IQOS marketing strategies in the USA before and after US FDA modified risk tobacco product authorisation

2021 ◽  
pp. tobaccocontrol-2021-056819
Author(s):  
Carla J Berg ◽  
Katelyn F Romm ◽  
Yael Bar-Zeev ◽  
Lorien C Abroms ◽  
Katharina Klinkhammer ◽  
...  
Keyword(s):  
Science Research ◽  
Tobacco Product ◽  
Home Delivery ◽  
The Us ◽  
Before And After ◽  
The Usa ◽  
Marketing Data ◽  
Us Fda ◽  
Ongoing Surveillance ◽  
Media Channels

IntroductionGiven that the US Food and Drug Administration (FDA) authorised reduced exposure messaging to be used in IQOS marketing, we examined: (1) IQOS ad content; (2) advertising media channels and (3) changes in advertising efforts over time.MethodsWe conducted a mixed-methods study regarding IQOS ad content (headlines, themes, images), ad occurrence characteristics (including content, media channels and adspend) in the USA from August 2019 to April 2021 using Numerator advertising/marketing data.ResultsAcross 24 unique ads and 591 occurrences (84.6% online, 8.0% print, 7.4% mobile), there was $4 902 110 total adspend (98.9% allocated to print). Across unique ads, occurrences and adspend, prominent themes included ‘real tobacco’ (45.8%, 47.4%, 30.1%, respectively), less odour/ash (29.2%, 21.0%, 29.9%) and switching from cigarettes (25.0%, 19.5%, 69.4%), and images mainly featured the product alone (58.2%, 61.4%, 99.5%) or with women (25.0%, 19.1%, 0.3%). Per occurrences and adspend, the most prominent media channel themes (eg, magazine/website topics) were technology (19.3%, 10.6%), women’s fashion (18.1%, 26.2%), weather/news (9.0%, 15.3%) and entertainment/pop culture/gaming (8.5%, 23.1%). Ad themes appearing only post-FDA authorisation included switching from traditional cigarettes, same-day/home-delivery, convenience (eg, use indoors), reduced exposure to some dangerous substances, science/research and distinction from e-cigarettes. Overall adspend per occurrence increased postauthorisation (p=0.016); the highest adspend per unique ad (69.3% of total) focused on ads featuring reduced exposure.ConclusionsRegulatory efforts must be informed by ongoing surveillance of IQOS marketing efforts and its impacts, particularly how specific consumer subgroups (eg, tobacco non-users, women, young people) are impacted by marketing exposure.

FDA’s reduced exposure marketing order for IQOS: why it is not a reliable global model

2021 ◽  
pp. tobaccocontrol-2020-056316
Author(s):  
Lauren Kass Lempert ◽  
Stella Bialous ◽  
Stanton Glantz
Keyword(s):  
Public Relations ◽  
Tobacco Control ◽  
Scientific Evidence ◽  
Tobacco Product ◽  
Tobacco Products ◽  
Sales And Marketing ◽  
Philip Morris ◽  
The Us ◽  
The Usa ◽  
The Difference

The US Food and Drug Administration (FDA) issued orders in July 2020 authorising Philip Morris Products S.A. to market its heated tobacco product (HTP) IQOS inside the USA with claims that it reduces exposure to some dangerous substances. FDA’s ‘reduced-exposure’ orders explicitly prohibit the marketing of IQOS with claims that IQOS will reduce harm or the risk of tobacco-related diseases. Under US law, FDA’s IQOS orders are problematic because FDA disregarded valid scientific evidence that IQOS increases exposure to other dangerous toxins and that Philip Morris Products S.A. failed to demonstrate that consumers understand the difference between reduced-exposure and reduced-harm claims. Unfortunately, both ‘reduced-exposure’ and ‘reduced-harm’ are classified as ‘modified risk tobacco products’ under US law. Exploiting this confusion, Philip Morris International used the FDA decision as the basis for marketing and public relations campaigns outside the USA to press governments to reverse policies that ban or regulate the sales and marketing of HTPs, including IQOS. Parties to the WHO Framework Convention on Tobacco Control should reject tobacco companies’ unsubstantiated explicit or implied claims of reduced harm associated with HTPs and resist Philip Morris International’s and other companies’ calls to relax HTP regulations based on the FDA’s actions. Instead, parties should adopt policies aligned with the Framework Convention on Tobacco Control when dealing with HTPs and other novel tobacco products.

The United States

2017 ◽  
Author(s):  
J. C. Sharman
Keyword(s):  
United States ◽  
The United States ◽  
Turn Of The Century ◽  
Patriot Act ◽  
Foreign Corrupt Practices Act ◽  
The Us ◽  
Before And After ◽  
The Status ◽  
The Usa ◽  
Successful Prevention

This chapter begins by tracing the origins of the anti-kleptocracy cause in the United States, starting with the harsh Cold War environment and the Foreign Corrupt Practices Act of 1977. It explores the status quo ante of dictators being able to launder their funds in the US financial system with impunity immediately before and after the turn of the century. At this time, there was no law prohibiting American banks and other institutions receiving the proceeds of foreign corruption. The USA Patriot Act closed this legal loophole, yet practice lagged, and laws at first failed to have much of an impact. More recent cases indicate at least partial effectiveness, however, with instances of successful prevention and some looted wealth confiscated and returned.

scholarly journals E-cigarette and cigarette purchasing among young adults before and after implementation of California’s tobacco 21 policy

2020 ◽  
pp. tobaccocontrol-2019-055417 ◽  
Author(s):  
Sara Schiff ◽  
Fei Liu ◽  
Tess Boley Cruz ◽  
Jennifer B Unger ◽  
Sam Cwalina ◽  
...  
Keyword(s):  
Population Based ◽  
Tobacco Product ◽  
Cigarette Use ◽  
Limited Data ◽  
Tobacco Products ◽  
Gas Stations ◽  
The Past ◽  
Before And After ◽  
The Usa ◽  
Vape Shops

BackgroundTobacco 21 (T21) laws, which raise the minimum legal age of sale of tobacco products to 21, have been proposed and implemented in states and cities across the USA. However, limited data are available on the effect of T21 laws on youth tobacco purchasing behaviours and access to tobacco products.MethodsParticipants in a population-based prospective cohort in southern California completed questionnaires before (n=1609, age=18–19 y) and after (n=1502, age=19–20 y) T21 was implemented in California (June 2016). We examined the prevalence of past 30-day cigarette and e-cigarette use, and among past 30-day users, purchase location of tobacco products before (pre-) versus after (post-) T21. We also examined whether, post-T21, participants were refused purchase of tobacco products due to their age, and the perceived relative ease of purchasing cigarettes and e-cigarettes (vs pre-T21).ResultsNegligible changes in cigarette and e-cigarette use were observed pre-T21 versus post-T21. At both time points, the majority of past 30-day users purchased cigarettes from gas stations and e-cigarettes from vape shops. Post-T21, the proportion of participants who reported purchasing cigarettes at gas stations decreased. Post-T21, most past 30-day cigarette or e-cigarette users were not refused purchase of cigarettes (65.4%) or e-cigarettes (82.0%) in the past 30 days, despite being under 21; half of the participants felt it was harder to purchase cigarettes (54.3%) and e-cigarettes (43.6%) post-T21.ConclusionPost-T21, few participants were refused purchase of any tobacco product, despite the illegality of such sales. Better enforcement of T21 is needed to improve the efficacy of T21 legislation.

Cigarette and cigar sales in Hawaii before and after implementation of a Tobacco 21 Law

2020 ◽  
Vol 30 (1) ◽  
pp. 98-102 ◽  
Author(s):  
Rebecca Glover-Kudon ◽  
Doris G Gammon ◽  
Todd Rogers ◽  
Ellen M Coats ◽  
Brett Loomis ◽  
...  
Keyword(s):  
Large Scale ◽  
Geographical Area ◽  
Upward Trend ◽  
Food Stores ◽  
The Us ◽  
Before And After ◽  
Youth And Young Adults ◽  
The Usa ◽  
Product Sales ◽  
The Impact

IntroductionOn 1 January 2016, Hawaii raised the minimum legal age for tobacco access from 18 to 21 years (‘Tobacco 21 (T21)’) statewide, with no special population exemptions. We assessed the impact of Hawaii’s T21 policy on sales of cigarettes and large cigars/cigarillos in civilian food stores, including menthol/flavoured product sales share.MethodsCigarette and large cigar/cigarillo sales and menthol/flavoured sales share were assessed in Hawaii, California (implemented T21 in June 2016 with a military exemption), and the US mainland using the only Nielsen data consistently available for each geographical area. Approximate monthly sales data from large-scale food stores with sales greater than US$2 million/year covered June 2012 to February 2017. Segmented regression analyses estimated changes in sales from prepolicy to postpolicy implementation periods.ResultsFollowing T21 in Hawaii, average monthly cigarette unit sales dropped significantly (−4.4%, p<0.01) coupled with a significant decrease in menthol market share (−0.8, p<0.01). This combination of effects was not observed in comparison areas. Unit sales of large cigars/cigarillos decreased significantly in each region following T21 implementation. T21 policies in Hawaii and California showed no association with flavoured/menthol cigar sales share, but there was a significant increase in flavoured/menthol cigar sales share in the USA (7.1%, p<0.01) relative to Hawaii’s implementation date, suggesting T21 may have attenuated an otherwise upward trend.ConclusionsAs part of a comprehensive approach to prevent or delay tobacco use initiation, T21 laws may help to reduce sales of cigarette and large cigar products most preferred by US youth and young adults.

scholarly journals Heated tobacco products likely appeal to adolescents and young adults

2018 ◽  
Vol 27 (Suppl 1) ◽  
pp. s41-s47 ◽  
Author(s):  
Karma McKelvey ◽  
Lucy Popova ◽  
Minji Kim ◽  
Benjamin W Chaffee ◽  
Maya Vijayaraghavan ◽  
...  
Keyword(s):  
Health Risks ◽  
Tobacco Industry ◽  
Tobacco Product ◽  
Adolescent And Young Adult ◽  
Tobacco Products ◽  
Design And Implementation ◽  
Philip Morris ◽  
The Us ◽  
The Usa ◽  
The 1960S

BackgroundBeginning in the 1960s in the USA and globally since 1998, tobacco companies have beenaggressively promoting heated tobacco products (HTP). In 2016, Philip Morris International (PMI) applied to the US Food and Drug Administration (FDA) seeking authorisation to market their IQOS HTP system and flavoured ‘HeatSticks’ in the USA as a modified-risk tobacco product (MRTP).MethodsWe systematically evaluated the publicly available data PMI submitted to FDA in its MRTP application to determine whether PMI’s IQOS product meets the US Tobacco Control Act’s standard for MRTP claims. We examined whether PMI provided sufficient data showing tobacco users will not initiate with IQOS, that youth will not misperceive the MRTP-related claims being made concerning IQOS, and how youth perceive health risks associated with IQOS.ResultsPMI’s own studies failed to provide evidence that youth, including non-users and former users, will not find IQOS appealing, will not initiate use of IQOS and will not perceive these products as risk-free. Further, PMI did not refer to independent studies conducted among adolescents which could influence their conclusions. Finally, their studies suffered from design and implementation flaws and cannot be relied on to support the proffered claims.ConclusionPMI’s own data and available evidence from scientific studies conducted independent of the tobacco industry regarding how novel tobacco products are currently being marketed suggest that introduction of IQOS will result in adolescent and young adult non-users initiating tobacco use with IQOS and could also increase poly-use of IQOS along with other tobacco products.

scholarly journals Correlates of tobacco product initiation among youth and adults in the USA: findings from the PATH Study Waves 1–3 (2013–2016)

2020 ◽  
Vol 29 (Suppl 3) ◽  
pp. s191-s202 ◽  
Author(s):  
Karin A Kasza ◽  
Kathryn C Edwards ◽  
Zhiqun Tang ◽  
Cassandra A Stanton ◽  
Eva Sharma ◽  
...  
Keyword(s):  
Older Adults ◽  
Tobacco Product ◽  
Health Study ◽  
Product Use ◽  
Frequent Use ◽  
The Us ◽  
The Usa ◽  
Nationally Representative ◽  
Tobacco Initiation

ObjectiveTo report on demographic and tobacco product use correlates of tobacco product initiation (cigarettes, electronic nicotine delivery systems (ENDS), cigars, hookah and smokeless tobacco) among the US population.DesignData were from the first three waves (2013–2016) of the Population Assessment of Tobacco and Health Study, a nationally representative, longitudinal cohort study of US youth (aged 12–17 years) and adults (aged 18+ years). Never users of at least one type of tobacco product at Wave 1 (W1, 2013/14) or Wave 2 (W2, 2014/15) were included (n=12 987 youth; n=25 116 adults). Generalised estimating equations were used to evaluate the association between demographic and tobacco product use characteristics at baseline, and tobacco product initiation at follow-up (ever, past 30 day (P30D), frequent (use on 20 or more of thepast 30 days)) over two 1-year periods (W1–W2 and W2–Wave 3).ResultsYouth aged 15–17 years were more likely than youth aged 12–14 years and adults aged 18–24 years were more likely than older adults to initiate P30D tobacco use across products; non-heterosexuals were more likely than heterosexuals to initiate P30D cigarette and ENDS use. Older adults were more likely than young adults, and males were more likely than females, to be frequent users of ENDS on initiation. Ever use of another tobacco product predicted P30D initiation of each tobacco product.DiscussionOther tobacco product use and age predict P30D tobacco initiation across products whereas associations with other demographic characteristics vary by product. Continued contemporary evaluation of initiation rates within the changing tobacco product marketplace is important.

scholarly journals Assessment of industry data on pulmonary and immunosuppressive effects of IQOS

2018 ◽  
Vol 27 (Suppl 1) ◽  
pp. s20-s25 ◽  
Author(s):  
Farzad Moazed ◽  
Lauren Chun ◽  
Michael A Matthay ◽  
Carolyn S Calfee ◽  
Jeffrey Gotts
Keyword(s):  
Pulmonary Inflammation ◽  
Tobacco Product ◽  
Industry Data ◽  
Dual Use ◽  
Cigarette Smokers ◽  
Tobacco Products ◽  
Aerosol Exposure ◽  
Philip Morris ◽  
The Us ◽  
The Usa

IntroductionHeated tobacco products are being touted as novel reduced-harm tobacco products by tobacco companies. In the USA, Philip Morris International submitted a modified risk tobacco product (MRTP) application to the US Food and Drug Administration in 2016 in which it purports that its heated tobacco product, I-Quit-Ordinary-Smoking (IQOS), is associated with reduced harm compared with conventional cigarettes.MethodsWe reviewed Philip Morris International’s MRTP application to assess the pulmonary and immune toxicities associated with IQOS use in both animal and human studies.ResultsAmong rats exposed to IQOS, there was evidence of pulmonary inflammation and immunomodulation. In human users, there was no evidence of improvement in pulmonary inflammation or pulmonary function in cigarette smokers who were switched to IQOS.ConclusionIQOS is associated with significant pulmonary and immunomodulatory toxicities with no detectable differences between conventional cigarette smokers and those who were switched to IQOS in Philip Morris International’s studies. Philip Morris International also failed to consider how dual use and secondhand aerosol exposure may further impact, and likely increase, the harms associated with these products.

STUDY OF DIFFERENT PROPERTIES AND APPLICATIONS OF POLY LACTIC-CO-GLYCOLIC ACID (PLGA) NANOTECHNOLOGY: AN OVERVIEW

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (12) ◽  
pp. 5-22
Author(s):  
A.P Gadad ◽  
◽  
G Vannuruswamy ◽  
Chandra P. Sharath ◽  
P.M. Dandagi ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Drug Delivery ◽  
Particle Size ◽  
Drug Release ◽  
Glycolic Acid ◽  
Science Research ◽  
Factors Affecting ◽  
Wide Range ◽  
The Us ◽  
Us Fda

In past decades poly lactic-co-glycolic acid (PLGA) has been one of the most attractive polymeric candidates used to fabricate devices for diagnostics and other applications of clinical and basic science research, including vaccine, cancer, cardiovascular disease, and tissue engineering. In addition, PLGA and its co-polymers are important in designing nanoparticles with desired characteristics such as biocompatibility, biodegradation, particle size, surface properties, drug release and target ability and exhibit a wide range of erosion times. PLGA has been approved by the US FDA for use in drug delivery. This article represents the more recent successes of applying PLGA-based nanotechnologies and tools in these medicine-related applications, and factors affecting their degradation and drug release. It focuses on the possible mechanisms, diagnosis and treatment effects of PLGA preparations and devices.

“We were cocked & loaded to retaliate”

2021 ◽  
Author(s):  
Mohammad Makki ◽  
Andrew S. Ross
Keyword(s):  
Systemic Functional Linguistics ◽  
Linguistic Analysis ◽  
Analytical Framework ◽  
Donald Trump ◽  
The Us ◽  
Before And After ◽  
The Usa ◽  
Iranian Government ◽  
The Relationship ◽  
Diplomatic Relationship

Abstract The diplomatic relationship between the USA and Iran has long been fraught and is characterised by various conflicts and the implementation of economic sanctions. It can be argued that the relationship became even more hostile after Donald Trump was elected president of the US. Trump’s sentiments towards Iran were made public through his behavior on Twitter, both before and after he took over the Presidency. These sentiments have been a mix of negative and sometimes positive views and opinions. This study uses a corpus of Trump’s tweets that explicitly mention ‘Iran’ as the basis of a linguistic analysis and applies to it the analytical framework of appraisal from Systemic Functional Linguistics. More specifically, this study focuses on how he established an Us vs. Them dichotomy. While the analysis shows that Iran has been generally portrayed negatively by Trump, there were several tweets where the Iranian government was appraised positively, too. More interestingly, in those tweets, he seemed to target Obama and democrats and represent them negatively while Iran was assessed in positive terms.

An update on the adalimumab biosimilar landscape following the approval of the first high-concentration biosimilar

Immunotherapy ◽  
2021 ◽  
Author(s):  
Enrico Fusaro ◽  
Patrick Durez ◽  
Johannes Wohlrab ◽  
Soohyun Lee ◽  
SangWook Yoon ◽  
...  
Keyword(s):  
Development Program ◽  
Biologic Therapies ◽  
Future Perspectives ◽  
High Concentration ◽  
Clinical Development Program ◽  
The Us ◽  
The Usa ◽  
Potential Impact ◽  
Us Fda ◽  
Totality Of Evidence

Biosimilars can reduce healthcare costs and expand patient access to biologic therapies. Currently, eight adalimumab biosimilars have received regulatory approval from the EMA and/or the US FDA. Following recent EMA approval of the first high-concentration adalimumab biosimilar, CT-P17, this review provides a contemporary update on adalimumab biosimilars currently licensed in Europe and the USA. The totality of evidence from each clinical development program is summarized, and characteristics of each formulation and/or device that potentially affect the convenience of treatment for patients are discussed. Future perspectives are considered, including the potential impact of the FDA’s first interchangeability designation for an adalimumab biosimilar, ahead of their entry into the US marketplace in 2023.

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