FDA’s Proposed Warning on Addiction is Inadequate and Do Not Reflect Current Understanding of Appropriate Messaging on Addiction

We just submitted this comment to FDA. The tracking number is 1jy-8cmm-zjhq

The FDA’s Proposed Warnings on Addiction are Inadequate and Do Not Reflect Current Understanding of Appropriate Messaging on Addiction

Docket No. FDA-2014-N-0189

ML Roditis1; BL Halpern-Felsher2, LK Lempert1, SA Glantz1, L Popova1, JK Cataldo1

1Center for Tobacco Control Research and Education
University of California San Francisco
2Department of Pediatrics, Stanford University

June 10, 2014

The FDA needs to change their current proposed required warning statements on addiction to include messages that account for the fact that nicotine addiction is a complicated concept, process and disease and needs to be communicated to youth and young adults using different language than for adults.

The warning that the FDA proposes regarding nicotine addiction, "WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical" fails to adequately message how easily addiction occurs, especially among youth, and does not address the fact that addiction is a complicated process that may be difficult to understand.

The FDA conducted extensive research for its "The Real Cost" campaign on how to communicate the concept of addiction; this knowledge should be reflected in the warning messages that the FDA requires on tobacco products.

Evidence shows that both youth and adults have difficulty quitting smoking. The 2007 Youth Risk Behavior Survey, for example, found that while 60.9% of high school daily smokers have tried to quit, only 12.2% were successful (1). In adult populations, 70% of current smokers reported wanting to quit, 44% attempting to quit, and between 4-7% being successful (2).

The process of addiction can happen well before the onset of daily smoking (3, 4). Despite clear evidence that adolescents and adults become addicted to nicotine (5), and do so well before regular daily tobacco use, both adults and children show confusion over the term addiction, and both adolescents and adults display skepticism about whether becoming addicted will and can happen. (6)

60% of adult smokers and close to half of adolescent smokers believe that they can smoke for a few years and then quit (7), though actual quit rates are much lower.

Qualitative research shows that adolescents display optimism regarding their ability to quit smoking as well as skepticism over the seriousness of nicotine addiction (8). Qualitative studies also show that while youth and young adults are aware of the risk of nicotine addiction, they display a great deal of uncertainty over what nicotine addiction actually entails. In particular, adolescents do not realize that "addiction" means it is very difficult to quit using these products (9), and that many of the “pleasures” of tobacco use, such as relaxation, are simply the results of self-medication (with nicotine) to treat the symptoms of acute nicotine withdrawal.(10)

These findings about adolescents’ and adults’ misperceptions about nicotine are particularly important for warning messages on tobacco products. If individuals think they can start using these products and quit whenever they wish, then warnings regarding the long- and even short-term health consequences become moot as individuals will think they can choose to quit smoking before ever having to deal with these health effects.

Given the evidence that adults and adolescents do not understand addiction, it is vitally important to provide comprehensive, detailed messages on nicotine addiction.

The FDA's proposed warning message (WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical) does not address any of these nuanced concerns regarding individuals’ understanding of addiction.

Specifically, the FDA's proposed warning fails to recognize youth and young adults’ lack of understanding and skepticism of addiction. Instead, messages need to provide more detailed examples and definitions of addiction in order to be effective.

Extensive research shows that youth and young adults do not just underestimate the risk of addiction. Adolescent smokers and those who eventually become smokers perceive significantly less risk of many health consequences, including long-term consequences such as heart attack and lung cancer, as well as short-term consequences such as having trouble breathing.(11) Such perceptions predict subsequent smoking.(12)

Warnings that are comprehensive and engage the reader emotionally are signiﬁcantly more effective at transmitting information than warning labels that present the information alone.(13)

The FDA should utilize its own research when finalizing the warning labels and tie warnings to its research-based "The Real Cost" educational campaign.[*] Results from the FDA’s qualitative research used to design the Real Cost campaign (14) shows that many youth and young adults smoke in emotionally charged situations, such as when they are stressed, mad, or frustrated and that teens respond the best to campaigns that focus on concepts such as “Why Let a Cigarette Tell You What to Do” and “Cigarettes are not the Answer.” Additionally, the FDA's own work indicates that effective portrayals of nicotine addiction should be straight forward, but also portray addiction as a sinister and unwanted presence in one's life (14).

The messages that the FDA created for the Real Cost Campaign from these findings effectively communicate important information by being visually stimulating and graphic; for example, images of a young man pulling out his own tooth or a young woman peeling at her skin as payment for a cigarette (FOIA material). The Real Cost Campaign’s website, for example, argues for messages that “highlights consequences that youth and young adults are concerned about, such as cosmetic health effects and loss of control due to addiction”(15).

Warnings should speak to the lack of control associated with addiction. This understanding should be reflected in the FDA’s warning labels on tobacco products.

For these reasons we suggest the following warning messages regarding addiction:

85% of smokers wish they had never started smoking. Nicotine is highly addictive.

70% of smokers want to stop smoking. Nicotine is highly addictive.

The process of nicotine addiction starts well before you are smoking every day. Nicotine is highly addictive.

Tobacco can be harder to quit than heroin or cocaine. Nicotine is highly addictive.

Most smokers smoke for years longer than they want. Nicotine is highly addictive.

Most smokers take 6-11 attempts to quit. Nicotine is highly addictive.

75% of teens who smoke are still smoking five years later. Nicotine is highly addictive.

Addiction is the disease. Smoking is the symptom. Nicotine is highly addictive.

References:

1.         Malarcher A, Jones S, Morris E, Kann L, Buckley R. High school students who tried to quit smoking cigarettes: United states, 2007. Centers for Disease Control and Prevention. 2009;58(16):428-431.
2.         Centers for Disease Control. Quitting smoking among adults--united states, 2001-2010. MMWR Morbidity and mortality weekly report. 2011;60(44):1513.
3.         DiFranza JR, Riggs N, Pentz MA. Time to re-examine old definitions of nicotine dependence. Nicotine & tobacco research. 2008;10(6):1109-1111.
4.         Scragg R, Wellman RJ, Laugesen M, DiFranza JR. Diminished autonomy over tobacco can appear with the first cigarettes. Addictive Behaviors. 2008;33(5):689-698.
5.         Fagerstrom KO, Heatherton TF, Kozlowski L. Nicotine addiction and its assessment. Ear Nose Throat J. 1990;69(11):763-5.
6.         DiFranza JR, Savageau JA, Fletcher K, O’Loughlin J, Pbert L, Ockene JK, et al. Symptoms of tobacco dependence after brief intermittent use: The development and assessment of nicotine dependence in youth–2 study. Archives of pediatrics & adolescent medicine. 2007;161(7):704-710.
7.         Arnett JJ. Optimistic bias in adolescent and adult smokers and nonsmokers. Addictive behaviors. 2000;25(4):625-632.
8.         Moffat BM, Johnson JL. Through the haze of cigarettes: Teenage girls’ stories about cigarette addiction. Qualitative Health Research. 2001;11(5):668-681.
9.         Haines RJ, Poland BD, Johnson JL. Becoming a ‘real’smoker: Cultural capital in young women's accounts of smoking and other substance use. Sociology of health & illness. 2009;31(1):66-80.
10.       Silverstein B. Cigarette smoking, nicotine addiction, and relaxation. Journal of personality and social psychology. 1982;42(5):946.
11.       Halpern-Felsher BL, Biehl M, Kropp RY, Rubinstein ML. Perceived risks and benefits of smoking: Differences among adolescents with different smoking experiences and intentions. Preventive medicine. 2004;39(3):559-567.
12.       Song AV, Morrell HE, Cornell JL, Ramos ME, Biehl M, Kropp RY, et al. Perceptions of smoking-related risks and benefits as predictors of adolescent smoking initiation. American journal of public health. 2009;99(3):487.
13.       Hammond D. Health warning messages on tobacco products: A review. Tobacco control. 2011;20(5):327-337.
14.       Sacksteder K. Fda teen experimenter qualitative researcher (foiad material): Tru Insight; 2013.
15.       Federal Drug Administration. The real cost campaign. 2014 [cited 2014 June 10th]; Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/AbouttheCenterforTobaccoProducts/PublicEducationCampaigns/TheRealCostCampaign/default.htm

[*]A copy of the FDA’s research from the Real Cost Campaign was provided to SA Glantz in response to a FOIA request and is being submitted with this comment.