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…
“As a public health agency, FDA must examine the problem of underage use of e-cigarettes holistically. When it comes to youth use of tobacco products, including e-cigarettes, we recognize there are many facets to the issue. We must not only seek to develop evidence-based programs to prevent youth and young adults from using tobacco in any form; we must also explore evidence-based approaches to address existing youth tobacco use.”
FDA’s Commissioner Scott Gottlieb, M.D., made these remarks at a public hearing on youth e-cigarette use and strategies to help them quit. The hearing, which focused, in particular, on the potential role for drug therapies in the effort to eliminate e-cigarette and other tobacco use among young people, exemplifies FDA’s broad perspective on the challenges and potential tools for reducing tobacco-related disease and death.
In this issue of Spotlight on Science, read about this recent public hearing and some of CTP’s additional wide-ranging scientific efforts that demonstrate the crucial role of research in guiding regulatory decision-making.
- NYTS Affirms Staggering Rise in Youth E-Cig Use, FDA Takes Ongoing Action to Confront the Epidemic
- CTP Experts Discuss Policy, Science at SRNT Annual Meeting
- FDA Issues Revised Draft Guidance About Investigational Tobacco Products
- Closing Date Established for Public Comments on Camel Snus MRTP Applications
- FDA Public Hearing Gathers Input Related to Youth E-Cigarette Cessation
- How Can Nicotine Change a Teen’s Brain? CTP Feature Article Explores What the Science Says
- CTP Research
- PATH Study Update
- Recent Publications by CTP Researchers
- Research Opportunities to Explore
Data released Feb. 11 from the joint FDA/Centers for Disease Control and Prevention (CDC) National Youth Tobacco Survey (NYTS) for 2018 elaborate on initial results from November 2018 showing a steep rise in youth use of tobacco products. According to the data, published in the Morbidity and Mortality Weekly Report article “Vital Signs: Tobacco Product Use Among Middle and High School Students—United States, 2011–2018,” approximately 4.9 million middle and high school students were current users of any tobacco product in 2018, up from 3.6 million in 2017. From 2017 to 2018, there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students. “The epidemic use of e-cigarettes among children is one of the biggest public health challenges currently facing FDA,” the agency’s commissioner said in a statement on the day the findings were released.
To address the youth e-cigarette use epidemic, FDA is taking forceful steps under its Comprehensive Plan for Tobacco and Nicotine Regulation and Youth Tobacco Prevention Plan. The agency’s actions are designed to significantly reduce tobacco-related disease and death in the U.S., by protecting youth while the agency also works to help addicted smokers quit. “FDA has repeatedly affirmed our collective view that e-cigarettes may have promise for helping currently addicted adult smokers quit smoking,” Commissioner Gottlieb said. But, he added, “I simply won’t allow their sale to come at the expense of addicting a generation of kids to nicotine.”
According to the NYTS findings, the increase in youth tobacco use from 2017 to 2018 was driven by a surge in e-cigarette use. More than 3.6 million middle and high school students were current e-cigarette users in 2018, a dramatic increase of more than 1.5 million students in a single year. Data from the recent National Institutes of Health “Monitoring the Future” study found comparable results.
The NYTS authors suggest the rise in e-cigarette use between 2017 and 2018 is likely due to the recent popularity of certain types of e-cigarettes such as JUUL. Youth who use e-cigarettes have also been found to be using them more frequently and using flavored products more often. And many youth tobacco product users are using multiple products.
What’s more, research recently published in JAMA Network Open sheds additional light on potential risks to youth e-cigarette users. The research showed that, compared to non-users, youth who use e-cigarettes are more likely to start smoking conventional cigarettes—risking a lifetime of addiction to smoking and, in turn, facing potential smoking-related disease and death.
The agency has ramped up enforcement efforts related to e-cigarette marketing and sales, and is taking ongoing steps to address youth appeal of, and access to, flavored tobacco products, which appear to be at the heart of the youth tobacco use problem. In a recent step, the agency published a draft guidance, “Modifications to Compliance Policy for Certain Deemed Tobacco Products,” discussing possible changes to compliance policies related to premarket review requirements for certain flavored electronic nicotine delivery system (ENDS) products and flavored cigars.
To stay up-to-date on FDA’s efforts to significantly reduce disease and death from tobacco, visit CTP’s Comprehensive Plan for Tobacco and Nicotine Regulation and Youth Tobacco Prevention Plan webpages.
Center for Tobacco Products leaders were among the presenters at the 25th annual meeting of the Society for Research on Nicotine and Tobacco (SRNT), held Feb. 20–23 in San Francisco. CTP Director Mitch Zeller, J.D., kicked off a symposium titled “FDA Center for Tobacco Products: An Update on FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation” by speaking about the Comprehensive Plan and specifically on related topics such as regulatory policies on addiction, appeal, and cessation; the Youth Tobacco Prevention Plan that focuses on growing concerns about youth use of, and access to, tobacco products and e-cigarettes in particular; and the agency’s science-based review of potential modified risk tobacco products (MRTPs).
Also during this symposium, CTP Office of Science Deputy Director Deirdre Lawrence Kittner, Ph.D., M.P.H., discussed the center’s research portfolio, current findings from the Population Assessment of Tobacco and Health (PATH), and how research informs FDA’s regulatory activities, including science-based review of tobacco products such as potential modified risk tobacco products (MRTPs). Finally, Gem Benoza, with CTP’s Office of Health Communication and Education, discussed the center’s public health education campaigns, including details of the recent expansion of “The Real Cost” to educate the target youth audience about potential risks associated with e-cigarette use.
CTP’s presence at the meeting also included:
- Two pre-conference workshops, one titled Authorship and Grantsmanship for Early Career Investigators and the other Precision Medicine in Smoking Cessation;
- Six oral presentations, on topics such as the flavored cigar sales restrictions, biomarkers of exposure among dual users of e-cigarettes and cigarettes, and the effect of FDA’s public education campaign on youth cigarette initiation; and
- More than 20 poster presentations on a wide range of topic areas, such as: an analysis of JUUL advertising strategies, trends in menthol smoking among youth, ENDS use and cigarette smoking among youth, and youth harm perceptions and initiation of use.
In addition, CTP hosted a booth in the exhibit hall to share regulatory and research materials, highlight CTP-led posters and presentations, and distribute information about CTP fellowships and job opportunities.
FDA has issued a revised draft guidance titled “Use of Investigational Tobacco Products.”
This draft guidance supersedes the draft guidance of the same title published in September 2015.
Based on careful review of comments received on the original draft guidance, FDA
determined that the guidance contained information that could be potentially confusing or misinterpreted. Therefore, this revised draft guidance aims to clarify FDA’s thinking on investigational tobacco products.
When final, the guidance will describe the current thinking of FDA regarding the definition of “investigational tobacco product” and discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of such products until regulations are issued and become effective or FDA provides written notice of its intent to change its enforcement policy. Although you can comment on the guidance at any time, to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, please submit comments by April 22, 2019.
For more information, read the revised draft guidance:
FDA has posted final materials from the modified risk tobacco product (MRTP) applications submitted by R. J. Reynolds Tobacco Company for six Camel Snus smokeless tobacco products. Public comments on these applications should be submitted to docket FDA-2017-N-4678 on regulations.gov by May 13, 2019. The application materials, redacted in accordance with applicable laws, can be read on the CTP website.
FDA takes into consideration all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee, before making a final determination on an MRTP application.
Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted, or check our R.J. Reynolds Tobacco Company MRTP applications webpage regularly for updates specific to those applications.
At a Jan. 18 public hearing, FDA heard from a range of stakeholders about possible approaches to help youth e-cigarette users quit. The focus was on the potential role for drug therapies in the effort to eliminate e-cigarette and other tobacco use among youth, as well as appropriate methods for evaluating such therapies. “There is little information about how drug or behavioral interventions might support youth e-cigarette cessation,” FDA Commissioner Gottlieb remarked at the hearing. “The data and other information presented at today’s hearing will be vitally important to helping FDA and other stakeholders begin to address these information gaps.”
If you were unable to attend the hearing or want to revisit the insights attendees shared, you can find meeting transcripts, a recorded webcast, and additional information related to the meeting on a CTP webpage dedicated to the hearing.
CTP Feature Article Explores What the Science Says
Read a brief excerpt here—read the complete article online.
Think E-Cigs Can’t Harm Teens’ Health?
The science says they can. The nicotine in e-cigarettes can change the young brain and get kids hooked.
Are you aware that the nicotine in tobacco products such as e-cigarettes can rewire the teen brain to crave more of the substance and create a nicotine addiction? The types of brain changes that can occur may have long-lasting effects on attention, learning, and memory. Also, nicotine addiction can lead to regular use of tobacco products, resulting in long-term exposure to toxic chemicals. Because cigarettes aren’t the only tobacco product that can lead to addiction, FDA is taking steps to keep e-cigarettes and all other tobacco products out of minors’ hands. Here’s why…
PATH Study Update:
Researchers Encouraged to Apply to Biospecimen Access Program; Access to Wave 1 State Identifier Restricted-Use Files Announced
The National Institutes of Health (NIH) and FDA have announced the release of State Identifier Restricted-Use Files (SIRUF) from the Population Assessment of Tobacco and Health (PATH) Study. These latest additions to the PATH Study’s Restricted-Use Files (RUF) include Adult State Identifier Data and Youth/Parent State Identifier Data collected during Wave 1 (September 2013-December 2014). Qualified researchers may apply for access through the PATH Study Restricted Use Files webpage.
Researchers interested in analyzing PATH Study biospecimens are also encouraged to consider the PATH Study Biospecimen Access Program. This program provides the research community with access to urine, serum, plasma and DNA collected from PATH Study participants.
Data from these specimens can be linked to the Wave 1 Biospecimen Restricted-Use Files. Investigators proposing meritorious and feasible studies consistent with PATH Study objectives and/or research priorities for tobacco regulatory science will be given highest priority for access to these biospecimens. Concept statements are being accepted for the next review cycle, May 1 – May 30, 2019.
The PATH Study is a household-based, nationally representative, longitudinal cohort study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. For the latest announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users, join the PATH Study Data User Forum. The forum enables researchers using PATH Study data to submit and answer questions.
Recent Publications by CTP Researchers
- Cigar smoking prevalence and morbidity among US adults, 2000-2015. Prev Med Rep 2019 Feb 11;14:100821
- Multi-item measures of tobacco health perceptions: a review. Am J Health Behav 2019 Mar 1;43(2):266-78
- Biomarkers of exposure among U.S. adult cigar smokers: Population Assessment of Tobacco and Health (PATH) study Wave 1 (2013-2014). Cancer Epidemiol Biomarkers Prev 2019 Feb 7 [Epub ahead of print]
- Longitudinal e-cigarette and cigarette use among US youth in the PATH Study (2013-2015). J Natl Cancer Inst 2019 Jan 25 [Epub ahead of print]
- Finding Pete and Nikki: defining the target audience for "The Real Cost" campaign. Am J Prev Med 2019 Feb;56(2S1):S9-15
- Evolving "The Real Cost" campaign to address the rising epidemic of youth e-cigarette use. Am J Prev Med 2019 Feb;56(2S1):S76-8
- The case and context for "The Real Cost" campaign. Am J Prev Med 2019 Feb;56(2S1):S5-8
- "The Real Cost": reaching at-risk youth in a fragmented media environment. Am J Prev Med 2019 Feb;56(2S1):S49-S56
- Fear and humor appeals in "The Real Cost" campaign: evidence of potential effectiveness in message pretesting. Am J Prev Med 2019 Feb;56(2S1):S31-9
- Lessons on addiction messages from "The Real Cost" campaign. Am J Prev Med 2019 Feb;56(2S1):S24-30
- Bringing "The Real Cost" to life through breakthrough, evidence-based advertising. Am J Prev Med 2019 Feb;56(2S1):S16-23
- How the Food and Drug Administration convinced teens to rethink their relationship with cigarettes. Am J Prev Med 2019 Feb;56(2S1):S1-4
- Ethylbenzene and styrene exposure in the United States based on urinary mandelic acid and phenylglyoxylic acid: NHANES 2005-2006 and 2011-2012. Environ Res 2019 Apr;171:101-10
- Comparison of nicotine and toxicant exposure in users of electronic cigarettes and combustible cigarettes. JAMA Netw Open 2018 Dec 7;1(8):e185937
- Curiosity about and susceptibility toward hookah smoking among middle and high school students. Prev Chronic Dis 2019 Jan 10;16:E04
- Youth perception of harm and addictiveness of tobacco products: findings from the Population Assessment of Tobacco and Health Study (Wave 1). Addict Behav 2019 May;92:128-35.
- Urinary biomarkers of carcinogenic exposure among cigarette, waterpipe and smokeless tobacco users and never users of tobacco in the Golestan Cohort Study. Cancer Epidemiol Biomarkers Prev 2019 Feb;28(2):337-47
- Frequency of use among middle and high school student tobacco product users--United States, 2015-2017. MMWR Morb Mortal Wkly Rep 2018 Dec 14;67(49):1353-7
- Disaggregating Asian American and Native Hawaiian and Other Pacific Islander (AANHOPI) adult tobacco use: findings from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study, 2013-2014. J Racial Ethn Health Disparities 2019 Jan 4 [Epub ahead of print]
- Evaluation of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) mutagenicity using in vitro and in vivo Pig-a assays. Mutat Res 2019 Jan;837:65-72
- Disease-related responses induced by cadmium in an in vitro human airway tissue model. Toxicol Lett 2019 Mar 15;303:16-27
- Effects of cellular differentiation in human primary bronchial epithelial cells: metabolism of 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanone. Toxicol In Vitro 2019 Mar;55:185-94
- Mental health problems and onset of tobacco use among 12- to 24-year-olds in the PATH study. J Am Acad Child Adolesc Psychiatry 2018 Dec;57(12):944-54
Research Opportunities to Explore
The Family Smoking Prevention and Tobacco Control Act tasked FDA with regulating the manufacture, distribution, and sale of tobacco products. Approaching this mission with a regulatory plan rooted in science, CTP seeks new research addressing the following areas: toxicity; addiction; health effects; behavior; communications; marketing influences; and impact analysis of regulatory actions.
More information on CTP-funded research can be found on the center’s website.
FDA Scientific Conference Grant Program (R13; PAR-16-378)
FDA recognizes the value of supporting high quality, small scientific conferences. A small scientific conference is defined as a symposium, seminar, workshop, or any formal meeting, whether conducted face-to-face or virtually to exchange information and explore a defined subject, issue, or area of concern that impact the public's health within the scope of the FDA's mission.
Application due dates: April 12, 2019 and October 11, 2019 by 11:59 p.m. EST
Tobacco Regulatory Science (R01; RFA-OD-18-002)
This Funding Opportunity Announcement (FOA) invites R01 applications to support biomedical and behavioral research that will provide scientific data to inform tobacco product regulation to protect public health. Research projects must address the research priorities related to CTP’s regulatory authority. Research results from this FOA are expected to generate findings and data that are directly relevant in informing FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
First Estimated Application due date: July 19, 2019, by 5:00 p.m. local time of applicant organization
Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01; RFA-OD-18-005 or RFA-OD-18-006)
This award provides support for an intensive, supervised career development experience of three, four, or five protected years in biomedical, behavioral, and social science research. This experience will inform the development and evaluation of tobacco regulation and will foster research independence. Projects must address one of FDA’s research priority areas. Application due dates: July 19 and November 8, 2019, by 5:00 p.m. local time of applicant organization
Pathway to Independence Award in Tobacco Regulatory Research (K99/R00; RFA-OD-18-007 or RFA-OD-18-008)
This FOA aims to increase and maintain a strong cohort of talented independent investigators conducting research that will inform the development and evaluation of tobacco product regulations. This program is designed to facilitate the timely transition of outstanding postdoctoral researchers from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. This program will provide NIH research support during this transition in order to help awardees launch competitive, independent research careers.
Application due dates: July 19 and November 8, 2019, by 5:00 p.m. local time of applicant organization
FDA Broad Agency Agreement (BAA; FDABAA-19-00123)
FDA puts out agency-wide proposal requests through a special tool called the Broad Agency Announcement (BAA). Since 2012, FDA has utilized the BAA to solicit novel theories and methods for developing and evaluating regulated products, including tobacco products, by drawing on external sources, such as industry, academia, and other government agencies in areas where FDA has limited expertise or capacities. These proposals help to give FDA a better understanding of what innovative scientific and technical solutions may be available to solve difficiult regulatory science problems. CTP participates in the BAA solicitation, and tobacco priority topics are included in sections 1, 2.6, and 5. More information is available online.
Applications due dates: Rolling