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Spotlight on Science - Spring 2020

 

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In This Issue…

FDA finalizes a rule on cigarette health warnings that include photorealistic color images of lesser known health consequences of smoking. Learn more in this latest issue of Spotlight on Science, a quarterly research and science digest from FDA’s Center for Tobacco Products.

FDA Final Rule Requires New Cigarette Health Warnings 

On March 17, 2020, FDA issued the “Required Warnings for Cigarette Packages and Advertisements” final rule to require new health warnings for cigarette packages and advertisements to promote greater public understanding of the negative health consequences of cigarette smoking. The 11 required warnings feature text statements accompanied by photorealistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, and diabetes.

Beginning June 2021, these new cigarette health warnings must appear prominently on cigarette packages and in advertisements, occupying at least the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements. Once implemented, the required warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.

Cigarette Health Warnings

Research shows that the current warnings on cigarettes, which have not changed since 1984, have become virtually invisible to both smokers and nonsmokers, in part because of their small size, location and lack of an image. Additionally, research shows substantial gaps remain in the public’s knowledge of the harms of cigarette smoking, and smokers have misinformation about cigarettes and their negative health effects. The new cigarette health warnings complement other critical FDA actions, including outreach campaigns targeted to both adults and youth, to educate the public about the dangers associated with using cigarettes, as well as other tobacco products.

As FDA outlined in the proposed rule issued last year, the agency used a science-based approach to develop and evaluate the new cigarette health warnings. These required warnings focus on serious health risks that are less known by the public as being negative health consequences of smoking. For example, current smokers have been found to have almost four times the risk of bladder cancer as never smokers, and it has been estimated that smoking is responsible for 5,000 bladder cancer deaths in the U.S. each year — yet research shows the public has limited awareness of bladder cancer as a consequence of smoking.

While the proposed rule put forward 13 warnings for consideration, the FDA finalized a set of 11 required warnings for the final rule based on the full results of the FDA's consumer research studies, the relevant scientific literature, public comments submitted to the proposed rule docket and other legal and policy considerations. The final cigarette health warnings each consist of one of the following textual warning statements paired with an accompanying photo-realistic image depicting the negative health consequences of smoking:

  • WARNING: Tobacco smoke can harm your children.
  • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
  • WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
  • WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
  • WARNING: Smoking causes cataracts, which can lead to blindness.
  • WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
  • WARNING: Smoking reduces blood flow, which can cause erectile dysfunction.
  • WARNING: Smoking causes head and neck cancer.
  • WARNING: Smoking can cause heart disease and strokes by clogging arteries.
  • WARNING: Smoking during pregnancy stunts fetal growth.
  • WARNING: Smoking causes COPD, a lung disease that can be fatal.

In addition, FDA has issued the guidance “Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide,” to help small businesses understand and comply with the final rule. The agency has also issued the final guidance, “Submission of Plans for Cigarette Packages and Cigarette Advertisements” to assist those submitting a cigarette plan detailing the random and equal display and distribution of the required warnings on cigarette packages and the quarterly rotation of the required warnings in cigarette advertisements.

Virtual Learning: FDA and Scholastic Launch Educational Resources on Youth E-Cigarette Prevention

At a time when many schools across the country are closed, FDA and Scholastic continue to develop youth e-cigarette prevention educational materials for middle and high school students. All of these materials are available, for free, on The Real Cost of Vaping website and are adaptable for virtual learning. 

As of April 6, 2020, new resources are also available, including two new lessons and worksheets and five short videos focused on content areas that align with e-cigarette prevention lesson plans. These new materials now join the previously developed content including other lesson plans, a guide for parents to talk to kids about e-cigarettes, infographics, and youth cessation resources.

FDA and Scholastic increase awareness about the health consequences of youth e-cigarette use.

FDA Seeks Public Input on Additional Steps to Address Vaping Lung Injuries

On Feb. 14, 2020, FDA opened a docket requesting public input on the use of vaping products associated with lung injuries. FDA has since extended the deadline for public comments to June 19, 2020. This request for information (RFI) responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps FDA could take to address the lung injuries reported to be associated with the use of e-cigarettes and vaping products.

For this RFI, FDA is seeking unpublished data, including information on product design and potential ways to prevent consumers from modifying or adding substances to these products that are not intended by the manufacturers.

PATH Study Update: Researchers Encouraged to Access Two Sets of Data Files 

FDA and NIH have made two new sets of data files available from the Population Assessment of Tobacco and Health (PATH) Study. This latest addition contains data from:

  • Biomarker Restricted-Use File (BRUF), Wave 3, Part 1 (Oct. 2015 – Oct. 2016), which includes data on urinary metals, creatinine, cotinine, hydroxycotinine, and other nicotine metabolites. 
  • Special Collection: Youth Only Restricted-Use File (RUF), Wave 4.5 (Dec. 2017 – Nov. 2018), which includes data collected only from youth aged 12 to 17, between Waves 4 and 5 of the PATH Study. 

Additionally, a PATH Study 101 video providing an orientation to the PATH Study is now available. Visit the FDA PATH Study webpage to access the video and data files.

The PATH Study helps scientists learn how and why people start using tobacco, quit using it, and start using it again after they’ve quit, as well as how different tobacco products affect health (such as cardiovascular and respiratory health) over time.

READ MORE

FDA Youth E-Cigarette Prevention Campaign Includes Teen Stories About Addiction

In January, FDA’s “The Real Cost” Youth E-Cigarette Prevention Campaign released videos featuring teenagers who share cautionary tales about their e-cigarette addiction. The campaign includes a series of four videos called “My Vaping Mistake” with teenagers describing the physical and emotional effects of vaping addiction.

Studies‎ have reported that youth who use a tobacco product, such as e-cigarettes, are more likely to go on to use other tobacco products, such as cigarettes. This evidence is particularly concerning given that over the past several years, e-cigarettes were the most commonly used tobacco product by youth in the U.S. In fact, more than 5 million middle and high school students across the country were current (within the past 30 days) e-cigarette users in 2019, according to the National Youth Tobacco Survey conducted by FDA and the U.S. Centers for Disease Control and Prevention.

“These new videos feature real stories from teens who have become addicted to e-cigarettes,” said FDA Commissioner Stephen M. Hahn, M.D. “These powerful narratives from youth show their peers the disastrous impact of e-cigarette addiction, like the teens who developed severe anxiety and depression after using e-cigarettes or the high school athlete who could no longer compete.”

“The Real Cost” Youth E-Cigarette Prevention Campaign educates youth that using e-cigarettes, just like cigarettes, puts them at risk for addiction and other health consequences. Since its launch in 2018, “The Real Cost” E-Cigarette Prevention Campaign is showing positive results for reach and engagement. The campaign, which originally focused on digital and social media sites popular among teens and has since expanded to TV advertisements, has generated significant viewership, including nearly 3.6 billion teen views in 16 months. Across social media platforms, FDA has engaged teen audiences with more than 950,00 likes, 130,000 shares and 50,000 comments.

More About CTP Research

Recent Publications by CTP Researchers

Search our recent research publications.

Research Opportunities to Explore

In support of its mission to develop regulation rooted in science, CTP seeks new research addressing the following areas of tobacco regulatory science: 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)
Next Application Due Date: July 17, 2020
FOA Number: RFA-OD-19-028
The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 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.

Notice of Special Interest: Research to Advance the Understanding of Tobacco Product Pharmacokinetic Research (R01 Clinical Trial Optional)
Next Application Due Date: July 17, 2020
FOA Number: NOT-OD-20-081
The purpose of this Notice is to invite applications focused on Tobacco Product Pharmacokinetic Research to support biomedical and behavioral research that will provide scientific data to inform the regulation 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 Support for Conferences and Scientific Meetings (R13)
Next Application Due Date: Oct. 13, 2020
FOA Number: PAR-19-306
FDA recognizes the value of supporting high quality, small scientific conferences. A small scientific conference is defined as a symposium, seminar, workshop, or any formal meeting, whether conducted face-to-face or virtually to exchange information and explore a defined subject, issue, or area of concern that impact the public's health within the scope of the FDA's mission.

Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01)
Next Application Due Date: July 8, 2020
FOA Number: RFA-OD-20-008 or RFA-OD-20-011
This award provides support for an intensive, supervised career development experience of three, four, or five protected years in biomedical, behavioral, and social science research. This experience will inform the development and evaluation of tobacco regulation and will foster research independence. Projects must address one of FDA’s research priority areas.

Pathway to Independence Award in Tobacco Regulatory Research (K99/R00)
Next Application Due Date: July 8, 2020
FOA Number: RFA-OD-20-009 or RFA-OD-20-010)
This FOA aims to increase and maintain a strong cohort of talented independent investigators conducting research that will inform the development and evaluation of tobacco product regulations. This program is designed to facilitate the timely transition of outstanding postdoctoral researchers from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. This program will provide NIH research support during this transition in order to help awardees launch competitive, independent research careers.

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.

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