Attachment A_Campaign Backgrounds 10.6.20.pdf

“THE REAL COST” ENDS CAMPAIGN

BACKGROUND INFORMATION

• Campaign Overview

• Formative Research Insights

• Sample Creative, Website and Social Media Platforms

OVERVIEW

FDA is expanding its award-winning youth tobacco prevention campaign, “The Real Cost,” with advertising designed to reach and educate the 10.7 million teens who have used e-cigarettes or are thinking about trying them.1 The campaign aims to challenge teens’ “cost-free” mentality with messages about the risks of using e-cigarettes, including nicotine addiction and potential exposure to harmful chemicals known to cause serious health effects.2-6

Most e-cigarettes contain nicotine, which can harm the developing adolescent brain.7-9 Further, emerging evidence suggests using e-cigarettes can expose users to toxic chemicals and may be harmful to the lungs.3-6,10-12 Despite these risks, about 80 percent of youth say they do not see great risk of harm in regular use of e-cigarettes, underscoring the need for a targeted public education effort on the dangers of using these products.13

The campaign target audience includes youth aged 12–17 who have used e-cigarettes or are open to trying them. Research with at-risk teens, conducted as part of campaign development, suggests:

• Teens don’t doubt that e-cigarettes are addictive, and, they see their friends showing signs of addiction.14 o “I see people who rely on their JUUL every day, so I think it is definitely addictive.”

o “My friend, he vapes a lot, but his mom took it. He came to school and said, ‘I haven’t been vaping in a while.’ It was clear that it was affecting him and he was addicted. Without it, he was like, ‘I don’t know what to do.’”

• However, teens are not afraid to become addicted to e-cigarettes, because they don’t perceive there to be any harm in using them.14 o “If you say something’s addictive, you also have to say why being addicted to it is bad.”

o “I understand vapes can be addictive, but I need a reason why that’s bad. Some people say like, ‘Well, it’s addictive, but will it hurt me if it’s addictive?’”

• Teens want to know the specific health consequences of using e-cigarettes.14 o “I feel like if you told us what the long-term effects could be and really emphasized that, that would help me stop vaping.”

o “If there were more facts about certain hazards that come along with vaping, not just being addicted, that would be even more alarming.”

KEY INSIGHTS INTO THE TEEN MINDSET

CAMPAIGN IMPLEMENTATION

E-cigarette prevention advertising will be hyper-targeted exclusively to teens on relevant digital and social media channels. Some of these media channels include YouTube, Spotify, Pandora, Facebook, and Instagram. All of the media sites require age verification, which helps ensure ads will be seen by teens. Furthermore, because reports of youth using e-cigarettes in school bathrooms and classrooms continue to increase—and teens are increasingly faced with the decision to use or not use these products when they are in the school environment —the campaign is expanding into schools to reach these teens with digital media and posters. Materials will be posted in the bathrooms of at least 10,000 high schools, and additional materials for students and educators will be distributed to schools, in collaboration with Scholastic and Students Against Destructive Decisions (SADD). The new campaign ads will be evaluated to measure changes in knowledge, attitudes, and beliefs over time.

YOUTH E-CIGARETTE

PREVENTION CAMPAIGN

REFERENCES

1. National Youth Tobacco Survey (NYTS) 2011–2017.

2. Hiler M, Breland A, Spindle T, et al. Electronic cigarette user plasma nicotine concentration, puff topography, heart rate, and subjective effects: Influence of liquid nicotine concentration and user experience. Experimental and clinical psychopharmacology.

2017; 25(5):380.

3. Goniewicz ML, Knysak J, Gawron M, et al. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tobacco Control. 2014; 23(2):133–139.

4. Cheng T. Chemical evaluation of electronic cigarettes. Tobacco Control. 2014; 23:ii11-ii17.

5. Bein K, Leikauf GD. Acrolein–a pulmonary hazard. Molecular Nutrition & Food Research. 2011; 55(9):1342–1360.

6. Occupational Safety and Health Administration (OSHA). Occupational safety and health standards: Medical surveillance – formaldehyde. Washington, DC: U.S. Department of Labor, Occupational Safety and Health Administration.

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10078. Accessed May 8, 2018.

7. Goniewicz ML, Hajek P, McRobbie H. Nicotine content of electronic cigarettes, its release in vapour and its consistency across batches: Regulatory implications. Addiction. 2014; 109(3):500–507.

8. Marynak KL, Gammon DG, Rogers T, Coats EM, Singh T, King BA. Sales of nicotine-containing electronic cigarette products: United States, 2015. American Journal of Public Health. 2017; 107(5):702–705.

9. U.S. Department of Health and Human Services (USDHHS). A report of the Surgeon General: How tobacco smoke causes disease:

What it means to you (consumer booklet). Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. 2010.

10. National Academies of Sciences, Engineering, and Medicine (NASEM). Public health consequences of e-cigarettes. Washington, DC:

The National Academies Press. 2018. doi: https://10.17226/24952

11. Sommerfeld CG, Weiner DJ, Nowalk A., Larkin A. Hypersensitivity Pneumonitis and Acute Respiratory Distress Syndrome From E-Cigarette Use. Pediatrics. 2018; 141(6):e20163927.

12. Khan MS, Khateeb F, Akhtar J, Khan Z, Lal A, Kholodovych V, Hammersley J. Organizing pneumonia related to electronic cigarette use: A case report and review of literature. The clinical respiratory journal. 2018; 12(3):1295–1299.

13. Johnston LD, Miech RA, O’Malley PM, Bachman JG, Schulenberg JE, Patrick ME. Monitoring the Future national survey results on drug use: 1975–2017: Overview, key findings on adolescent drug use. Ann Arbor: Institute for Social Research, The University of Michigan. 2018. http://www.monitoringthefuture.org/pubs/monographs/mtf-overview2017.pdf. Accessed September 9, 2018.

14. U.S. Food and Drug Administration (FDA). Findings of unpublished focus group research from with at-risk youth e-cigarette experimenters: February–March 2018.

FDA Public Education Campaigns: Youth E-Cigarette Prevention Campaign

The Real Cost youth e-cigarette prevention campaign is designed to reach and educate the 27.5% (4.0 million) high school students nationwide who currently use electronic cigarettes.1

Current e-cigarette use among high schoolers continues to increase. E-cigarettes are the most commonly used tobacco product among both middle and high school students, underscoring the need for a targeted public education effort on the dangers of using these products.2,3

Teens have dangerous misperceptions about e-cigarettes that lead them to believe that they are harmless.

The Real Cost e-cigarette prevention campaign launched in September 2017. The campaign aims to challenge teens’ “cost-free” mentality with messages about the risks of using e-cigarettes.

The campaign’s advertising has been informed by research and messages about the risks of using e-cigarettes, including nicotine addiction and potential exposure to harmful chemicals known to cause serious health effects.

The media campaign reaches youth where they spend most of their time, including popular sites such as YouTube, Spotify, and Instagram, among others. We also place ads on platforms that teens usually access while they are in school, such as Edmodo and Hudl. Finally, we geo-target our ads to school locations so that teens see our messages while they are at school. The media campaign is hyper-targeted to teens on relevant channels, and expanded in July 2019 to include broadcast TV to reach even more teens.

We’re also reaching teens through print materials, such as posters, at relevant school locations. Based on research insights that teens use e-cigarettes in the school bathroom, the campaign shipped posters with a prevention message to every high school in the U.S., asking that they be placed in their student bathrooms.

Our campaign strategy and tactics are reaching teens effectively. From the launch in September 2018 through December 2019, the campaign drove 3.8 million unique website visitors to ENDS pages on TRC.gov and 99K* active viewers interacted with whatsinavape.com. Additionally, the campaign averaged 8.1 million monthly social interactions.**

*WIAV updated through 12.31.2019 **Social Media Interactions include Likes, Shares, Comments, Link Clicks, and Video Views across traditional social channels; Likes and Shares on YouTube; Swipe Ups, Views, and Story Opens on Snapchat and Likes, Shares, Link Clicks, and Views on TikTok.

Updated through 3.31.20

1. Cullen KA, Gentzke AS, Sawdey MD, et al. e-Cigarette Use Among Youth in United States, 2019. JAMA. 2019;322(21):2095- 2103.

2. Wang TW, Gentzke AS, Sharapova S, Cullen KA, Ambrose BK, Jamal A. Tobacco Product Use Among Middle and High School Students — United States, 2011–2017. MMWR Morb Mortal Wkly Rep. 2018;67:629–33.

3. Cullen KA, Ambrose BK, Gentzke AS, Apelberg BJ, Jamal A, King BA. Notes from the Field: Increase in E-Cigarette Use and Any Tobacco Product Use Among Middle and High School Students — United States, 2011-2018. MMWR Morbid Mortal Wkly Rep. 2018;67(45).

Updated through 3.31.20

| The Real Cost – ENDS CENTER FOR TOBACCO PRODUCTS0

TARGET AUDIENCE INSIGHTS

BASED ON FORMATIVE ENDS RESEARCH

| The Real Cost – ENDS CENTER FOR TOBACCO PRODUCTS1

• As teen vaping has continued to increase, there is an increased importance to counteract this with large-scale, national media campaigns.

• The evidence-based model used to develop “The Real

Cost” cigarette advertisements is proven effective through years of research. This proven strategy is used to address the rise of youth vaping.

• Since fall of 2017, we have released a suite of e-cigarette prevention advertisements for teens. This includes advertisements on TV, online radio, social media, and digital platforms popular to teens.

• Additionally, the campaign created posters to be displayed in high school bathrooms. These posters were distributed to all high schools across the country.

THE REAL COST E-CIGARETTE PREVENTION

| The Real Cost – ENDS CENTER FOR TOBACCO PRODUCTS2

• Vaping is still highly prevalent in their lives. While the bathroom is still the

“nerve center” (and some schools have gone on “bathroom lockdown” to counteract it), it’s a socially accepted and present behavior (parties, hanging out, etc.) and even a “first thing in the morning” behavior. It’s also a behavior they’re seeing in their feeds from influencers, peers, etc.

• There’s always a way to get ENDS. Whether it’s a gas station that doesn’t card, someone’s friend, or even a parent, teens don’t seem to have much trouble finding a vape/ENDS if they want it, and would pay a markup for the access.

• Vaping is a clique or lifestyle-agnostic behavior. It can be any teen – the valedictorian, the quiet kid, the band geek, the theater group, etc. And, that teen is almost always vaping with other teens around who are likely vaping with them.

• They don’t have a clear story, but are hearing more about potential dangers.

Their schools are ramping up prevention efforts, and there are some questions about whether it’s OK to do it. But they don’t have a consistent reason to point to as to why not to vape.

ENDS USE AMONG TEENS

| The Real Cost – ENDS CENTER FOR TOBACCO PRODUCTS3

• Teens are starting to see that addiction is a bad thing. In previous research, teens were more dismissive of addiction, saying they are also addicted to their phones or chocolate or even “breathing.” Teens are now starting to believe that addiction to vaping is a possible consequence and are even starting to see some negative emotional consequences from vaping. However, they still also want to hear about stronger, harmful health consequences.

• Teens mentioned friends or peers who would “fiend” for a vape or a hit. They acknowledged that they’ve seen negative behavior like irritability and irrational anxiety about losing access to vaping for something like a weekend trip away with parents.

• Teens acknowledged that addiction can be emotional, not just physical. For some teens, vaping is a consistent part of their daily ritual and don’t like when it’s disrupted or suddenly limited.

ADDICTION PERCEPTIONS AND REACTIONS AMONG TEENS

“I remember one time before a cheer competition this girl had a panic attack, she was like ‘I need my Suorin, I need my Suorin.’ We all ran to the bathroom right before we went on so she could hit it.”

– Hip Hop, ENDS Experimenter, Older, LA

| The Real Cost – ENDS CENTER FOR TOBACCO PRODUCTS4

Experimenter Older

– It makes people very irritable. Anything you say makes them want to just snap on you. I have this one friend, he’s super addicted, he walks into the bathroom every five minutes and his head twitches if he doesn’t have nicotine for more than five minutes. It literally looks like he’s possessed by it.

– Honestly, two of my best friends, actually, almost stopped being friends, because he refused to give the other guy the Juul. They literally got into a screaming match, cussed each other out, almost started fighting, because he refused to give it to him.

Dual Experimenter Older

– I think, yeah, they do blow things out of proportion. I remember one of my friends – he’s pretty addicted to nicotine – and we forgot to pick him up for the beach. We offered him an Uber, but he kept yelling at us and was just really upset at us. He would just blow things out of proportion.

Experimenter Younger

– A lot of people don’t consider themselves addicted. They are like “I like doing it when I want to do it.” They don’t consider it necessary but it is but they don’t really consider it like that. They don’t want to say they are addicted because it is not a nice word.

At Risk Older

– I knew a friend that wouldn’t even be able to sleep the night, have to wake up in the middle of the night like someone would get water, she would have to hit it.

At Risk Younger

– Yeah, my best friend. It’s where he’s desperate, like he needs it. He says he needs it, he can’t live without it. I don’t know why.

HEAR IT DIRECTLY FROM TEENS…

| The Real Cost – ENDS CENTER FOR TOBACCO PRODUCTS5

Our initial analysis of more than 47K comments from

October 2017 to December 2019 told us….

• Teens are frustrated. They are beginning to understand vaping is harmful yet there is not enough information about the facts. They believe that vaping is addictive, but there is not sufficient evidence to help them quit (when the news about the first teen death from vaping was announced, teens showed more concern, not only for their own health, but for their peers’ health as well).

• Teens are confused. They hear vaping is a smoking cessation tool for adult smokers so they interpret that to mean “safer.”

Additionally, exposure to conflicting news headlines and information about harms and benefits of vaping showed that teens are confused and are looking for a clear stance from

TRC.

KEY SOCIAL MEDIA ANALYSIS FINDINGS

The Real Cost ENDS Sample Creative, Website and Social Media Channels

• YouTube

• Website

• Instagram

• Facebook

• Twitter https://www.youtube.com/watch?v=bWVS82hS070&list=PLgf1d4CujVYZ6eMDdezsmQrcgfBSlfBQ5 https://www.youtube.com/watch?v=bWVS82hS070&list=PLgf1d4CujVYZ6eMDdezsmQrcgfBSlfBQ5 https://therealcost.betobaccofree.hhs.gov/vapes https://therealcost.betobaccofree.hhs.gov/vapes Instagram Instagram https://www.facebook.com/KnowTheRealCost/ https://www.facebook.com/KnowTheRealCost/ https://twitter.com/knowtherealcost?lang=en

“THE REAL COST” CIGARETTES CAMPAIGN

• Brand Overview

• Target Audience Segmentation

• Resources, Sample Creative, Website and Social Media Platforms

What It Is FDA’s award-winning youth tobacco prevention campaign, “The Real Cost,” aims to prevent susceptible youth from trying tobacco and keep experimenters from becoming regular tobacco users. Launched in 2014, initial campaign advertising focused on reaching the more than 10 million youth ages 12–17 in the United States who are either open to smoking or are already experimenting with cigarettes by challenging their “cost-free” mentality of tobacco use.1,2

Why It's Important

Tobacco use is the leading preventable cause of disease, disability, and death in the United States, responsible for more than 480,000 deaths each year.3 But the consequences of tobacco use are not limited to adults.

In fact, tobacco use is almost always initiated and established during adolescence. Every day in the United States, more than 2,300 youth under age 18 smoke their first cigarette—highlighting a critical need for stronger, more targeted youth tobacco prevention efforts.4

Through “The Real Cost” campaign, FDA seeks to reduce the number of youth who experiment with tobacco and ultimately reduce the number of future tobacco users.

Who It Targets “The Real Cost” campaign targets at-risk youth ages 12–17—teens who are open to or already experimenting with cigarettes (i.e., have smoked fewer than 100 cigarettes in their lifetime). Key demographic and psychographic insights for the target audience are embodied through the campaign’s at-risk personas, Nikki and Pete.

1CAMPAIGN OVERVIEW

The Real Cost:

CAMPAIGN OVERVIEW

What It Does “The Real Cost” campaign was developed using evidence-based best practices and multiple phases of research to identify promising messages. The campaign is specifically designed to affect at-risk youth who experiment with tobacco but do not consider themselves users, do not believe they will become addicted, and are not particularly interested in the topic of tobacco. Campaign messages are intended to make the target audience acutely aware of the risks of tobacco use by highlighting consequences youth are concerned about, such as loss of control due to addiction, dangerous chemicals in tobacco products, and health effects like tooth loss and skin damage.

“The Real Cost” message areas include:

• Loss of Control: Reframes addiction as a loss of control to disrupt the beliefs of independence-seeking youth who currently think they will not get addicted or feel they can quit at any time.

• Dangerous Chemicals: Depicts the dangerous chemicals in tobacco and tobacco smoke to motivate youth to find out more about what’s in them and reconsider the harms of tobacco use.

• Health Consequences: Dramatizes the negative health consequences of tobacco use in a meaningful way to demonstrate that all tobacco use comes with a “cost” that is more than just financial.

How It Is Being Implemented The campaign uses a multi-channel advertising approach that surrounds teens with “The Real Cost” messages. Through national and local media buys, the campaign advertising airs on traditional broadcast media channels such as TV and radio, as well as through a mix of other multimedia channels including web, cinema, print publications, and billboards. Daily engagement with youth via multiple social media platforms also helps broaden the campaign’s reach and creates spaces for teens to engage in peer-to-peer conversations about tobacco use in ways that are authentic to who they are.

A critical factor in reducing youth tobacco use is to produce and maintain effective levels of campaign awareness within the target population. The Centers for Disease Control and Prevention (CDC) indicates new tobacco prevention campaigns that reach 75 percent of the target audience within one year can expect to influence attitudes and create behavior change within two years if the time in-market is adequately sustained.

To achieve behavior change and improve public health, “The Real Cost” campaign has exceeded the benchmark of reach, frequency and time in-market recommended by CDC.

The campaign brand, “The Real Cost,” focuses on making youth hyper-aware of the cost that comes with every cigarette to challenge their “cost-free” mentality. “The Real Cost” is designed to be candid, empowering, and respectful. It speaks directly to teens in a straightforward and authentic manner.

2CAMPAIGN OVERVIEW

How It Is Evaluated FDA hired an independent research firm, RTI, to conduct large, multi-year outcome evaluation studies to measure the campaign’s success in changing tobacco-related attitudes, beliefs, and behaviors among youth. The first outcome evaluation study found that 89% of youth were aware of at least one campaign ad 7 months from launch, and “The Real Cost” positively influenced tobacco-related risk perceptions and beliefs specific to campaign messages after 15 months.5,6 Most notably, final results from the first study indicate that exposure to “The Real Cost” from 2014–2016 was associated with a 30% decrease in the risk for smoking initiation, preventing an estimated 350,000 U.S. youth ages 11–18 from smoking.6

How You Can Get Involved We recommend adults and stakeholder audiences use CTP’s Exchange Lab, a free resource library of tobacco-related digital content that can be easily syndicated on existing websites or other applications. Orders can also be placed for free printing and shipping of select materials.

FDA’s goal is to keep “The Real Cost” campaign an authentic and effective youth tobacco prevention brand. Thus, “The Real Cost” campaign website and social channels are intended for teens. Stakeholders should use FDA’s social media channels to engage with us around the campaign.

Organizations that work directly with youth can help extend the campaign by encouraging teens to share campaign messages with their peers. Stakeholders who do not work directly with youth can share our resources with youth-focused organizations. For more information, please contact TheRealCost@fda.hhs.gov.

Last Updated January 2018

RC-11-R1

3CAMPAIGN OVERVIEW

Sources:

1 U.S. Census Bureau. Annual Estimates of the Resident Population by Single Year of Age and Sex for the United States: April 1, 2010 to July 1, 2014. Washington, D.C.: U.S.

Census Bureau, Population Division; 2015.

2 Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA). Total At-risk Experimenters and Susceptible Non-trier Estimates: 2012 NYTS Dataset and Codebook. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Updated October 1, 2015. http://www.cdc.gov/ tobacco/data_statistics/surveys/nyts/. Accessed May 26, 2016.

BROUGHT TO YOU BY

THE CENTER FOR TOBACCO PRODUCTS.

www.facebook.com/KnowTheRealCost www.facebook.com/FDA www.fda.gov/therealcost www.YouTube.com/KnowTheRealCost www.YouTube.com/USFoodandDrugAdmin

@KnowTheRealCost #TheRealCost

@FDATobacco #TobaccoFreeYouth

TheRealCost.gov

SOCIAL MEDIA CHANNELS FOR YOUTH

SOCIAL MEDIA CHANNELS FOR STAKEHOLDERS

3 U.S. Department of Health and Human Services (USDHHS). The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta, GA:

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.

4 Substance Abuse and Mental Health Services Administration (SAMHSA). 2016 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: U.S. Department of Health and Human Services, SAMHSA, Center for Behavioral Health Statistics and Quality; 2017. https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/ NSDUH-DetTabs-2016.htm. Accessed October 12, 2017. (Original Data Source: NSDUH 2016, Table 4.10A)

5 Duke J, Alexander T, Zhao X, et al. Youth’s awareness of and reactions to The Real Cost national tobacco public education campaign. PLoS ONE. 2015;10(12):e0144827.

6 Farrelly MC, Duke JC, Nonnemaker J, et al. Association Between The Real Cost Media Campaign and Smoking Initiation Among Youths — United States, 2014–2016.

Morbidity and Mortality Weekly Report (MMWR) 2017;66:47–50. DOI: http://dx.doi.org/10.15585/mmwr.mm6602a2.

https://digitalmedia.hhs.gov/tobacco https://digitalmedia.hhs.gov/tobacco mailto:TheRealCost%40fda.hhs.gov?subject=

The Real Cost:

RESEARCH + EVALUATION

“ The Real Cost” campaign is grounded in scientific research and uses evidence-based practices proven to reduce youth tobacco use.

FDA’s youth tobacco prevention campaign, “The Real Cost,” is based on a robust body of evidence that supports the use of mass media campaigns to prevent and reduce youth tobacco use. Some of this evidence is derived from state and national youth tobacco prevention campaigns as well as youth-focused health campaigns on topics other than tobacco. Campaign efforts are informed by recognized best practices for mass media campaigns, lessons learned from previous efforts to educate the public about tobacco, and FDA’s own research.

Formative Research FDA conducted extensive research to develop effective outreach strategies and messaging to reach “The Real Cost” target audiences.

These efforts included:

Comprehensive literature reviews and target audience analyses to identify and refine our target audiences;

Consultation with experts in tobacco public health education, marketing, and campaign development;

Focus groups with members of each target audience to identify promising messages, and assess their perceptions of draft advertising concepts; and

Testing of near-final TV advertisements with members of each target audience to measure perceived effectiveness, levels of engagement, and message comprehension, and to check for any unintended consequences.

Campaign Evaluation FDA’s goal is to reduce the number of youth ages 12–17 who use cigarettes.

FDA hired an independent research firm, RTI, to conduct large, multi-year outcome evaluation studies to measure the campaign’s success in changing tobacco-related attitudes, beliefs and behaviors among youth. The first outcome evaluation study found that 89% of youth were aware of at least one campaign ad 7 months from launch, and “The Real Cost” positively influenced tobacco-related risk perceptions and beliefs specific to campaign messages after 15 months.1,2 Most notably, final results from the first study indicate that exposure to “The Real Cost” from 2014–2016 was associated with a 30% decrease in the risk for smoking initiation, preventing an estimated 350,000 U.S. youth ages 11–18 from smoking.2

AD COPY TESTING

Research results indicated the near-final TV advertisements provided understandable and engaging messages about the harms of tobacco use without potential unintended adverse or counterproductive message effects.

Testing indicated all the ads would likely lead to increased negative feelings about tobacco use, decreased intention to initiate, and increased intention to quit using tobacco products.

EVALUATION RESEARCH

Evaluation results will be used to assess changes in tobacco-related knowledge, attitudes, beliefs, intentions, and behaviors over time. The studies will focus on behavior change associated with cigarette use among youth ages 12–17.

Last Updated March 2017

RC-11-R1

BROUGHT TO YOU BY

THE CENTER FOR TOBACCO PRODUCTS.

www.fda.gov/therealcost

Sources:

1 Duke J, Alexander T, Zhao X, et al. Youth’s awareness of and reactions to The Real Cost national tobacco public education campaign. PLoS ONE. 2015;10(12):e0144827.

2 Farrelly MC, Duke JC, Nonnemaker J, et al. Association Between The Real Cost Media Campaign and Smoking Initiation Among Youths — United States, 2014–2016.

Morbidity and Mortality Weekly Report (MMWR) 2017;66:47–50. DOI: http://dx.doi.org/10.15585/mmwr.mm6602a2.

http://dx.doi.org/10.15585/mmwr.mm6602a2

THE REAL COST BRAND OVERVIEW

WHY THE BRAND EXISTS

The Job Is Not Done

• Tobacco use is the leading preventable cause of disease, disability, and death in the United States.

• Close to 90% of adult daily smokers smoked their first cigarette by age 18.

• Every day in the U.S., more than 2,600 youth under age 18 smoke their first cigarette and nearly 600 youth become daily cigarette smokers.

Teens Think Tobacco Is “Cost-Free” Teens think they know the facts about tobacco. They know that “it kills you,” eventually. But teens live in the now and think there is no cost to a cigarette today.

BRAND ESSENCE

The Real Cost is a “for teens” brand designed to provoke teens to rethink what they know about the “costs” of today’s tobacco use and snap them out of their “cost-free” mentality.

Focus on Three Costs The Real Cost uses science-based facts as the foundation for messages that are the “new news” teens crave and provoke teens to reassess what they think they know about:

• The cost to my body

• The cost to my mind

• The cost of using just one

What Teens Think Now Reassessment The cost to my body Death is in the distant future

Focus on health costs that matter now:

appearance and sports performance

The cost to my mind Addiction is something that happens to “old people”

Teens have a strong desire for control over their lives and are just getting their first taste of freedom.

Portray that every time you smoke, you sign up to lose control.

The cost of using just one It’s just one, it’s no big deal

Reinforce that every cigarette is… toxic chemicals doing you harm.

BRAND AUDIENCE

The Real Cost brand audience is teens, aged 12 to 17, who are either open to tobacco use or experimenting with cigarettes (used less than 100 times).

What Makes Them Tick

• Being in-the-know - Perceive themselves as “smarter” and always want to feel like they have the information/inside track.

• Control over their lives – their time, identity, and future. They believe they have the right and the ability to make choices for themselves.

• Not being treated like a kid - Want to be treated and talked to as peers or equals.

Attitude Toward Tobacco

• Not “smokers” or “dippers” – Don’t define themselves by their tobacco use and do not think they will become addicted.

• Immune to consequences – Believe tobacco use is bad for them in the long run, but “cost-free” in the short-term.

Cigarette Users Are Likely to Be

• Surrounded by smokers – Likely to have parents, siblings and even friends who smoke.

• Stressed out – Dealing with the stress of school and family life; do not have good coping skills.

• Other risk factors – The at-risk teen is more likely to be of lower socioeconomic status, not academically driven, sensation seeking and not involved in extracurricular activities.

HOW THE BRAND SPEAKS TO TEENS

The Brand needs a voice that comes from a place of knowledge and credibility, but without turning off teens by sounding controlling or authoritative.

The Real Cost voice… is… Is not… Blunt (no bullshit) Boring or condescending

Confident Stilted or overly formal Informed Trying to be your friend

Snarky

HOW THE BRAND TREATS TEENS

Be Candid The Brand doesn’t sugarcoat the truth. It tells it like it is. And it doesn’t hide who is behind it (the FDA).

Be Respectful Brand communications are a conversation between equals.

We don’t judge or tell teens what to do.

Be Empowering The Brand provides more than facts. It delivers power through knowledge. It trusts teens’ abilities to make decisions.

WHERE THE BRAND INTERACTS WITH TEENS

Be Where Teens Want to BE

To create maximum messaging impact the Brand is placed where teens are and want to be. Not in environments where they “have to go” (e.g., schools, doctors, penal system).

Put Messaging in the Mouths of Influencers Who Resonate with At-Risk Teens

The Brand directly leverages relevant influencers to get the message into teen culture; those influencers teens look to for nonjudgmental guidance, information, or advice.

Peers (i.e., other teens) Cultural Influencers (e.g., musicians) Community Influencers (e.g., YMCA, YWCA)

The Brand does not directly leverage those influencers whom teens would view as potentially judging or dictating; influencers that are “telling me what to do” (e.g., doctors).

Be a Conversation Starter

Conversation is the primary means to become a part of teen culture. The Brand…

• Creates conversations with campaign elements – advertisements, placements, partnerships, social platforms

• Embraces relevant conversations in the social landscape

THE REAL COST

Who is the at-risk teen?

XXX X, 2014

Disclaimer: This information is not a formal dissemination of information by the FDA and does not represent Agency position or policy.

• Purpose

• Defining the at-risk teen

• Understanding at-risk teens

• Meet Pete and Nikki

• The Real Cost: engaging at-risk teens

AGENDA

Share research-based insights to refine the understanding of the target audience for The Real Cost campaign

The Real Cost:

• Is a national, general market campaign – it includes all race and ethnicities

• Targets youth, ages 12-17, who are at-risk for smoking cigarettes or those who have begun experimenting but are not regular users (i.e. < 100 cigarettes lifetime)

PURPOSE

To gain insights into the campaign’s audience, CTP reviewed an extensive list of youth smoking prevention literature, including:

• Monitoring the Future (NIDA 2012, 2013)

• National Survey on Drug Use and Health (SAMHSA 2013)

• National Youth Tobacco Survey (CDC 2013)

• Report on Youth Tobacco Use (RTI 2012)

• Surgeon General Reports (USDHHS 2012, 2014)

RESEARCH

SMOKING PREDICTORS

Sources: Audrain-McGovern, 2004; Augustson, 2013; Brennen et al., 2013; Cowell et al., 2009; Karen et al., 1993; Mowery et al., 2004; RTI, 2012;

USDHHS, 2012; White et al., 2002

• Lower socioeconomic status

• Access to tobacco

• Exposure to pro-tobacco advertising, etc.

Environmental Factors

• Peers or relative’s attitudes and behaviors of tobacco use

• Participation in group activities

• Susceptibility to peer pressure, etc.

Social Influences

• Sensation-seeking behaviors

• Perceived stress level

• Poor coping skills

• Low academic performance, etc.

Personal Behaviors & Attitudes

Research analysis led to the conclusion that youth may be at-risk for tobacco use when certain smoking predictors are present, potentially including:

• Overestimate peer tobacco use

• Believe that tobacco use is acceptable or serves a purpose (i.e. social benefits)

• Previous tobacco use and intention to use tobacco in the future, etc.

Social Norming Factors

According to the Handbook of Adolescent Psychology, adolescence is characterized by:

• Extraordinary brain changes and high levels of emotionality, impulsivity, and risk-taking

• Immaturity in consequential thinking and decision-making skills

• Peer group influences emerge as powerful motivators of behavior change in potentially positive and negative ways

These changes create a unique window of vulnerability for tobacco use onset in adolescence and young adulthood

ADOLESCENCE + SMOKING PREDICTORS = AT-RISK

Sources: Steinberg 2007, USDHHS 2012

THE REAL COST TARGET AUDIENCE

At-Risk Youth

At-Risk <100 5.9M

At-Risk Open 4.3M

Committed Non-user

(54%)

Not our target

Committed User

(3%)

Not our target

Total Target: 10.2 million or 43% of teens Based on NYTS 2012 & US Census 2012 data

25M U.S. Teens

To understand teens and their culture, The Real Cost reviewed the TRU Youth Monitor Report, which includes data on teen:

• Demographics

• Lifestyle

• Media use

• Culture

The TRU Report serves as a proxy for how we target youth in paid media.

The Report does not collect data on smoking behavior, so sensation-seeking behavior is used as a proxy. At-risk youth tend to rate tobacco as “in” or “on the way in” at significantly higher rates than low risk youth.

UNDERSTANDING AT-RISK TEENS

Source: TRU Report, 2013

TRU research reveals that at-risk teens are more likely to:

• Spend more time per week engaging with media – 81+ hours

• Be employed or work odd jobs for money

• Spend more money on clothing, apparel and going out to eat

• Own a smartphone

• Engage in social networking

• Play sports, but are less likely to be involved in school athletic programs

AT-RISK TEENS

Source: TRU Report, 2013

These kids do not think they are “down and out” or victims, but they do think their lives are stressful and many think smoking helps with that stress

MEET PETE

I’m Pete. I live with my mom and step-dad and sister in the city. I’m a freshman in high school, just trying to figure out what’s going on. School sucks but whatever, I guess I have to go.

My step-dad smokes, but my mom doesn’t let him do it in the house. A couple of my friends have started too, they seem to like it.

Yeah, I might try it, just to see what it’s about. I know it causes cancer and crap, but, whatever, that’s years away. I don’t want to be a smoker – I’ll just smoke once in a while, so I won’t get addicted. Besides lots of people at school smoke, and some do stuff that’s way worse, so it’s no big deal.

KEY INSIGHTS FOR PETE

Smoking occasionally is no big deal

Most people I hang out with in my school smoke

I’ll stop long before smoking hurts me

Addiction happens to smokers, not people just trying it out

MEET NIKKI

Hey, I’m Nikki. I live with my mom and brother in the suburbs. I’m a senior in high school and I can’t wait to be done! School just isn’t my thing, but I’m not really sure what’s next. I already have a job, so I’ll probably stick with that for awhile.

I smoke sometimes, but I’m not a smoker, I mean, I just like doing it when I’m hanging out with my friends. I don’t really think about it, it’s just a way to chill out.

Weekends are for hanging out with my friends, shopping, music, whatever. Oh, and social media, yeah, that’s all the time. Whenever my brother’s driving me crazy or mom won’t stop yelling, I just retreat, into music, social media and yeah, sometimes smoking.

KEY INSIGHTS FOR NIKKI

Smoking sometimes is no big deal

Most people I hang out with in my school smoke

I don’t really think about it, I just do it

It’s just a way to cope with stress

PETE/NIKKI SUMMARY

According to Pete and Nikki:

• They aren’t smokers

• Smoking occasionally is “cost-free”

• Smoking is just a way to cope with stress and relax with friends

• They don’t really think about it, they just do it

• They’ll stop smoking long before they get addicted or it harms them

THE REAL COST STRATEGY FOR ENGAGING PETE & NIKKI

Focus on health effects that matter to teens…

…cosmetic effects

Disrupt their beliefs about addiction by stressing loss of control

Give them new information to break through their “cost-free” mentality

Make teens hyperconscious of the real cost of every cigarette through breakthrough, fresh portrayals of the health and addiction risks of tobacco

THE REAL COST BRAND IDENTITY

To successfully engage Pete and Nikki, The Real Cost must be authentic and credible without being authoritative.

The brand’s voice is:

CANDID We do not sugarcoat the truth. We are factual, giving teens the information they need to make their own decisions

RESPECTFUL We are not judgmental and do not tell teens what to do

EMPOWERING We deliver power through knowledge. We provide new information in compelling ways to change what youth think they know about tobacco

Engage their passion points: music, fashion, irreverent comedy, extreme sports, violent gaming, etc.

Be where they are: TV, online, mobile, social media, gaming, search, radio, malls and skate parks, magazines, etc.

• We are not where they “have to go” (e.g., schools, doctor offices)

Leverage influencers to integrate the message in teen culture:

• Peers (e.g., other teens)

• Cultural influencers (e.g., musicians, athletes)

• Community influencers (e.g., youth-serving community coalitions)

WHERE & HOW THE REAL COST ENGAGES TEENS

RETHINKING THEIR RELATIONSHIP WITH TOBACCO

“I always thought smoking was foul and killed people.

The only difference is now I understand how.”

“OMG, I never knew there were near that many [chemicals in cigarette smoke] #7000chemicals.”

“I used to think it made people look cool until I saw my teeth getting yellow and I got sores on my gums all the time.”

“It’s hard [not to smoke] because of the influence of my friends.”

THE4 A COST-EFFECTIVE APPROACH TO !Bit,- PREVENTING YOUTH CIGARETTE SMOKING

Between Feb. 2014 and Nov. 2016 .. The Real Cost" campaign ...

UPTO

MORETHAN

MORETHAN

587,000 youth ages 11-19 from trying cigarettes, half of whom may have become adult smokers

$180,000 for each of the up to 293,500 youth prevented from becoming established smokers

$53 Billion in total by reducing smoking-related costs like medical care, lost wages, and increased disability

"The Real Cost" smoking prevention campaign educates the more than 10 million at-risk youth in the U.S. about the harmful effects of smoking.

Public health campaigns like "The Real Cost" can play a crucial role in reducing tobacco-related disease and death and protecting youth from a lifetime of addiction.

Sources: (1) Duke JC, MacMonegle AJ, Nonnemaker J, et al. Impact of The Real Cost Media Campaign on Youth Smoking Initiation.

Am J Prev Med. 2019. (2) MacMonegle AJ, Nonnemaker J, Duke JC, et al. Cost-Effectiveness Analysis of The Real Cost Campaign ·s Effect on Smoking Prevention. Am J Prev Med. 2018;55(3):319-325.

CENTER FOR TOBACCO PRODUCTS www.fda.gov/tobacco O @Fda Tobacco O Facebook.com/FDA Ii www.fda.gov/tobacco

The Real Cost Cigarettes Publications and Announcements

• Statement on new results demonstrating continued success of the agency’s youth smoking prevention efforts and significant public health cost savings, https://www.fda.gov/news-events/press-announcements/statement-new-results-demonstrating-continued-success-agencys-youth-smoking-prevention-efforts-and

• Impact of The Real Cost Media Campaign on Youth Smoking Initiation, https://www.ajpmonline.org/article/S0749-3797(19)30280-6/fulltext

• Fifth Anniversary Retrospective of “The Real Cost,” the Food and Drug Administration’s

Historic Youth Smoking Prevention Media Campaign, https://www.ajpmonline.org/issue/S0749-3797(18)X0018-X

• Youth's Awareness of and Reactions to The Real Cost National Tobacco Public Education

Campaign, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0144827

The Real Cost Cigarettes Sample Creative, Website and Social Media Channels

• YouTube

• Website

• Instagram

• Facebook

• Twitter https://www.fda.gov/news-events/press-announcements/statement-new-results-demonstrating-continued-success-agencys-youth-smoking-prevention-efforts-and https://www.fda.gov/news-events/press-announcements/statement-new-results-demonstrating-continued-success-agencys-youth-smoking-prevention-efforts-and https://www.fda.gov/news-events/press-announcements/statement-new-results-demonstrating-continued-success-agencys-youth-smoking-prevention-efforts-and https://www.fda.gov/news-events/press-announcements/statement-new-results-demonstrating-continued-success-agencys-youth-smoking-prevention-efforts-and https://www.ajpmonline.org/article/S0749-3797(19)30280-6/fulltext https://www.ajpmonline.org/article/S0749-3797(19)30280-6/fulltext https://www.ajpmonline.org/issue/S0749-3797(18)X0018-X https://www.ajpmonline.org/issue/S0749-3797(18)X0018-X https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0144827 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0144827 https://www.youtube.com/user/KnowTheRealCost https://therealcost.betobaccofree.hhs.gov/cigarettes Instagram https://www.facebook.com/KnowTheRealCost/

AMERICAN INDIAN/ALASKA NATIVE

(AI/AN) CAMPAIGN

• Literature Review

• Secondary Data Analysis

• AJPM Publication on AI/AN Youth Tobacco Use

American Indian and Alaska Native Youth Tobacco Prevention Campaign

Background To complement The Real Cost ENDS campaign, CTP is also developing a tobacco prevention campaign designed to reach American Indian and Alaska Native (AI/AN) youth, ages 13-17, who are at-risk for using e-cigarettes.

There are roughly 400,000 AI/AN teens in the United States, and more than half of them are at-risk for tobacco use (CDC, 2018; U.S. Census Bureau, 2017). A literature review revealed that the AI/AN youth population demonstrates higher tobacco susceptibility and tobacco use than their non-AI/AN peers, and a tendency toward earlier initiation, possibly influenced by the home (CDC, 2018; RTI International, 2013).

A majority of AI/AN youth will experiment with tobacco at some point (RTI International, 2013). Target audience insights shows that many AI/AN youth are protective of who they are and where they come from; prioritize family and respect; believe that positivity and motivation are key to achieving one’s goals; and view body, mind, and culture as integrated parts of overall health. These insights will inform campaign development.

1. Centers for Disease Control and Prevention. (2018). 2017 Youth Risk Behavior Survey Data. Available at:

www.cdc.gov/yrbs

2. RTI International. (2013). Year 2, Ad-Hoc Report #2: Formative Research on American Indian and Alaska Native Youth (No. 2). Prepared for U.S. Food Administration, Center for Tobacco Products

3. United States Census Bureau. (2018). Annual Estimates of the Resident Population by Sex, Age, Race, and Hispanic Origin for the United States and States: April 1, 2010 to July 1, 2017, 2017

October 2013

Year 2, Ad-Hoc Report #2:

Formative Research on American

Indian and Alaska Native Youth

Draft Report

Prepared for

U.S. Food and Drug Administration Center for Tobacco Products

Office of Health Communication and Education 9200 Corporate Blvd Rockville, MD 20850

Prepared by

RTI International 3040 Cornwallis Road

Research Triangle Park, NC 27709

RTI Project Number 0212926.011.001

RTI International is a trade name of Research Triangle Institute.

RTI Project Number 0212926.011.001

Year 2, Ad-Hoc Report #2:

Formative Research on American

Indian and Alaska Native Youth

October 2013

Prepared for

U.S. Food and Drug Administration Center for Tobacco Products

Office of Health Communication and Education 9200 Corporate Blvd Rockville, MD 20850

Prepared by

RTI International 3040 Cornwallis Road

Research Triangle Park, NC 27709

This report was prepared by RTI International (a trade name of Research Triangle Institute), Research Triangle Park, North Carolina. Work by RTI was performed for the Center for Tobacco Products, U.S. Food and Drug Administration, U.S. Department of Health and Human Services under Contract No. HHSF223201110005B. All information and materials including data developed under this contract are the property of the U.S. Federal Government.

Suggested Citation

RTI International (2013, October). Year 2, Ad-Hoc Report #2: Formative Research on American Indian and Alaska Native Youth. Prepared for the U.S. Food and Drug Administration, Center for Tobacco Products.

Reported by

Annice Kim, PhD (Project Director)

Section 1: Introduction: Annice Kim, PhD

Section 2: AI/AN Population Characteristics, Media Use, and Tobacco Use: Paul Shafer, MA;

Kristin Arnold, MSPH; James Nonnemaker, PhD; Maggie O’Neil, MS

Section 3: Risk and Protective Factors for Tobacco Use among AI/AN Youth—Literature Review: Mindy Herman-Stahl, PhD; Matthew Eggers, MPH

Section 4: Tobacco Prevention Programs Targeting AI/AN Youth: Allie Lieberman, MPH;

Mindy Herman-Stahl, PhD; Jane Allen, MA; Mary Council, BA

Section 5: Working with AI/AN Populations—Stakeholder Interviews: Mary Council, BA; Barri Burrus, PhD; Mindy Herman-Stahl, PhD

Section 6: Summary: Annice Kim, PhD; James Nonnemaker, PhD; Mindy Herman-Stahl, PhD iii

Contents

Section Page

1. Introduction 1-1

1.1 Background and Purpose ......................................................................... 1-1

1.2 Organization of Report ............................................................................ 1-1

2. AI/AN Population Characteristics, Media Use, and Tobacco Use 2-1

2.1 Data Sources ......................................................................................... 2-1

2.1.1 Population Data ........................................................................... 2-1

2.1.2 Media Use Data ............................................................................ 2-1

2.1.3 Tobacco Use Data ......................................................................... 2-1

2.2 Results ................................................................................................. 2-2

2.2.1 Population Size of AI/AN and Specific Tribes ..................................... 2-2

2.2.2 Geographic Distribution of AI/AN Populations ................................... 2-3

2.2.3 Sociodemographic Characteristics of AI/AN Populations...................... 2-6

2.2.4 Media Use by AI/AN Populations ..................................................... 2-7

2.2.5 Prevalence of Tobacco Use among AI/AN Youth ................................ 2-8

3. Risk and Protective Factors for Tobacco Use among AI/AN Youth— Literature Review 3-1

3.1 Data Sources ......................................................................................... 3-1

3.2 Results ................................................................................................. 3-1

3.2.1 Risk Factors for Tobacco Use among AI/AN Youth ............................. 3-1

3.2.2 Protective Factors ......................................................................... 3-7

4. Tobacco Prevention Programs Targeting AI/AN Youth 4-1

4.1 Data Sources ......................................................................................... 4-1

4.2 Results ................................................................................................. 4-1

4.2.1 Effects of General Tobacco Prevention Mass Media Campaigns on

AI/AN Youth ................................................................................ 4-2

4.2.2 Tobacco Prevention Programs Targeting AI/AN Youth ........................ 4-3

4.2.3 Tobacco Prevention Programs Targeting AI/AN Youth: Findings from Grey Literature ..................................................................... 4-5

5. Working with AI/AN Populations—Stakeholder Interviews 5-1

5.1 Data Sources ......................................................................................... 5-1 iv

5.2 Results ................................................................................................. 5-2

5.2.1 Data on AI/AN Youth Tobacco Use and Risk Factors ........................... 5-2

5.2.2 Tobacco Prevention Campaigns/Programs Targeting AI/AN Youth ........ 5-2

5.2.3 Recommendations in Developing Tobacco Prevention…