Modified Risk Tobacco Product Application Research Articles

Effects of a Reduced Risk Claim on Adolescents' Smokeless Tobacco Perceptions and Willingness to Use

PurposeUnited States Smokeless Tobacco Company LLC submitted a modified risk tobacco product application to the US Food and Drug Administration, proposing a claim that switching to Copenhagen snuff fine cut from cigarettes reduces lung cancer risk. This claim could affect adolescents' smokeless tobacco perceptions and its use. MethodsStudents (N = 592; mean age: 15.3 years; 46% male; 32% nonHispanic White; 8% smokeless tobacco ever-users) at seven California high schools were randomized within a survey to view a Copenhagen snuff image, either with or without the proposed reduced risk claim. Participants were then asked about the harm of smokeless tobacco and their willingness to try Copenhagen snuff if a friend offered. Postimage harm rating and willingness were compared between image groups overall, stratified by past 30-day tobacco use (87% of tobacco users were e-cigarette users), and adjusted for participant characteristics using multivariable regression. ResultsParticipants who viewed the claim were less likely to perceive smokeless tobacco to cause “a lot” of harm (56% vs. 64%; p = .03), including after statistical adjustment (risk ratio [RR]: 0.84; 95% confidence interval [CI]: 0.75, 0.94), and with a numerically stronger effect among tobacco users (RR: 0.65; 95% CI: 0.48, 0.86). The claim did not increase willingness overall (17% vs. 20%; p = .41) but did increase willingness among tobacco users (RR: 1.67; 95% CI: 1.05, 2.67). DiscussionBrief exposure to a reduced-risk claim decreased adolescents' smokeless tobacco harm perceptions and increased willingness to try among tobacco users. The Food and Drug Administration order permitting this claim could increase some adolescents' susceptibility to smokeless tobacco, particularly those already using other tobacco products like e-cigarettes.

Impact of a reduced nicotine standard on young adult appeal for menthol and non-menthol cigarettes

IntroductionThe Food and Drug Administration (FDA) announced its intention to reduce the nicotine content in cigarettes as a strategy to promote cessation and reduce smoking-related harm. A low nicotine product...

IQOS debut in the USA: Philip Morris International’s heated tobacco device introduced in Atlanta, Georgia

Following the Food and Drug Administration’s (FDA) April 2019 authorisation on their premarket tobacco product application,1 Philip Morris (PM) has officially launched its heated tobacco product, IQOS, in the USA...

Heated tobacco products likely appeal to adolescents and young adults

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...

Revolution or redux? Assessing IQOS through a precursor product

BackgroundPhilip Morris International (PMI) currently claims that its heated tobacco product, IQOS, reduces health risk by reducing users’ exposure to harmful and potentially harmful constituents present in tobacco smoke. Given...

IQOS: examination of Philip Morris International’s claim of reduced exposure

BackgroundNew electronic heated tobacco products are being introduced in the global market and are gaining popularity. In 2016, Philip Morris International, Inc. (PMI) submitted a modified risk tobacco product (MRTP)...

IQOS labelling will mislead consumers

BackgroundPhilip Morris International (PMI) continually expands and diversifies their nicotine product portfolio, which includes IQOS, a heated tobacco product. In December 2016, PMI filed a modified risk tobacco product (MRTP)...

Assessment of industry data on pulmonary and immunosuppressive effects of IQOS

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...

Possible hepatotoxicity of IQOS

On 25 January 2018, the Food and Drug Administration (FDA) Tobacco Scientific Advisory Committee unanimously voted (with one abstention) that Phillip Morris International (PMI) could not claim their heated tobacco...

Heat-not-Burn Tobacco Products: Tobacco Industry Claims No Substitute for Science.

* Abbreviations: FDA — : US Food and Drug Administration HNB — : heat-not-burn IQOS — : I Quit Ordinary Smoking In the wake of the rapid rise of e-cigarettes over the past decade, the tobacco industry has launched its latest response to the documented harms of cigarette smoking: heat-not-burn (HNB) tobacco products. Philip Morris International created and is heavily marketing their version of these products, called the IQOS (I Quit Ordinary Smoking), which involves disposable tobacco sticks soaked in propylene glycol that are inserted into a holder in the HNB cigarette. Philip Morris markets these products as being “designed to create a flavorful and satisfying nicotine-containing vapor, without burning and without smoke.”1 Advertisements claim this product releases no smoke because the tobacco leaves are heated rather than burned, with no tobacco combustion. Claims and distracting wording, however, are no substitute for science. The authors of a recent report have shown that these tobacco products release cancer-causing chemicals.2 The IQOS is not yet sold in the United States, but in December 2016, Philip Morris submitted a modified risk tobacco product application to the US Food and Drug Administration (FDA). If its application is successful, Philip Morris will face looser restrictions in marketing HNB tobacco products than it does for conventional tobacco cigarettes. Moreover, Philip Morris seeks to make affirmative safety statements on packaging and advertising for IQOS, including “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.”3 … Address correspondence to Brian P. Jenssen, MD, MSHP, Department of Pediatrics, PolicyLab, The Children’s Hospital of Philadelphia, 2716 South St, Philadelphia, PA 19146. E-mail: jenssenb{at}email.chop.edu

Perceptions of harm and addiction of snus: An exploratory study.

Tobacco companies in the United States are prohibited from making reduced harm claims without filing a modified risk tobacco product application with the Food and Drug Administration and obtaining an order to market as such. However, it is possible that product marketing may suggest reduced risk to individuals. This study examines perceptions, in particular those related to harm and addiction, of snus print advertisements using a combination of eye-tracking, survey, and semistructured interviews. Participants were 22 male smokers ages 19-29 (M = 26.64, SD = 2.92). Five snus advertisements were each displayed for 20 s and eye movements were tracked. Participants responded to questions about harm and addiction after each advertisement and interviews were conducted after seeing all advertisements. For each advertisement, descriptive statistics were calculated and regression analyses predicted harm and addiction perceptions from eye tracking areas of interest (e.g., warning label). Qualitative data were analyzed using inductive/deductive thematic analysis. For certain advertisements, areas of interest were significantly associated with harm and/or addiction perceptions. For example, higher total fixation duration on the graphic in the Smokeless for Smokers advertisement was associated with decreased perceptions of addiction (B = -.360, p = .048). Qualitative themes emerged and in many instances corroborated quantitative results. This study indicates that for some advertisements, attention on certain areas (measured through eye tracking) is associated with perceptions among young male smokers. Understanding how smokers perceive and understand products after viewing advertisements may inform regulations regarding claims about product harm and addiction and may guide public health efforts to educate smokers on the risks of emerging products. (PsycINFO Database Record

Associations of Proposed Relative-Risk Warning Labels for Snus With Perceptions and Behavioral Intentions Among Tobacco Users and Nonusers.

The US Food and Drug Administration can require changes in warning statements for modified risk tobacco products. We report an independent analysis of a consumer perception survey sponsored by Swedish Match as part of a Modified Risk Tobacco Product application to change warning labels for Swedish snus products. The survey exposed each of 4324 daily exclusive cigarette smokers, 1033 daily smokeless tobacco users, 1205 daily other tobacco users, 726 former users, and 5915 triers/never users to one of four current warnings and two proposed relative-risk labels (No tobacco product is safe, but this product presents lower risks to health than cigarettes, or No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes) for snus. Descriptive and logistic regression analyses examined four outcomes: believability, harmfulness, motivation to use, and intention to buy snus. Compared with the current not-safe-alternative warning, adult tobacco users who viewed the proposed labels perceived them as less believable, perceived snus as less harmful and were more likely to use and buy snus. The proposed labels had no impact on former smokers' likelihood to use and buy snus; triers/never users viewing the substantially lower risk label were more likely to buy snus. Tobacco users viewing the proposed labels perceived snus as less harmful than cigarettes and may be more likely to use and buy snus. If labeling changes lead to increased snus use and cigarette reduction or abstinence, public health may benefit. If the opposite occurs, public health could suffer.