Assignment Help!!! Due tomorrow

New Product Marketing Blurs the Line Between Nicotine Replacement Therapy and Smokeless Tobacco Products

Ganna Kostygina, PhD, Lucinda England, MD, MSPH, and Pamela Ling, MD, MPH

Tobacco companies have begun to acquire pharmaceutical

subsidiaries and recently started to market nicotine replacement

therapies, such as Zonnic nicotine gum, in convenience stores.

Conversely, tobacco companies are producing tobacco prod-

ucts such as tobacco chewing gum and lozenges that resemble

pharmaceutical nicotine replacement products, including a nicotine

pouch product that resembles snus pouches.

This convergence of nicotine and tobacco product marketing has

implications for regulation and tobacco cessation. (Am J Public

Health. 2016;106:1219–1222. doi:10.2105/AJPH.2016.303057)

In response to declining ciga-rette sales, Reynolds American Inc. (the second largest US cig- arette manufacturer) and other cigarette companies have ventured into the manufacturing and sales of smokeless tobacco and other nicotine-containing products.1 In 2009, Reynolds American ac- quired the Swedish company Niconovum AB, which makes nicotine replacement therapy (NRT) products, including nico- tine gum and oral spray.2 In Sep- tember 2012, Reynolds American began test marketing Zonnic nic- otine gum, the company’s first NRT product to be sold in the United States, in the state of Iowa and in Omaha, Nebraska.3

Each package of Zonnic nico- tine gum contained 10 pieces of mint-, cinnamon-, or fruit- flavored gum and cost $3.65, about half the price of a pack of cigarettes in Des Moines, Iowa.2,3 Zonnic is available in both 2-mg and 4-mg strengths, delivering 1 and 2 mg of nicotine, respectively, less than the amount typically delivered by

cigarettes.4 However, gum prod- ucts do not deliver nicotine as quickly as cigarettes.5 Zonnic is currentlysoldnationwide,primarily in convenience stores and gas stations.3

In contrast to Zonnic, most nicotine gum and lozenge products traditionally have been packaged as 80 to 100 pieces for $20 and up and have been sold mainly in drugstores. According to Tommy Payne, president of Niconovum USA Inc. (and former Reynolds American ex- ecutive vice president of public affairs), the company is seeking to “bring smokers into NRT that haven’t been in the category before, whether because of cost, access and motivation.”6

EVOLVING SMOKING CESSATION ADVERTISING

Niconovum claims that it takes “an inspirational, positive approach” in its marketing communications,6 which state

that “[e]ach cigarette not smoked is a victory” and emphasize the benefits of a gradual reduction in cigarettes for smokers who cannot “go from all to nothing.”3

Zonnic’s advertising includes Web commercials and direct mailings.

Zonnic’s advertising messages may encourage smokers to use NRT to cut back on cigarette smoking without quitting. Cutting back as a cessation strategy has been proposed in the United Kingdom, where “cut down to stop” was endorsed by Action on Smoking and Health in 2005.7,8 Changes in NRT regulations in the United King- dom reduced restrictions on use and allowed extended NRT use to cut down on smoking (or cigarettes smoked) as a step toward quitting, endorsing con- current use of NRT and ciga- rettes over an extended period of time. According to several early evaluation studies, the cut down to stop approach in the United Kingdom resulted in in- creased sales of NRT but had very limited, if any, impact on

patterns of nicotine replacement use or cessation rates.8 None- theless, in June 2013, the Na- tional Institute for Health and Care Excellence in the United Kingdom issued public health guidance on tobacco harm re- duction approaches recom- mending reducing to quit as a viable approach to cessation.9

In April 2013, the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) issued a Federal Register notice announcing that it was softening the warnings on the labeling of over-the-counter NRT products regarding the concomitant use of these products and cigarettes in the United States. However, CDER rejected a request that it add a formal indication for the use of NRT as part of a “reduce to quit” approach.10 The Zonnic Web site references the new FDA approach on its “News from the FDA” Web page3 and implies that the FDA approves a reduce to quit approach: “The FDA is on your side. Now if you need more time, you can take it.”11

ABOUT THE AUTHORS At the time of study, Ganna Kostygina and Pamela Ling were with the Center for Tobacco Control Research and Education and the Division of General Internal Medicine, Department of Medicine, University of California, San Francisco. Lucinda England was with the Centers for Disease Control and Prevention, Atlanta, GA.

Correspondence should be sent to Pamela Ling, MD, MPH, Center for Tobacco Control Research and Education, University of California, San Francisco, 530 Parnassus Ave, Suite 366, Box 1390, San Francisco, CA 94143-1390 (e-mail: [email protected]). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link.

This article was accepted December 19, 2015. doi: 10.2105/AJPH.2016.303057

July 2016, Vol 106, No. 7 AJPH Kostygina et al. Peer Reviewed Public Health Policy 1219

AJPH POLICY

In addition, the company frames the FDA’s argument on less abuse liability associated with NRT use to claim that there is no risk of product dependence: “Sources you can trust (like the FDA) have agreed that people don’t find themselves dependent on gums like ZONNIC.”11 This statement misrepresents the FDA language.12

It is unknown how the in- troduction of easily accessible NRT products such as Zonnic will affect cessation rates. Some tobacco treatment specialists have expressed concern that previous limitations on NRT sales and marketing inhibited its uptake among smokers13; others have argued that simply marketing it over the counter without linking NRT promotion to counseling may not be effective.14 In fact, there is evidence that promotion of over-the-counter NRT di- rectly to consumers has not been accompanied by an increase in population cessation rates.14

Reynolds American’s marketing

tactics do not link Zonnic to counseling and further divorce NRT use from a therapeutic context by making it available for sale mainly in convenience stores rather than pharmacies. Further- more, the new packaging and promotional strategies for Zonnic (which include reframing cessation in terms of success with each singlecigarettereduced)might encourage situational use of NRT rather than increasing cessation.

The Zonnic advertising may be part of a larger trend in NRT advertising. The 2013 Nicorette Web site includes features that are similar to Zonnic advertise- ments and highlights “new” smaller “pocket packs” and “starter packs” of 20 pieces. In addition, recent commercials for Nicorette lozenges celebrate “each cigarette not smoked,” and the Web site also makes references to the new FDA approach.15

Furthermore, as NRT products such as Zonnic become more readily available to consumers in convenience stores or gas stations

and are prominently displayed next to the check-out register (Figure 1), there may be an in- crease in use among people, es- pecially youths, enticed to use nicotinerecreationallyorforother reasons unrelated to smoking cessation, such as weight loss.16,17

REGULATION CATEGORY

NRT product manufacturing and marketing by companies that sell cigarettes and other to- bacco products are expanding. For example, Reynolds American is testing Zonnic pouches in clinical trials in New Zealand; these pouches resemble Camel Snus and are packaged in round cans similar to those used for smokeless tobacco (Figure 2).18–20

Altria recently announced the launch of Tju “chewing tobacco gum” in Denmark and of Verve tobacco-derived nicotine discs, which are currently being test

marketed in Virginia.21 Camel Orbs produced by RJ Reynolds, which were introduced in 2011 in Charlotte, North Carolina, and Denver, Colorado, are analogous in appearance to Nicorette Mini Lozenges.22

Although not directly pro- moted as smoking cessation aids, these tobacco products resemble NRT products and so may be perceived as analogous to NRT gums and lozenges in regard to product safety. Research is needed to address how the marketing of new smokeless tobacco products that resemble NRT, or as line extensions of leading cigarette brands (e.g., Camel), influences the perceived risks and benefits, adoption, and use of these products.

In 2009, the Family Smoking Prevention and Tobacco Control Act (HR 1256) gave the FDA’s Center for Tobacco Products authority to permit a company to market a product as a “modified risk tobacco product” (MRTP) if the manufacturer could

a b

Note. Photographs by Garin Buttermore, printed with permission.

FIGURE 1—Images of (a) a Zonnic Display From a Promotional Video Created by Reynolds American Inc. and (b) an Actual In-Store Zonnic Counter Display in Ames, IA

AJPH POLICY

1220 Public Health Policy Peer Reviewed Kostygina et al. AJPH July 2016, Vol 106, No. 7

demonstrate that the product, as used by consumers, would “sig- nificantly reduce the risk of tobacco-related diseases to indi- vidual tobacco users” as well as “benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”23 By contrast, the FDA’s Center for Drug Evalua- tion and Research regulates over- the-counter and prescription drugs, including NRT products and other smoking cessation medications. If a company is to market a product as a smoking cessation aid, it must submit research to prove that the drug is safe and effective for its intended use. The generic drug version of Zonnic gum was approved by CDER before Reynolds American acquired Niconovum.24

By submitting new nicotine- containing products to CDER as NRT, the tobacco companies are able to circumvent the MRTP submission process of the Center for Tobacco Products, which includes a population health standard. Although the CDER approval process is gen- erally regarded as quite rigorous,

it does not regulate pricing or venues for sales distribution. To date, few applications for novel smokeless products have been received by the Center for Tobacco Products for MRTP review.

Although the Zonnic nicotine gum product itself appears to be similar to traditional NRT gum products, changes in pack- age size, sales locations, market- ing channels, and consumer communications may radically change how this product is used, and the resulting effects on the health of the population are unknown. Tobacco companies have a strong motivation to ex- ploit the market potential of al- ternative nicotine products to generate new profits, without losing existing profits from cigarettes, by creating new forms of nicotine and tobacco use.25

RESEARCH AND REGULATORY NEEDS

The tobacco industry is en- gaging in development of pure nicotine and pharmaceutical products worldwide.26,27 It is important to monitor the

development of these products. Monitoring should be accom- panied by research to determine whether the increasing re- semblance between novel to- bacco products and NRT affects consumer perceptions of health risks associated with NRT-like tobacco products and changes in perceptions of what constitutes cessation (i.e., whether cutting down increases successful quit attempts or whether it is per- ceived as an alternative to cessa- tion). In regard to Zonnic specifically, research is needed to determine whether the “Each cigarette not smoked is a victory” messages enhance or deter ces- sation. In the United States, tracking and comparing tobacco industry applications to the FDA for NRT products and novel tobacco products could help prevent exploitation of the reg- ulatory system to get new prod- ucts intended for recreational use approved as NRT. Such ef- forts could ensure that promotion of these novel products is not detrimental to public health.

Tobacco products and NRT products are evolving to become increasingly similar to each other in appearance, with more widespread availability through

nonmedical channels, reduced pricing, and an increased variety of flavored options (e.g., Zonnic is produced in mint, fruit, and cinnamon flavors, which are the most popular flavors on the smokeless tobacco market other than wintergreen28). In addition, the marketing of these products is beginning to converge with similar messages (i.e., cutting down to quit or situational use of nicotine). Finally, the regulatory framework may allow the to- bacco industry to introduce new tobacco products as NRT products.

The result is a blurring of the lines between cessation products and novel tobacco products and potentially confusion and misuse by consumers which may result in initiation or situational and dual use of tobacco products. Since the first surgeon general’s report in 1964, evidence has linked smoking and tobacco use to diseases of nearly all organs of the body.29 The recommenda- tion of the 2014 surgeon general’s report 50 years later is to employ only proven, evidence-based tobacco control strategies and programs, such as counseling and promotion of cessation treatment in clinical settings, to help achieve a society free of tobacco-related death and disease.29

CONTRIBUTORS Alloftheauthorsconceptualizedthearticle. G. Kostygina collected the data and led the writing. All of the authors contributed to revisions and reviews of the article.

ACKNOWLEDGMENTS This research was supported by the National Cancer Institute (grant R01-CA141661).

Note. Thecontentofthisarticleissolely the responsibility of the authors and does notnecessarilyrepresenttheofficialviewsof the Centers for Disease Control and Pre- vention or the National Cancer Institute.

HUMAN PARTICIPANT PROTECTION No protocol approval was needed for this research because no human participants were involved.

a b

Note. Photographs (a) by Ganna Kostygina, printed with permission and (b) Niconovum AB, printed with permission.

FIGURE 2—Images of (a) Camel Snus Pouches and (b) Zonnic NRT Pouches Produced by Niconovum AB

AJPH POLICY

July 2016, Vol 106, No. 7 AJPH Kostygina et al. Peer Reviewed Public Health Policy 1221

REFERENCES 1. Mejia AB, Ling PM. Tobacco industry consumer research on smokeless tobacco users and product development. Am J Public Health. 2010;100(1):78–87.

2. Craver R. Reynolds subsidiary selling smoking-cessation gum. Available at: http://www.journalnow.com/business/ business_news/local/reynolds-subsidiary- selling-smoking-cessation-gum/ article_c17a52e8-cca0-11e2-8683- 0019bb30f31a.html. Accessed March 5, 2016.

3. Niconovum USA. Zonnic. Available at: https://www.zonnic.com/default. aspx#. Accessed March 5, 2016.

4. Henningfield JE, Fant RV, Buchhalter AR, Stitzer ML. Pharmacotherapy for nicotine dependence. CA Cancer J Clin. 2005;55(5):281–299.

5. Russell M, Feyerabend C, Cole P. Plasma nicotine levels after cigarette smoking and chewing nicotine gum. BMJ. 1976;1(6017):1043–1046.

6. CSPnet. Reynolds readies nicotine- replacement therapy products, will launch Zonnic in Iowa in September; also testing e-cigs, pouches, pellets, ex- tracts. Available at: http://www.cspnet. com/category-news/tobacco/articles/ reynolds-readies-nicotine-replacement- therapy-products. Accessed March 5, 2016.

7. Nicotine Assisted Reduction to Stop. London, England: Action on Smoking and Health; 2005.

8. Shahab L, Cummings KM, Hammond D, Borland R, West R, McNeill A. The impact of changing nicotine replacement therapy licensing laws in the United Kingdom: findings from the International Tobacco Control Four Country Survey. Addiction. 2009;104(8):1420–1427.

9. National Institute for Health and Care Excellence. Tobacco: harm-reduction approaches to smoking. Available at: http://www.ncsct.co.uk/usr/pub/ NICE_Harm_reduction.pdf. Accessed March 5, 2016.

10. Food and Drug Administration. Nico- tine replacement therapy labels may change. Available at: http://www.fda.gov/ ForConsumers/ConsumerUpdates/ ucm345087.htm. Accessed March 5, 2016.

11. Niconovum USA. New FDA in- formation and answers to other questions we hear a lot. Available at: https://www. zonnic.com/Frequently_Asked_ Questions.aspx. Accessed March 5, 2016.

12. Niconovum USA. FDA consumer health information: nicotine replacement therapy labels may change. Available at: https://www.zonnic.com/pdf/ NRT_Label_Change_0413.pdf. Accessed March 5, 2016.

13. Kozlowski LT, Giovino GA, Edwards B, et al. Advice on using over-the-counter

nicotine replacement therapy—patch, gum, or lozenge—to quit smoking. Addict Behav. 2007;32(10):2140–2150.

14. Pierce JP, Gilpin EA. Impact of over- the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA. 2002;288(10):1260–1264.

15. Nicorette.Nicoretteproducts.Available at: http://www.nicorette.com/nicorette- mini-lozenge. Accessed March 5, 2016.

16. Reynolds American Inc. Niconovum Zonnic NRT Gum. Available at: http:// vimeo.com/47451514. Accessed March 5, 2016.

17. Caria MP, Bellocco R, Zambon A, Horton NJ, Galanti MR. Overweight and perception of overweight as predictors of smokeless tobacco use and of cigarette smoking in a cohort of Swedish adolescents. Addiction. 2009;104(4): 661–668.

18. Craver R. Snus focus of yearlong study. Winston-Salem Journal. May 22, 2011. Available at: http://www. journalnow.com/business/ article_19f644b0-4b16-5885-a34a- 4ca8b63a4c0d.html. Accessed March 5, 2016.

19. Niconovum USA. Press images. Available at: http://www.niconovum.se/ PressImages.aspx. Accessed March 5, 2016.

20. Caldwell B, Burgess C, Crane J. Randomized crossover trial of the ac- ceptability of snus, nicotine gum, and Zonnic therapy for smoking reduction in heavy smokers. Nicotine Tob Res. 2010; 12(2):179–183.

21. Altria Group. 2013 Investor Day. Available at: http://investor.altria.com/ phoenix.zhtml?c=80855&p=irol- EventDetails&EventId=5168875. Accessed March 5, 2016.

22. Craver R. Reynolds moves to be on top when smoke clears. Available at: http://www.journalnow.com/business/ reynolds-moves-to-be-on-top-when- smoke-clears/article_aea2bfbb-c19b- 502f-85f9-d068160b8009.html. Accessed March 5, 2016.

23. Food and Drug Administration. Modified risk tobacco products. Available at: http://www.fda.gov/ TobaccoProducts/Labeling/ TobaccoProductReviewEvaluation/ ucm304465.htm. Accessed March 5, 2016.

24. HIPAASpace. Nicotine Polarcrilex Gum. Available at: http://www. hipaaspace.com/Medical_Billing/ Coding/National.Drug.Codes/11822- 0854-1. Accessed March 5, 2016.

25. Peeters S, Gilmore AB. Transnational tobacco company interests in smokeless tobacco in Europe: analysis of internal industry documents and contemporary industry materials. PLoS Med. 2013;10(9): e1001506.

26. British American Tobacco. Other nic- otine products. Available at: http://www. bat.com/nicotine. Accessed March 5, 2016.

27. Japan Tobacco. Pharmaceutical business. Available at: http://www.jt.com/about/ division/pharma. Accessed March 5, 2016.

28. Delnevo CD, Wackowski OA, Giovenco DP, Manderski MT, Hrywna

M, Ling PM. Examining market trends in the United States smokeless tobacco use: 2005–2011. Tob Control. 2014;23(2): 107–112.

29. The Health Consequences of Smoking— 50 Years of Progress: A Report of the Surgeon General. Rockville, MD: US Department of Health and Human Ser- vices; 2014.

AJPH POLICY

1222 Public Health Policy Peer Reviewed Kostygina et al. AJPH July 2016, Vol 106, No. 7

Copyright of American Journal of Public Health is the property of American Public Health Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.