Dec. 21, 2017
Spotlight on Science is a quarterly science and research digest from the FDA Center for Tobacco Products.
On this page:
- Tobacco Regulatory Science Fellowship
- “Every Try Counts”
- Focus on FDA and Medicinal Nicotine at Recent Public Event
- Upcoming Meetings
- CTP Research
- Funding Opportunities to Explore
Call for Applications Is Approaching for the Paid 12-Month Fellowship
Are you interested in helping to shape the future of tobacco regulation, or do you know someone who is? Have you considered a fellowship? The tobacco regulatory science fellowship program is a collaboration between CTP and the National Academy of Medicine (NAM). Started in 2012, the 12-month multidisciplinary program was designed for mid-career professionals from various disciplines to gain experience in developing regulatory science relating to tobacco products and FDA’s authorities under the Family Smoking Prevention and Tobacco Control Act.
Fellows are placed in various areas within the Center, including compliance and enforcement; health communication and education; administrative management; regulations; or science. Over the course of a year, fellows help lead defined projects, actively participate in the development of science-based public health strategies, and meet with policy leaders. The fellowship culminates with a formal presentation to CTP leadership about project outcomes and lessons learned.
Each fellow will be awarded a stipend and may be eligible to receive funding for relocation.
2018 Call for Applications: Jan. 3–March 1, 2018
Each year, several fellows are selected through a national competition based on professional achievements, expertise in an area of relevance to the center, and the quality of submitted essays and letters of recommendation. If selected as a finalist, each applicant must participate in an in-person interview at NAM in Washington, D.C.
The next call for applications begins Jan. 3, 2018. Candidate webinars are scheduled for Jan. 23 and Feb. 8. Visit the FDA Tobacco Regulatory Science Fellowship website, where you can join the mailing list, learn about important deadlines, and more.
For a more personal perspective on the program, read what some fellows had to say.
The Fellows’ Viewpoint
Alison Kulas, MSPH
Class of 2016
Before becoming a CTP fellow, Alison worked as the program manager for Alaska’s Tobacco Prevention and Control Program, where she led a comprehensive program focused on eliminating exposure to secondhand smoke, supporting adults in quitting tobacco, and preventing youth from starting to use tobacco. She had worked for more than a decade raising public awareness about tobacco’s dangers at the state, regional, and community levels when a coworker suggested she apply for the CTP-NAM fellowship program and gain an inside look at FDA’s Center for Tobacco Products.
“I have worked in tobacco control for many years, so I had seen the fellowship announcements since the program’s inception,” said Alison, who relocated to Washington, D.C., to accept the new challenge of working at the federal level.
“I was most interested in seeing how the regulatory agency worked from the inside,” she said. “There is a lot of work gathering the science and ensuring that messages, product regulation, and policies are on point. Coming from a state program, it was nice to see what you can do if given the resources.”
Alison advises fellows to use their time wisely. “A fellowship year is what you make it,” she said. “Use every opportunity to boost your knowledge by going beyond even what the program requires.”
Babita Das, PhD
Class of 2016
Babita was no stranger to tobacco when she applied to the CTP-NAM program. It was during her time in a postdoctoral fellowship at the Tobacco Center of Regulatory Science at the University of Maryland School of Public Health that she saw an email announcement and explored the CTP program by visiting the fellowship website and attending an online informational webinar.
“The application process for this fellowship was surprisingly easy,” she said. One feature she found especially helpful was a timeline highlighting the dates on which preliminary and final interviews and selection notifications would take place.
With 20 years of research experience studying responses to smoking denicotinized cigarettes, pharmacological and behavioral treatments for opiate use, and cognitive enhancement in individuals diagnosed with schizophrenia and schizoaffective disorder, Babita was selected as a fellow for CTP’s Office of Science. She used her time as a fellow to learn about the relationship between science and the regulatory process.
“I learned how tobacco regulation takes place within a regulatory agency, which I believe to be an incredibly valuable perspective,” Babita said. “I developed relationships with many influential CTP leaders and collaborators through my daily fellowship activities and events, and I learned the ins and outs of how tobacco research is translated into tobacco policy.”
For those interested in applying, Babita recommends using the fellowship website. “Use the website as a tool to gain information about the fellowship, and then to directly contact alumni of the program,” she suggested. “Contacting alumni will help fellowship candidates develop relationships with colleagues who were in the same place just a few years before, and will provide the opportunity for candidates to hear first-hand about the experience.”
Shovaughn Chism, MSW
Class of 2017
Shovaughn previously worked as the tobacco enforcement and education coordinator for the Baltimore City Health Department. In this position, he addressed tobacco cessation and prevention through community education and retail engagement. In addition to engaging with youth in Baltimore schools, he also directed in-depth education visits for owners and clerks at more than 850 stores, helping them remain compliant with federal and local laws relating to tobacco sales. He also handled legal administrative matters associated with tobacco violations. Shovaughn, who applied for the CTP fellowship at the suggestion of a coworker, was selected as an Office of Compliance and Enforcement fellow.
“I have seen the profound power that nicotine addiction has had on people’s ability to purchase food or pay their electric bill, considering their craving to smoke tobacco products,” Shovaughn said. “I had a deep curiosity about how CTP functions and about FDA’s regulatory framework–how does the agency apply its authorities to protect public health?”
He went on to say he has learned so much in the few months of the fellowship. “I am now thinking about how I could help CTP define and meet goals that lie ahead,” said Shovaughn, who encourages anyone with an interest in tobacco regulatory science to apply for the fellowship.
A recently released federal government study, “Tobacco Product Use Among Adults—United States, 2015” (summarized below), found that 1 in 5 U.S. adults reported current use of a tobacco product in 2015, and cigarettes were the most commonly used tobacco product. At the same time, most adult smokers say they want to quit. In 2015, of the 55 percent of adult smokers who made a quit attempt, only 7 percent were successful.
As research shows, it often takes multiple quit attempts before a smoker can quit successfully, FDA recently launched an adult smoking cessation education campaign, “Every Try Counts,” to encourage adult smokers who recently tried to quit smoking to try again to quit. Messages of support underscoring the health benefits of quitting and celebrating each quit attempt will be displayed in and around gas stations and convenience stores, where smokers face triggers such as cigarette advertising that prompt tobacco purchases.
This campaign complements FDA’s comprehensive plan on tobacco and nicotine regulation announced this past summer, which places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. “FDA is committed to reducing tobacco-related disease and death by helping people quit combustible cigarettes and implementing comprehensive policies to reduce addiction to nicotine,” said FDA Commissioner Scott Gottlieb, M.D.
On Dec. 12, the Duke-Margolis Center for Health Policy in Washington, D.C., held a public event to discuss FDA’s new tobacco regulatory framework and the agency’s approach to medicinal nicotine, including scientific and policy questions related to the development of innovative nicotine replacement therapies. FDA Commissioner Scott Gottlieb, M.D., delivered a keynote address, and a panel discussion included CTP Director Mitch Zeller and several other experts.
To watch a captioned recording of the event, visit the Duke-Margolis Center for Health Policy website.
TPSAC Meeting: Philip Morris Products S.A. MRTP Applications
Jan. 24–25, 2018
During a January meeting of the Tobacco Products Scientific Advisory Committee (TPSAC), the committee will discuss scientific issues related to the modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. for its iQOS system and several Marlboro HeatSticks products, which are currently under scientific review by FDA. Those interested in submitting a comment can view the docket on Regulations.gov.
For more information—including details about the agenda, requesting to present an oral comment, and watching via webcast—please visit the 2018 TPSAC Meeting Materials and Information page.
Public Hearing: Evaluating Nicotine Replacement Therapies
In support of FDA’s comprehensive new tobacco regulatory plan announced in July, the agency has formed a Nicotine Steering Committee to help develop and implement nicotine policy and regulation. The committee will address the public health crisis of addiction to tobacco products in this country. The group, which includes senior leadership from the Center for Tobacco Products, Center for Drug Evaluation and Research, and Office of the Commissioner, will focus on nicotine replacement therapies (NRTs), which are designed to help people quit smoking. The committee will examine the evolving science behind the agency’s evaluation of NRTs, including the types of safety and efficacy studies FDA requires and how these products are used and labeled.
As the committee’s first public action, it will hold a public hearing for FDA to obtain feedback on public health, scientific, regulatory, and legal considerations relating to NRT products and how they are used for cessation. The hearing is planned for Jan. 26, 2018, at FDA’s White Oak Campus in Silver Spring, Maryland. Those who want to attend or present at the hearing must register by Jan. 2. Electronic or written comments will be accepted after the public hearing until Feb. 15.
For more information, read the Federal Register notice announcing the public hearing. You can also learn more about the committee and public hearing in a blog post by the FDA commissioner and the directors of the Center for Drug Evaluation and Research and Center for Tobacco Products.
PATH Study’s Wave 1 Biospecimens Now Available
FDA and NIH recently launched the PATH Study’s Biospecimen Access Program, which allows researchers to apply to gain access to urine, serum, and plasma collected from adult PATH Study participants during Wave 1 (Sept. 2013–Dec. 2014). To request the PATH Study biospecimens, researchers must submit a research concept statement and application. Concept statements for the next review cycle will be due in May 2018.
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.
“Tobacco Product Use Among Adults—United States, 2015”
On Nov. 10, CDC and FDA released a study, “Tobacco Product Use Among Adults—United States, 2015,” which found that nearly 49 million, or 1 in 5, adults in the United States reported current use of some form of tobacco product in 2015. Of all current adult tobacco users, more than 87 percent reported using a combustible product such as cigarettes, cigars, or pipes, including hookahs and water pipes. Cigarettes were the most commonly used tobacco product among adults (15.1 percent).
After cigarettes, the next most commonly used tobacco products among adults were e-cigarettes (3.5 percent), and cigars, cigarillos and filtered little cigars (3.4 percent). The findings show that 9.5 million adults reported using two or more tobacco products.
The study, based on data from the 2015 National Health Interview Survey (NHIS), was published in the Morbidity and Mortality Weekly Report. NHIS is an annual, nationally representative, in-person survey of the U.S. population. This is the first time CDC, in coordination with FDA, assessed the spectrum of different tobacco products used by U.S. adults.
“U.S. Adult Interest in Less Harmful and Less Addictive Hypothetical Modified Risk Tobacco Products”
Descriptors such as “low tar” and “light” have been used by the tobacco industry to market cigarettes as less harmful than other cigarettes and attempt to allay public concerns about the health effects of smoking. Now that modified risk tobacco products are regulated by FDA, researchers examined consumer interest in hypothetical MRTPs with current, former, and never established smokers by asking participants their likelihood of using tobacco products with claims of being less addictive and less harmful than other products.
Data was analyzed from the 2015 Health Information National Trends Survey, or HINTS. The researchers found that about half of current smokers and a tenth of both former and never established smokers reported that they were “somewhat” or “very” likely to try hypothetical MRTPs that claimed to be less harmful or less addictive. Of those interested in the hypothetical MRTPs, it was found that female smokers, former smokers with lower smoking harm perceptions, and young adults who never smoked or those without college educations who never smoked were more interested in the MRTPs. The study showed that the interest in using these products was positively associated with believing that smoking status is a changeable individual characteristic, and that it is possible for tobacco products to be made without some harmful chemicals. With this, the researchers stated that it is important to study how the population is affected by the marketing of MRTPs to understand the potential population health impact of authorizing the marketing of MRTPs.
Additional Recent Publications
- Quantitative Differentiation of Whole Smoke Solution-Induced Mutagenicity in the Mouse Lymphoma Assay
- Impact of Non-Menthol Flavours in Tobacco Products on Perceptions and Use Among Youth, Young Adults and Adults: A Systematic Review
- Cherry-flavoured Electronic Cigarettes Expose Users to the Inhalation Irritant, Benzaldehyde
- U.S. Adult Cigar Smoking Patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type; PATH Study (2013-2014)
- The Most Natural Tobacco Used: A Qualitative Investigation of Young Adult Smokers’ Risk Perceptions of Flavored Little Cigars and Cigarillos
- Establishing a Novel Pig-A Gene Mutation Assay in L5178YTk+/- Mouse Lymphoma Cells
- Nicotine Concentration of E-Cigarettes used by Adolescents
- Evaluation of a Reduced Nicotine Product Standard: Moderating Effects of and Impact on Cannabis Use
- Associations Between Tobacco and Nicotine Product Use and Depressive Symptoms Among College Students in Texas
- Little Cigars and Cigarillos Use Among Young Adult Cigarette Smokers in the United States: Understanding Risk of Concomitant Use Subtypes
- Estimations and Predictors of Non-Compliance in Switchers to Reduced Nicotine Content Cigarettes
- Impact of the Real Cost Campaign on Adolescents’ Recall, Attitudes, and Risk Perceptions About Tobacco Use: A National Study
- College Students’ Perceptions of Risk and Addictiveness of E-Cigarettes and Cigarettes
- The Prevalence and Marketing of Electronic Cigarettes in Proximity to At-Risk Youths: An Investigation of Point-of-Sale Practices Near Alternative High Schools
- The Association Between Sensation Seeking and E-Cigarette Use in Texas Youth Adults: a Cross-Sectional Study
- Graphic Warning Labels and the Cost Savings from Reduced Smoking Among Pregnant Women
- Perceptions and Experiences with Flavored Non-Menthol Tobacco Products: A Systematic Review of Qualitative Studies
- U.S. Adult Cigar Smoking Patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type: Findings from the Population Assessment of Tobacco and Health (PATH) Study, 2013-2014
- U.S. Adult Interest in Less Harmful and Less Addictive Hypothetical Modified Risk Tobacco Products
- A Novel Method of Nicotine Quantification in Electronic Cigarette Liquids and Aerosols
- Menthol Disrupts Nicotine’s Psychostimulant Properties in an Age and Sex-Dependent Manner in C57BL/6J Mice
- Point of Sale Scanner Data for Rapid Surveillance of the E-Cigarette Market
- The Effects of Framed Messages for Engaging Adolescents with Online Smoking Prevention Interventions
- Calls to Poison Centers for Hookah Smoking Exposures
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 the National Institutes of Health to foster tobacco regulatory research, offers funding for scientists whose research can inform CTP’s regulatory activities.
R01—Research Project Grant
FOA Number: RFA-OD-17-007
Next Application Due Date: Feb. 13, 2018
R21—Exploratory/Developmental Research Grant
FOA Number: RFA-OD-17-009
Next Application Due Date: Feb. 13, 2018
R03—Tobacco Regulatory Science Small Grant Program for New Investigators
FOA Number: RFA-OD-17-008
Next Application Due Date: Feb. 13, 2018