In addition to lung cancer, heart disease, and COPD, smoking also causes numerous other serious health conditions, including many types of cancer, premature birth, low birth weight, SIDS, respiratory illnesses, clogged arteries, reduced blood flow, diabetes, rheumatoid arthritis, and vision conditions such as age-related macular degeneration and cataracts (Ref. Fong, P. Driezen, et al. Cigarette smoking remains the leading cause of preventable disease and death in the United States and is responsible for more than 480,000 deaths per year. Vidrine, S. Shete, et al. 11/30/2020, 130 Klein, R., C.F. Also, as described in section VI.D, FDA carefully developed and tested concordant color graphics, in the form of photorealistic images, depicting the negative health consequences of smoking to accompany each of the textual warning statements included in this proposed rule. and H.S. 3 However, current e-cigarette use increased 78% among high school students during the past … Reports of the Surgeon General, US Public Health Service. edition of the Federal Register. 26). Garcia-Retamero, R. and M. Galesic. Hackshaw, A., J.K. Morris, S. Boniface, et al. 211. As with the proposed requirement in § 1141.10(d)(4), the required warnings would be required to be accurately reproduced as specified in “Required Cigarette Health Warnings,” but for these warnings this would also include the substitution and insertion of a true and accurate translation of the textual warning label statement in place of the English-language version. *205. Available at​10.1136/​tobaccocontrol-2014-052047. The first medical studies that raised serious concerns were published in Great Britain in the late 1940s. are not part of the published document itself. (4) Record retention. Jung, M. “Implications of Graphic Cigarette Warning Labels on Smoking Behavior: An International Perspective.” Journal of Cancer Prevention, 21(1):21-25, 2016. Deputy Secretary, Department of Health and Human Services. “How Reactions to Cigarette Packet Health Warnings Influence Quitting: Findings from the ITC Four-Country Survey.” Addiction, 104(4):669-675, 2009. 73. More details about the study methodology, including the sample size calculation and analysis plan, can be found in the study report, which we have included in this docket (Ref. “Cataracts.” for better understanding how a document is structured but 136 and 137). 154), building on the strong conclusions of causality from previous reports. Pictorial cigarette warnings have also been shown to be effective in communicating the health consequences of smoking to youth (Refs. Section 201(a)(1) of the FD&C Act (21 U.S.C. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, email: Last updated June 30, 2018.​nihfactsheets/​ViewFactSheet.aspx?​csid=​77. 208. Vigilante. The victory secured central Arkansas for the Union and lifted Northern morale just three weeks after the disastrous Battle of more, Francis Salvador, the first Jewish person to hold an elected office in the Americas, takes his seat on the South Carolina Provincial Congress on January 11, 1775. As provided by section 201(b), after the 30-day period, manufacturers would not be permitted Start Printed Page 42785to introduce into domestic commerce any cigarette packages that do not contain the required warnings, irrespective of the date of manufacture. 161-164). Washington, DC: U.S. Department of Education, National Center for Education Statistics, 2006. 26). For both adults and adolescents, exposure to pictorial cigarette warnings that highlighted specific health topics led to increases in correct beliefs about smoking causing the specific health topic in the warning. b. Pictorial cigarette warnings increase information processing and learning of new information about the negative health consequences of smoking. Tobacco City & Lottery, Inc. v. U.S., at 530-31. 165. As described in detail in sections VI-VII, the proposed required warnings are intended to promote greater public understanding of the negative health consequences of cigarette smoking. 2013; Nov 8. Rather, these labeling statements are a “public disclosure” of information originally supplied by the Federal Government to the recipient for the purpose of “disclosure to the public” (5 CFR 1320.3(c)(2)). Nattinger, and T.L. WARNING: Smoking reduces blood flow, which can cause erectile dysfunction. 123. Proposed § 1141.3 sets forth the meaning of terms as they apply to proposed subparts A and B of part 1141. Hori, M., H. Tanaka, K. Wakai, et al. 11. Studies demonstrate that increasing notice of and attention to the information in a cigarette health warning promotes understanding of the message. In parallel with FDA's efforts to develop and test revised warning statements, the Agency also undertook an iterative, research-based approach to develop color graphics depicting the negative health consequences of cigarette smoking to accompany those statements. 212. “Meta-Analyses of the Effectiveness of Warning Labels.” Journal of Public Policy and Marketing, 23(2), 193-208, 2004. The proposed rule would require that the inserted textual warning label statement comply with all requirements of section 4 of the FCLAA and this proposed part. It also includes an express preemption provision that preempts any “requirement or prohibition based on smoking and health . 93. 83. The proposed rule would implement a provision of the Tobacco Control Act that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. Data from the ITC-4 showed that noticing health warnings on cigarette packages was associated with increased knowledge about the health consequences of smoking (Ref. 39. 24). Hollands. All comments should be identified with the title of the information collection. As per the requirements laid out in section 4 of the FCLAA, the text of the cigarette health warnings in advertisements must be black if the background is white and white if the background is black. Ramlau-Hansen. “Eye Movements When Viewing Advertisements.” Frontiers in Psychology, 5:1-15, 2014. informational resource until the Administrative Committee of the Federal Another article estimates that “over 90% of all limb amputations in the Western world occur as a direct or indirect consequence” of PAD/PVD (Ref. These findings suggest that the public does not Start Printed Page 42762understand the complete range of illnesses caused by smoking, indicating gaps in public understanding of the negative health consequences of smoking. While this statutory limitation applies to only manufacturers, FDA believes that keeping products without the required warnings under any final rule on the market for an extended period would not be in the interest of public health. The 2014 Surgeon General's Report on cigarette smoking concluded, for the first time, that the evidence is sufficient to infer a causal relationship—the highest level of evidence of causal inferences from the criteria applied in the Surgeon General's Reports—between cigarette smoking and the two major types of advanced age-related macular degeneration (Ref. “Vital Signs: Tobacco Product Use Among Middle and High School Students—United States, 2011-2018.” Morbidity and Mortality Weekly Report, 68(6):157-164, 2019. 186. In 1972, the Federal Trade Commission (FTC) issued consent orders requiring six major cigarette manufacturers and distributors to include in all of their cigarette advertisements a clear and conspicuous disclosure of the same warning required to be on packages (Ref. Maloney, et al. Ebbert, J.O., P. Yang, C.M. The inclusion of health warnings on cigarette packages and in advertisements therefore can provide a critical opportunity to help smokers and nonsmokers of all ages better understand the negative health consequences of smoking. Mahwah, NJ: Lawrence Erlbaum Associates, Inc., 2006. Doak, C.C., L.G. “Associations Between Health Literacy and Established Predictors of Smoking Cessation.” American Journal of Public Health, 103(7):e43-e49, 2013. Throughout this proposed rule, and in the context of the word “cause” or “causes” used in the textual warning statements included therein, FDA relied on the four-level classification provided in the Surgeon General's Reports. Gupta, et al.

surgeon general warning cigarettes 2019

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