Spotlight on Science — Winter 2018

Spotlight on Science header — Spotlight on Science is a quarterly science and research digest from the FDA Center for Tobacco Products.

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 the author(s) alone, and findings and conclusions are those of the author(s) and do not necessarily represent the views of FDA.

On this page…

Eminent Nicotine and Tobacco Science Meeting Features FDA Commissioner, CTP Leaders and Researchers

The Society for Research on Nicotine & Tobacco (SRNT)—the only professional association dedicated exclusively to the support of those working across disciplines in nicotine and tobacco research—held its annual scientific conference Feb. 21–24 in Baltimore, Maryland. Policy leaders shared their perspectives on science in the field and researchers presented their latest findings, in support of the organization's self-described mission “to stimulate the generation and dissemination of new knowledge concerning nicotine in all its manifestations.” Dr. Gottlieb and Mitch Zeller at SRNT 2018

Scientific presentations covered diverse areas of research in tobacco and nicotine. One symposium focused on the recent Public Health Consequences of E-cigarettes study—conducted for CTP by the National Academies of Science, Engineering, and Medicine—about health effects of e-cigarettes and recommendations for research. (See related story below: “E-cigarettes and Public Health: Findings of the National Academies.”)

FDA Commissioner Scott Gottlieb, M.D., was among the meeting’s keynote speakers, along with U.S. Surgeon General Jerome Adams, M.D., M.P.H. Other FDA presenters and discussants included CTP Director Mitch Zeller, J.D.; Office of Science Director Matthew Holman, Ph.D.; Office of Health Communication and Education Director Kathy Crosby; and Center for Drug Evaluation and Research Office of New Drugs Deputy Director Peter Stein, M.D. Additionally, CTP and CTP-funded researchers presented research results from a wide range of tobacco and nicotine studies.

FDA Commissioner: Science Shapes Policy

As keynote plenary speaker on Feb. 23, Dr. Gottlieb spoke about FDA’s comprehensive new tobacco regulatory plan and its focus on the root issue in tobacco addiction: nicotine. By viewing the tobacco product marketplace as fundamentally a landscape of products delivering nicotine, he explained, a fertile foundation is set for a dialogue about goals and progress in the area of tobacco harm reduction that historically has been more contentious than constructive.

With the understanding that cigarettes are designed to create and sustain addiction and that addiction causes the long-term, sustained use and associated health dangers, the commissioner stated, two vital questions need to be addressed: How do we stop nicotine addiction from taking hold of youth? And how do we help adults who are addicted to the nicotine in cigarettes quit smoking?

Among other regulatory actions, the commissioner mentioned first steps being taken by FDA toward a proposed product standard that could be “game-changing” by limiting the amount of nicotine in cigarettes to make them minimally or nonaddictive. A journal article nearing publication, he said, would show, using modeling statistics, the “remarkable” public health promise of such a standard.

The FDA commissioner also discussed various other central FDA actions under the new framework that, in concert, could “drastically shift the trajectory of tobacco-related disease and death in this country.” Nicotine and tobacco research has real-world policy implications, and FDA is listening, Dr. Gottlieb told attendees, pointing out that “our policies can only go as far as the science takes us.” As FDA moves forward on its regulatory framework, he told attending researchers, “there are many more opportunities for science—your science—to inform policies and save lives.”

CTP Leaders: Current, Ongoing Regulatory Priorities

In a presentation titled “FDA’s Center for Tobacco Products: An Update on Regulatory Activities and Priorities,” CTP Director Mitch Zeller elaborated on some early steps toward implementing the new tobacco regulatory framework, with consideration to two primary objectives: achieving appropriate science-based regulation of cigarettes, and encouraging innovation in the development of less harmful products for delivering nicotine to those who seek it.

Two of CTP’s office directors highlighted some important projects: On behalf of the Office of Science, Matt Holman provided an overview of CTP scientific accomplishments and ongoing research. Research projects since 2010 number nearly 400, he said, including research associated with the Tobacco Centers of Regulatory Science (TCORS) and the Population Assessment of Tobacco and Health (PATH) Study.

Kathy Crosby discussed CTP’s education campaigns and their public health impact. Examples of primary campaigns are:

“The Real Cost.” This campaign prevented nearly 350,000 U.S. youth aged 11 to 18 from smoking from 2014 to 2016, and was recently expanded to include messaging on e-cigarettes.
“Every Try Counts.” The recently launched point-of-sale campaign presents supportive messages at locations such as gas stations and convenience stores to encourage adult smokers who have tried unsuccessfully to quit to try again.

During this CTP activities update, center leaders also discussed CTP’s compliance efforts in 2017. Among them: more than 45 tobacco manufacturing facilities and 200 vape shops engaged in manufacturing activities were inspected. More than 150,000 compliance check inspections of tobacco retailers were conducted, and more than 13,500 warning letters, 5,500 civil money penalties, and 50 no-tobacco-sale order complaints were issued.

More About the 2018 Meeting

In additional presentations and poster sessions, CTP and CTP-supported researchers were among those informing attendees about their scientific efforts. SRNT’s website provides information about the 2018 annual meeting , including research abstracts . Also, SRNT has posted the remarks of the FDA commissioner and the surgeon general on its YouTube channel.

E-Cigarettes and Public Health: Findings of the National Academies

A report titled Public Health Consequences of E-cigarettes was released on Jan. 23 by the National Academies of Sciences, Engineering, and Medicine (NASEM). The report adds to FDA’s knowledge base on e-cigarettes and other electronic nicotine delivery systems (ENDS), while raising some important questions about the health impact of e-cigarettes.

The independent report, commissioned by FDA at the request of Congress, evaluated scientific evidence about the health effects linked to the use of e-cigarettes and other ENDS. According to the report, evidence suggests that current smokers who completely switch to e-cigarettes may see improved short-term health outcomes. Meanwhile, in a finding FDA Commissioner Scott Gottlieb, M.D., characterized as “particularly troubling,” the report also found that kids and young adults who use e-cigarettes are more likely to try smoking cigarettes.

The report calls for additional research on the short- and long-term health effects of e-cigarettes, as well as their impact on public health. The recommended research should consider factors such as whether these products are leading to youth initiation of cigarettes, resulting in adult dual use with cigarettes, or helping accelerate the transition of current adult smokers entirely away from combustible-cigarettes. The report notes that the wide diversity of ENDS products presents a challenge for researchers.

“We appreciate the National Academies’ review of the complex public health considerations around e-cigarettes,” said FDA Commissioner Gottlieb. As the agency works to reduce tobacco-related disease and death and protect kids from tobacco products, the report “helps identify areas that need further study to better understand the net public health impact of e-cigarettes,” he stated.

FDA continues to invest in many of the areas of research identified in the National Academies report to assess whether certain tobacco products are, in fact, less harmful and whether they have the potential to help smokers transition completely away from combustible-cigarettes. “We need to put novel products like e-cigarettes through an appropriate series of regulatory gates,” the commissioner emphasized, “to fully evaluate their risks and maximize their potential benefits.”

Reminder: PATH Study Biospecimen Access Dates for Review Cycle 2

FDA and the National Institutes of Health’s PATH Study Biospecimen Access Program allows researchers to apply for access to urine, serum, and plasma collected from PATH Study participants. To request PATH Study biospecimens, researchers must submit a research concept statement and application. Concept statements for an upcoming second review cycle are being accepted May 1–31.

Investigators proposing meritorious and feasible studies consistent with PATH Study objectives or research priorities for tobacco regulatory science will be given highest priority for access to these biospecimens. Proposals addressing other objectives that advance the knowledge of tobacco use or tobacco-related health outcomes will also be considered.

Visit the Biospecimen Access Program webpage for more information about the program and how to apply, and the PATH Study webpage to learn about the study and other available data files.

CTP Research

Study Snapshots

Following are examples of tobacco studies that can inform CTP’s regulatory and public education efforts.

Tsai J, Walton K, Coleman BN, et al. Reasons for Electronic Cigarette Use Among Middle and High School Students—National Youth Tobacco Survey, United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Feb 16;67(6):196-200.

This study found that, among middle and high school students who ever used an e-cigarette in 2016, the most commonly selected reasons for use were: use by “friend or family member”; availability of “flavors such as mint, candy, fruit, or chocolate”; and the belief that “they are less harmful than other forms of tobacco such as cigarettes.” The least commonly selected reasons were: “they are easier to get than other tobacco products such as cigarettes,” “they cost less than other tobacco products such as cigarettes,” and “famous people on TV or in movies use them.”

Christensen CH, Rostron B, Cosgrove C, et al. Association of Cigarette, Cigar, and Pipe Use With Mortality Risk in the U.S. Population. JAMA Intern Med. 2018 Feb 19.

This nationally representative longitudinal cohort study of more than 350,000 participants provides additional evidence that use of cigars, pipes, or cigarettes each confers significant mortality risks. The authors also reported a statistically significantly elevated risk of death from most examined causes of death among nondaily cigarette smokers. According to the authors, the findings underscore the importance of cessation to reduce death and disease from use of combustible tobacco.

Anic GM, Holder-Hayes E, Ambrose BK, Rostron BL, Coleman B, Jamal A, Apelberg BJ. E Cigarette and Smokeless Tobacco Use and Switching Among Smokers: Findings From the National Adult Tobacco Survey. Am J Prev Med. 2018 Feb 8.

In this study estimating the prevalence of e-cigarette and smokeless tobacco use and switching among current and recent former adult cigarette smokers, researchers found that current and recent former adult smokers are more likely to use e-cigarettes than smokeless tobacco. Current e-cigarette use was most prevalent among unsuccessful quitters and recent quitters, who were more likely to switch completely to e-cigarettes than smokeless tobacco.

Corey CG, Chang JT, Rostron BL. Electronic Nicotine Delivery System (ENDS) Battery-Related Burns Presenting to U.S. Emergency Departments, 2016. Inj Epidemiol. 2018 Mar 5;5(1):4.

In 2016, the National Electronic Injury Surveillance System captured 26 burn cases related to ENDS batteries, which translates to a national estimate of 1,007 injuries presenting in U.S. emergency departments. Most burns were thermal burns and occurred to the upper leg/lower trunk, and at least 20 occurred while ENDS batteries were in the user’s pocket.

Additional Recent Publications

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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: April 12, 2018
Letter of Intent Due Date: 8 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-17-007
Next Application Due Date: July 17, 2018

R21—Tobacco Regulatory Science Exploratory/Developmental Research Grant

FOA Number: RFA-OD-17-009
Next Application Due Date: July 17, 2018

R03—Tobacco Regulatory Science Small Grant Program for New Investigators

FOA Number: RFA-OD-17-008
Next Application Due Date: July 17, 2018