This guidance document discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products and describes how we intend to prioritize our enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization.
Addictive Behaviors, Volume 91, Pages 1-258 (April 2019)
A link to the Special Issue can be found here.
Addictive Behaviors (Electronic ISSN: 0306-4603) is an international peer-reviewed journal publishing high quality human research on addictive behaviors and disorders since 1975. The journal accepts submissions of full-length papers and short communications on substance-related addictions such as the abuse of alcohol, drugs and nicotine, and behavioral addictions involving gambling and technology. We primarily publish behavioral and psychosocial research but our articles span the fields of psychology, sociology, psychiatry, epidemiology, social policy, medicine, pharmacology and neuroscience.
Tobacco Regulatory Science (Electronic ISSN 2333-9748) is a rigorously peer-reviewed online scientific journal for the dissemination of research relevant to the regulation of tobacco products. The journal content includes a broad array of research domains, including chemistry, biology, behavior, community, and population-level surveillance and epidemiology, as well as knowledge syntheses (eg, meta-analyses or state-of-the-art reviews) and analytic modeling. All articles describe the policy relevance of the research outcomes. Given the global nature of tobacco regulation, particularly as a result of international and national policies, Tobacco Regulatory Science publishes high quality research that is relevant to global regulatory needs and requirements. Tobacco Regulatory Science is published electronically 6 times per year.
The link to the issue can be found here
The special issue from the TCORS Health Communication Working Group has recently been published online. We expect the issue to come out in a print issue of Health Communication in 2018.
in the special issue can be found here.
Tobacco Prevention and Cessation published a special issue on Vape Shops in the United States. Subscribers can read it here.
Tobacco Regulatory Science just published a special issue on behavioral laboratory methods with articles by members of the TCORS Behavioral Pharmacology Working Group, organized by Gerry Valentine. Subscribers can read it here (two articles are open access).
Adolescents' interest in trying flavoured e-cigarettes
J K Pepper, K M Ribisl, N T Brewer
Tob Control Published Online First: 15 September 2016 doi:10.1136/tobaccocontrol-2016-053174
Distribution, quantification and toxicity of cinnamaldehyde in electronic cigarette refill fluids and aerosols
Rachel Z Behar, Wentai Luo, Sabrina C Lin, Yuhuan Wang, Jackelyn Valle, James F Pankow,Prue Talbot
Tob Control Published Online First: 15 September 2016 doi:10.1136/tobaccocontrol-2016-053224
Flavour preferences in youth versus adults: a review
Allison C Hoffman, Raydel Valdes Salgado, Carolyn Dresler, Rachel Williams Faller,Christopher Bartlett
Tob Control Published Online First: 15 September 2016 doi:10.1136/tobaccocontrol-2016-053192
Flavoured tobacco products and the public's health: lessons from the TPSAC menthol report
Jonathan M Samet, Mary Ann Pentz, Jennifer B Unger
Tob Control Published Online First: 15 September 2016 doi:10.1136/tobaccocontrol-2016-053208
Cigarette smoking and electronic cigarette vaping patterns as a function of e-cigarette flavourings
Mark D Litt, Valerie Duffy, Cheryl Oncken
Tob Control Published Online First: 15 September 2016 doi:10.1136/tobaccocontrol-2016-053223
Flavourings significantly affect inhalation toxicity of aerosol generated from electronic nicotine delivery systems (ENDS)
Noel J Leigh, Ralph I Lawton, Pamela A Hershberger, Maciej L Goniewicz
Tob Control Published Online First: 15 September 2016 doi:10.1136/tobaccocontrol-2016-053205
Association between menthol-flavoured cigarette smoking and flavoured little cigar and cigarillo use among African-American, Hispanic, and white young and middle-aged adult smokers
K Sterling, C Fryer, I Pagano, D Jones, P Fagan
Tob Control Published Online First: 7 October 2016 doi:10.1136/tobaccocontrol-2016-053203
Association between use of flavoured tobacco products and quit behaviours: findings from a cross-sectional survey of US adult tobacco users
Danielle M Smith, Maansi Bansal-Travers, Jidong Huang, Dianne Barker, Andrew J Hyland,Frank Chaloupka
Tob Control Published Online First: 5 October 2016 doi:10.1136/tobaccocontrol-2016-053313
Changes in the prevalence and correlates of menthol cigarette use in the USA, 2004–2014
Andrea C Villanti, Paul D Mowery, Cristine D Delnevo, Raymond S Niaura, David B Abrams, Gary A Giovino
Tob Control Published Online First: 11 October 2016 doi:10.1136/tobaccocontrol-2016-053329
Menthol decreases oral nicotine aversion in C57BL/6 mice through a TRPM8-dependent mechanism
Lu Fan, Shrilatha Balakrishna, Sairam V Jabba, Pamela E Bonner, Seth R Taylor, Marina R Picciotto, Sven-Eric Jordt
Tob Control Published Online First: 3 October 2016 doi:10.1136/tobaccocontrol-2016-053209
Role of sweet and other flavours in liking and disliking of electronic cigarettes
Hyoshin Kim, Juyun Lim, Stephanie S Buehler, Marielle C Brinkman, Nathan M Johnson, Laura Wilson, Kandice S Cross, Pamela I Clark
Tob Control Published Online First: 5 October 2016 doi:10.1136/tobaccocontrol-2016-053221
Detection of 5-hydroxymethylfurfural and furfural in the aerosol of electronic cigarettes
Sarah Soussy, Ahmad EL-Hellani, Rima Baalbaki, Rola Salman, Alan Shihadeh, Najat A Saliba
Tob Control Published Online First: 25 October 2016 doi:10.1136/tobaccocontrol-2016-053220
Flavoured non-cigarette tobacco product use among US adults: 2013-2014
Michèle G Bonhomme, Enver Holder-Hayes, Bridget K Ambrose, Cindy Tworek, Shari P Feirman, Brian A King, Benjamin J Apelberg
Tob Control Published Online First: 28 October 2016 doi:10.1136/tobaccocontrol-2016-053373
Tobacco industry use of flavourings to promote smokeless tobacco products
Ganna Kostygina, Pamela M Ling
Tob Control Published Online First: 9 November 2016 doi:10.1136/tobaccocontrol-2016-053212
Commissioner Gottlieb released a statement related to guidance that addresses FDA advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars. Two key points highlighted in his statement include:
- FDA is proposing to end current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes (other than tobacco-, mint-, and menthol-flavored products), and prioritize enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products.
- In addition, FDA expects manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under these new conditions to submit premarket applications to the agency by Aug. 8, 2021. This application date is one year earlier than the agency previously proposed.
Here is the new draft guidance: Modifications to Compliance Policy for Certain Deemed Tobacco Products
The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) announce the release of State Identifier Restricted-Use Files (SIRUF) from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study. These latest additions to the PATH Study’s Restricted-Use Files (RUF) collection include Adult State Identifier Data and Youth/Parent State Identifier Data from Wave 1.
The PATH Study is a household-based, nationally representative, longitudinal cohort study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. For more information on the PATH Study, researchers are encouraged to visit: http://doi.org/10.3886/Series606 and to join the PATH Study Data User Forum at: https://pathstudyforum.icpsr.umich.edu/.
Researchers interested in analyzing PATH Study biospecimens are encouraged to consider the PATH Study Biospecimen Access Program. This program provides the research community with access to urine, serum, plasma and DNA collected from PATH Study participants. Data from these specimens can be linked to the W1 BRUF. Investigators proposing meritorious and feasible studies consistent with PATH Study objectives and/or research priorities for tobacco regulatory science will be given highest priority for access to these biospecimens. Concept statements are being accepted for the next review cycle, May 1 – May 30, 2019. For more details please visit: https://www.icpsr.umich.edu/icpsrweb/content/NAHDAP/pathstudy-biospec-index.html
The New England Journal of Medicine (NEJM) published a new paper yesterday about a year-long randomized control trial of e-cigarettes as cessation aids. The study was conducted in Britain and funded by the National Institute for Health Research and Cancer Research UK. In the study, 886 smokers were randomly assigned to use either e-cigarettes or traditional nicotine replacement therapies (NRT) to help them quit. Results showed that e-cigarettes were nearly twice as effective as NRT.
The New York Times (NYT) wrote a piece about this study and other e-cigarette papers published in conjunction by NEJM. These show different perspectives on the e-cigarette debate. One editorial
written by Belinda Borrelli, a behavioral health expert and Dr. George
T. O’Connor, a pulmonologist discussed the prescription drugs buproprion and varenicline which have achieved higher cessation rates in research studies than the current study of e-cigarettes.
NEJM Study Link: here
NEJM Editorial Link: here
NYT Link: here
NEJM Recently Published Link (includes other recent e-cigarette papers mentioned in the NYT piece): here
In a deal that will likely have profound effects on the cigarette and ENDS markets, Altria, maker of
Marlboro and other top-selling cigarettes, has agreed to pay
nearly $13 billion for a 35 percent stake in Juul Labs. Part of the deal involves giving a bonus of
$2 billion to Juul’s 1,500 employees.
get a 35% stake in the proceeds from Juul vaporizers and
nicotine pods (which have captured more than 70% of the US ENDS market) and Juul will get access to Altria’s marketing and distribution power, lobbying power, and regulatory influence.
"In a call with investors and analysts Altria’s chief executive, Howard Willard, said his company was ready to help Juul take on the Food and Drug Administration."Link: here
On November 12th, BBC News reported on the results of a scientific study recently published in Tobacco Control.
In this study, Edinburgh University researchers looked at Scottish maternity records with information on all Scottish tobacco retailers. Results showed tht pregnant women living in Scottish neighbourhoods with the highest availability of tobacco products were 70% more likely to smoke than those living in areas where no tobacco was sold.
The research team said "restricting the supply of tobacco could help tackle health inequalities" and that limiting the supply of tobacco could help to cut rates of smoking among pregnant women, and the general population.
Earlier this week Philip Morris launched a new ad campaign encouraging people to stop smoking and published advertisements in several U.K. newspapers.
CNBC reports that the campaign is called "Hold My Light" and links to a website where smokers can create a profile and have friends commit to help them quit. People who sign up agree to have Philip Morris contact them about its Smoke Free Future program.
This new campaign was not received well by public health groups:
- Cancer Research UK called it "a staggering hypocrisy" and said that Philip Morris is just trying to promote its smoking alternatives, such as heated tobacco. "The best way Philip Morris could help people to stop smoking is to stop making cigarettes," George Butterworth, Cancer Research UK's tobacco policy manager said.
- Action on Smoking and Health also criticized the campaign and said that it was a way for Philip Morris to get around the UK's strong anti-tobacco advertising rules.
PATH Study Wave 3 PUF and Wave 1 Bio RUF release announcement
The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) announce the release of data files from the Population Assessment of Tobacco and Health (PATH) Study. The PATH Study is a household-based, nationally representative, longitudinal cohort study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. For more information on the PATH Study, please visit: http://doi.org/10.3886/Series606
Updates in the latest release include:
Wave 3 Public Use Files (PUF)
Public-use questionnaire data files (PUFs) from the third wave of the PATH Study may be downloaded from the National Addiction & HIV Data Archive Program (NAHDAP) of the Inter-university Consortium for Political and Social Research (ICPSR). Data in the third wave were collected from October 2015 to October 2016. For information on the Wave 3 PUF, please visit: https://doi.org/10.3886/ICPSR36498
Wave 1 Biomarker Restricted Use File (BRUF) Update
Data and documentation for five Wave 1 Biomarkers of Potential Harm assay panels were added to the PATH Study Biomarker Restricted-Use Files (BRUF) including:
1. F2PG2a: oxidative stress biomarker (8-isoprostane)
2. hsCRP: high-sensitivity C-reactive protein
3. IL6: interleukin 6
4. sICAM: soluble Intercellular Adhesion Molecule 1
5. Fibro: fibrinogen activity (Clauss)
The updated files were added to the existing biomarkers of tobacco exposure data in the Biomarker RUF, which include measurements of arsenic, creatinine, metals, polycyclic aromatic hydrocarbons, tobacco-specific nitrosamines, nicotine metabolites, and volatile organic compounds in urine and measurements of cotinine and hydroxycotinine in serum. Qualified researchers may apply for access to the PATH BRUF at: https://doi.org/10.3886/ICPSR36840
Researchers interested in the PATH Study are encouraged to join the PATH Study Data User Forum at https://pathstudyforum.icpsr.umich.edu/
The forum enables researchers using PATH Study data to submit and answer questions. Announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users are also posted to the forum.
Please share this information with others who may be interested.
Last week, the FDA announced a series of critical
and historic enforcement actions related to the sale and marketing of
e-cigarettes to kids. FDA Commissioner Scott Gottlieb referred to youth e-cigarette as an "epidemic" and announced a number of strategies to reverse these use trends, such as: step up enforcement by targeting illegal sales to youth and kid-friendly marketing, re-examine the compliance policy about flavored e-cigarettes, expand the "Real Cost" campaign, and develop an overall policy roadmap.
Click here for the FDA Press Announcement: Link
Click here for a Washington Post article about the announcement: Link
This past week, the New York Times has written two articles about tobacco control issues.
The first article profiles how the tobacco companies are using social media to get around existing laws that restrict adversting to young people.
Read the article here: Link
The second article is about Juul and the federal investigation into whether PAX Labs (now Juul Labs), has intentionally marketed its devices to youth over the years that Juul has existed. The attorney general of Massachusetts is also investigating Juul Labs:
“From our perspective, this is not about getting adults to stop smoking,” the Massachusetts attorney general, Maura Healey, said in an interview. “This is about getting kids to start vaping, and make money and have them as customers for life.”
Read the article here: Link
NPR reports on a shocking US child labor practice:
The Fair Labor Standards Act, which governs child labor, makes exceptions to child labor laws for small farms. For large farms, the law allows them to hire children as young as 12. During tobacco picking season, some of the smaller farms in North Carolina will hire kids as young as 7 years old.Child worker advocates say that poor U.S. regulations and tobacco industry policies have left these children vulnerable to the health risks of nicotine and pesticide exposure.
Read the article here: Link
The New York Times reports that Chinese men in New York City smoke at much higher rates than men or women of any other ethnic group. This reflects a global trend and has led to an increase in deaths from lung cancer among this group. Now, the New York City health department has launched an anti-smoking PSA campaign aimed at Chinese men.
Find the article here: Link
NPR published an article about a June ballot measure in San Francisco that would ban all favored tobacco products, from menthol cigarettes to candy-flavored e-cigarette liquids.
"City supervisors last year unanimously approved a ban on the products, but the tobacco industry funded a referendum, Proposition E, to put the issue before voters instead. San Francisco residents will decide in the June 5 election whether the ordinance goes into effect."
There is a city-wide debate on what the outcome should be and lots of money is being poured into the battle from both sides.
Find the article here: Link
The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) announce the availability of the questionnaire data files from the third wave of the Population Assessment of Tobacco and Health (PATH) Study. Qualified researchers may now apply for access to the restricted-use file (RUF) from the Inter-university Consortium for Political and Social Research (ICPSR).
The PATH Study is a household-based, nationally representative, longitudinal cohort study of approximately 46,000 youth (12-17 years) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act that was signed into law in 2009. Data in the third wave were collected from October 2015 to October 2016.
To apply for access to the Wave 3 RUF, please visit https://doi.org/10.3886/ICPSR36498
For more information on the PATH Study, please visit: http://doi.org/10.3886/Series606.
Please share this information with others who may be interested.
The mission of the NIH Tobacco and Nicotine Research Interest Group is to increase collaboration, coordination and communication of tobacco- and nicotine-related research across NIH Institutes and Centers and with other DHHS agencies.
Last week, The New York Times wrote a story about Disney's acquisition of Fox and its Fox Searchlight specialty label, which are included in Disney's $54.2 billion purchase from Rupert Murdoch.
In 2015, Walt Disney Studios announced it would “prohibit smoking in movies
across the board: Marvel, Lucas, Pixar and Disney films.” Now
antismoking advocates want them to extend this rule to all future
youth-rated films (G, PG, PG-13) made by Fox and its Fox Searchlight
specialty label. The
requests were made in a previously undisclosed Feb. 20 letter to Disney chief executive Robert Iger that was signed by
46 activists and faith-based shareholders.
FDA Announces Enforcement Actions and New Youth Tobacco Prevention Plan Related to JUUL and Other E-Cigarettes
Today, FDA Commissioner Scott Gottlieb, M.D., announced several enforcement actions as part of a new Youth Tobacco Prevention Plan to stop youth use of – and access to – JUUL and other e-cigarettes.
FDA understands that many kids are using e-cigarettes with a particular set of characteristics: an appearance that closely resembles a USB flash drive, high levels of nicotine, and emissions that are hard to see. These characteristics may facilitate youth use by making the products more attractive to children and teens. Several of these products fall under the JUUL brand, but other brands with similar characteristics are emerging.
As part of the Youth Tobacco Prevention Plan to stop youth use of tobacco products – particularly e-cigarettes – the FDA is announcing several new actions and efforts, including:
As part of the FDA’s responsibility to protect kids and significantly reduce tobacco-related disease and death, these are the first steps in a new effort aimed at stopping youth use of e-cigarettes.
The 6th Edition of The Tobacco Atlas was recently published online by Vital Strategies and the American Cancer Society. The Tobacco Atlas has been creating maps and infographics out of current global tobacco data for almost twenty years. This most recent edition provides tobacco control experts and organizations with new information to craft the best tobacco control research and policies.
Find the Tobacco Atlas website here - Link
Find the direct PDF of the 6th Edition here - Link
Find an article in The Atlantic's City Lab about the new edition here - Link
A new study, published in Pediatrics, suggests that adolescents who use e-cigarettes are exposed to significant levels of potential carcinogens which are also found in traditional tobacco cigarettes. This finding is true even when the e-cigarettes do not contain nicotine. Researchers frame these findings as a warning to youth that though these devices may be marketed to adults as potentially less harmful than tobacco cigarettes or as cessation aides, e-cigarettes should still be avoided by youth. This peer-reviewed journal article comes from a NIH-funded study with work done by UC San Francisco researchers.
Find the press release from UCSF here: Link
Find the full journal article here with currently free full text options: Link
Find a Newsweek article about the findings here: Link
Find a NBC News article about the findings here: Link
The New York Times published an informative article about the new electronic nicotine device called Juul and how it is being used and perceived by American youth.
Read the article here: Link
The New York Times reports that a FDA committee has recommended that the FDA reject Philip Morris' proposal that their product IQOS be the first product sold under the FDA's new "modified risk" label.
FDA is not required to follow this recommendation, they usually do and they are expected to make a final decision in the coming months.
Read the article here: Link
A new report by the National Academies of Sciences, Engineering and Medicine was released today, January 23, 2018. It is the most comprehensive scientific analysis of all current research on e-cigarettes. The panel concluded that e-cigarettes with nicotine could increase the chance of youth using regular combustible cigarettes, but also that these devices are safer than combustible products and can help smokers quit.
This article can be found here: Link
The recently updated US National Institutes of Health clinical trials policies will apply broadly to studies involving experimental manipulations of humans. These studies will require registration and reporting in ClinicalTrials.gov, grant application submission under a clinical trials funding opportunity announcement, and Good Clinical Practice training for investigators.
To read more, please click here.
Since 2009, the United States (US) Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has had the authority to regulate the manufacture, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers could play an important role across a number of FDA regulatory activities, including assessing new and modified risk tobacco products and identifying and evaluating potential product standards.
On April 4–5, 2016, FDA/CTP hosted a public workshop focused on biomarkers of potential harm (BOPH) with participants from government, industry, academia, and other organizations. The workshop was divided into five sessions focused on: (1) overview of BOPH; (2) cardiovascular disease (CVD); (3) chronic obstructive pulmonary disease (COPD); (4) cancer; and (5) new areas of research.
The full link to the article can be found here
NPR and The New York Times recently published articles showcasing different perspectives on e-cigarettes.
First, NPR writes about JUUL, a new electronic nicotine device that has become big with teenagers. The article specifically relates this new product to findings from a new Pediatrics article titled "Trajectories of E-Cigarette and Conventional Cigarette Use
Among Youth." The journal article shows a connection between youth e-cigarette use and future use of conventional cigarettes.
The New York Times writes about older adult smokers using e-cigarettes to end their use of conventional cigarettes. This is a trend shown by a recent CDC study which found that more people are using e-cigarettes in quit attempts than more conventional methods. Currently there is not "conclusive evidence” that e-cigarettes help long-term cessation, so the government cannot recommend this strategy. However, many tobacco control experts believe that e-cigarettes are a valid form of harm reduction.
The U.S. Food and Drug Administration said on Wednesday it is considering measures to speed development of products that help people quit smoking, including easing requirements for approval of over-the-counter nicotine replacement therapies. The agency said it is “re-evaluating and modernizing” its approach to regulating nicotine replacement therapies (NRT), which are typically sold as gums, patches and lozenges. Because their effectiveness is limited, the FDA wants to give consumers a wider range of options.
You can read more about the new measures here.
Cigars may have a reputation for being safer than cigarettes, but they may be just as harmful and addictive, according to Penn State researchers who add that small cigars have just as much if not more nicotine than cigarettes.
You can read more regarding the research here.
Biomarkers of exposure to new and emerging tobacco delivery products
Accurate and reliable measurements of exposure to tobacco products are essential for identifying and confirming patterns of tobacco product use and for assessing their potential biological effects in both human populations and experimental systems. Due to the introduction of new tobacco-derived products and the development of novel ways to modify and use conventional tobacco products, precise and specific assessments of exposure to tobacco are now more important than ever. Biomarkers that were developed and validated to measure exposure to cigarettes are being evaluated to assess their use for measuring exposure to these new products. The journal article "Biomarkers of exposure to new and emerging tobacco delivery products" reviews current methods for measuring exposure to new and emerging tobacco products, such as electronic cigarettes, little cigars, water pipes, and cigarillos. The journal also discusses the strengths and limitations of current approaches, including whether they provide reliable exposure estimates for new and emerging products. For more information about this study, read the full journal article in the American Journal of Physiology-Lung Cellular and Molecular Physiology.
For the first time, FDA’s “The Real Cost” campaign will address teen e-cigarette use
The U.S. Food and Drug Administration is expanding “The Real Cost” public education campaign to educate teens about the dangers of using e-cigarettes and other electronic nicotine delivery systems (ENDS), specifically regarding how nicotine can rewire a teen’s developing brain to crave more nicotine. New campaign content, including online video and radio ads, will appear on platforms such as YouTube, Hulu, and Spotify, as well as on the campaign’s website. This is the first time FDA will explicitly address youth use of e-cigarettes through campaign advertising.
In addition to these new digital materials, FDA is planning to launch a full-scale campaign focused on youth use of e-cigarettes and other ENDS in fall of 2018. These efforts are part of the agency’s new, comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers of using tobacco products.
For more information on the FDA's "The Real Cost" campaign click here.
Just one e-cigarette might raise adrenaline in the heart
Research suggests smoking just one e-cigarette might expose users to enough nicotine to trigger an adrenaline surge in the heart that can contribute to high blood pressure and other health problems. Read the Reuters article for more information.
New ads accuse Big Tobacco of targeting soldiers and people with mental illness
Truth Initiative, a leading tobacco-control nonprofit, bought TV ads that accuse tobacco companies of purposely targeting mentally ill people and U.S. soldiers. Read the Washington Post article for more information.
A Nicotine-Focused Framework for Public Health
The attached editorial by Mitch Zeller and Scott Gottlieb explores the FDA's plan for a nicotine-focused framework for public health..
Big Tobacco’s new cigarette is sleek, smokeless — but is it any better for you?
Philip Morris International says it has created a less toxic cigarette, but is it any better for you? Read the Washington Post article for more information.
FDA to Expand Public Education Campaign to Focus on Prevention of Youth E-Cigarette Use
On Aug. 8, the FDA announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by kids.
The agency plans to expand its “The Real Cost” public education campaign to include messaging to teens about the dangers of using these products this fall while developing a full-scale campaign to launch in 2018. These efforts are part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.
More than 2 million middle and high school students were current users of e-cigarettes and other ENDS in 2016. Data also show about half of all middle and high school students who were current tobacco users also used two or more tobacco products last year. This use by children and teens is especially concerning because of evidence that youth exposure to nicotine affects the developing brain and may rewire it to be more susceptible to nicotine addiction in the future.
For more information, read the FDA press annoucement.
FDA releases new webinar as part of the Tobacco Compliance Webinar series
The FDA invites you to watch the new webinar, “Required Warning Statements for Cigars.” This webinar provides further clarification on the required health warning statements for cigars sold in various sizes and types of packaging, including packaging too small to fit the required warning statements, which was not covered in the “Cigar Warnings and Warning Plan Requirements” webinar from November 2016. This webinar also provides information regarding retailers’ responsibilities when packaging and advertisements are received from a manufacturer, importer or distributor, and some options for complying when selling cigars that are not packaged.
Once the required warning statements in the deeming regulation take effect on August 10, 2018, it will be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United Sates any cigar unless the product packaging bears one of the required cigar warning statements. Manufacturers should note that warning plans are due to the FDA for review and approval no later than August 10, 2017, or 12 months before advertising or commercially marketing a product that is subject to the requirement, whichever is later.
Tobacco use is the leading cause of preventable disease and death in the United States, and nearly all tobacco use begins during youth and young adulthood. View the full report from the CDC Tobacco Morbidity and Mortality Weekly Report.
This study explores the experiences of early career and senior scientists regarding mentorship and career trajectories in tobacco regulatory science (TRS). Find out more about effective mentorship in TRS requires that mentors possess an in-depth understanding of the scientific, regulatory, and legislative processes inherent to tobacco regulatory policy-making here.
In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational programs. The purpose of this paper is to describe the Panel’s work to develop core TRS domains and competencies. Learn more here.
A bill is expected in the U.S. House of Representatives this week that would diminish FDA’s authority over e-cigarettes. The bill would exempt e-cigarettes from much of the Deeming Rule, including the requirement that new products be reviewed and authorized by the FDA before going to market. The bill is one of a series of legal and legislative efforts by tobacco and e-cigarette companies to thwart the Deeming Rule, but it is unclear how much support the bill will receive.
To read the full article, click here.
A recent study in JAMA Pediatrics found that 1 in 4 youths, or approximately 6.5 million youths, have reported exposure to secondhand smoke from e-cigarettes in the past 30 days. Using data from the 2015 National Youth Tobacco Survey, researchers found that of the nearly 6.5 million youths reporting exposure, 4.4 million youth were not e-cigarette users and that over 1 million youths reported secondhand exposure only from e-cigarettes. Exposure was greater among girls than boys (~27% vs. 22%) and among white students than black students (27% vs. 15%).
To read more on the study and the implications of its findings, click here.
A recent study in the American Journal of Public Health found that after CVS removed tobacco products from its stores, household- and population-level cigarette purchasing declined significantly. Rather than alter their purchasing habits, individuals who bought cigarettes exclusively at CVS were 38% more likely to stop buying cigarettes altogether. According to CVS Health chief medical officer, this study shows that CVS’s removal of tobacco products had a strong public health impact by disrupting access to cigarettes.
To read the full article, click here.
A recent study published in the New England Journal of Medicine estimated the number of adult and youth smokers in the United States between 2013 and 2014.
To read more on the study findings, click here.
A recent study published in Tobacco Control found that many users of Natural American Spirit (NAS) tobacco products, a brand marketed as “natural” and “additive free,” consider their brand to be safer to smoke than other brands. Using data from over 30,000 adult smokers who participated in a national study in 2013 and 2014, researchers found that 2.3% of smokers reported NAS as their usual brand and of those, nearly 64% believed their brand to be less harmful than others.
To read more on the study findings and implications, click here.
A new study suggests that seeing someone use an e-cigarette may increase one’s desire to smoke. The lab experiment, which randomly assigned young adult smokers (n=108) to interact with someone using either a traditional cigarette or vape pen, found that both scenarios resulted in an increased desire to smoke. Researchers note that the small sample size and lab setting limit their ability to know how seeing vaping devices would impact smoking urges among smokers in real life situations.
To read more on the study, click here.
British American Tobacco has reached an agreement to acquire the remaining 57.8% of Reynolds American that it did not already own for $49 billion. The deal is expected to close in the third quarter, pending shareholder and regulatory approval.
To read more the history of the companies and their agreement, click here.
The National Cancer Institute (NCI) of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services is pleased to announce the release of a report titled, "The Economics of Tobacco and Tobacco Control," which was developed in collaboration with the World Health Organization.
This report provides the first comprehensive review of the economics of global tobacco control efforts since the 2003 adoption and 2005 entry into force of the World Health Organization Framework Convention on Tobacco Control and presents extensive new evidence from low- and middle-income countries. The report discusses the current evidence base surrounding the economics of tobacco control and concludes that evidence-based tobacco control interventions make sense from an economic as well as a public health standpoint.
A recent study published in the American Journal of Preventive Medicine examined the science on e-cigarettes. Researchers reviewed nearly 700 peer-reviewed studies on e-cigarettes published between 2010 and May 2016. Findings from the review highlight a wide variation in products, an overall increase in e-cigarette use and the need for more research.
The FDA found four tobacco manufacturers – Swisher International, Inc., Cheyenne International LLC, Prime Time International Co. and Southern Cross Tobacco Company Inc. – to be in violation of the Tobacco Control Act by selling flavored cigarettes labelled as little cigars or cigars. Although labelled as little cigars or cigars, FDA found the products to meet the definition of cigarettes set forth in the Tobacco Control Act, because they are likely to be purchased as cigarettes based on their overall presentation, appearance, and packaging and labeling. FDA issued warning letters to the companies and requested a response within 15 working days of receiving the letter.
Read the full press release here.
Philip Morris filed the first application for U.S. approval to market a tobacco product as less harmful than combustible cigarettes. The application is for a new type of cigarette that heats rather than burns tobacco. According to Philip Morris, the vapor produced by heating tobacco has less than 10% of the harmful chemicals of combustible cigarette smoke. The device is currently sold without the reduced harm claim in several countries.
Read the full article here.
U.S. Surgeon General, Vivek H. Murthy, released a report calling the use of e-cigarettes among youth “a major public health concern,” and suggesting policymakers take strong action to keep the products out of the hands of the nation's young people, while research continues on its potential side effects
For more information, read the full article here.
America has reemerged as a tobacco industry hot spot. The increased interest in the U.S. is in part due to the U.S. having one of the world’s highest wage-to-cigarette price ratios, which enables the tobacco industry to pursue growth through pricing. This resurgence may prompt the remerger of Phillip Morris International (PMI) and Altria. When PMI was spun out from Altria in 2008, it was expected that PMI would thrive in emerging markets, away from the U.S. consumer’s fondness for pricey litigation. However, since the demerger Altria has generated more than twice the total return of PMI. PMI is further troubled by a mismatch of its cash flows and dollar dividends, all of which could be resolved if PMI and Altria were reunited.
For more information, read the full article here.
A new study has found that teens who regularly use e-cigarettes are more likely to become frequent and heavy cigarette smokers. Nearly 3,100 10th-graders in Los Angeles County public schools were surveyed in fall 2014 and then again 6 months later. Study findings have been heavily criticized by the e-cigarette industry, in part due to the study’s definition of “frequent” vaping or smoking as three or more days each month. E-cigarette advocates argue that the study only identified a fraction of youth who progressed onto any cigarette smoking, let alone truly frequent or heavy use. Researchers acknowledge that among youth sampled 95% reported being non-smokers and approximately 98.5% had never vaped.
To read the full article, click here.
The summary of the FDA workshop on biomarkers of tobacco exposure is now published online at Cancer Epidemiology, Biomarkers & Prevention.
To read the full summary, click here.
A recent study in Tobacco Control used e-cigarette liquids with various concentrations of sugars to test the vapor for levels of the toxins 5-hydroxymethylfurfural (HMF) and furfural (FA). Prior to vaping, there were no detectable quantities of furan in the e-cigarette liquids. Under certain conditions sweetened e-cigarettes released toxins at levels similar to traditional cigarettes. Researchers note that with the wide variety of devices and the differences in how people use them, toxicity may be directly associated with a person’s e-cigarette behavior.
For more on the study and its findings, click here.
With sales slowing and use slumping, the excitement of e-cigarettes seems to have stalled. Some attribute this the nation’s leading public health authorities depicting e-cigarettes as a threat to public health. Yet, there is growing evidence that e-cigarettes are less dangerous than smoking. However, with regulatory restrictions preventing companies from making such claims and more states passing legislation that treats e-cigarettes like traditional cigarettes, the American public rarely hears that e-cigarettes are less harmful.
For more on the portrayal of e-cigarettes, read the full article here.
British American Tobacco (BAT) may become the world’s largest publicly traded tobacco business if a $47 billion deal to take over Reynolds American goes through. The new company would have a strong share in the U.S. market and a significant presence in Africa, Asia, the Middle East and South America. If completed, the deal is not expected to face the same regulatory scrutiny as the 2014 Reynolds American – Lorillard deal due to the limited overlap of operations between BAT and Reynolds American.
For additional information, read the full article here.
Public health groups filed a lawsuit against the FDA on Tuesday in an effort to uphold the 2009 Family Smoking Prevention and Tobacco Control Act. The Tobacco Control Act required the FDA to issue rules by late 2011 for graphic warning labels. The FDA initially sought to comply with the law, but lawsuits filed by the tobacco industry eventually resulted in the proposed graphic warning labels being struck down in federal court. In the new lawsuit, public health groups are requesting the court set a deadline for new graphic warning labels from the FDA.
To read the full article, click here.
Version:1.0 StartHTML:000000213 EndHTML:000017886 StartFragment:000017004 EndFragment:000017781 StartSelection:000017004 EndSelection:000017781 SourceURL:https://betobaccofree.hhs.gov/campaigns/index.html Campaigns | BeTobaccoFree.gov
The National Cancer Institute's (NCI’s) Smokefree.gov provides free, accurate, evidence-based information and professional assistance to help support the immediate and long-term needs of people trying to quit smoking. The site provides tips and tools, including apps and text messaging programs, to help you quit smoking, and has subsites specifically for veterans, women, teens, Spanish-speakers, and people over 60.
Launched nationally in November 2017, the FDA’s Center for Tobacco Products has developed a new education program called “This is Our Watch.” This program helps tobacco retailers better understand FDA tobacco regulations, the importance of compliance, and the greater purpose—protecting the nation’s youth from the harms of tobacco use.
You can read more about the newly launched campaign here: https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Retail/ucm237741.htm
There are more than 2 million lesbian, gay, bisexual, and transgender (LGBT) young adults ages 18-24 living in the United States, with LGBT young adults being nearly twice as likely to use tobacco as other young adults, ultimately resulting in the loss of tens of thousands of LGBT lives to tobacco use each year.
“This Free Life” is FDA’s public education campaign designed to prevent and reduce tobacco use among LGBT young adults who use tobacco occasionally. Through the use of authentic and credible messages from tobacco-free members of the LGBT community, the campaign encourages these young adults to draw inspiration from their peers to also live tobacco-free.
You can read more about the campaign here: https://www.fda.gov/TobaccoProducts/PublicHealthEducation/PublicEducationCampaigns/ThisFreeLifeCampaign/ucm20082738.htm
Nearly 5 million multicultural youth are open to smoking or are already experimenting with cigarettes—meaning they have already smoked up to 100 cigarettes in their lifetime, highlighting a critical need for stronger, more targeted youth tobacco prevention efforts.
"Fresh Empire" is FDA's first public education campaign designed to prevent and reduce tobacco use among at-risk multicultural youth ages 12-17 who identify with hip-hop culture, specifically African American, Hispanic, and Asian American/ Pacific Islander youth.
You can read more about it here: https://www.fda.gov/TobaccoProducts/PublicHealthEducation/PublicEducationCampaigns/FreshEmpireCampaign/default.htm
Every day in the U.S., nearly 2,500 youth under age 18 smoke their first cigarette, and more than 1,000 male youth use smokeless tobacco for the first time. "The Real Cost" campaign launched nationally in February 2014 across multiple media platforms including TV, radio, print, web, social media, and out-of-home sites, like billboards. Initial campaign advertising focused on reaching the nearly 10 million youth ages 12-17 in the United States who are either open to smoking or are already experimenting with cigarettes.
You can read the full campaign here: https://www.fda.gov/TobaccoProducts/PublicHealthEducation/PublicEducationCampaigns/TheRealCostCampaign/default.htm
The Sexual & Gender Minority Research Office (SGMRO) at the National Institutes of Health (NIH) has developed the document “Methods and Measurement in Sexual & Gender Minority Health Research: Identifying Research Opportunities” pertaining specifically and exclusively to methods and measurement research in SGM health research. Experts in the field identified research opportunities related to methods and measurement in SGM health research during a workshop held in the Spring of 2018. The document reflects the content of the discussion among participants at the Methods and Measurement in SGM Health Research Workshop and does not represent an official position of NIH or any other government agency. We would like to obtain comment on the specifics of this document to consider for the purposes of informing and enhancing its content.
To ensure consideration of your comments, responses must be received by April 15, 2019.
Announcement can be found HERE.
FDA has issued a revised draft guidance titled Use of Investigational Tobacco Products. This draft guidance supersedes the draft guidance of the same title published in September 2015. Based on careful review of comments received on the original draft guidance, FDA determined that the guidance contained information that could be potentially confusing or misinterpreted. Therefore, this revised draft guidance aims to clarify FDA’s thinking on investigational tobacco products and replaces the previously published draft guidance.
When final, the guidance will describe the current thinking of FDA regarding the definition of “investigational tobacco product” and discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations are issued and become effective or FDA provides written notice of its intent to change its enforcement policy. Although you can comment on any guidance at any time, to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, please submit comments by April 22, 2019. More information.
The Food and Drug Administration (FDA or the Agency) is reopening the period for public comment on modified risk tobacco product applications (MRTPAs) for specific General Snus products submitted by Swedish Match North America Inc. and announcing the availability for public comment of a recently received amendment to the MRTPAs.
The original notice of availability for the applications appeared in the Federal Register of August 27, 2014. In that notice, FDA requested comments on the originally filed MRTPAs that are posted on https://www.regulations.gov and FDA's website. In the Federal Register of July 31, 2015, FDA issued a notice to reopen and extended the comment period for comments on amendments to the MRTPAs. That comment period closed on August 31, 2015. FDA is now reopening the comment period to seek comment specifically on a recent amendment to the MRTPAs.
Modified Risk Tobacco Product Applications: Applications for IQOS
System with Marlboro Heatsticks, IQOS System with Marlboro Smooth Menthol
Heatsticks, and IQOS System with Marlboro Fresh Menthol Heatsticks Submitted by
Philip Morris Products S.A.; Availability
Docket No: FDA‐2017‐D-3001
Date: Comment period extended
*Clarification: No Deadline Set for Public Comments on Philip Morris Products S.A. MRTP Applications
Summary: The FDA is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks submitted by Philip Morris Products S.A. Due to the large size of these applications, FDA will post the application documents in batches on a rolling basis as they are redacted in accordance with applicable laws.
Modified Risk Tobacco Product
Applications: Applications for Six Camel Snus Smokeless Tobacco Products
Submitted by the R.J. Reynolds Tobacco Company; Availability
Docket No: FDA-2017-N-4678-0001
Date: Currently no deadline for public comments
Summary: FDA is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for six Camel Snus smokeless tobacco products submitted by R.J. Reynolds Tobacco Company.
Modified Risk Tobacco Product Applications:
Application for Copenhagen Snuff Fine Cut submitted by U.S. Smokeless Tobacco
Docket No: FDA‐2018‐N-3261
Date: Currently no deadline for public comments
Summary: The FDA is announcing the availability for public comment of a modified risk tobacco product (MRTP) application for Copenhagen Snuff Fine Cut, a loose moist snuff tobacco product submitted by U.S. Smokeless Tobacco Co. LLC. FDA will post the application materials on a rolling basis as they are redacted in accordance with applicable laws.
Tobacco Product Application Review;
Public Meeting; Request for Comments
Docket No: FDA‐2018‐N-3504
Date: December 7, 2018
Summary: The Food and Drug Administration (FDA) is announcing a public meeting entitled "Tobacco Product Application Review." This meeting is intended to improve public understanding and provide FDA feedback on the policies and processes for submitting and reviewing tobacco product marketing applications, including the general scientific principles relevant to various application pathways, to assist those considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Request for Nominations for
Voting Members on a Public Advisory Committee; the Tobacco Products Scientific
Docket No: FDA-2018-N-3263
Date: November 13, 2018
Summary: The FDA is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
The Federal Register has issued a notice establishing a docket on regulations.gov to receive public comments on one modified risk tobacco product (MRTP) application submitted by U.S. Smokeless Tobacco Co. LLC for Copenhagen Snuff Fine Cut. The FDA filed this application on Sept. 14, 2018, for scientific review and will continue to make application materials publicly available, in accordance with applicable laws, on a rolling basis via the CTP website.
Starting tomorrow, Sept. 21, anyone may submit research, data, or other public comments related to these MRTP applications to docket FDA-2018-N-3261 on regulations.gov.
The FDA encourages interested parties to submit public comments earlier in the comment period, as the agency may be less able to review later comments before the MRTP applications are referred to the Tobacco Products Scientific Advisory Committee.
FDA Extends Comment Periods for ANPRMs and Draft Concept Paper
On June 7, 2018, FDA announced extensions of 30 days for the following advance notices of proposed rulemaking: “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,” “Regulation of Flavors in Tobacco Products,” and “Regulation of Premium Cigars.” The agency has also extended the comment period for the “Draft Concept Paper: Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.”
The updated comment period deadlines are:
- Tobacco Product Standard for Nicotine Level of Combusted Cigarettes – July 16, 2018
- Regulation of Flavors in Tobacco Products – July 19, 2018
- Regulation of Premium Cigars – July 25, 2018
- Draft Concept Paper: Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard – July 16, 2018
For more information, please visit the Comment Opportunities page.
On May 9, FDA posted data from clinical, consumer perception, and secondary data analysis and modeling studies submitted by R.J. Reynolds Tobacco Company as part of modified risk tobacco product (MRTP) applications for the following smokeless tobacco products:
- Camel Snus Frost
- Camel Snus Frost Large
- Camel Snus Mellow
- Camel Snus Mint
- Camel Snus Robust
- Camel Snus Winterchill
FDA has also extended the period for public comment on these MRTP applications. At this time, there is no deadline. Once all documents from these MRTP applications, including amendments, are posted, FDA will announce the closing date for this comment period, which will be at least 30 days from the date the last application materials are posted. You may submit online public comments to docket FDA-2017-N-4678-0001 on regulations.gov.
Please note that the docket URL on regulations.gov to submit public comments has been updated since the public comment period was extended. FDA is also aware that there may be conflicting deadlines posted on regulations.gov and federalregister.gov. While we cannot control how information is displayed on those websites, the docket will remain open beyond any currently posted, specific closing dates.
For a more in-depth look, click here
Submit comments by April 16, 2018
The Food and Drug Administration (FDA or Agency) is establishing a public
docket to receive suggestions, recommendations, and comments on topics or
policy issues for consideration by FDA’s Nicotine Steering Committee
(NSC). FDA would like to receive feedback from interested parties,
including academic institutions, regulated industries, patient representatives,
and other interested organizations. These comments will help the Agency
identify and address priorities related to the use of therapeutic nicotine for
combustible tobacco product cessation.
Submit comments by June 14, 2018
The Food and Drug Administration (FDA) is issuing this advance
notice of proposed rulemaking (ANPRM) to obtain information for consideration
in developing a tobacco product standard to set the maximum nicotine level for
cigarettes. Because tobacco-related harms ultimately result from addiction to
the nicotine in such products, causing repeated use and exposure to toxicants,
FDA is considering taking this action to reduce the level of nicotine in these
products so they are minimally addictive or nonaddictive, using the best
available science to determine a level that is appropriate for the protection
of the public health.
Docket No: FDA-2018-N-0529
Date: Submit comments by June 14, 2018
The Food and Drug Administration (FDA) is announcing the availability of a
draft concept paper entitled "Illicit Trade in Tobacco Products after
Implementation of an FDA Product Standard." FDA seeks public comment on
the draft concept paper regarding the potential for illicit trade markets to
develop in response to a tobacco product standard. This draft concept paper is
offered to stimulate dialogue around the subject of possible illicit trade in
connection with tobacco product standards.
Flavors in Tobacco Products
Docket No: FDA-2017-N-6565
Date: Submit comments by June 19, 2018
The Food and Drug Administration (FDA) is issuing this advance notice of
proposed rulemaking (ANPRM) to obtain information related to the role that
flavors play in tobacco products. Specifically, this ANPRM is seeking
comments, data, research results, or other information about, among other
things, how flavors attract youth to initiate tobacco product use and about
whether and how certain flavors may help adult cigarette smokers reduce
cigarette use and switch to potentially less harmful products. FDA is
seeking this information to inform regulatory actions FDA might take with
respect to tobacco products with flavors, under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention
and Tobacco Control Act (Tobacco Control Act). Potential regulatory
actions include, but are not limited to, tobacco product standards and
restrictions on sale and distribution of tobacco products with flavors.
Docket No: FDA-2017-N-6107
Date: Submit comments by June 25, 2018
The Food and Drug Administration (FDA) is issuing this
advance notice of proposed rulemaking (ANPRM) to obtain information related to
the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act), and regulations regarding the sale and distribution
of tobacco products. Specifically, this ANPRM is seeking comments, data,
research results, or other information that may inform regulatory actions FDA
might take with respect to premium cigars.
Tobacco Product Applications: Applications for IQOS System with Marlboro
Heatsticks, IQOS System with Marlboro Smooth Menthol Heatsticks, and IQOS
System with Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris
Products S.A.; Availability
Date: Comment period extended
The FDA is announcing the availability for public comment of modified risk
tobacco product applications (MRTPAs) for IQOS system with Marlboro Heatsticks,
IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with
Marlboro Fresh Menthol Heatsticks submitted by Philip Morris Products S.A. Due
to the large size of these applications, FDA will post the application
documents in batches on a rolling basis as they are redacted in accordance with
Today, the U.S. Food and Drug Administration issued an advance notice of proposed rulemaking (ANPRM) to seek comments and scientific data related to the patterns of use and resulting public health impacts from what are often referred to as “premium” cigars to inform the agency’s regulatory policies. The agency is specifically requesting comments and information not previously submitted in response to the proposed deeming rule.
In 2016, FDA finalized the deeming rule extending its authority under the Family Smoking Prevention and Tobacco Control Act to additional tobacco products, including e-cigarettes, cigars, pipe tobacco and hookah tobacco, among others. The rule includes provisions making these products subject to a range of requirements, such as mandatory age and photo-ID checks to prevent illegal sales to minors, required warning statements, submission of health documents, and the prohibition on marketing modified risk products without an FDA order in effect.
When proposed, the deeming rule put forth two, alternative regulatory options, one of which would have excluded so-called “premium” cigars from FDA regulation. After carefully considering the public comments on the rule, FDA concluded all cigars pose serious negative health risks, and the evidence did not provide a public health basis for FDA to exclude any type of cigars from regulation.
“All tobacco products, including “premium” cigars, remain subject to manufacturing, distribution and marketing oversight by FDA. However, given the ongoing interest from many parties on this issue ‒ as well as the potential for new data on the topic since the deeming rule published‒ we’re providing stakeholders an opportunity to submit relevant new information that could inform FDA’s regulation of “premium” cigars,” said Mitch Zeller, director of FDA’s Center for Tobacco Products.
Through the ANPRM announced today, the agency is requesting comments, data, research results, or other information not submitted in response to the proposed deeming rule on topics including, but not limited to:
• The definition of “premium” cigars;
• Use patterns of “premium” cigars generally and among youth and young adults specifically;
• Public health considerations associated with “premium” cigars, including the health effects;
• Studies or information regarding consumer perceptions of the health risks of “premium” cigars; and
• Studies or information on whether any applicable manufacturing, marketing, sale, distribution, advertising, labeling, and/or packaging requirements and restrictions should be applied differently to “premium” cigars compared to other tobacco products, including other cigars.
The FDA will consider all submissions to help inform the agency’s regulatory decision-making regarding “premium” cigars. The ANPRM will be available for comment from March 26 through June 25, 2018.
The ANPRM is one of three previously announced in July 2017 as part of FDA’s comprehensive plan on nicotine and tobacco regulation. Earlier this month, FDA published the other two ANPRMs, “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes” and “Regulation of Flavors in Tobacco Products.” The comprehensive plan serves as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death.
FDA is establishing a
public docket to receive suggestions, recommendations, and comments on topics
or policy issues for consideration by the agency’s Nicotine Steering Committee.
The agency would like to receive feedback from academic institutions, regulated
industries, patient representatives, and other interested organizations and
individuals to help the agency identify and address priorities related to the
use of therapeutic nicotine for combustible tobacco product cessation.
The Nicotine Steering Committee was established in November 2017 and includes senior leaders from the Office of the Commissioner, Center for Drug Evaluation and Research, and Center for Tobacco Products. The committee was formed to help develop and implement nicotine policy and regulation, especially on issues related to therapeutic nicotine for combustible tobacco product cessation.
Submit electronic or written comments by April 16.
For more information, including details on how to submit comments to the public docket, read the Federal Register notice establishing the docket.
Dear Tobacco Control Researchers and Partners,
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is requesting information from the public to inform future activities regarding how to efficiently and cost effectively help people quit using tobacco using evidence-based treatment options.
OSH’s Federal Register Notice (FRN), soliciting information about Effective, Large-Scale, Sustainable Approaches to Help People Quit Using Tobacco by Employing Evidence-based Treatment Options, published October 31st. The docket will be open for 60 days. Here is a link to the FRN for public comment: https://www.federalregister.gov/documents/2017/10/31/2017-23669/requests-for-information-effective-large-scale-sustainable-approaches-to-help-people-quit-using. Public comment will close on January 2, 2018.
In support of FDA’s comprehensive new tobacco regulatory plan announced in July, the agency is forming a Nicotine Steering Committee to help develop and implement nicotine policy and regulation to address the public health crisis of addiction to tobacco products in this country. The committee, which will include senior leadership from the Center for Tobacco Products, Center for Drug Evaluation and Research, and Office of the Commissioner, will focus on nicotine replacement therapies (NRTs), which are designed to help people quit smoking. The committee will examine the evolving science behind the agency’s evaluation of these NRTs, including the types of safety and efficacy studies FDA requires and how these products are used and labeled.
As the committee’s first action, it will hold a public hearing for FDA to obtain feedback on public health, scientific, regulatory, and legal considerations relating to NRT products and their use for cessation. The hearing is planned for Jan. 26, 2018, at FDA’s White Oak Campus in Silver Spring, Md. Those who want to attend or present at the hearing must register by Jan. 2. Electronic or written comments will be accepted after the public hearing until Feb. 15.
To learn more, click here.
On Nov. 28, FDA posted data from clinical studies, consumer perception studies, and behavioral assessments from modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A., which FDA filed for substantive scientific review on May 24. The originally submitted applications (redacted in accordance with applicable laws) are now publicly available. You may submit online comments to docket FDA-2017-N-3001 on regulations.gov.
You can see the full release here.
In May, FDA filed MRTP applications for Philip Morris Products S.A.’s iQOS system and several varieties of Marlboro HeatSticks. In a June Federal Register notice, FDA announced that the applications were being made available for public comment pursuant to section 911(e) of the Federal Food, Drug, and Cosmetic Act and that due to the large size of the applications, the Agency would post the applications in installments. FDA plans to post the remaining documents of the originally submitted applications by Nov. 24, 2017. FDA anticipates making amendments received thus far publicly available over the next several months, and amendments received in the future will be made publicly available as they are redacted.
On Nov. 21, FDA issued a Federal Register notice extending the period for public comment on the MRTP applications. Once all documents from these MRTP applications, including amendments, are posted, FDA intends to issue another notice in the Federal Register announcing when the comment period will close, which will be at least 30 days from the date the last documents are posted.
You may read the publicly available application materials on the FDA website. Online comments should be submitted to docket FDA-2017-N-3001 on regulations.gov.
Those who wish to submit comments can do so by clicking here.
FDA has issued a Federal Register notice establishing a public docket to obtain input on recommendations for regulations on tobacco product manufacturing practices (TPMPs) for electronic nicotine delivery systems (ENDS). These recommendations were submitted to FDA by a group of 13 tobacco companies and related associations. FDA is authorized, under the Family Smoking Prevention and Tobacco Control Act and the deeming rule finalized in 2016, to issue TPMP regulations to protect the public health and to ensure tobacco products, including ENDS, are in compliance with the law.
The public will have 30 days after the date of publication in the Federal Register to comment on this docket.
Those who wish to submit comments can click here.
On Nov. 9, FDA posted some study reports and datasets from modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. These materials add to the information previously made public after FDA filed the applications for substantive scientific review on May 24. FDA plans to post the remaining documents of the originally submitted applications by Nov. 24, 2017. Amendments received thus far and any received in the future will be posted at a later date. As stated in previous guidance, FDA will extend the comment period to allow for 30 days or more of public comment from the date the last amendment is posted.
FDA is making these MRTP applications publicly available in accordance with applicable laws.
You can submit online comments about these applications to docket FDA-2017-N-3001 on regulations.gov. Public comments may be submitted on all available application materials throughout the comment period, including during the time for comments on amendments received in the future.
On July 28, 2017, the U.S. Food and Drug Administration (FDA) announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.
Read the full press release on the FDA website.
The Federal Register has issued a notice establishing a docket on regulations.gov to receive public comments on three modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. for its IQOS system and several Marlboro Heatsticks products. The FDA filed these applications on May 24, 2017, for scientific review and will continue to make these documents publicly available, in accordance with applicable laws, on a rolling basis via the CTP website.
From Jun. 15 through Dec. 12, anyone may submit research, data, or other public comments related to these MRTP applications to docket FDA-2017-D-3001 on regulations.gov.
The FDA encourages interested parties to submit public comments earlier in the comment period, as the agency may be less able to review later comments before the MRTP applications are referred to the Tobacco Products Scientific Advisory Committee.
On July 14, the FDA posted product descriptions and formulations, proposed labeling and advertising information, and a tobacco product master file letter of authorization from modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. These materials add to the information previously made public when the FDA formally filed the applications for scientific review on May 24, with 7 of 9 application modules now available on the CTP website. The FDA is making these MRTP applications publicly available in accordance with applicable laws and posting the materials in batches due to large file sizes.
- Public comments about these applications may be submitted through Dec. 12, 2017 to docket FDA-2017-N-3001 on regulations.gov.
- Read the New Documents on the FDA website.
Click on the link below to view all public comments submitted by UCSF.
Electronic cigarette marketing attracts youth and young adults and has contributed to skyrocketing use of these products, as well as poly-use of e-cigarettes along with other tobacco products. E-cigarettes have also contributed to the renormalization of other tobacco products. Thus, the proposed FTC data and reports would help public health researchers develop the information necessary to inform policies to counteract these effects.
FTC File No: P144504
FDA's draft guidance exempting tobacco products intended for investigational use from premarket submission requirements supports public health research, protects the health of human subjects, and ensures that investigational tobacco products are not commercialized
Docket No. FDA-2014-D-1939
November 19, 2015
Docket ID: FDA-2017-N-0932
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Warning Statements for Cigarette Graphic Health Warnings
This notice solicits comments on the Experimental Study on Warning Statements for Cigarette Graphic Health Warnings that is being conducted in support of the graphic label statement provision of the Tobacco Control Act. FDA invites comments on the following topics: 1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; 2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3) ways to enhance the quality, utility, and clarity of the information to be collected; and 4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Due Date: May 30, 2017
Docket ID: FDA-2015-N-2002
Title:Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments
This notice solicits comments on the issues raised in a petition regarding the amendments to the regulations regarding “intended uses.” FDA is particularly interested in comments on the following questions:
- How should FDA consider situations where companies and individuals distribute medical products and/or seek to import medical products without explicit promotional claims as we evaluate whether to adopt any of petitioners’ suggested approaches to determining intended use?
- What are the potential public health consequences, positive and negative, that should be considered in evaluating whether to adopt any of petitioners’ suggested approaches to determining intended use? What other policy considerations are relevant when assessing approaches to intended use?
- To the extent that your comment cites to First Amendment considerations as the legal rationale underlying your recommendations, how (if at all) do those considerations apply to the use of non-speech evidence in determining intended use, such as the circumstances surrounding the distribution of a product of the context in which it is sold?
- In light of the petitioners’ concerns about the language in the final rule, do stakeholders believe there is a distinction between considering “any relevant source of evidence” and “the totality of evidence”? Do stakeholders have suggestions about what wording provides the most clarity to regulated entities?
Due Date: May 19, 2017
Docket ID: FDA-2016-N-2406
Title: Emerging Issues and Cross-Cutting Scientific Advances; Establishment of a Public Docket
FDA is establishing a public docket to receive input on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-Agency activities. The focus is to identify issues and advances that may impact the Agency in 5 years and thus may be in their infancy.
Due Date: October 21, 2019
The 5th Annual VCBH Conference, held October 5-6 in Burlington, Vermont, brought together leading tobacco researchers from universities and medical centers nationwide to share their knowledge on tobacco regulatory science. Mitch Zeller, J.D., served as the keynote speaker and presented the FDA's new plan for nicotine regulation, which has the potential to reduce overall smoking prevalence and improve public health.
To view this presentation and all of the other session vides click here.