On this page:
- FDA’s Nicotine-Centered Regulatory Framework
- CTP’s Enduring Priority: Protecting Kids
- Heat-Not-Burn Device Under FDA Review for Modified Risk
- CTP Omsbudsman's Office
- Did You know...?
As summer turns to fall and kids settle into the new school year, the FDA keeps an unwavering focus on protecting our country’s youth from tobacco’s dangers. In fact, the agency is redoubling its efforts to safeguard this young generation, and future ones, from the harms of cigarettes and other tobacco products, while keeping its sights set, as well, on reducing tobacco’s death and disease toll among adults. In this issue of CTPConnect, learn about the center’s current efforts, including the agency’s updated plan for tobacco regulation, designed to protect the public from the harms associated with an evolving landscape of tobacco products. Also, hear from those in the CTP Ombudsman’s Office, which exists to address questions, concerns, or complaints about the center’s regulatory actions and why and how we do what we do.
Strategy aims to decrease cigarettes’ addictiveness, reduce tobacco products’ toll
FDA Commissioner Scott Gottlieb, M.D., announced in July a comprehensive plan for tobacco and nicotine regulation designed to shift the trajectory of tobacco-related disease and death. The strategy places nicotine and the issue of addiction front and center, focusing on reducing the addictiveness of—and in turn, the use of—combustible cigarettes. Used as intended, these traditional cigarettes will kill half of all long-term users, making them responsible for the overwhelming majority of tobacco-related deaths, which the Surgeon General reports total over 480,000 each year. By lowering nicotine levels in cigarettes to nonaddictive levels, we could decrease the likelihood that future generations will become addicted to cigarettes and help many addicted smokers quit.
Along with the aim of lowering nicotine levels in cigarettes to reduce their addictiveness, the strategy recognizes the role potentially less harmful tobacco products could play in reducing tobacco’s tragic toll. “Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it’s vital that we pursue this common ground,” said the FDA commissioner.
To encourage innovation that could improve public health, the FDA has extended timelines for submitting tobacco product review applications for newly regulated products that were on the market as of Aug. 8, 2016. The adjustment affords the agency time to establish foundational rules for the regulation of all tobacco products and to explore measures that could make tobacco products less toxic, appealing, and addictive. Importantly, no other timelines for deeming rule provisions are being altered, whether they are already in effect, such as mandatory age and photo ID checks to prevent illegal sales to minors, or are scheduled to go into effect at a later date. (See related article below: “CTP’s Enduring Priority: Protecting Kids.”) The agency also plans to examine actions that could increase access to and use of FDA-approved medicinal nicotine products, and will consider what steps could be taken under the safety and efficacy standard for products intended to help smokers quit.
As the FDA explores ways to best protect the public health in the context of an evolving tobacco marketplace, the agency will seek input from the public on a variety of topics. For example, the FDA intends to issue advance notices of proposed rulemaking (ANPRMs) relating to kid-appealing flavors in tobacco products and the public health impacts from premium cigars.
Find Out More
To learn about the commissioner-announced regulatory framework and associated subjects, including the FDA’s plans to seek public input on various significant topics, visit the agency’s dedicated webpage with information related to the announcement.
And, you can learn more about the nicotine-based framework that could save millions of lives by reading an Aug. 16 New England Journal of Medicine (NEJM) Perspective piece by Commissioner Gottlieb and CTP Director Mitch Zeller.
CTP is committed to protecting today’s kids and future generations from the dangers of tobacco use. While findings from recent studies provide some encouraging signs about the declining use of certain types of tobacco products by youth and about the effectiveness of CTP’s efforts aimed at safeguarding youth from the harms of tobacco use, continued center efforts in this area are needed to build on successes and further improve public health.
2016 National Youth Tobacco Survey: Highlighting Positive Signs, Continuing Challenges
Recent studies have revealed some positive news about youth use of tobacco. For example, findings released this June from the 2016 National Youth Tobacco Survey (NYTS), a collaboration between the FDA and the Centers for Disease Control and Prevention (CDC) to study tobacco use by middle and high school students, point to a drop in the number of these youth who say they are current tobacco users, from 4.7 million in 2015 to 3.9 million in 2016.
Calling the decline in middle and high school students’ use of some products in 2016 “encouraging,” the FDA commissioner meanwhile stressed the need for ongoing work to ensure that declines continue over the long term and across all tobacco products. The latest NYTS data highlight some areas in need of particular attention. Despite a decline in e-cigarette use among these middle school and high school students from 2015 to 2016, for example, e-cigarettes remained the most commonly used tobacco product for both age groups, with more than 2 million middle and high school students reporting current use of e-cigarettes and other electronic nicotine delivery systems (ENDS) in 2016. And looking at 2011 to 2016, overall high school tobacco use showed no significant decline, due to sharp increases during the earlier part of that time period in e-cigarette and hookah use.
Building on Successes in Education, Compliance
Where the use of certain tobacco products decreased, NYTS researchers cited tobacco prevention and control strategies at the national, state, and local levels as likely contributors to the positive trends. For its part, CTP’s “The Real Cost” public education campaign, launched in 2014 to discourage youth smoking, was shown by a recent study to be associated with preventing about 350,000 youth in the targeted 11-to-18 age range from smoking. “The Real Cost”; which was expanded in 2016 to discourage smokeless tobacco use, is being expanded again this year to inform youth of the potential harms of e-cigarettes and other ENDS.
Helping people comply with the law, along with ensuring compliance, is another aspect of CTP’s regulatory work that, like public education, continues as a top priority for the center. To help retailers comply with age restriction laws for tobacco purchase, CTP recently introduced the “FDA Age Calculator” app, available through the Google Play and iTunes app stores, which allows retailers to use their personal smartphones to help determine if a person is old enough, under federal law, to buy tobacco products. Using the smartphone’s camera feature, the app scans a customer’s driver’s license to determine if a person is at least 18 years old. Or, the retailer can manually enter the birthdate on the photo ID for a quick age calculation. The customer’s personal information is not transmitted or shared, and is not saved in the app, the retailer’s smartphone, or any third-party or government server. Also, CTP’s upcoming retailer education program, “This Is Our Watch,” will offer free print and online resources to help retailers educate staff on enforcing federal laws and regulations and maintain good customer relations with visually appealing materials. Print materials such as posters, fact sheets, register stickers, and age verification calendars will be mailed to retailers in November 2017 and will also be available digitally from CTP’s Exchange Lab.
Eight years after the Tobacco Control Act authorized the FDA to regulate tobacco products, CTP’s expanding knowledge and updated regulatory approaches represent the abiding commitment to protect Americans, and especially kids, from tobacco-related death and disease.
Comment Period Open
Three modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. for its IQOS system and various Heatstick products are under scientific review by CTP, and public comments may be submitted either online or in hard copy by Dec. 12. The applications can be viewed on CTP’s website, and public comments may be submitted online to docket FDA-2017-D-3001 on regulations.gov.
The public nature of the MRTP application process is unique. By law, the FDA must make MRTP applications available for public comment, while ensuring commercial and confidential information is properly redacted. In its scientific review of an MRTP application, the FDA considers public comments, as well as recommendations from the Tobacco Products Scientific Advisory Committee.
Congress set high standards in the Tobacco Control Act to prevent misleading claims about relative risks such as “light,” “low,” or “mild,” claims which in the past were not always supported by the science. Today, companies that want to market a tobacco product with explicit or implied claims of reduced harm or risk of tobacco-related disease must first demonstrate to the FDA that the product, as actually used by consumers, does reduce harm or risk of disease. They also must show the FDA that the proposed modified risk information is understandable by the public.
The FDA thus serves as a regulatory gatekeeper, protecting consumers from unsubstantiated modified risk claims. By submitting scientific evidence, members of the public can inform the FDA’s determination of whether a proposed MRTP will benefit the health of the U.S. population as a whole.
The three MRTP applications submitted by Philip Morris Products S.A. for the IQOS system and Heatstick products are only the second set of applications to undergo the full FDA scientific review. In December 2016, the FDA took action on the first MRTP applications to complete scientific review for eight Swedish Match North America Inc. snus smokeless tobacco products, sold under the General brand name.
You can find more information about MRTPs, including regulatory guidance documents, publicly available application materials, and details on past application actions on CTP’s website.
‘We’re just making sure that people are connecting and understanding one another’
Have a complaint or concern, or just don’t know where to find information regarding CTP and its regulatory process? The CTP Ombudsman’s Office is available to help.
Established in 2010, the Ombudsman’s Office responds to inquiries and complaints from anyone who calls—be that a consumer, health care provider, or someone associated with industry, an advocacy group, or a research institution. The team works as an impartial party to resolve disputes, address complaints, and communicate appeal and dispute resolution options.
Nathan Hurley has been in the role of CTP ombudsman for almost a year, transitioning from his previous position as a lead regulatory health project manager in the center’s Office of Science. “Being a regulatory health project manager, I worked a lot with applications, trying to answer applicants’ questions and developing processes for the pathway programs” for legally marketing and distributing tobacco products, said Hurley. “When the ombudsman position opened, I thought this was the perfect opportunity to help the center be transparent, which is something I really believe in.”
Hurley joined Allison Monyei, the associate ombudsman, who has worked in the office for almost 2 years. “I took this job because I wanted the big picture of what the center was doing and how it was creating change,” said Monyei.
“At first, I wasn’t sure if the job fit me, because I had never been an ombudsman before, but I’ve learned that there isn’t really one set path to become one. I’ve gone to conferences and met ombudsmen from various agencies and companies, and they all come from different backgrounds and career paths. The job is really about the heart of a person.”
Hurley and Monyei advise the Center Director’s Office on issues of fairness and equality in CTP’s procedures, policies, and decisions (although Monyei explains the group doesn’t have any decision-making “powers”). “There will always be challenges, but that’s why we’re here,” Hurley said. “In relative terms, CTP is still fairly new, and the industry is learning along with us. Actions the center takes will be disputed, so there’s always going to be a need for that neutral dispute resolution party and that ‘safe space’ that stakeholders can come to.”
Both Hurley and Monyei can also provide general information on the regulatory process. Sometimes a caller contacts the Ombudsman’s Office to simply voice a concern, Hurley and Monyei emphasized. Part of the job is just listening, Monyei said, even if the issue does not rise to the level of a complaint or dispute. “Often, we receive general inquiries because people aren’t sure where to go for answers,” Monyei said.
But if they are unable to assist the caller themselves, they work to connect the caller with the appropriate point of contact. “First, we try to get a little background information from the caller—what the issue is, who it is with, what the communication history is, and how we can resolve it,” said Hurley. “Do Allison and I need to work as intermediaries toward a resolution, or is it just a matter of further educating the caller?”
When the final deeming rule was published in May 2016, the Ombudsman’s Office received a great number of calls. According to that year’s Ombudsman’s annual report—a report listing all complaints, disputes, inquiries, and comments the office has received during the calendar year—the majority of initial contacts came from consumers who wanted to share stories of e-cigarette use and vaping, those expressing frustration about the rule’s feared effects, and people seeking clarity about what the FDA considers to be a tobacco product. “We were the right place for those calls. People didn’t know where to voice their opinions over deeming, and our policy is to always respond,” Monyei said.
Hurley and Monyei agree there is no such thing as a typical day in the Ombudsman’s Office. “The variety is ultimately one of the interesting aspects of the job,” said Hurley. As for Monyei, her favorite part of the job “is feeling useful, like I’m helping somebody. I feel I’m able to make change for the individuals I speak with.” Monyei sums up the goal of the Ombudsman’s Office this way: “We’re just making sure that people are connecting and understanding one another.”
You can view the CTP Ombudsman’s 2016 Annual Report [PDF – 262KB] here. The report includes the number of contacts and their source, subject matter, and status. The Ombudsman’s Office can be reached at 301.796.3095 or via email at CTPOmbudsman@fda.hhs.gov.
September is National Healthy Aging Month.
Smoking can not only damage what’s inside your body, but can also make you look much older than you are. Wrinkles caused by smoking can appear in just a few years and may never disappear.