Effects of FDA Authorized Smokeless Tobacco Claims Among US Adults Who Smoke Cigarettes

This study will be an online survey experiment conducted with adults who smoke cigarettes (ages 21+) to examine their reactions to modified risk advertising claims authorized by the Food & Drug Administration (FDA) for two smokeless tobacco brands (General Snus and Copenhagen), which describe the lower risks of these products compared to cigarette smoking. The study will compare effects of ads with different two different claim types (i.e. claims about reduced lung cancer risk and claims about reduced risks for multiple disease) versus ads with no reduced-risk claims, and examine effects on message and product perceptions, and interest in using the smokeless tobacco products. This study will also examine how smokers' reactions/interest may vary based on the product brand, and asses prior awareness/exposure to the authorized claims.

Study Overview

• Status: Completed
• Conditions: Tobacco Product Beliefs and Use
• Intervention / Treatment: Behavioral: Modified Risk Claim Type - None; Behavioral: Product Brand - General Snus; Behavioral: Modified Risk Claim Type - Multiple Diseases; Behavioral: Modified Risk Claim Type - Lung Cancer; Behavioral: Product Brand - Copenhagen

• Study Type: Interventional
• Enrollment (Actual): 1257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Institute for Nicotine & Tobacco Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults (age 21 and over) who are current established cigarettes smokers (i.e., smoked 100 cigarettes in their lifetime and now smoke every day or somedays), based in the US, members of Ipsos' KnowledgePanel, and have chosen to complete their research panel surveys in English

Exclusion Criteria:

• Panel participants who do not meet the criteria outlined above will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1 (General Snus-Control Ads); Participants in this group will view 4 ads for the brand General Snus that do not include a modified risk claim.	Behavioral: Modified Risk Claim Type - None; Participants will view smokeless tobacco ads with no modified risk claim (control); Behavioral: Product Brand - General Snus; Participants will views ads for the smokeless tobacco brand General Snus
Experimental: Group 2 (General Snus-Multiple Disease Ads); Participants in this group will view 4 ads for the brand General Snus that include a modified risk claim about the lower risk of multiple diseases.	Behavioral: Product Brand - General Snus; Participants will views ads for the smokeless tobacco brand General Snus; Behavioral: Modified Risk Claim Type - Multiple Diseases; Participants will view smokeless tobacco ads with a claim about lower risks for multiple diseases
Experimental: Group 3 (General Snus- Lung Ads); Participants in this group will view 4 ads for the brand General Snus that include a modified risk claim about the lower risk of lung cancer only.	Behavioral: Product Brand - General Snus; Participants will views ads for the smokeless tobacco brand General Snus; Behavioral: Modified Risk Claim Type - Lung Cancer; Participants will either view smokeless tobacco ads with a modified risk claim about lower risks for lung cancer only
Experimental: Group 4 (Copenhagen-Control Ads); Participants in this group will view 4 ads for the brand Copenhagen that do not include a modified risk claim.	Behavioral: Modified Risk Claim Type - None; Participants will view smokeless tobacco ads with no modified risk claim (control); Behavioral: Product Brand - Copenhagen; Participants will views ads for the smokeless tobacco brand Copenhagen
Experimental: Group 5 (Copenhagen-Multiple Disease Ads); Participants in this group will view 4 ads for the brand Copenhagen that include a modified risk claim about the lower risk of multiple diseases.	Behavioral: Modified Risk Claim Type - Multiple Diseases; Participants will view smokeless tobacco ads with a claim about lower risks for multiple diseases; Behavioral: Product Brand - Copenhagen; Participants will views ads for the smokeless tobacco brand Copenhagen
Experimental: Group 6 (Copenhagen- Lung Ads); Participants in this group will view 4 ads for the brand Copenhagen that include a modified risk claim about the lower risk of lung cancer only.	Behavioral: Modified Risk Claim Type - Lung Cancer; Participants will either view smokeless tobacco ads with a modified risk claim about lower risks for lung cancer only; Behavioral: Product Brand - Copenhagen; Participants will views ads for the smokeless tobacco brand Copenhagen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Relative Harm Perception	Single item measure asking participants how harmful they think daily use of the viewed smokeless tobacco product would be to their health compared to daily cigarette smoking, (1=a lot less harmful, 2=somewhat less harmful, 3=about the same, 4=somewhat more harmful, 5=a lot more harmful). Higher scores mean thinking the viewed smokeless tobacco product is more harmful than cigarettes.	Assessed in survey measures completed immediately after viewing the study stimuli
Perceptions of Perceived Relative Risks of Diseases	Assessment of perceived risks of getting various smoking related diseases from using the viewed smokeless tobacco product versus from smoking cigarettes. Responses to 6 parallel questions (each asking about a different disease) were averaged together in this composite item. The question stated: "If you used only [General Snus/Copenhagen - inserted based on brand condition] or only cigarettes every day, which product would make it more likely that you would get": 1) lung cancer; 2) heart disease; 3) mouth cancer; 4) stroke; 5) chronic bronchitis; 6) emphysema. Response options to each were on a 5 point scale from (1=much more likely with General Snus/Copenhagen to 5=much more likely with cigarettes). Results presented here are based on the averages responses to the six items. Higher scores mean thinking risks are greater from smoking cigarettes than from using the viewed smokeless tobacco product.	Assessed in survey measures completed immediately after viewing the study stimuli
Absolute Harm Perception	Single item measure asking participants how likely or unlikely they think the viewed smokeless tobacco product would be to cause serious health problems during their lifetime, if they used it every day (from 1=not at all likely to 5=extremely likely). Higher scores mean greater likelihood of thinking the product is harmful to health.	Assessed in survey measures completed immediately after viewing the study stimuli
Product Use Intentions	Assessment of intentions to use the viewed smokeless tobacco products based on averaging responses to three parallel questions: "Thinking about the ads you saw for [General Snus or Copenhagen] products, how interested, in the next 6 months, would you be in: 1) Using or trying these products? 2) Using these products as a way to quit or cut down on your cigarette smoking? 3) Completely switching from cigarettes to these products? Response options to each were on a 5 point scale from (1=not at all interested to 5=extremely interested). Results presented here are based on the averaged responses to these three items. Higher scores mean greater interest in using the products.	Assessed in survey measures completed immediately after viewing the study stimuli

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Message Recall	Participants are asked to recall (yes/no) if the ads they viewed include any statement saying that using the product can lower risks of certain diseases.	Assessed in survey measures completed immediately after viewing the study stimuli
Ad Persuasiveness	A composite measure based on the average of 6 advertisement perceptions, asking participants to rate whether they agreed or disagreed that they ads they viewed: 1) included important information; 2) were understandable; 3) included believable information; 4) included credible information; 5) included information new to me; 6) make me want to learn more about those products. Response options were on a 6 point agreement scale from 1=strongly disagree to 6=strongly agree. Higher scores mean greater agreement that the ads were effective and persuasive.	Assessed in survey measures completed immediately after viewing the study stimuli
Claim Believability & Credibility	A composite measure based on the average of 2 claim perception items, asking participants to rate whether they agreed or disagreed that the modified-risk claim in the ads they viewed was : 1) believable 2) credible. Participants responded to this while seeing the claim again on the survey screen. Response options were on a 7 point agreement scale from 1=strongly disagree to 7=strongly agree. Higher scores mean greater agreement that the claims were believable and credible.	Assessed in survey measures completed immediately after viewing the study stimuli
Overall Perceived Claim Persuasiveness	A composite measure based on the average of 7 claim perception items, asking participants to rate whether they agreed or disagreed that the modified-risk claim in the ads they viewed was : 1) believable; 2) credible; 3) important; 4) new to me; 5) makes me think using this product could be less harmful to my health than smoking; 6) makes me more interested in trying this product; 7) would make me think seriously about completely switching to this product. Participants responded to this while seeing the claim again on the survey screen. Response options were on a 7 point agreement scale from 1=strongly disagree to 7=strongly agree. Higher scores mean greater agreement that participants thought the claim was persuasive/effective.	Assessed in survey measures completed immediately after viewing the study stimuli
Switching Comprehension	An item assessing participants' understanding of the need to completely switch to the smokeless tobacco product viewed in order to reduce risks. It said: Please answer the next question based on your understanding of the ads you viewed earlier. Based on the ads, [General Snus OR Copenhagen, inserted based on condition] can reduce a smoker's health risks if you: (Select all that apply); Use only [General Snus/Copenhagen] and not smoke any cigarettes anymore; Use [General Snus/Copenhagen] and smoke fewer cigarettes than before; Use both products ([General Snus/Copenhagen] and cigarettes) about equally; None of the above; I don't know/not sure	Assessed in survey measures completed immediately after viewing the study stimuli

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Olivia A Wackowski, PhD, MPH, Rutgers University

Publications and helpful links

Helpful Links

• Information about FDA's authorization of modified risk order for Copenhagen snuff
• Information about FDA's authorization of modified risk order for General Snus products

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2025
• Primary Completion (Actual): May 4, 2025
• Study Completion (Actual): May 4, 2025

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: smokeless tobacco; snus; moist snuff; tobacco advertising; modified risk claims
• Additional Relevant MeSH Terms: Behavior; Tobacco Use
• Other Study ID Numbers: Pro2024000097; R21CA289541 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study ad stimuli, survey instrument, codebook, and de-identified dataset will be deposited to a data repository - we anticipate this will be the National Addiction and HIV Data Archive Program (NAHDAP), currently managed by ICPSR at the University of Michigan.
• IPD Sharing Time Frame: The scientific community will be able to access the data at the end of the award period. All publications using the data will also reference the data location in NAHDAP/ICSPR using DOIs. ICPSR engages in long-term preservation of the research data upon receipt of a signed deposit form, including migration to new formats, platforms, and storage media as required. ICPSR has a commitment to designate a successor repository in the unlikely event that such a need arises.
• IPD Sharing Access Criteria: To request access, interested researchers will use the standard processes at NAHDAP/ICSPR for requesting data.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No