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Impact of FDA endorsement and modified risk versus exposure messaging in IQOS ads: a randomised factorial experiment among US and Israeli adults
  1. Carla J Berg1,
  2. Zongshuan Duan1,
  3. Yan Wang1,
  4. James F Thrasher2,
  5. Yael Bar-Zeev3,
  6. Lorien C Abroms1,
  7. Katelyn F Romm4,
  8. Amal Khayat3,
  9. Hagai Levine3
  1. 1Department of Prevention and Community Health, The George Washington University Milken Institute School of Public Health, Washington, District of Columbia, USA
  2. 2Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, South Carolina, USA
  3. 3Braun School of Public Health and Community Medicine, Faculty of Medicine, The Hebrew University of Jerusalem and Hadassah, Jerusalem, Israel
  4. 4Department of Pediatrics, College of Medicine; TSET Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA
  1. Correspondence to Dr Carla J Berg, Prevention and Community Health, The George Washington University Milken Institute of Public Health, Washington 20052, District of Columbia, USA; carlaberg{at}


Background IQOS was the first heated tobacco product to receive Food and Drug Administration (FDA) authorisation for ‘reduced exposure’ marketing claims, which has been exploited globally.

Methods In November–December 2021, we conducted a survey-based 3×3 factorial experiment among US (n=1128) and Israeli adults (n=1094). We presented: (1) reduced exposure, reduced risk and control messaging and (2) 2 variations of FDA endorsement and control messaging. Each participant was randomly assigned to evaluate 2 ads (displayed on different ad imagery), then completed assessments of perceived relative harm, exposure and disease risk and likelihood of personally trying or suggesting IQOS to smokers. Ordinal logistic regression examined messaging conditions and their interactions, on the 5 outcomes, respectively, adjusting for covariates.

Results Control (vs reduced exposure) messaging resulted in higher perceived relative harm (adjusted OR (aOR)=1.29, 95% CI=1.12 to 1.48), exposure (aOR=1.34, 95% CI=1.17 to 1.54) and disease risk (aOR=1.23; 95% CI=1.08 to 1.40), and lower likelihood of suggesting IQOS to smokers (aOR=0.85; 95% CI=0.74 to 0.97). Reduced risk (vs exposure) messaging resulted in lower perceived relative harm (aOR=0.86; 95% CI=0.75 to 0.99). One FDA endorsement message (‘IQOS (completed) the US FDA examination of tobacco products. FDA concluded that IQOS is a better choice for adult smokers’) was associated with greater likelihood of suggesting IQOS to smokers, relative to control (aOR=1.19; 95% CI=1.04 to 1.37). No interactions between risk/exposure messaging and FDA endorsement messaging were found. Additionally, Israeli participants, cigarette users and men perceived lower relative harm and exposure and greater likelihood of trying or suggesting IQOS to smokers.

Conclusions Regulators must monitor direct and indirect advertising content of modified risk tobacco product-authorised products and prevent potentially harmful misinterpretations.

  • advertising and promotion
  • harm reduction
  • media
  • packaging and labelling
  • non-cigarette tobacco products

Data availability statement

Data are available on reasonable request.

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  • Contributors HL, YB-Z, LCA and CJB designed the study, obtained grant funding and oversaw project administration. ZD, AK, JFT, KFR and YW contributed to study design and methodology. HL, ZD and CJB analysed the data and wrote the draft manuscript. All authors reviewed the manuscript and confirm the approval of the submitted manuscript. CJB accepts full responsibility for the finished work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

  • Funding This work was supported by the US National Cancer Institute (R01CA239178-01A1; Multiple Principal Investigators [MPIs]: CJB, HL). CJB is also supported by other US National Institutes of Health funding, including the National Cancer Institute (R01CA215155-01A1; Principal Investigator [PI]: CJB; R01CA179422-01; PI: CJB), the Fogarty International Center (R01TW010664-01; MPIs: CJB, Kegler), the National Institute of Environmental Health Sciences/Fogarty (D43ES030927-01; MPIs: CJB, Caudle, Sturua) and the National Institute on Drug Abuse (R01DA054751-01A1; MPIs: CJB, Cavazos-Rehg). KFR is supported by the National Institute on Drug Abuse (F32DA055388-01; PI: KFR; R25DA054015; MPIs: Obasi, Reitzel), the Oklahoma Tobacco Settlement Endowment Trust (TSET) contract #R22-03, and the National Cancer Institute grant awarded to the Stephenson Cancer Center (P30CA225520).

  • Competing interests HL had received fees for lectures from Pfizer Israel Ltd (distributor of a smoking cessation pharmacotherapy in Israel) in 2017. YB-Z has received fees for lectures from Pfizer, Novartis NCH and GSK Consume Health (distributors of pharmacotherapy in Israel) in the past (2012–July 2019). LCA receives royalties for the sale of Text2Quit. No other conflicts of interest are declared.

  • Patient and public involvement statement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.