Spotlight on Science - Spring 2021
Email Updates from CTP
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In This Issue…
FDA has committed to advance two product standards: one to ban menthol as a characterizing flavor in cigarettes and another to ban all characterizing flavors (including menthol) from cigars. Learn more in this latest issue of Spotlight on Science, a quarterly research and science digest from FDA’s Center for Tobacco Products (CTP).
- FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers
- PATH Study Update: Researchers Encouraged to Access Latest Files, Including Wave 5 Data (2018 – 2019)
- Letter to the Editor Highlights Data on Youth Disposable ENDS Use
- New FDA & AAP Video Series: Pediatricians Discuss Youth E-Cigarette Use
- Request a Speaker from CTP’s Speakers Bureau
- More About CTP Research
FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers
On April 29, FDA announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products – the leading cause of preventable death in the U.S.
FDA is working toward issuing proposed product standards within the next year: one to ban menthol as a characterizing flavor in cigarettes and another to ban all characterizing flavors (including menthol) in cigars. The authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave the agency. The decision to advance these product standards is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009.
The agency is taking urgent action to reduce tobacco addiction and curb deaths. There is strong evidence that a menthol ban will help people quit. Studies show that menthol increases the appeal of tobacco and facilitates progression to regular smoking, particularly among youth and young adults. Menthol masks unpleasant flavors and harshness of tobacco products, making them easier to start using. Tobacco products with menthol can also be more addictive and harder to quit by enhancing the effects of nicotine.
Furthermore, after the 2009 statutory ban on flavors in cigarettes other than menthol, use of flavored cigars increased dramatically, suggesting that the public health goals of the flavored cigarette ban may have been undermined by continued availability of these flavored cigars.
If implemented, the FDA’s enforcement of any ban on menthol cigarettes and all flavored cigars will only address manufacturers, distributors, wholesalers, importers and retailers. The FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product. The FDA will work to make sure that any unlawful tobacco products do not make their way onto the market.
HHS Secretary Xavier Becerra issued a statement in support of these actions, which are an important opportunity to achieve significant, meaningful public health gains and advance health equity. FDA is working expeditiously on the two issues, and the next step will be for the agency to publish proposed rules in the Federal Register, allowing an opportunity for public comment.
FDA recognizes the importance of ensuring broad and equitable access to all the tools and resources that can help currently addicted smokers seeking to quit, including those who smoke menthol cigarettes and would be impacted by these public health measures. FDA will work with partners in other federal agencies to make sure the support is there for those who are trying to quit.
PATH Study Update: Researchers Encouraged to Access Latest Files, Including Wave 5 Data (2018 – 2019)
Researchers can now access five new data sets from the Population Assessment of Tobacco and Health (PATH) Study, including the following:
- Wave 5 Restricted-Use File (RUF)
- Wave 5 State Identifier Restricted-Use File (SIRUF)
- Wave 5 Tobacco Universal Product Code Restricted-Use File (TUPCRUF)
- Special Collection Wave 4.5 Youth State Identifier Restricted-Use File (SIRUF)
- Special Collection Wave 4.5 Ever/Never Reference Data File
Instructions for requesting access to the new content along with other PATH Study resources can be found on the PATH Study webpage.
Qualified researchers may also apply for access to the updated biomarker data restricted-use files (BRUFs) for Waves 2 and 3, and the Wave 4 BRUF, through the PATH Study Biomarker Restricted-Use Files webpage.
To learn more, please view a video that provides an orientation to the study. Questions about the collection, content, weighting, documentation, or structure of PATH Study data (this excludes questions on statistical analysis or analytic guidance) may be submitted to PATHDataUserQuestions@Westat.com.
Letter to the Editor Highlights Data on Youth Disposable ENDS Use
FDA and CDC researchers published a Letter to the Editor of the New England Journal of Medicine. The letter summarizes findings from the latest National Youth Tobacco Survey about youth use of disposable ENDS, including some new findings not previously published in the report on youth e-cigarette use in the Morbidity and Mortality Weekly Report (MMWR). Some highlights from the letter to the editor include:
- Among middle school students currently using any type of e-cigarette, disposable e-cigarette use was reported by 3.0 percent (30,000 students) in 2019 and by 15.2 percent (80,000 students) in 2020.
- Among high school students currently using any type of e-cigarettes, disposable e-cigarettes use was reported by 2.4 percent (90,000 students) in 2019 and 26.5 percent (790,000 students) in 2020.
- Among all middle school students, use of disposable e-cigarettes was reported by 0.3 percent in 2019 and by 0.7 percent in 2020; 0.7 percent and 5.1 percent of all high school students reported disposable cigarette use in 2019 and 2020, respectively.
- Prefilled pods or cartridges remained the most commonly used device type in 2020, as reported by 220,000 middle school students and 1.45 million high school students.
New FDA & AAP Video Series: Pediatricians Discuss Youth E-Cigarette Use
FDA and the American Academy of Pediatrics (AAP) collaborated to develop a video series featuring pediatricians answering common questions about youth e-cigarette use.
Request a Speaker from CTP’s Speakers Bureau
Request a speaker from CTP’s Speakers Bureau, a centralized place to request expert speakers on CTP’s regulatory actions and public education initiatives.
To request a speaker from CTP’s Speakers Bureau, submit the following to CTPSpeakerRequests@fda.hhs.gov:
- A completed speaker request form;
- A formal invitation on organization letterhead, and;
- A program agenda with all invited speakers and topics.
For more information, please visit our Speakers Bureau webpage or contact us at CTPSpeakerRequests@fda.hhs.gov.
More About CTP Research
Recent Publications by CTP Researchers
- Disposable E-Cigarette Use among U.S. Youth — An Emerging Public Health Challenge. N Engl J Med. 2021 Mar 16.
- Changes in cigarillo availability following implementation of a local flavoured tobacco sales restriction. Tob Control. 2021 Feb 4;tobaccocontrol-2020-056229. doi: 10.1136/tobaccocontrol-2020-056229. Online ahead of print.
- Exposure to Nicotine and Toxicants Among Dual Users of Tobacco Cigarettes and E-Cigarettes: Population Assessment of Tobacco and Health (PATH) Study, 2013-2014. Nicotine Tob Res. 2021 Feb 16;ntaa252. doi: 10.1093/ntr/ntaa252. Online ahead of print.
- E-Cigarette Device Types Used by Middle School Students and High School Students-The U.S., 2019. J Adolesc Health. 2021 Feb 16;S1054-139X(21)00002-1. doi: 10.1016/j.jadohealth.2021.01.001. Online ahead of print.
- Integration of transcriptome analysis with pathophysiological endpoints to evaluate cigarette smoke toxicity in an in vitro human airway tissue model. Arch Toxicol. 2021 Mar 3. doi: 10.1007/s00204-021-03008-0. Online ahead of print.
- Tobacco-Specific Nitrosamines in the Tobacco and Mainstream Smoke of Commercial Little Cigars. Chem Res Toxicol. 2021 Mar 5. doi: 10.1021/acs.chemrestox.0c00367. Online ahead of print.
- Social media use by leading US e-cigarette, cigarette, smokeless tobacco, cigar and hookah brands. Tob Control. 2020 Dec;29(e1):e87-e97. doi: 10.1136/tobaccocontrol-2019-055406. Epub 2020 Mar 26.
- Influencer prevalence and role on cigar brand Instagram pages. Tob Control. 2020 Oct 12;tobaccocontrol-2020-055994. doi: 10.1136/tobaccocontrol-2020-055994. Online ahead of print.
- Characterization of acrylonitrile exposure in the United States based on urinary n-acetyl-S-(2-cyanoethyl)-L-cysteine (2CYEMA): NHANES 2011-2016. J Expo Sci Environ Epidemiol. 2021 Mar;31(2):377-385. doi: 10.1038/s41370-020-00286-1. Epub 2021 Jan 11.
- No Butts on the Beach: Aquatic Toxicity of Cigarette Butt Leachate Chemicals. Tob Regul Sci. 2021 Jan;7(1):17-30. doi: 10.18001/TRS.7.1.2.
- Volatile Organic Compounds in Mainstream Smoke of Sixty Domestic Little Cigar Products. Chem Res Toxicol. 2021 Mar 15;34(3):704-712. doi: 10.1021/acs.chemrestox.0c00215. Epub 2021 Jan 29.
- LGBT young adults' awareness of and receptivity to the This Free Life tobacco public education campaign. Tob Control. 2021 Jan;30(1):63-70. doi: 10.1136/tobaccocontrol-2019-055239. Epub 2020 Jan 15.
Research Opportunities to Explore
In support of its mission to develop regulation rooted in science, CTP seeks new research to address key areas of tobacco regulatory science such as toxicity, addiction, health effects, behavior, communications, marketing influences, and impact analysis of regulatory actions.
CTP encourages research studies to include, where appropriate to the research question, populations of special relevance, including (but not limited to): youth, socioeconomically disadvantaged populations, racial/ethnic minorities, underserved rural populations, people with co-morbid mental health conditions and/or substance use disorders, military/veteran populations, pregnant women or women of reproductive age, and sexual and gender minorities.
- Tobacco Regulatory Science Program: FDA’s partnership with NIH to foster tobacco regulatory research, offers funding for scientists whose research can inform CTP’s regulatory activities.
- Current Funding Opportunities
Spotlight on Science is a quarterly science and research digest from FDA’s Center for Tobacco Products.
Note: The contents of publications discussed in this newsletter are the responsibility of their authors alone, and findings and conclusions are those of the authors and do not necessarily represent the views of FDA.