The extensive discussion provided in the MRTPA related to the impact of the modified risk claim on the population groups of interest.
(page 5), [47] Altria Client Services LLC. 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. It is not clear why other males are not included, but this omission will lead to a difference in net benefits. The model is developed following recommendations for model development from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Society for Medical Decision Making (SMDM). Scientific Standards for Studies on Modified Risk Tobacco Products. 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.
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. Pouch Citrus Tobacco Blend 2016 Jan 19;49(1):106-14. Fine Cut (overseas military only) In addition, USSTC argues that: “A harm reduction strategy that informs adult smokers about reduced risk products, subject to FDA oversight, will complement, not compete, with proven prevention and cessation strategies.”[40] However, it is likely that these modified risk messages will be seen by youth. The select cans subject to this recall: 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”.
Long Cut Straight (overseas military only) 6-4-effect-tobacco-use-init-nonusers_Release in Full.pdf. 2.3.: Executive Summary, p. 43, 2.3-executive summary _Redacted.pdf. MMWR Surveill Summ. Module 6.5: Population Health Model Research Summary.
USSTC MRTP Application for Copenhagen Snuff Fine Cut. 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. 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. 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]). 2008 Nov;10(11):1645-52. The extensive discussion provided in the MRTPA related to the impact of the modified risk claim on the population groups of interest[55] is not relevant given that the CCI study does not indicate that any changes in behavior are likely to occur. Dual use of smokeless tobacco (ST) products (including SNUS) and other products is common. Exposure to modified risk claims in smokeless tobacco marketing may lead to an increase in exposure to harmful and potentially harmful chemicals among never- and former-smokers, including adolescent never-smokers who might initiate nicotine use with smokeless tobacco. In its MTRPA, USSTC states, “Collectively, the findings suggest that, for tobacco users and non-users, a single exposure to the modified risk claim does not have a meaningful effect upon behavioral intentions and perceptions of risk.”[9], Despite its own findings, of no effect for both smokers and non-smokers, the USSTC nonetheless claims different long-term effects for these two groups. USSTC MRTP Application for Copenhagen Snuff Fine Cut. Pouch Plastic Can (only available in Alaska and Hawaii), Fine Cut Natural
BMC Public Health. 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. Guidance for Industry. The model only considers mortality, despite the fact that tobacco use (including snus) causes considerable morbidity. 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. The modified risk message proposed by USSTC for Copenhagen does not have enough evidence to show it will motivate smokers to switch to the exclusive use of their product nor do they demonstrate that there will be no unintended consequences on non-smokers which will increase overall tobacco consumption.
Registration on or use of this site constitutes acceptance of our User Agreement, Privacy Policy and Cookie Statement, and Your California Privacy Rights (each updated 1/1/20). Perceived lung cancer risk of cigarettes and smokeless tobacco, rural male adolescents. 2019 (In Press).
Long Cut Straight (overseas military only) Long Cut Southern Blend Xtra Pouch Mint Blend [43] Boone RJ, Muhammed-Kay RS PY, Wei L, et al.
Cigarette and Smokeless Tobacco Perception Differences of Rural Male Youth. [13] USSTC MRTP Application for Copenhagen Snuff Fine Cut. The model does not include the impact of snus on non-users of tobacco products, as required by the FDA. 2018 Jun 15;67(8):1-114. To see more on the recall, visit the US Smokeless Tobacco Company website.
2015;15(1):258. Module 6: Summary of All Research Findings: 6.4.: Effect on Tobacco Use Initiation Among Nonusers: Section 6.4.3: The Likelihood that Nonusers Who Adopt the Tobacco Product Will Switch to Other Tobacco Products That Present Higher Levels of Individual Health Risk. are critical parameters in the ALCS Cohort Model, but the rates used for the base case are obtained from published studies from 2002, 2003, and 2009. Module 6.5: Population Health Model Research Summary. [30] Smoking cigarettes but not identifying as a smoker is common among non-daily smokers who were formerly daily smokers,[31] opening the likelihood that smokeless tobacco users may consider themselves to have "switched completely" even if they continue to smoke combustible cigarettes. Polytobacco use and nicotine dependence among U.S. adults, 2012-2014. 911. http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf, [3] International Agency for Research on Cancer. Module 6: Summary of All Research Findings: 6.2.: Effect of Marketing on Consumer Understanding and Perceptions: 6.2.4.1.: Claims Language Development & Assessment, 6-2-risk-perceptions_Release in Full.pdf, California Consortium for Thirdhand Smoke, Tobacco Companies to force a referendum on California state flavored tobacco product ban, Two big national studies show E-cigarettes Won’t Help Smokers Quit, but they may become Addicted to Vaping, Gov Newsom signs Calif ban on sales of flavored tobacco products. [45] Caro JJ, Briggs AH, Siegert U, et al. [32] Institute of Medicine. USSTC MRTP Application for Copenhagen Snuff Fine Cut. Journal of Adolescent Health.
USSTC MRTP Application for Copenhagen Snuff Fine Cut. Wang TW, Gentzke A, Sharapova S, Cullen KA, Ambrose BK, Jamal A. 2.3.: Executive Summary, p. 6, 2.3-executive summary _Redacted.pdf, FDA’s The Real Cost Campaign.
Adolescents’ Perceptions of Health Risks, Social Risks, and Benefits Differ across Tobacco Products. Available from: https://monographs.iarc.fr/iarc-monographs-on-the-evaluation-of-carcinogenic-risks-to-humans-17/ (accessed 10 Dec 2018). "We also are working closely with federal authorities to investigate," Brian W. Quigley, president and CEO of U.S. Smokeless Tobacco Company, said in a statement. Nicotine Tob Res. USSTC MRTP Application for Copenhagen Snuff Fine Cut. [22] Chaffee BW, Couch ET, Urata J, Gansky SA, Essex G, Cheng J. Predictors of Smokeless Tobacco Susceptibility, Initiation, and Progression Over Time Among Adolescents in a Rural Cohort. The mortality models are based on data from the Kaiser Permanente Medical Care Program Cohort study and appear to reflect mortality ratios for insured individuals in 1991. [36] Watkins SL, Glantz SA, Chaffee BW. The language used in these claims must be tested thoroughly among the entire population for salience, credibility, readability, and accuracy of consumers' interpretations. Bandit Wintergreen 6-4-effect-tobacco-use-init-nonusers_Release in Full.pdf, [28] USSTC MRTP Application for Copenhagen Snuff Fine Cut. [46] Altria Client Services LLC. [23] While this perceived difference in systemic health risks between cigarettes and smokeless tobacco was observed among both tobacco users and non-users, the difference was more pronounced among current smokeless tobacco users and smokeless/combustible dual- users. Journal of Adolescent Health. Long Cut (overseas military only) As such, they will directly compete, not complement the FDA’s proven prevention strategies, specifically, the Real Cost campaign, which has been communicating to youth at-risk for smokeless tobacco use that “smokeless doesn’t mean harmless.”[41]. BMC Public Health. BL. Nicotine Tob Res. [19] Song, AV, Morrell, HE, Cornell, JL, Ramos, ME., Biehl, M., Kropp, RY., Halpern-Felsher. The ALCS Cohort Model has not been published in the peer-reviewed literature; rather it is documented only in a conference poster. USSTC’s sales representatives will assist wholesalers and retailers in returning the product. If this unproven marketing campaign is approved and the result is greater smokeless tobacco use but without harm reduction, the only remedy USSTC suggest is “post market surveillance” (void of any details on how such surveillance would be conducted).
Personal Habits and Indoor Combustions: A Review of Human Carcinogens, IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 100E (2012). 7.3.3-1: CS-01- Claims Qualitative Study, p. 6, app-7-3-3-1-cs-01-claims-qual-study_Redacted.pdf, [16] USSTC MRTP Application for Copenhagen Snuff Fine Cut. Docket No. USSTC MRTP Application for Copenhagen Snuff Fine Cut. Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products. 2008 Nov;10(11):1645-52. Healthcare expenditures attributable to smokeless tobacco use among U.S. adults. The cans were distributed nationally and, so far, complaints have been made by consumers in Indiana, North Carolina, Ohio, Tennessee, Texas and Wisconsin.
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