Spotlight on Science — Spring 2017
Spotlight on Science is a quarterly science and research digest from the FDA Center for Tobacco Products.
David Ashley, Ph.D., founding director of CTP’s Office of Science (OS), has handed off leadership of the office responsible for the scientific underpinnings of FDA tobacco regulatory activities. Ashley, who came to the Center as its chief scientist in 2010, soon after the Family Smoking Prevention and Tobacco Control Act authorized the FDA to regulate tobacco products, will retire from the Center only after helping to ensure a smooth transition by serving for several months as science and policy advisor to Center leadership. CTP Director Mitch Zeller described Ashley as “extraordinarily accomplished” and his contributions to CTP’s efforts to reduce the health harms from tobacco “immeasurable.”
Sitting at a round table in Ashley’s office, we asked him about his public health career and plans for the future. He would sit at the same circular table the next hour, hosting a “meet and greet” for a small group of incoming CTP scientists. It’s a part of the director's job he has delighted in—and will miss—the most.
“My favorite thing here is when a group of brand new employees comes in and sits around my office table, and I get to help them better understand what we do in the Office of Science,” Ashley explained. “How did it get to be here? What’s its purpose? And what do these new employees find to be most inspiring as they think about working to improve the public health? I enjoy talking to people, answering their questions, and also sharing ideas back and forth.”
What is the Office of Science’s public health purpose within CTP? Here, Ashley shares his perspective on this and much more.
What made public health science so important to you that you made it your life’s work?
When I was in 8th grade, my mother was diagnosed with colon cancer, and she died a few years later. She and I were very close, and I wanted so much to be able to do something to help her. I was sure then that I wanted to go to NIH and work on colon cancer and do something to change people’s lives who were dealing with cancer. Although I didn’t end up going to NIH or working on cancer directly, I did follow my desire to change people’s health and lives by my work at CDC and the FDA.
What moment stands out as particularly gratifying from your work championing public health, even before you turned your focus to tobacco?
Among the unforgettable moments was a time in 1990 when my team at CDC analyzed a sample from a batch of syrup from a Nigerian hospital where 45 children who received the liquid for malaria-related upper respiratory infections, instead of getting well, got sicker and died. My team quickly figured out and sent a notification that the batch of liquid contained toxic diethylene glycol instead of the propylene glycol that’s used in the acetaminophen the kids were supposed to receive. A later incident in Haiti was solved by the same type of CDC analysis, and when we heard of a similar fatal poisoning in Nigeria years later, we knew it was the same issue of diethylene glycol even before lab tests confirmed it. The knowledge CDC conveyed had the power to stop needless illnesses and deaths among these hospitalized children.
Is there an early accomplishment in tobacco science that made you think “I can really make a public health impact in this area”?
When I started working in tobacco, science in the tobacco industry was walled off and there was very little knowledge of how cigarettes were designed and what ingredients they contained. I’m proud of what light I could shine on this and that my research teams’ findings have held up over time. To mention just one example, I was part of a CDC team that, in 2003, found that tobacco-specific nitrosamines—a type of carcinogen formed during the processing and burning of tobacco—existed in significantly higher levels in U.S.-made cigarettes than in non-U.S. brands sold in various countries around the world. That was an important finding and surprising to many, including us. While some research had been published looking at product design and carcinogen levels, there was little clarity about the association. Our work that looked globally at this relationship was an important moment in our understanding of product design and its potential to increase or decrease health risks.
Given CTP’s regulatory mission, how would you sum up the role of science within the Center?
Science is the foundation for all that CTP does to protect the public health. CTP’s regulatory decision-making is a marriage of science and the law. We take regulatory action when supported by the best available science and also by relevant legal principles. An example of an area in which science has taken on immense importance is the FDA’s consideration of product applications. Deciding about whether we should grant marketing authorization for products like cigarettes, which we know will kill about half the people who use them, presents incredibly challenging scientific regulatory questions that no one in the world has ever faced.
What drew you to CTP in the first place to pursue your path as public health scientist and leader, and do you feel fulfilled by the role you have played as the Center’s chief scientist?
My time at CDC consisted of taking very small programs and building them into more robust programs for public health protection. What’s the strategic plan? What are the needs? How can we get there? Whom should we hire to get us there? With my experience developing these types of programs, it made sense for me to cultivate this Office of Science from its inception, too. I’m proud I had the chance to help grow our initial small group of 10 to 15 scientists into a team of more than 300 experts superbly equipped to examine the complex scientific issues continually facing CTP.
Based on this front-row perspective you’ve had on the CTP science team, what do you think might surprise people about this group?
The scientists in CTP are incredibly smart, have a remarkable understanding of their subjects, and are extremely dedicated to doing the right thing. People sometimes view the government as made up of people on the job just to get a paycheck, but I don’t know people here like that. They are inspired to come and do what they do by the mission to make Americans’ lives better, which takes constant commitment, not to mention long hours.
As you switch gears, what are you most looking forward to in your next chapter?
With my wife remaining at our Atlanta area home during my years with CTP, we have had more than 600 miles between us, which I have commuted almost weekly. She encouraged me to take on the position, which has been a challenging and worthwhile experience that has changed me in many good ways—while giving her the opportunity for her own extraordinary pursuits in support of our community. I would not have had the chance to venture into this challenge without my wife’s support, and I’m looking forward to being home with her again. I would love to continue working in the field and helping to teach those who want to learn more about this incredible public health challenge.
While I feel very good about what I’ve been able to do so far, here at CTP and elsewhere, a person always wants to have done more. Not surprisingly, I want to continue to have the biggest impact possible.
Also as you look ahead, what would be your advice to the next OS director, Dr. Matt Holman, and what do you hope the Office of Science and CTP can accomplish in the future toward reducing tobacco’s toll?
I have worked closely with Matt for a long time, and he’s smart and knows his stuff. We shared the directorship for a couple of months to achieve the most seamless transition possible, and our minds are in very much the same place. I have no doubt he will be an outstanding director—without additional advice from me.
One primary focus for CTP is this: We don’t want any kids using any nicotine product. How can we differentiate less harmful products so adults want to use them instead of more harmful ones, while discouraging kids from starting? That’s really hard to do. But that’s what we need to do. That’s the public health assignment.
Beyond that, making the most difference by reducing death and disease from tobacco seems to me to involve a twofold vision: Reduce products’ harm, and meanwhile encourage people to move to less harmful products. I hope CTP can do both of these things. I view product regulation as an important public health tool for reducing harm. And as for encouraging people to move to less harmful nicotine products, e-cigarettes might be part of the answer, but only if they are scientifically shown to be less harmful than traditional cigarettes, encourage users of conventional cigarettes to switch completely, and don’t attract a new generation of addicted young people.
Stay tuned! In an upcoming issue, hear from new OS Director Matt Holman on what it means to head up CTP’s scientific nerve center.
The chemicals found in cigarette smoke number more than 7,000, with upward of 70 of these linked to cancer. It may come as no surprise that cigarettes contain chemicals that can cause death and disease. But what types of chemicals are in cigarettes, and where do they come from?
A series of new FDA videos, along with web content, helps consumers better understand these chemicals. The new resources present information in three stages: plant, product, and puff.
The first video explains how harmful chemicals end up in the tobacco plant itself.
The second video highlights how some toxic chemicals make their way into cigarettes as they are manufactured.
And the last video explores additional dangerous chemicals created when a smoker lights up.
Researchers can now apply for access to restricted-use files (RUFs) on questionnaire data from Wave 2 of the Population Assessment of Tobacco and Health (PATH) Study.
2017 FDA Science Forum: Dates Announced
May 31–June 1
The 2017 FDA Science Forum is taking place May 31 and June 1. The forum, to be held on the FDA’s White Oak campus, will focus on the agency’s cutting-edge science and how this research informs the FDA’s regulatory decision-making.
For more information about the forum agenda and registration as it becomes available, visit CTP’s 2017 FDA Science Forum webpage.
ENDS Battery Safety Concerns: Public Workshop, Vape Battery Tips
A two-day public workshop hosted by the FDA is designed to gather scientific information and discuss the hazards and risks associated with the use of batteries in e-cigarettes and other electronic nicotine delivery systems (ENDS). The agency is interested in gaining knowledge during the April 19–20 workshop about ENDS battery safety hazards, risk mitigation, and design parameters of the ENDS apparatus. The agency also wants to collect information on how these safety hazards and risks are communicated to consumers.
Electronic or written comments to the public docket will be accepted until May 22. Also, the FDA will post a webcast of the workshop, along with complete transcripts, as soon as they are available.
Vape Battery Tips Infographic, How to Report Unexpected Issues
To help reduce the risk of vape battery overheating, fires, and explosions, the FDA has developed a “Tips to Help Avoid Vape Battery Explosions” infographic with five key tips.
This infographic is available on a new CTP webpage, along with related tips, a video on how to report adverse events to the FDA’s Safety Reporting Portal, and shareable and downloadable content to help spread the word about vape battery safety.
Tobacco Product Application Review the Focus of Recent TPSAC Meeting
At an April 6 meeting of the Tobacco Products Scientific Advisory Committee (TPSAC), the FDA presented information to the committee on the processes used for review of tobacco product applications, including premarket tobacco, substantial equivalence, and modified risk tobacco product applications.
Find TPSAC meeting information and materials on CTP’s website.
“Flavored Tobacco Product Use in Youth and Adults: Findings From the First Wave of the PATH Study (2013–2014)”
Based on a cross-sectional analysis of baseline data from the first wave of the Population Assessment of Health and Tobacco (PATH) Study, this paper describes the prevalence and reasons for use of flavored tobacco products, the proportion of ever tobacco users reporting that their first product was flavored, and correlates of current flavored tobacco product use.
Overall, the findings show that youth and young adult tobacco users (ages 12–24) were far more likely than older adult users (ages 65+) to report currently using a flavored tobacco product (80 percent and 73 percent, respectively, vs. 29 percent), including menthol. Flavor was a primary reason for using a given tobacco product, particularly among youth, and reporting that one’s first tobacco product was flavored was associated with a higher prevalence of current tobacco use among youth and adult ever users. The researchers concluded that these results add to the evidence base that flavored tobacco products may attract young users and serve as starter products to regular tobacco use.
“U.S. Adults’ Addiction and Harm Beliefs About Nicotine and Low-Nicotine Cigarettes”
Using the nationally representative Health Information National Trends Survey (HINTS), researchers examined U.S. adults’ beliefs about nicotine and low-nicotine cigarettes and published the results in the March issue of Preventive Medicine. About three-quarters of people surveyed either were unsure of the relationship between nicotine and cancer or incorrectly believed that nicotine causes cancer. More than a quarter of them held the potentially inaccurate beliefs that low-nicotine cigarettes would be less harmful and addictive than typical cigarettes.
“I think the biggest takeaway is that most people don’t fully understand the health effects of nicotine,” said the CTP Office of Science’s Erin Keely O’Brien, the study’s lead author. “While they do understand nicotine is addictive, they don’t understand nicotine doesn’t cause cancer.”
The study highlights the need for public education about both nicotine and low-nicotine cigarettes, according to its authors.
“Association Between The Real Cost Media Campaign and Smoking Initiation Among Youth—United States, 2014–2016”
About 900,000 U.S. youths smoke their first cigarette each year. In February 2014, the FDA launched its first national tobacco public education campaign, “The Real Cost,” designed to prevent youths from starting to smoke, while also discouraging further smoking in those youths who had already experimented with smoking.
The findings of this study, published in the Jan. 20 issue of Morbidity and Mortality Weekly Report, indicate that exposure to “The Real Cost” from 2014–2016 was associated with a 30 percent decrease in the risk for smoking initiation, preventing nearly 350,000 U.S. youth aged 11 to 18 from smoking.
The authors concluded that sustained youth-focused tobacco education campaigns like “The Real Cost” can contribute to the prevention of tobacco use among youths in the United States.
“Why Peer Crowds Matter: Incorporating Youth Subcultures and Values in Health Education Campaigns”
The FDA’s “Fresh Empire” public education campaign was designed to prevent and reduce tobacco use among youth who identify with the hip-hop “peer crowd.” In the article, published in the March issue of the American Journal of Public Health, the authors describe the campaign and its use of an approach called peer crowd targeting.
The authors explain that by focusing on the target audience’s peer crowd—that is, youth who share core ideals and have similar life experiences and common interests—the campaign differs from some other public education campaigns that focus on friendship groups, which are defined by interactions or time spent together.
“By replacing unhealthy behavioral norms with desirable, healthy lifestyles,” the authors write, “peer crowd-targeted interventions can create a lasting impact that resonates in the target audience’s culture.”
- Media Exposure and Tobacco Product Addiction Beliefs: Findings From the 2015 Health Information National Trends Survey (HINTS-FDA 2015)
- Engagement With Online Tobacco Marketing and Associations With Tobacco Product Use Among U.S. Youth
- Characteristics of Hookah Tobacco Smoking Sessions and Correlates of Use Frequency Among US Adults: Findings from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study
- Nicotine Content and Physical Properties of Large Cigars and Cigarillos in the United States
- Acrolein Yields in Mainstream Smoke From Commercial Cigarette and Little Cigar Tobacco Products
- Flavored Tobacco Product Use in Youth and Adults: Findings From the First Wave of the PATH Study (2013–2014)
- It’s Complicated: Examining Smokers’ Relationships With Their Cigarette Brands
- High-Throughput Patch Clamp Screening in Human α6-Containing Nicotinic Acetylcholine Receptors
- US Adult Tobacco Users’ Absolute Harm Perceptions of Traditional and Alternative Tobacco Products, Information-seeking Behaviors, and (Mis)Beliefs About Chemicals in Tobacco Products
- Pre-adolescent Receptivity to Tobacco Marketing and Its Relationship to Acquiring Friends Who Smoke and Cigarette Smoking Initiation
- The Use of Charcoal in Modified Cigarette Filters for Mainstream Smoke Carbonyl Reduction
- Characteristics of Electronic Cigarette Use Among Middle and High School Students—United States, 2015
- Measuring Youth Beliefs About the Harms of E-Cigarettes and Smokeless Tobacco Compared to Cigarettes
- FDA in the 21st Century: Focus on Tobacco Policies and Heart Failure Prevention
- Tobacco-Product Use by Adults and Youths in the United States in 2013 and 2014
- Evaluating the Toxicity of Cigarette Whole Smoke Solutions in an Air-Liquid-Interface Human In Vitro Airway Tissue Model
- Effect of Smokeless Tobacco Products on Human Oral Bacteria Growth and Viability
- Criterion Validity of Measures of Perceived Relative Harm of E-cigarettes and Smokeless Tobacco Compared to Cigarettes
- Tobacco-specific Nitrosamines in the Tobacco and Mainstream Smoke of U.S. Commercial Cigarettes
Featured below are new announcements from among the list of current CTP funding opportunities. For these new opportunities, you can go directly to additional information by clicking on the appropriate funding opportunity announcement (FOA) number.
Center for Coordination of Analytics, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54)
The overall objective of CASEL is to support research programs that can inform CTP in its tobacco product regulatory activities and actions. Through its support of collaborative efforts, CASEL can accelerate the advancement of science relevant to the Tobacco Control Act.
Application Due Date: July 19, 2017
Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54)
The TCORS program objective is to conduct programs of multidisciplinary research to inform the manufacture, distribution, and marketing of tobacco products related to CTP’s regulatory authority.
Application Due Date: July 19, 2017