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CTP Connect—August 2018

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This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our Spotlight on Science newsletter and CTP News e-blasts.

In This Issue…

Since the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was signed into law in 2009, empowering FDA with the tools to protect public health from tobacco’s harms, CTP has taken a wide range of science-based regulatory actions and educational efforts toward tackling U.S. tobacco use, the leading cause of preventable disease and death in this country. FDA is committed to using the full strength of its authorities to stop a new generation of kids from getting hooked on tobacco products, while also helping adults who want to quit smoking cigarettes. This requires the agency to continually maintain an appropriate balance between regulating harmful tobacco products and encouraging innovation in the development of potentially less harmful products for adults.

Catch up here on CTP’s latest efforts to reduce tobacco products’ health harms in keeping with the agency’s comprehensive plan for tobacco and nicotine regulation.

On this page:

National Youth Tobacco Survey, 2017

Overall Tobacco Use Has Declined

Findings from the 2017 National Youth Tobacco Survey (NYTS), published in the June 8 Morbidity and Mortality Weekly Report, point to declines from 2011 to 2017 in current use of any tobacco product among both middle and high school students. Also, decreases were seen among both middle and high school students in the current use of cigarettes, cigars, smokeless tobacco, pipes, and bidis (small imported cigarettes wrapped in a leaf).

Use of Tobacco Product Decreased from 2011 to 2017

Still, in 2017, about 1 in 5 high school students and 1 in 18 middle school students currently used a tobacco product, according to the nationally representative school-based survey. And for the fourth year in a row, e-cigarettes continued to be the most commonly used tobacco product among middle and high school students.

The MMWR article authors concluded that sustained implementation of population-based strategies, in coordination with FDA’s tobacco product regulation, are critical to reducing all forms of tobacco product use and initiation among U.S. youth.

FDA Commissioner Scott Gottlieb, M.D., said in a statement that the agency is encouraged by declines shown in overall tobacco use, but must work aggressively to ensure that no tobacco products, including e-cigarettes, are marketed to, sold to, or used by kids. For example, the commissioner said, “We must do more to address the disturbingly high number of youth who are using e-cigarettes and vaping products.” As part of its comprehensive plan on tobacco and nicotine regulation, the agency developed a Youth Tobacco Prevention Plan to build on efforts to keep tobacco products out of kids’ hands. And, among its additional efforts, the agency is considering a policy to render cigarettes minimally or non-addictive that would help prevent future generations from becoming addicted.

Much more information, including graphics on key findings and links to the MMWR article and a Centers for Disease Control and Prevention (CDC) press release about the study, is available on CTP’s “Youth Tobacco Use: Results from FDA’s National Youth Tobacco Survey” webpage.


Center Ombudsman Releases 2017 Report

Who reached out last year, and why?

The CTP Ombudsman’s 2017 Annual Report, now available on the center’s website, summarizes complaints, disputes, inquiries, and comments the office received during that calendar year. Unsure how a dispute even differs from a complaint? The report explains distinctions in some of these terms, along with other Ombudsman’s Office basics such as “What is an ombudsman?” and “What does the CTP Ombudsman’s Office do?”

Among other issues, the report discusses two notable observations: First, the number of contacts with the Ombudsman’s Office was lower in 2017 than in 2016 but higher than in years before that. Second, as explained further in the report, the number of “appeals” to the CTP Office of the Center Director notably increased in 2017. Deadlines for submissions, retailer and manufacturer compliance with the Food, Drug, and Cosmetic Act, and CTP’s electronic submission gateways were the top topics of interest in the recent calendar year.

Many consumers, retailers, manufacturers, and other tobacco industry representatives, public health officials, and others reached out to the office in 2017. Some had questions, complaints, or disputes related to CTP’s regulatory authorities and processes. Types of concerns included: Is this product regulated by CTP? What options are available if I disagree with a decision CTP has made? The ombudsman also takes on an internal role, helping to resolve scientific disputes in regulatory decision-making between CTP managers and staff.

The ombudsman himself, Nathan Hurley, says about his role and the office’s functions, “I believe in effective communication; we are here to listen when needed, answer questions, and help our contacts navigate CTP.” Recognizing CTP has more stakeholders since the deeming rule was finalized in 2016, Hurley has made concerted efforts to reach out to newly regulated industry members. “We have already had conversations with these groups; listened to their stories, questions, and concerns; and let them know we are here to listen,” Hurley stated, adding, “We will continue this in 2018 and beyond.”


"Flavors in Tobacco Products: What Are the Potential Risks and Benefits to Public Health?”

Find the Feature Article Online

Read an article excerpt here… read the full feature on CTP’s website!

When the Tobacco Control Act gave FDA authority to regulate tobacco products in 2009, it banned flavors such as strawberry, vanilla, and cinnamon from cigarettes to minimize the attractiveness of these products to kids. Although all “characterizing” flavors in cigarettes—excluding menthol and tobacco flavors—were prohibited in a regulation known as the “Special Rule for Cigarettes,” other flavored tobacco products—including hookah, smokeless tobacco, cigars, and e-cigarettes—remained available on the market.

Flavored noncombustible tobacco products, while shown to be alluring to youth, may also be a factor in helping some addicted adult smokers transition from cigarettes to potentially less harmful means of nicotine delivery. Looking toward the future of tobacco regulation, with nicotine and the issue of addiction at the center of its regulatory plan, FDA issued an advance notice of proposed rulemaking (ANPRM) to examine the role of flavors—including menthol—in use of all tobacco products.


Report on CTP Research: 2010–2017

Now 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.

2018 OS Research Report Thumbnail

Regulatory science research crucially informs tobacco product regulation. 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), 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.


TPSAC Meeting To Be Held in September

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, Maryland. At the meeting, the committee will discuss scientific issues 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. Requests to present oral comments at the September meeting must be received by Aug. 16. And written comments related to the meeting must be received by Aug. 29. 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.


Information for Industry

Resources for Retailers, Manufacturers, and Importers

New Information for Retailers…

  • Webinar—Tips for Retailers: Preventing Sales to Minors. The new webinar provides an overview of the various resources available to retailers to help prevent tobacco product sales to minors. Specifically, the webinar focuses on age verification, internal compliance checks, and recommended training practices. The webinar also provides information on specific FDA programs and technologies that can assist retailers in preventing sales to minors, such as the “This is Our Watch” retailer education program and the age calculator app.
  • Guidance for Industry—Tobacco Retailer Training Programs. This document is designed to help retailers implement training programs for employees to learn about and comply with federal laws, including regulations. The laws discussed relate to the sale and distribution of, including youth access to, tobacco products; and advertising and promotion of cigarettes, smokeless tobacco, and covered tobacco products. The Tobacco Control Act does not require retailers to have these programs. But in some cases, lower civil money penalties for certain violations may apply for retailers who have these types of training programs that meet standards developed by FDA.

New Information for Manufacturers and Importers…

  • Revised Guidance for Industry—Listing of Ingredients in Tobacco Products. This document is intended to help manufacturers and importers making tobacco product ingredient submissions to FDA, as required by the Tobacco Control Act. The guidance provides clarification related to ingredient listing requirements and agency enforcement as it applies to finished tobacco products and their components and parts. The guidance also provides examples of components and parts of finished tobacco products for which the agency intends, and does not intend, to enforce the ingredient listing submission requirements, at this time.

    The guidance also clarifies: ways in which manufacturers or importers can satisfy the ingredient listing requirements by providing one listing for multiple products, what information should be included in submissions, how and when to submit this information, applicable FDA compliance policies, and certain definitions.

    The updated guidance and additional information to assist with preparation of ingredient listing submissions are available on CTP’s “Submit Ingredient Listing for Tobacco Products” webpage.

Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender

Scientific Conference—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 Sept. 27–28 public meeting is taking place at the agency’s White Oak campus in Silver Spring, Maryland. Registration is required by Sept. 24 at 5 p.m. Eastern Time to attend the conference in person (seating is limited—register early!) or 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., and U.S. Surgeon General, VADM Jerome M. Adams, M.D., M.P.H., 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.


Did You Know…?

Aug. 1 is World Lung Cancer Day!

Smoking can result in a wide range of deadly lung conditions
Nearly 9 in 10 lung cancers are caused by smoking. And smoking is to blame for more than 8 in 10 deaths from lung cancer. Get tips about how to quit smoking at smokefree.gov.



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