The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. Five of the 15 revised statements were “new content” statements, without a comparator TCA statement on the same health condition. The victory secured central Arkansas for the Union and lifted Northern morale just three weeks after the disastrous Battle of ...read 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. Both U.S. and non-U.S. studies have found that consumers are largely unaware of the negative health consequences of cigarette smoking not mentioned in current warnings as well as more specific information about the negative health effects and their mechanisms (Refs. Participants assigned to the control condition viewed the nine TCA warning statements again. Available at https://doi.org/10.1111/j.1444-0938.2012.00789.x. Available at https://doi.org/10.7326/0003-4819-155-2-201107190-00005. U.S. “Passive Smoking and Lung Cancer: A Cumulative Meta-Analysis.” Australian and New Zealand Journal of Public Health, 25(3):203-211, 2001. Whether participants reported beliefs linking smoking and the health consequences in the warning statement (“health beliefs”). In a letter to Congress on March 15, 2013, the U.S. Attorney General reported FDA's intention to undertake research to support a new rulemaking consistent with the Tobacco Control Act (Ref. Additionally, maternal smoking (i.e., smoking while pregnant) has been found to be associated with low birth weight (Ref. Evidence is inadequate to infer the presence or absence of a causal relationship (which encompasses evidence that is sparse, of poor quality, or conflicting). (2) Rotation. 2). Proposed § 1141.3 includes the following definitions from the FCLAA (15 U.S.C. “More Than Meets the Eye: On the Importance of Retail Cigarette Merchandising.” Tobacco Control, 16:270-274, 2007. McQueen, A., M.W. to the courts under 44 U.S.C. U.S. Department of Health, Education, and Welfare. Surgeon General's Reports classify the strength of causal inferences in a four-level hierarchy based upon work of the IOM (now the National Academy of Medicine) and the International Agency for Research on Cancer (IARC) (Refs. 21-23). Proposed § 1141.10(d)(1) includes some of these examples for reference but neither the examples in § 1141.10 (d) nor this discussion are intended to be exhaustive. Available at https://doi.org/10.1038/sj.eye.6701955. 7). In the event any court or other lawful authority were to temporarily or permanently invalidate, restrain, enjoin, or suspend any provision of the final rule, FDA intends for the remaining parts to continue to be valid. Root, Eds. On January 11, 1978, Toni Morrison wins the National Book Critics Circle Award for Song of Solomon. This process required considering how to help promote greater public understanding of the negative health consequences of cigarette smoking given that the general public comprises individuals with many varied backgrounds, knowledge, beliefs, and abilities to read and understand health information. The required warnings would need to be accurately reproduced as specified in “Required Cigarette Health Warnings,” to help ensure that the required warnings are not distorted or obscured, and are prominent and legible, consistent with the requirements of the FCLAA and this proposed part. "use strict";(function(){var insertion=document.getElementById("citation-access-date");var date=new Date().toLocaleDateString(undefined,{month:"long",day:"numeric",year:"numeric"});insertion.parentElement.replaceChild(document.createTextNode(date),insertion)})(); FACT CHECK: We strive for accuracy and fairness. Over 16 million Americans alive today live with disease caused by smoking cigarettes (Ref. Available at https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_01.pdf. 207. 25. 112. The required warnings for packages specified in paragraph (a) of this section must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the tobacco product manufacturer, distributor, or retailer to, and approved by, the Food and Drug Administration. “Secondhand Smoke Exposure and Asthma Outcomes Among African-American and Latino Children with Asthma.” Thorax, 73(11):1041-1048, 2018. This proposed rule would replace part 1141 in Title 21 of the Code of Federal Regulations to implement these FCLAA requirements. 59). “Smoking and Risk of Age-Related Cataract: A Meta-Analysis.” Investigative Ophthalmology & Visual Science, 53(7):3885-3895, 2012. WARNING: Smoking during pregnancy causes premature birth (premature birth). (v) WARNING: Smoking reduces blood flow to the limbs, which can require amputation. the current document as it appeared on Public Inspection on “CDC WONDER (Wide-ranging Online Data for Epidemiologic Research).” CDC.gov. Cigarette Health Warnings That Are Noticeable Will Lead to Increased Attention to the Warning Message, 2. The 1965 warning requirement was modified by later amendments to the FCLAA, including the Comprehensive Smoking Education Act of 1984 (Pub. The image shows the chest of a man (aged 60-70 years) wearing an open hospital gown. If a court were to invalidate some of FDA's revised textual warnings with their paired images but some remained valid, FDA intends that the remaining revised textual warning statements and their paired images would go into effect. Born in 1747, Salvador was descended from a line of prominent Sephardic Jews who made their home in London. Roth, L.K. Summary of the Major Provisions of the Proposed Rule, D. 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