Tobacco Products

Spotlight on Science — Summer 2018

Spotlight on Science

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...

Nine years after the Family Smoking Prevention and Tobacco Control Act was signed into law, and a year after FDA unveiled its Comprehensive Plan for Tobacco and Nicotine Regulation, the agency has made great strides toward the vision of a world where cigarettes no longer create or sustain addiction, and where adults who quit smoking and still seek nicotine can get satisfying levels from potentially less harmful sources.

In marking these milestones, FDA Commissioner Scott Gottlieb, M.D., and Center for Tobacco Products Director Mitch Zeller, J.D., shared their perspective in an August 2018 FDA Voice blog about the agency’s important progress to date, and future plans toward, stopping kids from becoming addicted to tobacco products and encouraging innovative options for adults who want to quit smoking. Among its important, ongoing work, FDA is beginning its review of comments on three advance notices of proposed rulemaking (ANPRMs): one on a potential product standard for lowering nicotine levels in combusted cigarettes; another on the regulation of flavors, including menthol, in tobacco products; and a third on the regulation of premium cigars. Among other topics, the blog also addresses the agency’s work to quickly advance initiatives to address the use of tobacco products by kids. Examples of issues being explored are flavors, including those in e-cigarettes and e-liquids; a possible product standard for e-cigarettes; and ways to accelerate enforcement when FDA becomes aware of violations associated with youth use of e-cigarettes.

As our tobacco regulatory efforts in these and other areas continue, we invite you to stay up-to-date by visiting the agency’s webpage dedicated to the Comprehensive Plan for Tobacco and Nicotine Regulation. Recently, a Youth Tobacco Prevention Plan page was added that highlights FDA’s intensive efforts to prevent youth use of, and access to, e-cigarettes and other tobacco products.

Even as the agency commits to improving the efficiency, as well as effectiveness, of our tobacco regulatory programs, we are likewise committed to maintaining our rigorous scientific standards. The stringent science that supports each FDA decision on tobacco regulation is exemplified in the scientific initiatives presented in this newsletter.

Read here about CTP’s current research and other science-based progress, all conducted with an eye to reducing disease and death caused by tobacco.


Cost-Effectiveness Analysis:

“The Real Cost” Will Save More Than $31 Billion 

FDA will save more than $31 billion by reducing smoking-related costs via mass media public education.

FDA’s “The Real Cost” campaign, launched in 2014, is having a meaningful impact in reaching youth, ages 12 to 17, in the U.S. who have already experimented, or who are open to experimenting, with smoking. In its first two years, the campaign prevented nearly 350,000 teens from starting to smoke cigarettes, half of whom might have gone on to become established adult smokers. This ultimately saved these kids, their families, and the country more than $31 billion by reducing smoking-related costs over their lifetime, such as costly medical care, lost wages, lower productivity, and increased disability. These findings are in a cost-effectiveness analysis published Aug. 16 in the American Journal of Preventive Medicine (AJPM).

The analysis highlights that preventing at-risk youth from smoking is very impactful to both individual teens and public health. FDA Commissioner Scott Gottlieb, M.D., emphasized this point in a statement about the impact reflected in the AJPM article: Preventing at-risk youth from smoking “is not only critical to every teen who does not become an addicted smoker,” he said, “but is also beneficial to public health.”

Find details of this cost-effectiveness analysis in the AJPM article.

Read More


FDA Issues Marketing Orders for Non-Combusted Cigarettes

On July 19, FDA issued substantial equivalence (SE) orders for two R.J. Reynolds Tobacco Company tobacco products, Eclipse and Eclipse Menthol. This marks the first time that FDA has issued SE orders on regular SE Reports for non-combusted cigarettes. This action demonstrates that the SE premarket review pathway is viable for non-combusted cigarettes. In addition, each of these products could serve as a predicate tobacco product for future SE Reports.

To receive an SE order, the manufacturer must demonstrate that the new tobacco product has the same characteristics as the predicate tobacco product or, if it has different characteristics than the predicate tobacco product, those differences do not cause the new tobacco product to raise different questions of public health. The SE order permits the marketing of the new tobacco product. The SE order means that FDA determined that the new tobacco products met the statutory standards of the SE pathway. The review did not assess the harm or risk of these products compared to other tobacco products beyond the finding that the differences in characteristics between the new and corresponding predicate tobacco products do not cause the new tobacco products to raise different questions of public health.

Several media reports and descriptions of these products have referred to the categorization of these products as “heat-not-burn” or “heated tobacco product.” These colloquial terms do not appear to have universally agreed upon definitions (although they seem to be used on an interchangeable basis). For FDA’s purposes, a tobacco product that meets the legal definition of a cigarette, but for which there is evidence that the heat does not reach a level sufficient to cause combustion of the tobacco product, is categorized as a “non-combusted cigarette.”
 
FDA’s scientific review of the SE Reports for these two products found there were differences in characteristics between the new and predicate tobacco products, but that these differences do not cause the new tobacco products to raise different questions of public health. The predicate tobacco product was an Eclipse non-combusted cigarette. The differences include, but are not limited to, tobacco types and ingredients, and the incorporation of a functional filter. This action is specific to the comparison between these new tobacco products and their respective predicate tobacco products.
 
For information on these actions, and a summary of all the actions FDA has taken, visit the Tobacco Product Marketing Orders webpage. The order letters and summary reviews, which include the scientific basis for this recent action, are available on FDA's website. FDA continues to review premarket applications for new tobacco products and issue decisions on those submissions. Since 2014, there is no backlog of regular SE Reports and review begins immediately upon receipt.

Read More


Research Report, 2010-2017—Available Online!

FDA recently unveiled a report spotlighting CTP’s scientific accomplishments in fiscal years 2010 to 2017. The report, titled Tobacco Regulatory Science Research Program at FDA’s Center for Tobacco Products: Summary and Highlights, provides an overview of CTP-funded research during this time frame and is now available online on CTP’s Tobacco Regulatory Science Research Program webpage.

Tobacco Regulatory Science ProgramRegulatory science research is important for informing tobacco product regulatory activities. Over eight years, CTP has funded almost 400 research projects—across different research domains, populations, and tobacco products—in collaboration with the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the FDA National Center for Toxicological Research (NCTR), and other partners. These projects have added significantly to the science base for informing regulatory decisions.

The research findings from CTP-funded projects have been disseminated through almost 800 peer-reviewed publications. Data from the published work adds to the tobacco regulatory science literature and informs CTP’s regulatory activities, such as the conduct of product reviews, development of product standards, development of public education campaigns, and implementation of compliance and enforcement actions. Together, this research helps achieve CTP’s mission of reducing the death and disease associated with tobacco use.

Read the full report for more details on FDA’s tobacco regulatory science research program, including research findings, partnerships, and training programs. The report, and additional information about CTP’s tobacco regulatory science research program, is available on CTP’s website. 

Read Report


Upcoming Meetings

TPSAC Meeting Sept. 13–14

A meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) is scheduled for Sept. 13–14 at FDA’s White Oak campus in Silver Spring, Md. At the meeting, the committee will discuss scientific questions related to the modified risk tobacco product (MRTP) applications submitted by R. J. Reynolds Tobacco Company for six Camel Snus smokeless tobacco products currently under scientific review by FDA.

General information about TPSAC meetings on MRTP applications is available on CTP’s website, as is additional information about the Sept. 13–14 meeting, including details about public participation and the meeting agenda.

Generally, TPSAC’s role is to review and evaluate scientific issues, including safety, dependence, and health issues, relating to tobacco products, and to provide advice, information, and recommendations to FDA. During this upcoming meeting, representatives from R. J. Reynolds Tobacco Company and CTP’s Office of Science will present information about the company’s MRTP applications under FDA review. Committee members may then discuss available scientific evidence related to issues and questions. During this discussion, voting members of the committee may vote on specific issues and questions or other topics arising during the committee’s discussion. FDA takes into consideration TPSAC members’ insights, along with public comments and other information made available to the agency, before making a determination on any MRTP application.

Members of the public may attend TPSAC meetings in person, or watch the live webcast. Instructions on how to submit public comments to TPSAC, along with other details about the committee and its upcoming meeting, are provided in a Federal Register notice. 

View Notice

Scientific Conference on “Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender”—Sept. 27–28

FDA’s Office of Women’s Health, Center for Drug Evaluation and Research, and CTP invite you to a conference on “Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender.” The public meeting is taking place at the agency’s White Oak campus in Silver Spring, Md. on Sept. 27–28. Registration is required by Sept. 24 at 5 p.m. Eastern Time to view it via webcast.

The meeting focuses on sex and gender influences on opioid and tobacco use, misuse, and cessation. The conference features keynote speeches by FDA Commissioner Scott Gottlieb, M.D., U.S. Surgeon General, VADM Jerome M. Adams, M.D., M.P.H., and CTP Director Mitch Zeller, J.D., along with presentations by researchers, clinicians, and policy experts.

Sex and gender differences may influence susceptibility to substance abuse, which could have implications for optimal prevention and treatment. Gender influences also impact public health from an environmental perspective. Researchers, educators, and clinicians must be able to recognize and consider both sex and gender differences to identify and treat women most at risk.

Learn More and Register

Learn About FDA’s Tobacco Product Review Process — Public Meeting Oct. 22–23

FDA plans to hold a public meeting Oct. 22–23 to discuss  the policies and processes for tobacco product application review, including the general scientific principles relevant to substantial equivalence reports, exemption requests, premarket tobacco applications, and modified risk tobacco product applications.

This meeting comes at a time when FDA is taking steps to improve the efficiency and transparency of the tobacco product application review process. Recently, for example, the agency took a step to improve transparency regarding applications for a subset of tobacco products—known as “provisional substantial equivalence (SE) tobacco products.” FDA Commissioner Scott Gottlieb, M.D., and CTP Director Mitch Zeller, have outlined new efforts and initiatives, including this action, in a new blog. And FDA plans to announce additional process improvements ahead of this October public meeting.

Topics at the meeting will include:

  • Overview of the tobacco product marketing application types
  • Information that should be included in a tobacco product marketing application
  • Administrative processes involved in the submission and review of a tobacco product marketing application
  • Other topics relevant to the submission of tobacco product marketing applications, including tobacco product master files, meeting requests, grandfathered review, and environmental assessments.

The meeting, which is taking place at the Tommy Douglas Conference Center in Silver Spring, Md., will feature presentations by FDA staff, expert panels, and a live Q&A. The meeting aims to make the agency’s tobacco product review process more efficient, predictable, and transparent. This is in keeping with the agency’s continued focus on helping industry comply with federal tobacco regulations, while also upholding our public health mission. The meeting is not intended to communicate any new policies or interpretations regarding tobacco product marketing applications and their review.

To attend the meeting in person, or to watch via webcast, register no later than Sept. 21. Both in-person seating and webcast viewership are limited, so early registration is recommended. FDA is also accepting nominations through Aug. 31 for panelists interested in addressing the meeting topics.

More information, including details about registering to attend and how to become a panelist, is available on FDA’s website.

Learn More 


CTP Research

Spotlight on a Study: Do ENDS Help Smokers Quit?

Weaver SR, Huang J, Pechacek TF, Heath JW, Ashley DL, Eriksen MP. Are electronic nicotine delivery systems helping cigarette smokers quit? Evidence from a prospective cohort study of U.S. adult smokers, 2015-2016. PLOS One, 2018 Jul 9;13(7):e0198047. DOI: 10.1371/journal.pone.0198047. eCollection 2018

This study, conducted by researchers with Georgia State University, and supported by NIH’s National Institute of Drug Abuse and CTP, examined the effect of real-world use of electronic nicotine delivery systems (ENDS) on population quit rates of adult smokers, taking into account frequency and duration of use, device type, e-liquid flavor, and reasons for use. Many report using ENDS for smoking cessation, but these tobacco products’ impact under real-world use patterns and conditions on adult smokers’ quitting behavior has been unclear, the authors state.

The Georgia State University study found no evidence that ENDS use helped adult smokers quit at rates higher than smokers who did not use these products. The findings, in the context of the current literature, have important regulatory implications, the authors state. “From the perspective of product characteristics,” they write, “helping smokers quit combustibles will need evidence-based product standards and pre-market reviews that will encourage innovations in products that truly increase population quit rates.” 

Regulations and policies are needed that incentivize smokers to switch completely to potentially reduced-harm and reduced-risk products or quit tobacco products altogether, the authors state, adding, “This notion is in line with recently announced plan by the FDA to reduce the nicotine within cigarettes while using regulations to promote the availability and acceptability of reduced-harm nicotine and tobacco products (as well as FDA-approved nicotine products).” Education campaigns that accurately communicate the risks of ENDS and other reduced-risk products may also be beneficial, the authors add.

Researchers point out that the observational design of the study limits the ability to draw causal inferences.

Study Snapshots

Silveira ML, Conway KP, Green VR, et al. Longitudinal associations between youth tobacco and substance use in waves 1 and 2 of the Population Assessment of Tobacco and Health (PATH) Study. Drug Alcohol Depend. 2018 Jul 25.DOI: 10.1016/j.drugalcdep.6.018 [Epub ahead of print]

Looking at a range of tobacco products, this study examined whether ever tobacco use predicted subsequent substance (alcohol or drug) use, and if ever substance use predicted subsequent tobacco use, among U.S. youth from PATH Waves 1 (2013–2014) and 2 (2014–2015).

Associations were observed in both directions between the use of tobacco products and alcohol and drugs among U.S. youth. Major findings include:

  • Any tobacco use predicted subsequent substance (alcohol or drug) use. The magnitude of the associations was lowest for alcohol, higher for marijuana, and highest for other drugs.
  • Having ever used an e-cigarette predicted substance use except non-prescribed painkillers/sedatives.
  • Having ever used a substance predicted tobacco use across products.
  • Having ever used marijuana predicted use of all tobacco products except smokeless tobacco.

Studying more waves of PATH Study data could provide additional useful information about the bidirectional associations observed between tobacco use and substance use, according to the authors. The researchers also state that preventive and intervention efforts may benefit from a comprehensive screening of tobacco, alcohol, and drug use among youth. In addition, future research should identify any risk factors shared across substances that, when mitigated, could most effectively prevent the onset of youth substance use.

Nguyen AB, Zhao X, Hoffman L, Morse AL, Delahanty J. Nicotine and addiction beliefs and perceptions among the U.S.-born and foreign-born populations. Prev Med. 2018 Sep;114:107-114. DOI: 10.1016/j.ypmed.2018.06.018. Epub 2018 Jun 26.

The demographic profile in the United States is becoming increasingly diverse, with a rapidly growing foreign-born population. But not much is known about foreign-born individuals’ nicotine and addiction beliefs. This study describes these beliefs and examines how they are related to race/ethnicity, English proficiency, and length of U.S. residency.

This analysis used data from two special cycles of the National Cancer Institute’s Health Information National Trends Survey (HINTS), called HINTS-FDA 2015 and HINTS-FDA 2017, which include additional questions related to tobacco. The study found that: 

  • Foreign-born respondents are more likely than U.S.-born respondents to believe that low-nicotine cigarettes have lower lung cancer risk than a typical cigarette.
  • Foreign-born respondents are more likely to be concerned about being addicted to nicotine than U.S.-born respondents.
  • Among foreign-born respondents, shorter U.S. residency was associated with higher ratings of addictiveness for cigarettes, while lower English proficiency was associated with stronger belief in the carcinogenic role of nicotine in cigarettes.

“Our research shows that foreign-born individuals may have misperceptions about nicotine, such as thinking incorrectly that it is the main cancer-causing agent in smoke,” says study author Bao Nguyen Zarndt, a CTP Office of Science social scientist. “These inaccurate beliefs may lead to lower quitting and cessation among these populations because of reluctance to try nicotine-containing cessation products such as nicotine-replacement therapies (NRTs). Our findings can help target these beliefs and inform tailored messaging that can be delivered through culturally appropriate channels.”

Kaufman AR, Persoskie A, Twesten J, Bromberg J. A review of risk perception measurement in tobacco control research. BMJ Journals: Tobacco Control. 2018 Feb 6. PII: tobaccocontrol-2017-054005. doi: 10.1136/tobaccocontrol-2017-054005. [Epub ahead of print].

Risk perceptions, as defined by this study’s authors, are subjective judgments about a potential health harm related to a hazard. This study was designed to describe the characteristics of risk perception measures used in tobacco control research and to evaluate whether these measures follow measurement suggestions by risk perception measurement scholars.

Based on a search in three databases—PubMed, PsycINFO, and Web of Science—the authors concluded there is little consistency across risk perception measures in tobacco research. It may be valuable, the researchers state, to develop and distribute best practices for tobacco risk perception assessment.

A set of risk perception consensus measures could benefit tobacco researchers by helping them apply measurement recommendations in a consistent way, the authors add. Also, says study author and CTP Office of Science social scientist Alexander Persoskie, Ph.D., “Risk perceptions play a role in tobacco use initiation, cessation, and product switching. Because of this, valid measures of consumers’ risk perceptions are useful to tobacco regulation stakeholders such as public health and consumer advocates, industry, and FDA.”

Additional Recent Publications by CTP Researchers

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: Oct. 12, 2018
Letter of Intent Due Date: Eight 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-18-002
Next Application Due Date: Feb. 13, 2019
Letter of Intent Due Date: 60 days before application due date
 
R21—Tobacco Regulatory Science Exploratory/Developmental Research Grant
FOA Number:- RFA-OD-18-003
Next Application Due Date: Feb. 13, 2019
Letter of Intent Due Date: 60 days before application due date

R03—Tobacco Regulatory Science Small Grant Program for New Investigators
FOA Number: RFA-OD-17-008
Next Application Due Date: Feb 13, 2019, by 5:00 PM local time of applicant organization.
Letter of Intent Due Date: 60 days before application due date

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