Perceptions
Conditions
Keywords
CBD, Cannabidiol, Marketing, Health claims
Brief summary
Over 46 million US adults report use of cannabidiol (CBD), primarily to treat medical ailments. The growing CBD market spans the range of products that the US Food and Drug Administration (FDA) regulates including drugs, dietary supplements, food/beverages and cosmetics. CBD cannot be marketed as having therapeutic benefits (without FDA's approval), be false or misleading to consumers, or convey the products are approved or endorsed by the FDA. In addition, CBD cannot be marketed as a food additive or dietary supplement since it is an active ingredient in an approved drug, Epidiolex. Despite this, CBD products have been illicitly advertised to consumers with these claims including unsubstantiated health claims that promote benefits including curing cancer and preventing Alzheimer's disease. These types of claims may reduce perceptions of harm and increase perceived benefits of use. This study aims to evaluate how consumers perceive real-world CBD advertisements. To that end, we will implement an online survey and randomize adult participants (ages 18-65) to see various advertisements made about CBD to determine if they interpret advertisements as making health claims that are currently prohibited by the FDA.
Detailed description
Cannabidiol (CBD) products have rapidly gained popularity, spanning the retail market with a range of products that the US Food and Drug Administration (FDA) regulates including drugs, dietary supplements, food/beverages and cosmetics. The FDA mandates that CBD cannot be marketed as having therapeutic benefits (without FDA's approval), be false or misleading to consumers, or convey the products are approved or endorsed by the FDA. In addition, CBD cannot be marketed as a food additive or dietary supplement since it is an active ingredient in an approved drug, Epidiolex. Despite this, CBD products have been unlawfully advertised to consumers with these claims including unsubstantiated health claims that promote benefits including curing cancer and preventing Alzheimer's disease and providing chronic pain relief. This project, focused on informing regulatory actions for CBD, aims to evaluate consumer perceptions of real-world health claims documented in brick and mortar CBD retailers in three US states. Setting: The survey will be a single online experiment with one survey. The survey will last approximately 20 minutes. Recruitment: Adult CBD and non-CBD users, ages 18-65, will be recruited through NORC, an online survey panel company. Interested prospective participants will complete a screening questionnaire to determine their eligibility. If eligible, NORC will invite them to enroll in the study. Approximately 3525 participants will complete the study. Informed consent: Participants will provide online consent prior to the main survey, after determining eligibility. Randomization: After providing informed consent, participants will be randomly assigned to one of eleven panels. Participants will have an equal chance of being randomized to any of the eleven panels. Each panel will view 5 advertisements about CBD that was documented in a CBD retailer in the US. Assessment: Participants in the study will complete one survey that will take approximately 20 minutes. During the survey, participants will view 5 advertisements about CBD. Participants will be randomized to 1 of 11 panels, each containing 5 different advertisements. Within each panel, participants will be randomized to the order of the images they see and will be asked a series of questions after each advertisement to determine the appeal CBD and if they perceive the ad to be making health claims that are prohibited by the US FDA. After viewing all 5 ads in their assigned panel, participants will complete measures assessing outcome expectancies of CBD use, perceived benefits of daily CBD use, and willingness to try CBD (non-users only).
Interventions
Participants will view the 5 images of CBD advertisements in their assigned panel and answer questions about their perceptions of the advertisement.
Sponsors
Study design
Intervention model description
Conduct a cross-sectional online survey with a nationally representative probability-based sample of adults, ages 18-65 to assess consumer perceptions of 55 documented advertisements about CBD. Participants will be randomly assigned to 1 of 11 panels that each contain 5 advertisements about CBD.
Eligibility
Inclusion criteria
* Age 18-65 * US Residents * Satisfies one of the following categories: 1. Current CBD users 2. Ever CBD users 3. Non-CBD users * Members of the AmeriSpeak™ panel
Exclusion criteria
* Non-English speakers * Younger than 18 or older than 65 * Not US residents * Not members of the AmeriSpeak™ panel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Claim Scores | Minute 15 | The primary outcome is consumer perception of the claims in the ads (n=55) and whether perceptions of prohibited claims vary by CBD use status. After viewing each of the 5 assigned ads participants will respond to six items that assess their perception of the prohibited claims made in the ads, including 1) drug effect 2) FDA approved/ endorsed 3) dietary supplement 4) food additive 5) false/misleading (scientific) and 6) false/misleading (targeting youth). The Study Team will use a 5-point response scale, (1) Not at all to (5) Extremely to assess perception of each prohibited claim type. For each use status group, the Study Team will report the overall mean score (all ads together) for each claim type to indicate if perception of prohibited claims differed by use status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Product Safety Scores | Minute 15 | For each ad that the participant views (n=5), the Participant will respond to a one-item measure that assesses the extent to which the participant perceives that CBD is safe to consume. Response options are on a 1 to 5 scale, with higher scores representing more perceived safety (i.e. 1- Not at all safe to 5- Extremely safe). For each use status group, the Study Team will report the mean score of perceived safety to indicate if the perceived safety of CBD in the advertisements differed by use status. |
| Appeal Scores | Minute 15 | For each ad that the participant views (n=5), the Participant will respond to a one-item measure to assess the extent to which the ad makes CBD appealing to them. Response options are on a 1 to 5 scale, with higher scores representing more appeal (i.e. 1- Not at all appealing to 5- Extremely appealing). For each use status group, the Study Team will report the mean score of appeal to indicate if the appeal of CBD in the advertisements differed by use status. |
Countries
United States
Contacts
Wake Forest University Health Sciences
Participant flow
Recruitment details
21 people were consented but dropped out of the study prior to being assigned a panel. 428 people were excluded from analysis due to poor data quality: The excluded ppts did not meet sufficient completion criteria. Participants must have met both of the following criteria to be included in the study: 1) at least 75% of the outcome variables answered (not skipped) and 2) survey completion time of \> 5min
Participants by arm
| Arm | Count |
|---|---|
| Panel 1 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 262 |
| Panel 2 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 281 |
| Panel 3 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 276 |
| Panel 4 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 262 |
| Panel 5 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 289 |
| Panel 6 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 280 |
| Panel 7 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 253 |
| Panel 8 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 266 |
| Panel 9 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 302 |
| Panel 10 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 312 |
| Panel 11 This panel consists of 5 photos that were found in CBD retail assessments. Photos were coded as at least one of six FDA prohibited claim types or contained product descriptors that may be potentially misleading to consumers. Photos did not differ substantially between panels and panels were only used to reduce participant burden, as 55 photos were to be included in the survey | 293 |
| Total | 3,076 |
Baseline characteristics
| Characteristic | Total | Panel 1 | Panel 2 | Panel 3 | Panel 4 | Panel 5 | Panel 6 | Panel 7 | Panel 8 | Panel 9 | Panel 10 | Panel 11 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 13.5 | 42.4 years STANDARD_DEVIATION 13.1 | 43.8 years STANDARD_DEVIATION 12.8 | 43.5 years STANDARD_DEVIATION 13.8 | 43.9 years STANDARD_DEVIATION 13.7 | 43.9 years STANDARD_DEVIATION 14.3 | 43.2 years STANDARD_DEVIATION 13.1 | 43.7 years STANDARD_DEVIATION 13.8 | 43.9 years STANDARD_DEVIATION 13.3 | 44.0 years STANDARD_DEVIATION 13.4 | 43.8 years STANDARD_DEVIATION 14 | 43.1 years STANDARD_DEVIATION 13.5 |
| Education Level Bachelor's Degree | 763 Participants | 70 Participants | 72 Participants | 57 Participants | 63 Participants | 55 Participants | 66 Participants | 74 Participants | 75 Participants | 65 Participants | 89 Participants | 77 Participants |
| Education Level HS graduate or equivalent | 514 Participants | 43 Participants | 56 Participants | 48 Participants | 41 Participants | 53 Participants | 49 Participants | 33 Participants | 34 Participants | 55 Participants | 48 Participants | 54 Participants |
| Education Level Less than High School | 198 Participants | 15 Participants | 13 Participants | 26 Participants | 17 Participants | 23 Participants | 20 Participants | 13 Participants | 15 Participants | 13 Participants | 19 Participants | 24 Participants |
| Education Level Post grad study/professional degree | 475 Participants | 36 Participants | 53 Participants | 46 Participants | 37 Participants | 43 Participants | 36 Participants | 44 Participants | 48 Participants | 54 Participants | 37 Participants | 41 Participants |
| Education Level Vocational/tech school/some college/associates | 1126 Participants | 98 Participants | 87 Participants | 99 Participants | 104 Participants | 115 Participants | 109 Participants | 89 Participants | 94 Participants | 115 Participants | 119 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 416 Participants | 44 Participants | 34 Participants | 49 Participants | 29 Participants | 51 Participants | 26 Participants | 36 Participants | 36 Participants | 39 Participants | 38 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2660 Participants | 218 Participants | 247 Participants | 227 Participants | 233 Participants | 238 Participants | 254 Participants | 217 Participants | 230 Participants | 263 Participants | 274 Participants | 259 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 17 Participants | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 118 Participants | 11 Participants | 15 Participants | 6 Participants | 15 Participants | 8 Participants | 7 Participants | 7 Participants | 10 Participants | 14 Participants | 15 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 414 Participants | 35 Participants | 26 Participants | 34 Participants | 31 Participants | 46 Participants | 37 Participants | 33 Participants | 39 Participants | 40 Participants | 48 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 150 Participants | 8 Participants | 13 Participants | 15 Participants | 13 Participants | 20 Participants | 10 Participants | 15 Participants | 16 Participants | 12 Participants | 12 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 9 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 126 Participants | 11 Participants | 10 Participants | 19 Participants | 8 Participants | 13 Participants | 8 Participants | 10 Participants | 9 Participants | 12 Participants | 15 Participants | 11 Participants |
| Race (NIH/OMB) White | 2242 Participants | 195 Participants | 213 Participants | 199 Participants | 195 Participants | 202 Participants | 214 Participants | 187 Participants | 190 Participants | 220 Participants | 216 Participants | 211 Participants |
| SES $10,000 to less than $25,000 | 343 Participants | 20 Participants | 42 Participants | 32 Participants | 32 Participants | 27 Participants | 33 Participants | 25 Participants | 33 Participants | 34 Participants | 30 Participants | 35 Participants |
| SES $25,000 to less than $50,000 | 630 Participants | 44 Participants | 48 Participants | 51 Participants | 60 Participants | 64 Participants | 61 Participants | 52 Participants | 49 Participants | 70 Participants | 67 Participants | 64 Participants |
| SES $50,000 to less than $75,000 | 573 Participants | 59 Participants | 54 Participants | 60 Participants | 47 Participants | 56 Participants | 59 Participants | 40 Participants | 46 Participants | 50 Participants | 50 Participants | 52 Participants |
| SES $75,000 to less than $100,000 | 438 Participants | 37 Participants | 43 Participants | 33 Participants | 31 Participants | 52 Participants | 40 Participants | 47 Participants | 39 Participants | 31 Participants | 43 Participants | 42 Participants |
| SES Less than $10,000 | 144 Participants | 9 Participants | 9 Participants | 19 Participants | 9 Participants | 17 Participants | 14 Participants | 6 Participants | 16 Participants | 12 Participants | 18 Participants | 15 Participants |
| SES More than $100,000 | 948 Participants | 93 Participants | 85 Participants | 81 Participants | 83 Participants | 73 Participants | 73 Participants | 83 Participants | 83 Participants | 105 Participants | 104 Participants | 85 Participants |
| Sex/Gender, Customized Current Gender Female | 1632 Participants | 132 Participants | 156 Participants | 146 Participants | 142 Participants | 159 Participants | 143 Participants | 142 Participants | 140 Participants | 157 Participants | 159 Participants | 156 Participants |
| Sex/Gender, Customized Current Gender Male | 1353 Participants | 121 Participants | 119 Participants | 121 Participants | 113 Participants | 121 Participants | 131 Participants | 105 Participants | 119 Participants | 133 Participants | 142 Participants | 128 Participants |
| Sex/Gender, Customized Current Gender Transgender | 18 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants |
| Sex/Gender, Customized Did not answer | 54 Participants | 7 Participants | 4 Participants | 6 Participants | 4 Participants | 6 Participants | 4 Participants | 3 Participants | 1 Participants | 6 Participants | 7 Participants | 6 Participants |
| Sex/Gender, Customized None of the Above Genders | 19 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 2 Participants |
| Sex/Gender, Customized Sex assigned at birth Did not answer | 64 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 7 Participants | 5 Participants | 3 Participants | 2 Participants | 8 Participants | 7 Participants | 10 Participants |
| Sex/Gender, Customized Sex assigned at birth Female | 1640 Participants | 134 Participants | 157 Participants | 146 Participants | 143 Participants | 157 Participants | 144 Participants | 142 Participants | 142 Participants | 160 Participants | 160 Participants | 155 Participants |
| Sex/Gender, Customized Sex assigned at birth Male | 1372 Participants | 122 Participants | 119 Participants | 124 Participants | 114 Participants | 125 Participants | 131 Participants | 108 Participants | 122 Participants | 134 Participants | 145 Participants | 128 Participants |
| State Cannabis policy CBD/Low THC states | 663 Participants | 54 Participants | 61 Participants | 62 Participants | 58 Participants | 65 Participants | 59 Participants | 52 Participants | 53 Participants | 72 Participants | 68 Participants | 59 Participants |
| State Cannabis policy Medical and Recreational states | 1686 Participants | 151 Participants | 149 Participants | 135 Participants | 145 Participants | 163 Participants | 155 Participants | 143 Participants | 143 Participants | 161 Participants | 172 Participants | 169 Participants |
| State Cannabis policy Medical only states | 639 Participants | 48 Participants | 62 Participants | 71 Participants | 54 Participants | 53 Participants | 57 Participants | 54 Participants | 60 Participants | 62 Participants | 62 Participants | 56 Participants |
| State Cannabis policy No cannabis access states | 88 Participants | 9 Participants | 9 Participants | 8 Participants | 5 Participants | 8 Participants | 9 Participants | 4 Participants | 10 Participants | 7 Participants | 10 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,008 | 0 / 1,053 | 0 / 1,015 |
| other Total, other adverse events | 0 / 1,008 | 0 / 1,053 | 0 / 1,015 |
| serious Total, serious adverse events | 0 / 1,008 | 0 / 1,053 | 0 / 1,015 |
Outcome results
Perceived Claim Scores
The primary outcome is consumer perception of the claims in the ads (n=55) and whether perceptions of prohibited claims vary by CBD use status. After viewing each of the 5 assigned ads participants will respond to six items that assess their perception of the prohibited claims made in the ads, including 1) drug effect 2) FDA approved/ endorsed 3) dietary supplement 4) food additive 5) false/misleading (scientific) and 6) false/misleading (targeting youth). The Study Team will use a 5-point response scale, (1) Not at all to (5) Extremely to assess perception of each prohibited claim type. For each use status group, the Study Team will report the overall mean score (all ads together) for each claim type to indicate if perception of prohibited claims differed by use status.
Time frame: Minute 15
Population: participants were pre-specified to be reported per CBD user status
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Current CBD Users | Perceived Claim Scores | Drug Effect | 2.96 score on a scale | Standard Error 0.02 |
| Current CBD Users | Perceived Claim Scores | FDA | 2.03 score on a scale | Standard Error 0.03 |
| Current CBD Users | Perceived Claim Scores | False and Misleading (Youth) | 2.68 score on a scale | Standard Error 0.02 |
| Current CBD Users | Perceived Claim Scores | Dietary Supplement | 2.44 score on a scale | Standard Error 0.02 |
| Current CBD Users | Perceived Claim Scores | Food Additive | 2.32 score on a scale | Standard Error 0.03 |
| Current CBD Users | Perceived Claim Scores | False and Misleading (Science) | 2.57 score on a scale | Standard Error 0.03 |
| Ever CBD Users | Perceived Claim Scores | Food Additive | 2.06 score on a scale | Standard Error 0.02 |
| Ever CBD Users | Perceived Claim Scores | False and Misleading (Science) | 2.27 score on a scale | Standard Error 0.02 |
| Ever CBD Users | Perceived Claim Scores | Dietary Supplement | 2.23 score on a scale | Standard Error 0.02 |
| Ever CBD Users | Perceived Claim Scores | Drug Effect | 2.81 score on a scale | Standard Error 0.02 |
| Ever CBD Users | Perceived Claim Scores | False and Misleading (Youth) | 2.55 score on a scale | Standard Error 0.02 |
| Ever CBD Users | Perceived Claim Scores | FDA | 1.76 score on a scale | Standard Error 0.02 |
| Non CBD Users | Perceived Claim Scores | False and Misleading (Youth) | 2.57 score on a scale | Standard Error 0.02 |
| Non CBD Users | Perceived Claim Scores | Drug Effect | 2.71 score on a scale | Standard Error 0.03 |
| Non CBD Users | Perceived Claim Scores | Dietary Supplement | 2.18 score on a scale | Standard Error 0.02 |
| Non CBD Users | Perceived Claim Scores | Food Additive | 2.00 score on a scale | Standard Error 0.02 |
| Non CBD Users | Perceived Claim Scores | False and Misleading (Science) | 2.11 score on a scale | Standard Error 0.02 |
| Non CBD Users | Perceived Claim Scores | FDA | 1.64 score on a scale | Standard Error 0.02 |
Appeal Scores
For each ad that the participant views (n=5), the Participant will respond to a one-item measure to assess the extent to which the ad makes CBD appealing to them. Response options are on a 1 to 5 scale, with higher scores representing more appeal (i.e. 1- Not at all appealing to 5- Extremely appealing). For each use status group, the Study Team will report the mean score of appeal to indicate if the appeal of CBD in the advertisements differed by use status.
Time frame: Minute 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Current CBD Users | Appeal Scores | 2.82 score on a scale | Standard Error 0.02 |
| Ever CBD Users | Appeal Scores | 2.42 score on a scale | Standard Error 0.02 |
| Non CBD Users | Appeal Scores | 1.81 score on a scale | Standard Error 0.02 |
Perceived Product Safety Scores
For each ad that the participant views (n=5), the Participant will respond to a one-item measure that assesses the extent to which the participant perceives that CBD is safe to consume. Response options are on a 1 to 5 scale, with higher scores representing more perceived safety (i.e. 1- Not at all safe to 5- Extremely safe). For each use status group, the Study Team will report the mean score of perceived safety to indicate if the perceived safety of CBD in the advertisements differed by use status.
Time frame: Minute 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Current CBD Users | Perceived Product Safety Scores | 3.34 score on a scale | Standard Error 0.02 |
| Ever CBD Users | Perceived Product Safety Scores | 3.11 score on a scale | Standard Error 0.02 |
| Non CBD Users | Perceived Product Safety Scores | 2.92 score on a scale | Standard Error 0.03 |
Outcome Expectancies Scores
Ten items will measure participants' perceptions about the possible effects of CBD. Response items are on a 1 to 5 scale, with higher scores representing more agreement with the stated effect (i.e. 1- Strongly disagree to 5- Strongly agree).
Time frame: Minute 15
Perceived Benefit Scores
Seventeen items will measure participants' perceived benefits of daily CBD use to treat various medical conditions. Response items are on a 1 to 4 scale (1-Worsen the condition; 2- No effect on the condition; 3-Improve the condition; 4- I don't know)
Time frame: Minute 15
Willingness to Try Cannabidiol (CBD) (Non-CBD Users Only) Scores
One item will be used to measure non-user's willingness to try CBD. Response items are on a 1 to 5 scale, with higher scores representing more likelihood to try CBD (i.e. 1- Extremely Unlikely to 5- Extremely Likely)
Time frame: Minute 15