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Spotlight on Science — Spring 2018


Spotlight on Science header

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

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 (SRNT). “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 through July 16 on topics related to this potential product standard.

Cigarettes are the category of tobacco product causing the greatest public health burden. As a cornerstone of FDA’s comprehensive new framework for tobacco regulation, the type of product standard being considered has the potential to save millions of lives, in the near and longer term.

If such a product standard was implemented, many positive health effects could be achieved, such as addicted smokers switching completely to a potentially less harmful product or quitting tobacco altogether, and future generations being much less likely to get addicted to cigarettes in the first place. A recent FDA-funded study, “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States,” published in the March 2018 issue of the New England Journal of Medicine, considered the public health implications of one possible policy scenario for a nicotine product standard. The analysis found that about 5 million additional adult smokers could quit smoking within one year of implementation, compared to a baseline scenario. And an even greater impact could be felt over time. By the year 2100, more than 33 million people—mostly youth and young adults—could avoid becoming regular smokers. This could result in more than 8 million fewer tobacco-related deaths by the end of the century. A summary of the main findings is available on CTP’s website: “How Could Lowering Nicotine Levels in Cigarettes Change the Future of Public Health?

“No statistical model can truly capture the full impact of this effort—including the joy from years of quality life gained with a loved one, or how much pain and suffering would be avoided for millions of families across the country,” said FDA Commissioner Gottlieb. He added, “Our estimates underscore the tremendous opportunity to save so many lives if we come together and forge a new path forward to combat the overwhelming disease and death caused by cigarettes.”

The ANPRM provides examples of issues on which FDA requests input. They include:

  • What potential maximum nicotine level would be appropriate for the protection of public health;
  • Whether such a product standard should be implemented all at once or with a gradual, stepped approach;
  • Whether a nicotine product standard should also cover additional combustible tobacco products; and
  • What unintended consequences—such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by increasing the amount they smoke—might result from such a standard.

As part of its announcement of this ANPRM, FDA also issued a draft concept paper, “Illicit Trade in Tobacco Products After Implementation of an FDA Product Standard,” discussing potential illicit trade implications of product standards generally. Under an updated deadline, comments on this paper are invited through July 16 to a separate docket.

View the ANPRM

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.”

FDA received a considerable number of public comments on previous rulemaking actions, including the July 2013 ANPRM on menthol in cigarettes, and questions about flavors generally in the 2014 deeming proposed rule. The current ANPRM on flavors in tobacco products is a new opportunity to look more broadly at the issue and consider all flavors, including menthol, as we comprehensively explore their public health impact and hear from the public what regulatory action, if any, the FDA should take with respect to any tobacco products with flavors.

Topics on which FDA seeks information through this ANPRM include:

  • The role flavors play in initiation and patterns of tobacco use, particularly among youth and young adults;
  • The role flavors may play in helping some adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products;
  • The role flavors in non-combusted tobacco products may play in quitting use of combusted tobacco products, quitting all tobacco use, or starting to use more than one type of tobacco product;
  • Consumer perceptions of health risks and addictiveness of flavored tobacco products;
  • Whether certain flavors used in tobacco products present potential adverse health effects on users or others; and
  • The impact of local, state, and international efforts to restrict the sale or marketing of flavored tobacco products.

View the ANPRM

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 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.

These are among the topics on which FDA is requesting comments, data, research results, or other information not submitted in response to the proposed deeming rule:

  • The definition of “premium” cigars;
  • Use patterns of “premium” cigars, generally and among youth and young adults specifically;
  • Public health considerations associated with “premium” cigars, including health effects;
  • Studies or information regarding consumer perceptions of the health risks of “premium” cigars; and
  • Studies or information on whether any applicable manufacturing, marketing, sale, distribution, advertising, labeling, and/or packaging requirements and restrictions should be applied differently to “premium” cigars compared to other tobacco products, including other cigars.

View the ANPRM

National Youth Tobacco Survey: Latest Findings

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.

Despite the overall decline, in 2017, about 1 in 5 high school students and 1 in 18 middle school students currently used a tobacco product. For the fourth year in a row, e-cigarettes continued to be the most commonly used tobacco product among high school (11.7 percent; 1.73 million) and middle school (3.3 percent; 0.39 million) students. Furthermore, about 1 in 2 (46.8 percent) high school students who currently used a tobacco product and 2 in 5 (41.8 percent) middle school students who currently used a tobacco product reported using two or more tobacco products.

The authors concluded that the sustained implementation of population-based strategies, in coordination with the regulation of tobacco products by FDA, are critical to reducing all forms of tobacco product use and initiation among U.S. youth.  

Youth tobacco use rates, particularly e-cigarette use, continue to be of concern to FDA. This spring, FDA announced a Youth Tobacco Prevention Plan, which includes a series of enforcement actions to prevent initiation of tobacco products, including e-cigarettes, by youth. Further, FDA continues to invest in compelling, science-based campaigns, like “The Real Cost” and “This Free Life,” to educate youth about the dangers of all tobacco products, including e-cigarettes. In fall 2017, FDA further expanded “The Real Cost” campaign to include an online e-cigarette prevention ad. A full-scale e-cigarette prevention effort under “The Real Cost” brand umbrella is planned for fall 2018.

NYTS is a nationally representative school-based survey that collects information on middle school (grades 6-8) and high school (grades 9-12) students’ tobacco use.

Learn More

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

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

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 with 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, 2018; Feb. 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, 2018; Feb. 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, 2018; Feb. 13, 2019
Letter of Intent Due Date: 60 days before application due date

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