Regulation of cigarettes

8/10/2019 Regulation of cigarettes

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P R O D U C T S A F E T Y

The U.S. Food and Drug Administration hasrecently proposed expanding its regulatoryauthority over tobacco products to includethe regulation of cigars, pipe tobacco, hoo-kah tobacco, electronic cigarettes (e-ciga-rettes), and other novel tobacco productssuch as dissolvable products and gels. Cigars

are the most commonly used among this group, though e-cig-arette use is rapidly expanding. If Federal Food, Drug, and Cos-

metic Act requirements were to be applied to those products,they would mandate establishment registration and productlisting, ingredient listing, submissions prior to the introductionof new products, labeling requirements, and prohibition of freesamples. Additional provisions would include minimum age andidentication requirements, vending machine restrictions, andrequired warning statements for packages and advertisements.

This article argues that the FDA jeopardizes public healthby not developing an appropriate benet-cost analysis of theproposed rule. The FDA anticipates, without quantifying, sub-stantial benets from reducing harm by regulating e-cigarettesand non-cigarette tobacco products. The FDA also does not ade-

quately assess costs that appear likely from its suppression of thee-cigarette market. The evolving literature on e-cigarettes stronglysuggests they help smokers to quit smoking. The proposed ruleendangers public health by pushing e-cigarette manufacturers tofocus efforts toward developing attributes unrelated to improvedpublic health, thereby promoting combustible tobacco use andreducing the number of smokers who would use e-cigarettes toquit or reduce cigarette consumption. Public health would worsenMICHAEL L. MARLOW is a professor of economics at California Polytechnic StateUniversity and an affiliated senior scholar of the Mercatus Center at George MasonUniversity. This article is based on his paper, Deeming Tobacco Products to Be Sub- ject to the Federal Food, Drug, and Cosmetic Act (Mercatus Center, 2014).

REGULATING A

LESS UNHEALTHYCIGARETTE

The FDAs treatment of e-cigarettes jeopardizes public health. BY MICHAEL L. MARLOW

because e-cigarettes are a safer alternative to tobacco cigarettes.

HARM REDUCTION THEORY

The FDA implicitly assumes that consumption of all tobaccoproducts should be reduced to zero. While tobacco use is knownto be risky, economic theory demonstrates that few to no activi-ties are optimally provided at zero quantity. This applies to con-sumption of risky products as well as efforts aimed at decreasing

their use. There are costs and benets to improving public health,and perfectionthe elimination of all risksis not an optimalpublic health strategy in a world with scarce resources.

The FDA simply states that current tobacco policies are subopti-mal and does not consider the possibilities that tobacco products arenot equally risky or that all tobacco products are equally controllablethrough regulation. In claiming this, the FDA dismisses the essenceof what is known as harm reduction theory. Harm reductiontheory asserts that minimizing damage from some risky behaviormay promote public health more effectively than simply attemptingto eliminate the behavior. Applied to tobacco use, placing highestpriority on reducing risks from combustible tobacco products is a

reasonable strategy that the FDA should at least discuss.Such a model is in line with estimates that up to 98 percent oftobacco-related deaths are attributable to combustible productssuch as cigarettes, pipes, and cigars. The FDA downplays the pos-sibility that noncombustible products (e.g., nicotine-replacementtherapies, smokeless tobacco, e-cigarettes) are substantially lessdangerous than combustible tobacco products by claiming thereis too little information available to make such judgments.

The American Medical Association published a JAMA Patient Page last January that lists the following potential benets ofe-cigarettes:


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indicate valid concerns regarding risks for nicotine addiction andinitiation of tobacco products, but the FDA should consider thoseconcerns within a more sophisticated theory of harm reduction.

E CIGARETTES AS HARM REDUCTION TOOLS

E-cigarettes are electronic nicotine delivery systems that are bat-

tery powered and simulate tobacco smoking by producing a vaporthat resembles smoke. A heating element is used to vaporize liquidsolutions that contain a mixture of propylene glycol, glycerin,nicotine, and avorings. Rapid market growth of these productscan be partially explained by smokers seeking help in their effortsat quitting. Data are scarce, but one top tobacco analyst estimatedthat e-cigarette sales in the United States topped $1.7 billion lastyear. This evidence suggests that consumers are interested in usinge-cigarettes as harm reduction tools, though it remains unclear thedegree to which smokers will switch to e-cigarettes.

The FDA errs on the side of assuming e-cigarettes pose more ofa health risk than an opportunity to improve the publics health.

Studies are readily available that suggest e-cigarettes help somesmokers reduce or quit smoking. Their effectiveness appears to berelated to the fact that, unlike nicotine replacement therapy (NRT),e-cigarettes deliver nicotine with a device that mimics smoking.

Summary results of relevant recent studies are described below.Evidence is imperfect but nonetheless strongly suggests e-cigarettesare effective harm reduction tools that help some smokers reduceor quit smoking. None of these results are discussed by the FDA:

Riccardo Polosa et al. (2011) conclude e-cigarettes helpsmokers remain abstinent or reduce their cigarette con-

Tobacco is what makes regular cigarettes so harmful tohealth, but e-cigarettes do not contain tobacco.

Tobacco products are addictive because of the nicotine theycontain and nicotine is not healthy. But nicotine probablydoes not contribute nearly as much to smoking-relateddiseases as tobacco.

Clean nicotine has been used as a safe way to help people

quit smoking for nearly three decades. Such productsinclude patches, lozenges, gum, orally inhaled products, andnasal spray.

Although e-cigarettes may contribute nicotine vapor to the air,the vapor is much less toxic than secondhand tobacco smoke.

Smokers may switch to e-cigarettes simply because they areless harmful than tobacco cigarettes.

The JAMA Patient Page also outlines various concerns regardingthe safety of noncombustible products. These include a lack ofstandardization and quality control among the more than 250brands. The unclear nature of whether there is a safe level of

toxins in the vapor and whether e-cigarettes may increase thesocial acceptability of smoking are also mentioned.The FDA expresses concern that e-cigarettes might lead youth

to use the product and become addicted to nicotine or else leadto use of tobacco products. Evidence so far is limited on theseissues. The FDA cites a Centers for Disease Control and Preven-tion report that found that e-cigarette experimentation and recentuse doubled among U.S. middle and high school students from2011 to 2012, resulting in an estimated 1.78 million studentshaving used e-cigarettes as of 2012. In 2012, about 9 percent ofthose students had never used tobacco cigarettes. Those estimates M

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sumption. This study monitored smoking habit changesof 40 regular smokers (unwilling to quit) experimentingwith e-cigarettes. Study participants were monitored dur-ing intervals of up to 24 weeks on product use, number ofcigarettes smoked, and exhaled carbon monoxide levels. Thestudy found a sustained reduction in numbers of cigarettes,with a sustained 50 percent reduction and smoking absti-nence shown in 22 of the participants (55 percent), with anoverall 88 percent fall in cigarettes consumed per day.

J. Foulds et al. (2011) found that a large majority ofe-cigarette users had repeatedly attempted to quit smok-ing, with most having previously failed despite using NRTtherapies. Data were collected from a face-to-face survey of104 experienced e-cigarette users. Some 78 percent had notsmoked in the prior 30 days but averaged 25 cigarettes perday previously; the average quit attempts were nine prior tousing e-cigarettes, with two-thirds having used NRT. Three-fourths used e-cigarettes as another attempt at quittingsmoking, with most stating it helped them to quit.

Pasquale Caponnetto et al. (2013) determined that nearly 1in 10 Italians quit smoking after trying e-cigarettes. A clini-cal trial of e-cigarettes tracked 300 smokers who agreed totry e-cigarettes between 2010 and 2012 and concluded that8.7 percent were not smoking cigarettes after one year. Quitrates were 4 percent for those given e-cigarettes withoutnicotine, but 13 percent for those given e-cigarettes with thehighest dose of nicotine. This study is noteworthy becausestudy participants said they had no intention of quittingsmoking when they entered the trial. Moreover, the 4 per-

cent quit rate for those given e-cigarettes without nicotine isconsistent with the view that e-cigarettes help smokers quitby mimicking the act of smoking. The study also reportedthat 73 percent of smokers who discontinued smoking ciga-rettes after one year had also quit using e-cigarettes.

Christopher Bullen et al. (2013) conducted a randomized,controlled superiority trial of 657 adult smokers in NewZealand between September 6, 2011 and July 5, 2013. Thestudy gave 289 participants nicotine e-cigarettes, 295 par-ticipants patches, and 73 participants placebo e-cigarettes.

At six months, veried abstinence was 7.3 percent (21 of289) with nicotine e-cigarettes, 5.8 percent (17 of 295) with

patches, and 4.1 percent (3 of 73) with placebo e-cigarettes.The study concluded that e-cigarettes, with or withoutnicotine, were modestly effective at helping smokers to quit,with similar achievement of abstinence as nicotine patches.The authors reported they had insufficient statistical powerto conclude superiority of nicotine e-cigarettes to patches orto placebo e-cigarettes.

Konstantinos Farsalinos et al. (2014) analyzed a worldwidesurvey of 19,414 dedicated e-cigarette users. Participantswere divided according to their smoking status: formersmokers and current smokers. Eighty-eight participants

reported they were not smokers when they initiatede-cigarette use. The most important reasons for initiatinge-cigarette use for both subgroups were to reduce the harmassociated with smoking and to reduce exposure of familymembers to secondhand smoking. The authors concludedthat e-cigarettes can be effective even in highly dependentsmokers. Complete substitution of smoking was reported by81 percent of participants (former smokers), while currentsmokers had reduced smoking from 20 to four cigarettesper day.

Jamie Brown et al. (2014) interviewed 5,963 smokers inEngland who had attempted to quit smoking without theaid of counseling from a health professional. Smokers weremuch more likely to succeed if they used e-cigarettes thanover-the-counter NRT. While about a tenth of those usingover-the-counter therapies had quit smoking at the time ofthe survey, about a fth of those using e-cigarettes were suc-cessful. That is, e-cigarette users were twice as likely to quitas those using NRT without counseling.

It is noteworthy that the FDA fails to discuss a widely reportedstudy by Hillel Alpert et al. (2013) that casts considerable doubton the efficacy of FDA-approved NRT treatments such as patches,gum, and drugs such as Zyban and Chantix. The study concludesthat persons who have quit smoking relapsed at equivalent rates,whether or not they used NRT to help them in their quit attempts.In other words, FDA-approved NRT may not be any more effective inhelping smokers quit their smoking habits than going cold turkey.The possibility that e-cigarettes represent a market response that

attempts to ll the need for harm reduction by smokers is worth pur-suing. This is especially true given concerns over the efficacy of NRT.

JEOPARDIZING PUBLIC HEALTH

The FDA acknowledges that its proposed rule is expected to slowdevelopment of the e-cigarette market and reduce consump-tion below levels that would be observed without regulation.The proposed rule prohibits manufacturers from marketinge-cigarettes as safer than tobacco cigarettes because the proposedrule expands Section 911 of the Family Smoking Preventionand Tobacco Control Act to cover e-cigarettes. Section 911 bans

marketing tobacco products as modied risk products withoutFDA approval. Moreover, manufacturers are unable to informconsumers their products do not contain tobacco, thus sug-gesting to some consumers that e-cigarettes are more similar totobacco cigarettes than is actually the case. The FDA states thatdeeming e-cigarettes to be subject to Chapter IX of the FederalFood, Drug, and Cosmetic Act would raise the cost of premarketapplications and therefore would increase the cost of enteringand remaining in the market. Warning labels are also believed toserve as a negative signal to consumers that possibly discouragee-cigarettes use.


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While the FDA might grant marketing claims of safer alter-natives or allow manufacturers to inform consumers that e-cig-arettes do not contain tobacco, such approval would probablyrequire many dollars of research. Many years of continued use bythousands of users would probably be required before the FDAwould be willing to make such a revision, going by the FDAs trackrecord with drug approvals: it has been estimated that it takes anaverage of 12 years for an experimental drug to travel from thelaboratory to FDA approval.

The following adverse consequences to public health appearlikely from slowing the evolution of the e-cigarette market:

Suppressing the e-cigarette market can be devastating toproduct innovation. Manufacturers will be unable to markettheir products as safer alternatives to tobacco cigarettes. Theproposed rule pushes manufacturers to enlist other market-ing angles such as avors, price, convenience, and appealingpackaging. Public health worsens to the extent that manu-facturers steer away from developing new products aimed athelping smokers reduce or quit smoking. In effect, the pro-posed rule removes much of the prot from developing saferand more effective harm-reduction products and redirectsresources toward other attributes unrelated to improvingpublic health.

Suppressing the e-cigarette market is likely to promote FDA-approved NRT. This effect might improve public healthif NRT is more effective than e-cigarettes in promotinglower consumption and quitting by smokers. However, asdiscussed above, the efficacy of NRT is debatable. Moreover,

the literature suggests that smokers nd e-cigarettes helpful.The FDA needs to explain why favoring the NRT industrypromotes public health in light of this evidence.

The e-cigarette industry is likely to become less competitiveas costs of bringing products to market and other costs rise.Limiting competition allows e-cigarette manufacturers togain market power, thus raising prices, curbing consumption,and limiting consumer choices. Larger rms carry an unfairadvantage because of greater nancial and legal resources,thus again limiting competition at the expense of consumers.Raising prices of e-cigarettes for smokers who might be inter-ested in quitting is unlikely to promote

public health when e-cigarettes areeffective harm reduction tools.Prohibition of health claims mightentice nonsmokersespecially youthto become e-cigarette consumers whenthey are susceptible to marketing thatfocuses on avors, convenience, andother factors unrelated to promotingpublic health. Fostering e-cigaretteuse among nonsmokers is unlikely topromote public health.

The proposed rule may promote traditional tobacco use.The number of cigarette users switching to e-cigarettes islikely to decrease when manufacturers are unable to informsmokers that e-cigarettes are safer alternatives or even thatthey do not contain tobacco. The proposed rule thus weak-ens the creative destruction that the e-cigarette industrymight otherwise exert on the tobacco industry.

The proposed rule fails to protect nonsmokers from sec-ondhand smoke in the event that e-cigarettes are safer thancombustible tobacco products. Public health worsens to theextent that e-cigarettes are a safer alternative.

BENEFITS FROM E CIGARETTES

In 2010, 43.5 million U.S. adults (19.3 percent) were smokers.The CDC estimates the annual costs attributed to smoking inthe United States are between $289 billion and $333 billion,including at least $130 billion for direct medical care of adults,over $150 billion for lost productivity from premature death ofsmokers, and more than $5 billion for lost productivity frompremature death as a result of exposure to secondhand smoke.

A recent Gallup poll nds that 74 percent of U.S. smokerswant to quit. That means that roughly 32.2 million smokerswant to quit out of the entire population of 43.5 million smok-ers. Smoking costs attributable to those looking to quit can beapproximated by multiplying the annual costs of $289$333billion by 74 percent, yielding the $214$246 billion range ofannual smoking costs attributable to smokers who want to quit.

Table 1 exhibits estimations of benets (that is, costs avoided)

associated with using e-cigarettes by all smokers interested in quit-ting. Column 1 displays three quit rates estimated from previouslydiscussed studies of e-cigarettes:

Bullen et al. (2013) concluded that 7.3 percent of adultsmokers using nicotine e-cigarettes no longer smoked aftersix months.

Caponnetto et al. (2013) found that nearly 10 percent ofsmokers quit smoking after trying e-cigarettes.

Brown et al. (2014) reported that roughly 20 percent ofsmokers who had attempted to quit smoking using e-ciga-rettes were successful.

T 1THE BENEFITS OF E CIGARETTES Annual benets (cost savings) associated with e-cigarette use

(1) (2) (3) (4) (5) (6)

( )-

( )($ ) ($ ) ($ ) ($ )

0.073 214 246 15.6 18 2.4

0.1 214 246 21.4 24.6 3.2

0.2 214 246 42.8 49.2 6.4


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Columns 2 and 3 display the $214$246 billion range of annualsmoking costs attributable to smokers looking to quit.

Benets are cost savings from successful quitting as approxi-mated by multiplying quit rates in column 1 by the range ofannual costs attributable to smokers looking to quit in columns2 and 3. Columns 4 and 5 indicate the estimated potential rangeof annual benets stemming from successful quitting by usinge-cigarettes is $15.6$49.2 billion. Column 6 displays the numberof e-cigarette users who successfully quit tobacco use, estimatedto be between 2.4 million and 6.4 million.

A full-scale analysis is beyond the scope of this article. Thereare many caveats to Table 1s estimation of benets. The CDCestimates of costs associated with smoking used here may be sub-

ject to considerable error. Information on risk, quit rates, youthaccess, addiction properties, whether e-cigarettes are gateways toriskier products, and other important public health issues requirefurther investigation. Estimates also assume all smokers lookingto quit using tobacco will try e-cigarettes in their quit efforts.Benets are only estimated for one year.

While this analysis is based on some assumptions and hassome obvious limitations, if even a small fraction of estimatedbenets or transformation of smokers into ex-smokers is achieved,the benets are substantial:

One-fourth of estimated annual benets stemming fromsuccessful quitting by using e-cigarettes indicate a range of$3.9$12.3 billion per year.One-fourth of the estimated range of individuals whobecome ex-smokers by using e-cigarettes is 600,000 to 1.6million individuals per year.

Those benets are expected to be lower under the proposed ruleto the extent that the rule slows down innovation and growth inthe e-cigarette market. A large potential cost of the proposed ruleis thus the forgone reduction in costs associated with smokingtobacco. The FDA needs to take them into account.

CONCLUSION

The FDA has failed to make a strong and compelling case thatits proposed e-cigarette rule improves public health. It has notdetermined what an optimal regulation might look like, failed

to quantify benets, and ignored the evolving literature on e-cig-arettes that strongly suggests they help smokers interested inquitting tobacco use. An optimal policy is likely to be one thatfocuses more effort on reducing riskier products rather thantreating all products as equal threats to public health.

The FDA has downplayed many adverse consequences topublic health that appear likely from its slowing of the e-cigarettemarket. The proposed rule removes much of the prot fromdeveloping safer and more effective harm reduction products andredirects resources toward developing new avors, packaging, andother attributes unrelated to improved public health.

Prohibition of health claims regarding e-cigarettes might keepsome nonsmokers (including youth) from purchasing e-cigarettes.On the other hand, the proposed rule might promote combus-tible tobacco use because manufacturers will be unable to markete-cigarettes as safer alternatives to tobacco cigarettes. Rates atwhich smokers quit or reduce consumption of tobacco productsare likely to fall as well. Public health worsens to the extent thate-cigarettes are a safer alternative that helps smokers in theirharm-reduction efforts.

This article estimates the range of annual benets associ-ated with e-cigarette use as $15.6$49.2 billion per year. Theestimates also suggest that, each year, 2.46.4 million smokersmight become ex-smokers. Fractions of those estimates indicatesubstantial benets that the FDA has ignored in its analysis.

Finally, this analysis does not conclude that the FDA shouldnot regulate e-cigarettes. Prohibiting sales to youth and requiringa clear description of product ingredients may be appropriate. Butprohibiting any information regarding potential effi cacy in harmreduction is hard to justify given substantial benets reported incurrently available studies. The FDA needs to develop a regulatorystrategy that fully considers the potential benets that smokersreceive from e-cigarettes and the many unintended adverse effectson public health associated with how this proposed regulationslows the evolution of a promising harm reduction tool.

RE AD ING S

A Prospective Cohort Study Chal-lenging the Effectiveness of Popu-lation-based Medical Interventionfor Smoking Cessation, by Hillel R.

Alpert, Gregory N. Connolly, and LoisBiener. Tobacco Control , Vol. 22 (2013).

Characteristics, Perceived SideEffects, and Benets of Electronic Ciga-rette Use: A Worldwide Survey of Morethan 19,000 Consumers, by Konstan-tinos E. Farsalinos, Giorgio Romagna,Dimitris Tsiapras, et al. International

Journal of Environmental Research and Public Health, Vol. 11 (2014).

E-cigarettes, by Deborah TolmachSugerman. JAMA, Vol. 311, No. 2 (Janu-ary 8, 2014).

Effect Of An Electronic Nicotine

Delivery Device (e-Cigarette) onSmoking Reduction and Cessation: AProspective 6-month Pilot Study, byRiccardo Polosa, Pasquale Caponnetto,

Jaymin B. Morjaria, et al. BMC Public Health, Vol. 11 (2011).

Effi Ciency and Safety of an eLec-tronic cigAreTte (ECLAT) as TobaccoCigarettes Substitute: A Prospective12-Month Randomized ControlDesign Study, by Pasquale Caponnetto,Davide Campagna, Fabio Cibella, et al.

PLoS One, Vol. 8, No. 6 (June 24, 2013).

Electronic Cigarettes (e-cigs): Viewsof Acionados and Clinical/PublicHealth Perspectives, by J. Foulds, S.

Veldheer, and A. Berg. International Jour-

nal of Clinical Practice, Vol. 65 (2011).Electronic Cigarettes at a Regulatory

Crossroads, by Thomas A. Hemphill. Regulation, Vol. 36, No. 3 (Fall 2013).

Electronic Cigarettes for SmokingCessation: a Randomized ControlledTrial, by Christopher Bullen, ColinHowe, Murray Laugesen, et al. The Lancet,

Vol. 382, Issue 9905 (November 16, 2013).Real-world Effectiveness of

E-cigarettes When Used to AidSmoking Cessation: A Cross-sectionalPopulation Study, by Jamie Brown,Emma Beard, Daniel Kotz, et al. Addic-tion, forthcoming.

Smoke, the Chief Killer: Strategiesfor Targeting Combustible TobaccoUse, by Michael C. Fiore, Steven A.Schroeder, and Timothy B. Baker. New

England Journal of Medicine, Vol. 370(January 23, 2014).

Tobacco Harm Reduction: An Alter-native Cessation Strategy for InveterateSmokers, by Brad Rodu and WilliamT. Godshall. Harm Reduction Journal ,

Vol. 3, No. 37 (2006).

Regulation of cigarettes

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