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Spotlight on Science — Summer 2017

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

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FDA Announces Tobacco Regulatory Plan With Nicotine as Centerpiece

The FDA has announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multiyear roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine and the issue of addiction at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Tobacco Control Act.

“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it’s vital that we pursue this common ground,” said FDA Commissioner Scott Gottlieb, M.D.

To learn more about the FDA’s tobacco regulatory plan, visit our landing page for a press release and additional information. For further elaboration on this nicotine-focused framework, read Dr. Gottlieb’s and CTP Director Mitch Zeller’s recently published article in the New England Journal of Medicine.

Read NEJM Article


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New CTP Science Chief Shares His Perspective: “We must stay on science’s cutting edge”

Matthew R. Holman, Ph.D.Matt Holman, Ph.D., became the second director of the CTP Office of Science (OS) in January, coming to that leadership position already an authority on the role of science in health and medicine. Sunscreen was Holman’s first focus when he came to the FDA—specifically, to the Center for Drug Evaluation and Research (CDER)—15 years ago. While at CDER, Holman, a scientist with a biochemistry doctorate, helped oversee the regulation of a broad spectrum of other over-the-counter products. As deputy director of the Division of Nonprescription Regulation Development, his last CDER position,  his policy decisions affected half of the OTC drugs regulated by the division. Holman’s interest in participating in CTP’s scientific efforts sprang from the same passion that brought him to the FDA in the first place: contributing to meaningful and far-reaching public health improvements.

Spotlight on Science asked Holman about his outlook and plans as he heads up the scientific hub of the Center for Tobacco Products. (For additional background, see Holman’s bio.)

What attracted you to CTP and ultimately to the head scientist position? And did your previous experience directing CTP’s OS Division of Product Science help prepare you for your current responsibilities?

Given tobacco’s enormous health toll in the United States, CTP has a critical responsibility to reduce associated death and disease. Not only are tobacco users affected, so are others such as family members, friends, and colleagues. The opportunity to have such a large impact piqued my interest in the Center. For 6 years, I worked in the Division of Product Science, which focused on chemical, engineering, and microbiology aspects of tobacco products and use, and I became interested in doing even more and having an even bigger impact.

My division director experience of 6 years was extremely helpful and made the transition to my current position seamless. I already knew the staff here, and my work as division leader focused on such a broad swath of tobacco-related subjects, it readied me to understand the nuances of each Office of Science discipline.

How do you view the role of science in achieving CTP’s public health mission?

In CTP, as in the other FDA centers, science is at the core of our public health mission and serves as the backbone of our Center’s work. CTP makes regulatory decisions based on the best available science—which goes hand in hand with protecting health—and so we must stay on science’s cutting edge.

OS’s work boils down to conducting ongoing research to further reduce morbidity and mortality from tobacco use. To contribute to optimal regulatory decisionmaking, the very active OS program focuses on identifying research topics that can add to the evidence base and on working to get research going in those areas. We continually work to better serve the public by asking: What are the next relevant areas we can understand even better? And how can we always strive to have as beneficial an effect as possible on tobacco-related morbidity and mortality?

In light of the FDA’s new nicotine-focused plan for tobacco product regulation, what do you foresee as the Office of Science’s role and priorities going forward?

The announcement of the new plan and roadmap for protecting kids and reducing tobacco-related disease and death requires us to not only continue, but even intensify, our scientific efforts. In the largest sense, our mission of building on the existing robust scientific base related to tobacco products remains the same. But some shift of focus will be required as we work toward a landscape in which combustible cigarettes don’t create or sustain addiction, and those who still need or want nicotine can get it from products that are less harmful than traditional cigarettes. For each policy under consideration, science will be at the heart of the Center’s decisionmaking.

Of course, our priorities will evolve over time, but in upcoming months and years, we will certainly be examining and building upon the science around the potential public health benefits and any possible adverse effects of lowering nicotine in traditional cigarettes. And we will explore the science related to making tobacco products less toxic, less appealing, and less addictive, which could help spur innovation in the development of less dangerous alternative products. As for OS’s more specific areas of focus in the near term, an example is the role flavors, including menthol, play in tobacco product use—for example, what role they play in attracting youth and how they might help some smokers switch to other, potentially less harmful forms of nicotine delivery. We also will build on the science related to patterns of use and public health impacts of premium cigars. 

In your time so far as OS director, what have you come to view as the most fulfilling, and the most challenging, aspects of the OS director role and the work of the Office?

I’m very excited about the depth and breadth of our projects. We are undertaking lots of great work, and it’s very proactive—not just reacting to what people outside the agency are saying, but thinking hard about what we need to do to meet our mission of reducing death and disease from tobacco.

I see some challenging issues, of course, but none we can’t solve when we work collaboratively to identify solutions. The staff here is exceptional at working together on issues and working creatively, based on scientific principles, to overcome any challenges we face.

And, during this time as OS’s head scientist, is there anything that has surprised you—or might surprise people generally—about the Office and the way it conducts its work?

People may not truly appreciate how grounded our decisions are in the science, and how seriously we take the challenge of applying the scientific foundation in the regulatory framework within which we operate. Even with my background in the Center, I’m still surprised, from my new perspective, how broad a portfolio we have, how far along some areas of study are, and how sophisticated the science we are involved in is.

I think people from outside our Center, who don’t see our staff up close on a daily basis, would be surprised by how extremely hardworking the scientists and others in our group are as they dedicate themselves to our mission. Staff here are—and need to be—smart and creative. They develop and apply novel solutions to very complicated issues. It also might surprise folks how extremely collaborative we are. Scientists from across varied disciplines bring their perspectives to help us understand the totality of available evidence.

Also, people may not know the extent of stakeholder participation in CTP’s decisionmaking process. We are committed to engaging a wide variety of stakeholders—including industry, other public health organizations, outside researchers, and the public—for consideration in our scientific and regulatory analyses. For example, our OS program engages researchers in various settings to work with us to fill in any research gaps and support our tobacco regulatory decisions. And many different labs, within the United States and outside the country, help us optimize the ways we design and conduct our studies. Further, we’ve held several public workshops over the years—including the recent ENDS [electronic nicotine delivery system] battery hazards workshop—which have engaged an extensive range of stakeholders. Additional examples of valuable collaborations are meetings of advisory committees, more narrowly framed collaborations with public health organizations such as WHO [World Health Organization], and standard-setting with ISO [International Organization for Standardization].

Finally, given your serious responsibilities as CTP science director, what do you enjoy doing in whatever free time you have?

I enjoy spending time with my wife, who is an art teacher, and our four children—three sons and a daughter ranging in age from 11 to 19. As a family, we enjoy going to museums and traveling. I love playing sports—predominantly basketball and soccer—and I’ve coached more than 20 youth sports teams in soccer, baseball, football, basketball, and lacrosse. Coaching allows me to combine my love of sports with the chance to spend time with my children. As for an individual pastime, I like to ride motorcycles, both on the street and off-road, and tackling home improvement projects. 


Comments Invited: Philip Morris Products’ Heat-Not-Burn Device Under Scientific Review for Modified Risk

Researchers are invited to submit data, analyses, or other information on three modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. for its IQOS system and various Heatstick products. The applications can be viewed on CTP’s website.

Public comments on the Philip Morris Products S.A. MRTP applications may be submitted online to docket FDA-2017-D-3001 on regulations.gov by Dec. 12. The FDA website has more information about MRTPs, including regulatory guidance documents, publicly available application materials, and details on past application actions.

The public nature of the MRTP application process is unique. By law, the FDA must make MRTP applications available for public comment, while ensuring commercial and confidential information is properly redacted. In a scientific review of an MRTP application, the FDA considers public comments on the application as well as recommendations from the Tobacco Products Scientific Advisory Committee.

Congress set high standards to ensure that the marketing of tobacco products does not mislead the public about relative risks. In the past, some cigarettes were marketed as “light,” “low,” or “mild,” which encouraged current smokers to perceive, inaccurately, those cigarettes as safer alternatives and to switch to those products rather than quit altogether. Today, companies that want to market a tobacco product with explicit or implied claims of reduced harm or risk of tobacco-related disease must first demonstrate that the product, as actually used by consumers, does reduce harm or risk of disease and that proposed modified risk information is understandable to the public.

The MRTP process is relatively new, with only 35 applications received since 2011 and no MRTPs authorized yet. In December 2016, the FDA took action on the first MRTP applications to complete scientific review for eight Swedish Match North America Inc. snus smokeless tobacco products, sold under the General brand name. The three MRTP applications submitted by Philip Morris Products S.A. for the IQOS system and Heatstick products currently under scientific review at the FDA are the second set of applications to reach this milestone.

The FDA serves as a regulatory gatekeeper, protecting consumers from modified risk claims that are not backed by science. Researchers and other members of the public help strengthen this role by providing scientific evidence that can inform the FDA’s determination of whether a proposed MRTP will benefit the health of the U.S. population as a whole. 


Missed the 2017 FDA Science Forum? Watch the Webcast!

2017 FDA Science ForumThis year’s FDA Science Forum, held on May 31 and June 1, featured the pioneering research efforts of CTP and the agency’s other centers. Topics of CTP scientific sessions included identification and evaluation of new biomarkers, patient and consumer engagement, and computational modeling and simulation. The Center also presented several posters. “The forum showcased some of CTP’s scientific research activities and highlighted how the FDA is working to protect and promote public health,” said Cathy L. Backinger, Ph.D., M.P.H., deputy director for research in the Center’s Office of Science.

If you missed the forum, you can watch the webcast offering all the presentations, along with introductions by FDA Commissioner Dr. Scott Gottlieb and the keynote speaker, Dr. Eric Lander, a famed geneticist, molecular biologist, and mathematician. Or check out the forum brochure [PDF - 3.63MB] for speaker profiles and an overview of featured projects.


PATH Study Wave 2 Public-Use Files Available

The National Institutes of Health and the FDA have announced the availability of the public-use questionnaire data files from the second wave of the Population Assessment of Tobacco and Health (PATH) Study. These public-use files (PUFs), along with other PATH Study files and information, can be accessed through the PATH webpage


CTP RESEARCH

Study Snapshot

2016 National Youth Tobacco Survey Reveals Positive News, Ongoing Challenges

In June, the Centers for Disease Control and Prevention and the FDA released findings from the 2016 National Youth Tobacco Survey (NYTS). This nationally representative, cross-sectional, pencil-and-paper survey collects information on tobacco use by students in middle school (grades 6 through 8) and high school (grades 9 through 12). Tobacco products assessed include cigarettes, cigars, smokeless tobacco, e-cigarettes, hookah, pipe tobacco, and bidis (small imported cigarettes wrapped in a leaf). The findings are published in the June 16 issue of Morbidity and Mortality Weekly Report (MMWR).

The study, designed to determine recent patterns of current (past 30-day) use of the seven tobacco product types, found that an estimated 3.9 million U.S. middle and high school students reported current use of a tobacco product, down from 4.7 million in 2015. Despite a decline in e-cigarette use among these youth, e-cigarettes remained the most commonly used tobacco product for the age group, with more than 2 million middle and high school students found to be currently using e-cigarettes and other electronic nicotine delivery systems (ENDS).

The FDA has a new infographic with highlights from the study: 

Youth Tobacco Use: Results from the 2016 National Youth Tobacco Survey Thumbnail

“While the latest numbers from the 2016 National Youth Tobacco Survey are encouraging, it is critical that we work to ensure this downward trend continues over the long term across all tobacco products,” said FDA Commissioner Scott Gottlieb, M.D.

The study revealed other declines among high school students between 2015 and 2016, including decreases in current use of any tobacco product (25.3 to 20.2 percent), two or more tobacco products (13.0 to 9.6 percent), any combustible tobacco product (17.2 to 13.8 percent), and hookah (7.2 to 4.8 percent). However, during 2011–2016, decreases in cigarette and cigar use were offset by sharp increases in the use of hookah tobacco and e-cigarettes, which resulted in no significant change in overall tobacco use.

The authors cited tobacco prevention and control strategies at the national, state, and local levels, such as the FDA’s “The Real Cost” public education campaign, as likely contributors to the reduction in youth use of certain tobacco products.  Results from “The Real Cost” campaign, published in the Jan. 20 issue of MMWR, show that the campaign was associated with preventing nearly 350,000 U.S. youth ages 11 to 18 from initiating smoking between 2014 and 2016.


Additional Recent Publications

View more scientific publications on tobacco by FDA staff.


New Funding Opportunities to Explore

Featured below are new announcements from the list of current CTP funding opportunities. For additional information on these new opportunities, click 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 the FDA’s mission and to the public health.

R13—Support for Conferences and Scientific Meetings

FOA Number: PAR-16-378
Next Application Due Dates: Oct. 12, 2017; April 12, 2018
Letter of Intent Due Date: 8 weeks before application due date

Tobacco Regulatory Science

The Tobacco Regulatory Science Program, the FDA’s partnership with the National Institutes of Health to foster tobacco regulatory research, offers funding for scientists whose research supports CTP’s regulatory activities.

R01—Research Project Grant

FOA Number: RFA-OD-17-007
Next Application Due Dates: Feb. 13, 2018

R21—Exploratory/Developmental Research Grant

FOA Number: RFA-OD-17-009
Next Application Due Dates: Feb. 13, 2018

R03—Small Grant Program

FOA Number: RFA-OD-17-008
Next Application Due Dates: Feb. 13, 2018
 

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