Perceptions of Smoking-Related Risks and Benefits as Predictors of Adolescent Smoking Initiation. Prev Med. Phantom smoking among young adult bar patrons. Nicotine Tob Res. The ALCS Cohort Model has not been published in the peer-reviewed literature; rather it is documented only in a conference poster. [44] Altria Client Services LLC. Tob Regul Sci. Consumers with one of the cans should contact the company at 1-866-201-9136 to return a recalled product for a refund. The tracking number on Regulations.gov is 1k3-97ps-3u1q. 6-4-effect-tobacco-use-init-nonusers_Release in Full.pdf. [13] USSTC MRTP Application for Copenhagen Snuff Fine Cut. USSTC attempts to paint the stagnant progress on reducing youth smokeless tobacco use in a positive light, arguing, illogically, that the persistence of youth smokeless tobacco use over this time period is not related to youth's diverging harm perceptions of smokeless tobacco relative to cigarettes. Draft Guidance., 2012. Richter P, Hodge K, Stanfill S, Zhang L, Watson C. Surveillance of moist snuff: total nicotine, moisture, pH, un-ionized nicotine, and tobacco-specific nitrosamines. Additionally, reducing the risk of a tobacco-related disease to individual tobacco users is only one prong of the two statutory requirements that USSTC must demonstrate to be granted a MRTP order. In January 2017, the FDA published a proposed product standard that would set a limit on the amount of NNN permissible in finished smokeless tobacco products. (page 5), U.S. Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products. Instead, in weighing the total public health impact of the proposed Copenhagen moist snuff marketing, the FDA should account for the fact that to any extent the marketing increases the uptake of smokeless tobacco among non-smokers, especially youth, those new smokeless tobacco users will be at risk of future combustible smoking, as well. The FDA should be concerned that consumers will interpret the proposed modified risk marketing of Copenhagen moist snuff to mean that smokeless tobacco conveys no risk of lung cancer or other tobacco-related systematic cancers when in truth, smokeless tobacco is a known human carcinogen and serious health risk. The FDA should not approve the proposed marketing order because USSTC has shown no evidence that the proposed marketing will encourage current smokers to switch completely to smokeless tobacco. Long Cut Spearmint Those participants who used smokeless tobacco, whether alone or in combination with other tobacco products, perceived a greater difference between cigarettes and smokeless. Under review 2018. Federal Register. 2016 May, 58(5):5558-66. FDA should not overlook that the International Agency for Research on Cancer (IARC) confirmed a causal role for smokeless tobacco in oral, esophageal, and pancreatic cancer. Modeling good research practices- overview: A report of the ISPOR-SMDM modeling good research practices task force - 1. Dual users of cigarettes and MST are assumed to have the same relative risk of mortality as sole cigarette smokers. The transition rates used for the modified case are based on the ALCS CCI study. Xtra Long Cut Rich Tobacco Blend Despite citing all of these publications in its application, as well as others showing a positive association between smokeless tobacco use and future smoking in youth and young adults,[39] USSTC claimed the opposite of what these papers found. https://doi.org/10.17226/13294. [53] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products. Assuming that the product will retain its current market share after 60 years -- a very questionable assumption given the highly dynamic nature of the tobacco products market -- the multi-cohort model projects an expected net benefit of 7,500 additional survivors from a starting cohort of 1 million native-born males after 60 years. USSTC MRTP Application for Copenhagen Snuff Fine Cut. The cans were distributed nationally and, so far, complaints have been made by consumers in Indiana, North Carolina, Ohio, Tennessee, Texas and Wisconsin. 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. According to an analysis of the 2012-14 National Adult Tobacco Survey,[51] 3.6% of U.S. adults aged 18+ were current ST users (See Table 1 of the cited paper). Docket No. [46] Altria Client Services LLC. Holding a perception that smokeless tobacco is associated with a lower risk of systemic disease, such as lung cancer, in comparison to smoking cigarettes is a strong predictor of smokeless tobacco use among adolescents. USSTC’s interpretation of their “Claim Comprehension and Intentions” study (CCI) findings is an attempt to “play it both ways.”. Journal of Adolescent Health. Nicotine Tob Res. These studies do not provide sufficient evidence that it is both necessary to the marketing of their product and will not impose further harms to the public’s health by increasing usage of their product by non-users, including youth. Tob Regul Sci. Module 6: Summary of All Research Findings: 6.4.: Effect on Tobacco Use Initiation Among Nonusers: Section 6.4.3.1: ST Use Has Been Shown Not to Predict Cigarette Smoking After Accounting for Other Factors That Typically Influence Smoking. Altria Client Services LLC. FDA-2016-N-2527. Altria Client Services LLC. Polytobacco use and nicotine dependence among U.S. adults, 2012-2014. Ignoring disease morbidity resulting from snus use underestimates its impact on health and medical costs. Washington, DC: The National Academies Press. 6-4-effect-tobacco-use-init-nonusers_Release in Full.pdf. Available from: https://monographs.iarc.fr/iarc-monographs-on-the-evaluation-of-carcinogenic-risks-to-humans-17/ (accessed 10 Dec 2018). Healthcare expenditures attributable to smokeless tobacco use among U.S. adults. It is essential that the USSTC demonstrate that such claims will be understood by youth and that consumers' (or potential consumers') interpretations of these claims are aligned with the actual risks of the smokeless tobacco. Substance Use and Misuse. Tob Control 2017;26(2):153-7 (PMC PMC5067225), [30] Leas EC, Zablocki RW, Edland SD, Al-Delaimy WK. Long Cut Southern Blend [26] 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. 2018 Jul;4(4):73-90. USSTC MRTP Application for Copenhagen Snuff Fine Cut. Pouches Wintergreen (overseas military only). [42] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products. 2.3.: Executive Summary. Smokeless Tobacco and Some Tobacco-specific N-Nitrosamines, IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 89 (2007). [36] Watkins SL, Glantz SA, Chaffee BW. Participants were considered "susceptible" to product use if answering anything other than "definitely not" to the question, if one of your best friends offered you [product], would you use it. Figure 1. As we will describe in more detail below, the USSTC MRTPA did not meet these statutory requirements; therefore, FDA must not issue the requested modified risk order. Guidance for Industry. Long Cut Wintergreen (overseas military only) Sung HY, Wang Y, Yao T, et al. Wang et al. [47] While this is correct, the modified risk statement may attract more females to use the product, including those who do not currently use tobacco. JAMA Pediatr. Available from: https://monographs.iarc.fr/iarc-monographs-on-the-evaluation-of-carcinogenic-risks-to-humans-32/, [4] International Agency for Research on Cancer. Despite section 911(g)’s requirement, this application failed to provide adequate scientific evidence demonstrating that their moist snuff products would “benefit the health of the population as a whole,” in particular non-users (including adolescents) as well as current users of other tobacco products. 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”[14]), 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”[15]). Is use of smokeless tobacco a risk factor for cigarette smoking? Based on the prevalent patterns of use and transitions between smoking and smokeless tobacco use,[12] smokers will likely continue to be uninterested in smokeless tobacco, and dual users will either continue dual use or transition to exclusive smoking. Furthermore, USSTC argues that it is necessary to change the risk perceptions because risk perceptions are one of the drivers of behavior. (p. 21-22), [49] Wang Y, Sung H, Yao T, et al. We also submitted this comment to TPSAC for its consideration; this letter, which summarizes the main points in the comment, is available here. This is a persistent problem that has been resistant to the tobacco control policies and social changes that have reduced youth cigarette smoking. Modified Risk Tobacco Product Applications. Modified Risk Tobacco Product Applications. Module 6: Summary of All Research Findings: 6.2.: Effect of Marketing on Consumer Understanding and Perceptions, Figure 6.2-7: General Harm Associated with the Candidate Product Pre-Post for Test and Control, p. 21, 6-2-risk-perceptions_Release in Full.pdf. 2007 Dec;9(12):1331-7. 2012. Medical Decision Making 2012;32(5):667-77. However, no tobacco company should be permitted to conduct research on youth below the legal age for tobacco use (21, to be conservative) because they could use such information to design marketing campaigns to attract youth to their products. Smokers who report smoking but do not consider themselves smokers: a phenomenon in need of further attention. Non-interventional study report, p. 14, app-7-3-2-1-ccis-report_Release in Full.pdf, [10] USSTC MRTP Application for Copenhagen Snuff Fine Cut. Journal of Adolescent Health. Module 7.4.2: Population Model. It is not clear whether this restriction in population will result in an overestimate or an underestimate. Youth Risk Behavior Surveillance - United States, 2017. Long Cut Straight (overseas military only) Public Law 111-31 (2009), Sec. These rates were then adjusted “by assigning weights that reflect mortality rates in the US population.”[50] Mortality rates for cigarette smoking from the early 1990’s are likely to be much higher than the comparable rates today due to changes in cigarettes, changes in other tobacco use patterns, and changes in intensity of cigarette smoking. Module 6: Summary of All Research Findings: 6.4.: Effect on Tobacco Use Initiation Among Nonusers: Section 6.4.3.1: ST Use Has Been Shown Not to Predict Cigarette Smoking After Accounting for Other Factors That Typically Influence Smoking. Tobacco Product Use Among Middle and High School Students - United States, 2011-2017. Institute of Medicine. USSTC initiated the recall after receiving eight consumer complaints of foreign metal objects, including sharp metal objects, found in select cans. [46] However, no such justification is provided. The FDA should not put faith in USSTC's ability or willingness to put the genie back in the bottle once widespread, untested marketing campaigns have been rolled out across the country and are shown to boost smokeless tobacco sales without appreciable reductions in cigarette smoking. Evidence that smokeless tobacco use is a gateway for smoking initiation in young adult males.
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