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Spotlight on Science - Winter 2020

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

In This Issue…

On Jan. 2, FDA finalized an enforcement policy on flavored cartridge-based e-cigarettes, including fruit and mint, that appeal to children. Companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk enforcement actions by FDA.

In this issue of Spotlight on Science, read about this policy, legislation raising the federal minimum legal age to buy tobacco products from 18 to 21, recently released National Youth Tobacco Survey data, and other news about CTP’s science-based regulatory policy.

FDA Finalizes Policy on Unauthorized Flavored Cartridge-based E-Cigarettes That Appeal to Children

On Jan. 2, FDA issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products, including fruit and mint flavors, that appeal to kids. Under this policy, companies that do not cease the manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk enforcement actions by FDA.

Teen using earphones

On Aug. 8, 2016, all e-cigarettes and other ENDS products became subject to FDA’s tobacco authorities, including the premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). All e-cigarettes and other ENDS products on the market at that time needed to have authorization from FDA to be legally marketed. However, as an exercise of its enforcement discretion, the agency had deferred enforcement of the premarket authorization requirements. To date, no ENDS products have been authorized by FDA — meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in FDA’s discretion.

Beginning 30 days after the January 7, 2020 publication of the notice of availability in the Federal Register, FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:

  • Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
  • All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
  • Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

 

READ MORE

Legislation Raises Minimum Legal Age to Buy Tobacco Products from 18 to 21

On Dec. 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product, including cigarettes, cigars and e-cigarettes, to anyone under the age of 21. As required by the legislation, FDA intends to publish a final rule updating its current regulations solely to carry out the amendments made by the legislation within 180 days. FDA will provide additional details on this issue as they become available. 

FDA has free resources available to assist retailers in calculating the age of customers. Retailers who use FDA’s This is Our Watch digital age verification calendar may update the minimum purchase age on the calendar to 21 years. Instructions on how to update the age on the digital calendar are available on FDA’s website. Retailers who would like a This is Our Watch digital age verification calendar may order one free of charge from FDA Center for Tobacco Products Exchange Lab. Additionally, retailers who use FDA’s Age Calculator app may update the age limit to 21 years through the app settings. Instructions are provided within the help feature of the app.

2019 National Youth Tobacco Survey Results

Initial results from the 2019 National Youth Tobacco Survey (NYTS) were published Nov. 5 in the Journal of the American Medical Association (JAMA) and further details were later published Dec. 6 in the Morbidity and Mortality Weekly Report (MMWR). The 2019 NYTS results show 6.2 million U.S. middle and high school students are current users of some type of tobacco product (having used in the past 30 days), while more than 5 million have used e-cigarettes at least once in the past 30 days. E-cigarettes are the most commonly used tobacco product among youth for the sixth year in a row. While cigarette smoking is at an all-time low among high school students, increases in e-cigarette use have reversed progress made in the decline of overall youth tobacco use. The survey, which is conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, also shows that of current youth e-cigarette users in 2019, approximately 1.6 million are using the product frequently (using on 20 or more days in a 30-day period), with nearly one million using e-cigarettes daily.

2019 NYTS shows youth e-cigarette use at alarming levels

READ MORE

FDA Grants First-Ever Modified Risk Orders

On Oct. 22, 2019, FDA granted the first-ever modified risk orders to Swedish Match USA, Inc. for eight General snus smokeless tobacco products. This means the eight products may be advertised with specific information about the lower risks of certain health effects using the products compared to smoking cigarettes. This does not mean that the products are safe or “FDA approved.” All tobacco products are potentially harmful, and people who do not use them should not start.

These products have been authorized for U.S. sale without modified risk claims by FDA since 2015. The October 2019 action authorizes the manufacturer to market these specific products with the claim “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

In a modified risk tobacco product application (MRTPA) review, FDA generally must look at whether the applicant has demonstrated that the product – as actually used by consumers – will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole. This includes taking into account both users of tobacco products and persons who do not currently use tobacco products. In making this assessment, the agency must consider, among other things, whether those who do not use tobacco products would start using the product and whether existing tobacco users who would have otherwise quit would switch to the modified risk product instead. 

FDA’s review determined that the claim proposed by the company in its application is supported by scientific evidence, that consumers understand the claim and appropriately perceive the relative risk of these products compared to cigarettes, and that the modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.

In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these specific smokeless tobacco products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. Evidence submitted in the application also demonstrates that consumers can understand the claim and the relative risk of the products, and that seeing the claim influences their intentions to buy the products among smokers 25 years of age or older – a group who stands to benefit the most from the modified risk tobacco products. Consumers also generally understand that the risk reduction is not achieved from partial switching (i.e., dual use of the products with continued use of cigarettes), thereby increasing the likelihood that smokers will switch completely. In addition to these lower risks relative to cigarette smoking, FDA previously determined that the levels of two potent carcinogens in smokeless tobacco products, NNN and NNK, are lower in these General snus products than the vast majority of smokeless tobacco products on the U.S. market. In addition, the evidence shows when used exclusively instead of other smokeless tobacco products, the General snus products offer the potential for reductions in oral cancer risk.

The available evidence does not demonstrate significant youth initiation of these products, and evidence submitted by the company also finds low levels of intentions to buy the product among non-users of tobacco (including young adults) and, importantly, finds that the inclusion of the modified risk claim does not affect these intentions. In addition, to further limit the likelihood of youth initiation, FDA is placing stringent restrictions on how the products are advertised and promoted – particularly via websites and through social media platforms – by including restrictions that prevent advertising from being targeted to youth.

FDA Permits Sale of Two New Reduced Nicotine Cigarettes 

On Dec. 17, 2019, FDA announced it has authorized the marketing of two new tobacco products manufactured by 22nd Century Group Inc. – Moonlight® and Moonlight® Menthol, which are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.

Following a rigorous science-based review of the premarket tobacco product applications (PMTAs) submitted by the company, the agency determined that authorizing these reduced nicotine products for sale in the U.S. is appropriate for the protection of the public health because of, among several key considerations, the potential to reduce nicotine dependence in addicted adult smokers, who may also benefit from decreasing nicotine exposure and cigarette consumption. The agency determined that non-smokers, including youth, are also unlikely to start using the products, and those who experiment are less likely to become addicted than people who experiment with conventional cigarettes.

TPSAC Meeting in February to Discuss 22nd Century Group Inc. MRTP Applications

FDA has issued a Federal Register notice announcing a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) scheduled for Feb. 14 at FDA's White Oak Campus. The committee will discuss scientific issues related to the modified risk tobacco product (MRTP) applications submitted by 22nd Century Group Inc. for VLNTM King and VLNTM Menthol King combusted, filtered cigarettes, which are currently under scientific review by FDA. These products recently received marketing authorization under the names Moonlight® and Moonlight® Menthol.

Please refer to the Federal Register notice for instructions on how to submit public comments related to TPSAC. Requests to present an oral comment at the February meeting must be received by Jan. 30. Written comments related to the TPSAC meeting must be received by Feb. 7.

These deadlines apply only to the TPSAC meeting and do not apply to the public docket for 22nd Century Group Inc.’s MRTP applications. There is currently no deadline for public comments on these applications.

CTP Director Mitch Zeller Gives TED Talk 

In March 2019, CTP Director Mitch Zeller gave a TEDxTalk at TEDxMidAtlantic discussing nicotine addiction and the history of cigarettes. His talk, The Past, Present, and Future of Nicotine Addiction, is now available online.

 

FDA Issues Guidance for Limited Modifications to Certain Tobacco Products 

FDA recognizes there are certain modifications manufacturers can make to their tobacco products to address a voluntary industry battery standard and to comply with requirements related to safe packaging of liquid nicotine products, known as flow restrictors. FDA encourages these limited safety-related modifications because they are intended to ensure the public is protected from risks such as battery explosions or accidental exposure to toxic levels of nicotine.

On Nov. 25, 2019, FDA issued a guidance, Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products, which sets out FDA’s compliance policy for limited safety modifications to tobacco products on the market as of Aug. 8, 2016: (1) battery-operated tobacco products modified solely and only to the extent necessary to comply with the voluntary industry UL 8139 battery standard; and (2) e-liquid products containing nicotine modified solely and only to the extent necessary to comply with the restricted-flow requirements for liquid nicotine containers set out in the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA). This guidance explains that FDA does not intend to enforce violations of the premarket review requirements against such modified products on the basis of these limited modifications.

FDA, alongside the U.S. Consumer Product Safety Commission, external stakeholders, and UL (a global safety certification company formerly known as Underwriters Laboratories), worked together to develop a voluntary industry standard, UL 8139, to help manufacturers mitigate potential battery-related risks associated with their battery-operated tobacco products. FDA recognizes that, to comply with this voluntary industry standard (UL 8139 Standard for Safety for Electrical Systems of Electronic Cigarettes and Vaping Devices), manufacturers of battery-operated tobacco products may need to change certain aspects of their product, which may render their products as “new” tobacco products. This compliance policy provides that FDA does not intend to enforce violations of the premarket review requirements against battery-operated tobacco products that were on the market as of Aug. 8, 2016, and that are then modified solely and only to the extent necessary to comply with UL 8139, on the basis of such modification.

Additionally, to help mitigate the potential risks of accidental exposure of children to liquid nicotine, Congress passed the Child Nicotine Poisoning Prevention Act (CNPPA), which requires liquid nicotine containers to have, among other things, special packaging that makes it difficult for children to open. FDA believes e-liquid containers that comply with the flow restrictor requirements will potentially reduce the risk of children becoming accidentally exposed to toxic levels of nicotine from e-liquids. This compliance policy provides that FDA does not intend to enforce violations of the premarket review requirements against liquid nicotine products on the market as of Aug. 8, 2016, and that are then modified solely and only to the extent necessary to comply with the CNPPA requirements for restricted flow, on the basis of such modification.

Materials from Oct. Public Meeting on Deemed Tobacco Product Applications

FDA posted materials from the Oct. 28-29, 2019 public meeting on the agency’s tobacco product application review processes, with a particular focus on deemed tobacco products.
The meeting covered a range of topics, including:

  • overview of the tobacco product marketing application pathways,
  • 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, and
  • other topics relevant to the submission of tobacco product marketing applications, including communications between FDA and industry during an application review process, use of Tobacco Product Master Files, as well as electronic submission resources and tools.

More About CTP Research

PATH Study Update:

Researchers Encouraged to Access Wave 4 Public Use Files, Apply to Biospecimen Access Program 

Public-use questionnaire data files from the fourth wave of the Population Assessment of Tobacco and Health (PATH) Study, containing data collected during Wave 4 (December 2016 – January 2018), may be downloaded from the PATH Study Public Use Files webpage.

Beginning in 2020, there will be a series of special collection PATH Study data releases. The first special collection data release will consist of data collected only from youth respondents between Waves 4 and 5 of the PATH Study.

In addition, the Biospecimen Access Program webpage provides information on how to access the urine, serum, and plasma collected from adult PATH Study participants during Wave 1 and Wave 2.

For the latest announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users, join the PATH Study Data User Forum.

READ MORE

New FDA Tobacco Regulatory Fellows

The tobacco regulatory science fellowship is a collaborative program between FDA’s Center for Tobacco Products (CTP) and the National Academy of Medicine (NAM). The 12-month, multidisciplinary program allows mid-career professionals to gain experience to further develop the field of regulatory science. Fellows for 2019-2020 include:

Ravi Choudhuri

Ravi Choudhuri is working in CTP’s Office of Health Communication and Education. He contributes to the development of various CTP public education campaigns such as This Free Life, Every Try Counts, and the Nicotine Education Project. Previously, Choudhuri worked for the American Lung Association, the University of California, Riverside and the Center for the Evaluation of Nicotine in Cigarettes. Choudhuri obtained a Bachelor of Science in neuroscience and a Bachelor of Arts in psychology from the University of California, Riverside and a Master of Public Health from the University of Pittsburgh.
 

Reema Goel

Reema Goel is working in CTP’s Office of Science, participating in the toxicological assessment of tobacco products by reviewing research data and applying novel computational methods. Goel previously was a research associate at the Pennsylvania State University (PSU) Tobacco Center of Regulatory Science and a postdoctoral fellow at BloodCenter of Wisconsin. Goel obtained a Bachelor of Science in human biology and Master of Science in medical biotechnology from All India Institute of Medical Sciences and a doctorate in physiology and pharmacology from Saint Louis University.
 

Marzena Hiler

Marzena Hiler is working in CTP’s Office of Science, where she evaluates tobacco products and relevant scientific data pertaining to nicotine and tobacco abuse liability and biomarkers of exposure. Previously Hiler’s research as a doctoral student at the Virginia Commonwealth University (VCU) Tobacco Center of Regulatory Science focused on evaluating the acute effects of novel tobacco products to inform regulation and product standards. She also served as a health educator at the University of California, Irvine. Hiler earned her Bachelor of Art in psychology and social behavior from the University of California, Irvine, and her Master of Science and doctorate in health psychology from VCU.
 

Deeba Syed

Deeba Syed works in the Office of Science interpreting toxicological studies to understand the mechanism of tobacco-related disease, specifically in Electronic Nicotine Delivery Systems (ENDS). Previously, Dr. Syed was a researcher at the University of Wisconsin-Madison, where her work focused on the efficacy of phytochemicals against environmental toxicants. Dr. Syed received a Bachelor of Medicine and Bachelor of Surgery from the Dow Medical College in Karachi, Pakistan, and a doctorate in molecular and environmental toxicology from the University of Wisconsin-Madison.

Recent Publications by CTP Researchers

For recent research publications, please follow this link.

Research Opportunities to Explore

In support of its mission to develop regulation rooted in science, CTP seeks new research addressing the following areas: toxicity, addiction, health effects, behavior, communications, marketing influences, and impact analysis of regulatory actions. Featured below are some current CTP funding opportunities. You can find more information by clicking on the appropriate funding opportunity announcement (FOA) number. 

More information on CTP-funded research can be found on the center’s website.

NIH Tobacco Regulatory Science Program

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. 

Tobacco Regulatory Science (R01 Clinical Trial Optional)
FOA Number: RFA-OD-19-028
Next Application Due Date: Feb. 13, 2020

The purpose of this Funding Opportunity Announcement (FOA) is to invite research project applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

Maximizing the Scientific Value of Existing Biospecimen Collections: Scientific Opportunities for Exploratory Research (R21 Clinical Trial Not Allowed)  
FOA Number: RFA-OD-19-021
Next Application Due Date: Aug. 7, 2020
Letter of Intent Due Date: 60 days prior to the application due date

This FOA invites R21 applications to stimulate exploratory research relevant to CTP’s mission using existing (publicly available) biospecimens currently stored in repositories in the United States. This will include, but not be limited to, collections associated with the PATH Study, the National Health and Nutrition Examination Survey (NHANES), the National Heart, Lung and Blood Institute’s (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC), and the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.  Proposed research should seek to maximize the scientific value of these stored collections and to provide researchers with an opportunity to generate preliminary data for subsequent research proposals. While other publicly available repositories would be considered, depending on analyses to be conducted, nationally representative analyses will receive priority.  These applications need to provide justification why the data set is unique, and the research questions cannot be answered from a publicly available, nationally representative, data set.  

Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21 Clinical Trial Not Allowed)
FOA Number: RFA-OD-19-022
Next Application Due Date: July 20, 2020
Letter of Intent Due Date: 60 days prior to the application due date

This FOA invites R21 applications proposing the innovative analysis of existing (publicly available) nationally representative U.S. cross-sectional and longitudinal data, to investigate novel scientific ideas and/or to generate new models, systems, tools, methods, or technologies that have the potential for significant impact on biomedical or biobehavioral research in areas relevant to CTP. Other publicly available data sets would be considered depending on the analyses to be conducted; however, nationally representative analyses will receive priority. Applications not using nationally representative data sets will need to provide justification why the data set is unique, and why the research questions cannot be answered from a (publicly available) nationally representative data set. This FOA encourages the analyses of public use datasets that may inform tobacco regulatory actions in the United States.

FDA Funding Opportunity Announcements

FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)
FOA Number: PAR-19-306
Next Application Due Date:  April 12, 2020
Letter of Intent Due Date:  Eight weeks before application due date

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.
FDA Broad Agency Agreement 
Solicitation Number: FDABAA-19-00123

FDA puts out agency-wide proposal requests through a special tool called the Broad Agency Announcement (BAA). Since 2012, FDA has utilized the BAA to solicit novel theories and methods for developing and evaluating regulated products, including tobacco products, by drawing on external sources, such as industry, academia, and other government agencies in areas where FDA has limited expertise or capacities. These proposals help to give FDA a better understanding of what innovative scientific and technical solutions may be available to solve difficult regulatory science problems. CTP participates in the BAA solicitation, and tobacco priority topics are included in sections 1, 2.6, and 5.  

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.
 

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