist snuff or other smokeless tobacco progress to cigarette smoking is “mixed” and that the “best way” to address this risk is by allowing USSTC to conduct their own “postmarket surveillance.”.
2008;9(7):667-75. Guidance for Industry. Modified Risk Tobacco Product Applications. BMC Public Health.  Institute of Medicine. Pouch Plastic Can (only available in Alaska and Hawaii), Fine Cut Natural 6-4-effect-tobacco-use-init-nonusers_Release in Full.pdf.  Smoking cigarettes but not identifying as a smoker is common among non-daily smokers who were formerly daily smokers, opening the likelihood that smokeless tobacco users may consider themselves to have "switched completely" even if they continue to smoke combustible cigarettes.
Exposure and Metabolic Activation Biomarkers of Carcinogenic Tobacco-Specific Nitrosamines. This is a persistent problem that has been resistant to the tobacco control policies and social changes that have reduced youth cigarette smoking. 6-4-effect-tobacco-use-init-nonusers_Release in Full.pdf. However, as discussed earlier in this comment (see Section 3), the findings do not demonstrate that consumers are likely to change their perceptions of or intentions to use Copenhagen moist snuff as a result of the proposed modified risk claim. Pouch (overseas military only)
 In fact, the data these studies are based on are from 1993 to 2003, i.e. Perceived lung cancer risk of cigarettes and smokeless tobacco, rural male adolescents Perceived risk estimated by asking participants to imagine the chance that they were to develop lung cancer if the used cigarettes and if they used smokeless tobacco. Watkins SL, Glantz SA, Chaffee BW.  U.S. Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products. BMC Public Health. The real question to be addressed is whether Copenhagen Snuff, with lower perceived risks, encourages never-smokers -- including adolescents and young adults -- who would otherwise not use any tobacco products to be more likely to try smokeless tobacco product.
Xtra Long Cut Wintergreen Tomar SL. JAMA Pediatr. Chaffee BW, Cheng J.
USSTC’s application presents evidence that use of moist snuff smokeless tobacco is associated with a lower risk of lung cancer than smoking cigarettes.
The studies USSTC conducted do not test this assertion. FDA. Tob Control 2017;26(2):153-7 (PMC PMC5067225),  Leas EC, Zablocki RW, Edland SD, Al-Delaimy WK.  However, no such justification is provided. Is use of smokeless tobacco a risk factor for cigarette smoking? However, Fails to demonstrate that such a perception is an impediment to smokers choosing to use smokeless tobacco as a substitute for cigarette smoking, Fails to demonstrate that changing smokeless tobacco harm perceptions will encourage current smokers to switch completely from smoking to using smokeless tobacco, Provides no evidence that the proposed marketing messages would either change current adult smokers’ perceptions of smokeless tobacco harms or increase their likelihood of switching completely to moist snuff instead of smoking, USSTC relies on a model developed for Altria Client Services LLC (ALCS) to estimate the population impact of their MRTPA.
2016 May, 58(5):5558-66. USSTC implies, without evidence, that the repeated exposure of an extended marketing campaign will lead to the desired harm reduction behavior among adult cigarette smokers but will not lead to expanded smokeless tobacco use among tobacco non-users and youth. Draft Guidance., 2012. MMWR Surveill Summ. Module 6.5: Population Health Model Research Summary. Modified Risk Tobacco Product Applications. Long Cut Straight (overseas military only) Tam J, Day HR, Rostron BL, Apelberg BJ. USSTC MRTP Application for Copenhagen Snuff Fine Cut. 2.3.: Executive Summary. Because the application did not consider the impact of smokeless tobacco on adolescent use, it did not demonstrate that the product, as actually used by consumers, will benefit the health of the population as a whole, including current non-users; in particular, it did not provide any scientific evidence regarding the effect that this product and its marketing would have on increasing the likelihood that adolescents who are currently not tobacco users will start using smokeless.
2016 May, 58(5):5558-66. Tob Control 2015;24(4):400-3 ; Guillory J, Lisha N, Lee YO, Ling PM. Xtra Long Cut Mint Association of Noncigarette Tobacco Product Use with Future Cigarette Smoking Among Youth in the Population Assessment of Tobacco and Health (PATH) Study, 2013-2015. In a longitudinal school-based study of male 7th and 9th grade students, youth who had never smoked a cigarette but had used smokeless tobacco in the prior month at baseline had 2.6 times greater odds of cigarette smoking at least weekly 2 years later, after adjusting for multiple known risk factors for smoking initiation, such as age, family and peer smoking, alcohol use, grades in school, and other behavioral risks. Pouch Citrus Tobacco Blend As seen during the current “epidemic” of youth e-cigarette use, potential ex post facto solutions are severely limited. Tob Regul Sci. Sung HY, Wang Y, Yao T, et al. U.S. Smokeless Tobacco Company - maker of popular brands such as Copenhagen, Husky and Skoal - has recalled multiple varieties of its products over concerns they could contain metal shards. Pouch Mint Perceived risks and benefits of smoking: Differences between adolescents with different smoking experiences and intentions. 15-25 years old. This recall applies to lots with no printed code on the bottom of the can, or with codes that begin with the letters "F", "R", "K", or "P". Pouches Wintergreen (overseas military only).