06/12/2018 - Spotlight on Science—Spring 2018

Spotlight on Science is a quarterly science and research digest from the FDA 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.
In This Issue… 
Guided by the nicotine-focused tobacco regulatory framework it announced last July, FDA is taking major strides toward reducing tobacco’s preventable disease and death toll in this country. These steps include issuing three advance notices of proposed rulemaking (ANPRMs), which are discussed in this Spotlight on Science along with additional examples of science-based advances.

Three ANPRMs for Scientific Comment
Potential Product Standard Limiting Cigarette Nicotine Level
Role of Flavors in Tobacco Products
Premium Cigars: Patterns of Use, Public Health Impact
National Youth Tobacco Survey: Latest Findings
PATH Update

CTP Research
Study Snapshots: Two Studies Using PATH Data
Additional Recent Publications by CTP Researchers
Funding Opportunities to Explore
Three ANPRMs for Scientific Comment

FDA is involved in a public dialogue to help guide its tobacco regulatory policy, and welcomes input from scientists to support the agency’s actions designed to save millions of lives. The agency relies on rigorous research from outside researchers to complement agency-conducted and -funded research and inform the agency’s nicotine-focused tobacco regulatory strategy. “Our regulatory thinking is guided by the best available science,” remarked FDA Commissioner Scott Gottlieb, M.D., at the February annual meeting of the Society for Research on Nicotine and Tobacco. “The process for issuing rules and regulations is a participatory one. And we welcome and encourage your involvement.”
To seek public input, FDA has recently issued advance notices of proposed rulemaking on three topics: the nicotine level in cigarettes, flavors in tobacco products, and premium cigars. The agency will consider all comments when determining its regulatory options in these areas. On each topic, if the agency decides to move forward, a notice of proposed rulemaking would be issued first in the Federal Register, providing the public with another opportunity to comment.

Potential Product Standard Limiting Cigarette Nicotine Level

As FDA works to solve the crisis of tobacco use in this country, the issues the agency must tackle include the root concern over nicotine’s role in tobacco addiction—an addiction that keeps cigarette users coming back to a product they know can kill them.
In one advance notice of proposed rulemaking (ANPRM), “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,” published in the Federal Register March 16, FDA is requesting public comment on a potential product standard that would limit nicotine in cigarettes to a minimally or non-addictive level.
Under an extended comment period, FDA is seeking comments, research, and data throughJuly 16 on topics related to this potential product standard.

Role of Flavors in Tobacco Products

Through another advance notice of proposed rulemaking, “Regulation of Flavors in Tobacco Products,” published in the Federal Register March 21, the agency is seeking comments, data, research results, or other information related to the role of flavors—including menthol—in tobacco product use, and regulatory approaches the agency could take to better protect kids and significantly reduce overall tobacco-related disease and death. Comments will be accepted through July 19 under an updated comment period.
“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” said FDA Commissioner Gottlieb upon issuance of the ANPRM. “And as a public health agency, it’s important that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain non-combustible forms of tobacco products.”

Premium Cigars: Patterns of Use, Public Health Impact

To inform FDA’s regulatory policies related to products often referred to as “premium” cigars, the agency has issued an advance notice of proposed rulemaking, “Regulation of Premium Cigars,” to seek related comments and scientific data. Specifically, the agency requests comments and information not previously submitted in association with the proposed deeming rule. Under an extended deadline, comments are now being accepted through July 25.
The now-final deeming rule extended FDA’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act to cigars, among other tobacco products. The rule made requirements such as mandatory age and photo-ID checks, warning statements, and submission of health documents applicable to these additional products.
As proposed, the deeming rule presented two alternative regulatory options, one of which would have excluded “premium” cigars from FDA regulation. After carefully considering public comments, FDA concluded all cigars pose serious negative health risks, and the evidence did not provide a public health basis for FDA to exclude any type of cigars from regulation.
Given the ongoing interest on this issue—as well as the potential for new data on the topic since publication of the deeming rule—stakeholders are being provided this opportunity to submit relevant new information that could inform the agency.

Latest Findings from NYTS Show Declines in Overall Tobacco Use

On June 7, FDA and CDC released findings from the 2017 National Youth Tobacco Survey (NYTS) in the Morbidity and Mortality Weekly Report. Findings show that among high school students, current use of any tobacco product decreased from 24.2 percent (3.69 million) in 2011 to 19.6 percent (2.95 million) in 2017, and among middle school students, current use of any tobacco product decreased from 7.5 percent (0.87 million) in 2011 to 5.6 percent (0.67 million) in 2017. By product, among both middle and high school students, there were decreases in use of cigarettes, cigars, smokeless tobacco, pipes, and bidis and an increase in e-cigarette use.

PATH Update: Wave 3 Questionnaire Data Files Now Available to Researchers

FDA and NIH have announced the availability of the questionnaire data files from Wave 3 of the Population Assessment of Tobacco and Health (PATH) Study. Qualified researchers may now apply for access to the restricted-use file (RUF) from the Inter-university Consortium for Political and Social Research. 
You can apply online to access the Wave 3 RUF. For more general information about the study and available data files, visit CTP’s PATH Study webpage.

CTP Research

Study Snapshots: Two Studies With Population Assessment of Tobacco and Health (PATH) Data
Pierce JP, Sargent JD, Portnoy DB, et al. Association between receptivity to tobacco advertising and progression to tobacco use in youth and young adults in the PATH Study.JAMA Pediatr. 2018 Mar 26. Doi: 10.1001/jamapediatrics.2017.5756 [Epub ahead of print]
This analysis used PATH Study data to examine whether receptivity to tobacco product advertising is a risk factor for progression toward tobacco product use among youth and young adults. In the analysis, funded by the NIH’s National Institute on Drug Abuse and CTP, receptivity to tobacco advertising was found to be significantly associated with progression toward cigarette, e-cigarette, and cigar use in adolescents. Overall, receptivity was highest for e-cigarette advertising, and those who were receptive to e-cigarette advertising (compared to those with no receptivity) had higher odds of trying smoking one year later, even if they were not receptive to cigarette advertising. “This analysis shows that tobacco product advertising continues to have important effects on youth and young adults,” says David Portnoy, Ph.D., M.P.H., CTP social science branch chief and an author on the paper. Why e-cigarette advertising was associated with trying a cigarette is a topic for further research, the authors write.   
Coleman B, Rostron B, Johnson SE, et al. Transitions in electronic cigarette use among adults in the Population Assessment of Tobacco and Health (PATH) Study, Waves 1 and 2 (2013–2015)Tob Control. 2018 Apr 25. Doi: 10.1136/tobaccocontrol-2017-054174 [Epub ahead of print]
The research assessed patterns of e-cigarette and cigarette use from Wave 1 to Wave 2  of the PATH Study among adults who were e-cigarette users at Wave 1. About half (48.8 percent) of adult e-cigarette users at Wave 1 ceased their use of e-cigarettes at Wave 2. Among dual users of e-cigarettes and cigarettes at Wave 1, 44.3 percent maintained dual use, 43.5 percent discontinued e-cigarette use and maintained cigarette smoking, and 12.1 percent discontinued cigarette use at Wave 2, either by abstaining from cigarette smoking only or discontinuing both products. Among dual users at Wave 1, daily e-cigarette users were more likely than non-daily users to report smoking abstinence at Wave 2. This study suggests that e-cigarette use patterns are highly variable over a one-year period. The authors write, “To date, few longitudinal studies have been published examining changes in e-cigarette use behavior; namely, the stability of e-cigarette use patterns and their relationship to use of other tobacco products. Our study addresses this gap by examining changes in e-cigarette behavior over one year.” Follow-up research can provide further insight into long-term patterns of e-cigarette use, the authors state, and inform our understanding of e-cigarettes’ net population health impact in the United States.
Find more information online about research using PATH data.

Additional Recent Publications by CTP Researchers
Stay Up to Date! Scientific Publications From CTP

Funding Opportunities to Explore

Featured below are some current CTP funding opportunities. You can find more information by clicking on the appropriate funding opportunity announcement (FOA) number.
Scientific Conference Grant Program
The Scientific Conference Grant Program recognizes the value of small, high-quality conferences and scientific meetings that are relevant to FDA’s mission and to public health.
            R13—Support for Conferences and Scientific Meetings
                        FOA Number: PAR-16-378
                        Next Application Due Date: Oct. 12, 2018
                        Letter of Intent Due Date: Eight weeks before application due date
Tobacco Regulatory Science 
The 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.
R01—Tobacco Regulatory Science Research Project Grant
FOA Number: RFA-OD-18-002
Next Application Due Dates: July 17, 2018Feb. 13, 2019
Letter of Intent Due Date: 60 days before application due date
R21—Tobacco Regulatory Science Exploratory/Developmental Research Grant
FOA Number:- RFA-OD-18-003
Next Application Due Dates: July 17, 2018Feb. 13, 2019
Letter of Intent Due Date: 60 days before application due date
R03—Tobacco Regulatory Science Small Grant Program for New Investigators
FOA Number: RFA-OD-17-008
Next Application Due Dates: July 17, 2018Feb. 13, 2019
Letter of Intent Due Date: 60 days before application due date
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