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Enactment of the Family Smoking Prevention and Tobacco Control Act creates a number of research opportunities, some of which are mandated by the statute. The Act establishes Food and Drug Administration jurisdiction over tobacco and reestablishes the FDA regulations initially issued in 1996 concerning the sale of tobacco to minors. The public health value of enforcing restrictions on the sale of tobacco to minors is now well established, but many questions remain regarding the most efficient approach to enforcement. Evaluations are needed concerning the effectiveness of restrictions on the distribution of free samples, restrictions on advertising of cigarettes to youth, and enforcement of sales restrictions on Indian lands. The potential impact of raising the minimum age for tobacco sales to 21 years needs investigation. Legal and regulatory strategies to encourage tobacco manufacturers to take responsibility for keeping their products out of the hands of children need to be explored.
This paper considers potential research opportunities and challenges concerning aspects of the Family Smoking Prevention and Tobacco Control Act that pertain to youth. These involve various aspects of the sale and promotion of tobacco. Each section begins with a brief overview of the issue and a description of prior regulation. The relevant aspects of the Act will be outlined, followed by a list of bulleted ideas for potential research. The ideas and opinions expressed are those of the author.
Individual states have long regulated the sale of tobacco to minors, but such laws were rarely enforced until the 1990s (Jason, Ji, Anes, & Birkhead, 1991). The first federal regulation of such sales was through the Synar Amendment, which was enacted in 1992 but did not go into effect until the publication of the final rules in 1996 (Department of Health and Human Services, 1996). The regulations for the Synar Amendment were coordinated with those issued by the Food and Drug Administration (FDA; FDA & Department of Health and Human Services, 1996). The Synar regulations require states to enact and enforce state laws that prohibit the distribution of tobacco products to minors. The 1996 FDA regulations made the sale of tobacco to minors under 18 years of age a federal offense for the first time. The FDA puts into effect a federal enforcement program that was distinct from the state enforcement of state laws. However, state and federal governments worked together to enforce the federal regulations as states were contracted to conduct enforcement inspections for the FDA (Natanblut, Mital, & Zeller, 2001). This joint effort was just getting started when the Supreme Court ruled that the FDA did not have jurisdiction over tobacco (Food and Drug Administration et al. v. Brown & Williamson Tobacco Corp. et al. 529 U.S. 120, 2000). The states have continued to enforce their laws under the Synar mandate with generally very good results in terms of the retailer compliance rates that states have measured (DiFranza & Dussault, 2005).
The intent of youth access interventions is to reduce the number of young smokers by reducing the supply of tobacco to youth from commercial sources. Access interventions that do not reduce the commercial supply of tobacco to youth cannot reduce smoking. Research conducted since 1987 has clearly identified strategies that are and are not effective at reducing commercial availability (DiFranza, 2005a; DiFranza, Norwood, Garner, & Tye, 1987). As knowledge has accumulated, authorities have improved the effectiveness of their programs substantially, and this is reflected in increased merchant compliance with the law (Center for Substance Abuse Prevention, 2010) and declining rates of youth smoking across the United States and Australia (DiFranza, Savageau, & Fletcher, 2009; Tutt, Bauer, & DiFranza, 2009).
The earliest research on youth access established that merely banning the sale of tobacco to children by enacting laws was an ineffective strategy (DiFranza et al., 1987; Jason, Berk, Schnopp-Wyatt, & Talbot, 1999; Radecki & Zdunich, 1993). Subsequent trials demonstrated that strategies based on merchant education alone could elicit only partial or temporary improvements in merchants’ compliance with the law (Altman, Foster, Rasenick-Douss, & Tye, 1989; Altman, Rasenick-Douss, Foster, & Tye, 1991). The first case reports of the implementation of active law enforcement using underage decoys indicated that this strategy could produce prompt and dramatic reductions in the number of young smokers (DiFranza, Carlson, & Caisse, 1992; Jason et al., 1991). These early case reports were followed by four controlled interventions of active enforcement conducted at the community level (Cummings, Hyland, Perla, & Giovino, 2003; Forster et al., 1998; Jason et al., 1999; Rigotti et al., 1997). Three of these studies demonstrated that active enforcement reduced adolescent smoking substantially. The authors of the only study that did not demonstrate an impact on youth smoking observed that the enforcement program had failed to reduce youths’ access to cigarettes from commercial sources (Rigotti et al.). A subsequent literature review revealed that in every study in which a youth access intervention had failed to reduce adolescent smoking, there was either no evidence that the intervention had reduced youth access to commercial sources or there was evidence that the intervention had not reduced access (DiFranza, 2005b).
Reductions in youth tobacco use resulting from youth access interventions have been observed in at least 18 studies (Altman, Wheelis, McFarlane, Lee, & Fortmann, 1999; Chaloupka & Pacula, 1998; Dent & Biglan, 2004; DiFranza, 2002; DiFranza et al., 1992, 2009; Forster et al., 1998; Jason, Pokorny, & Schoeny, 2003; Levinson & Mickiewicz, 2007; Jason et al., 1991, 1999; Perla, 1999; Pokorny & Jason, 2003; Powell, Tauras, & Ross, 2003; Ross & Chaloupka, 2001; Staff, Bennett, & Angel, 2003; Staff et al., 1998; Tutt, Bauer, Edwards, & Cook, 2000; Tutt et al., 2009; Widome, Forster, Hannan, & Perry, 2007). There are no studies in which an impact on access was documented without a concomitant impact on youth smoking (DiFranza, 2005b). The literature is clear and consistent. Strategies that are ineffective in curtailing youth access to tobacco through commercial sources (such as relying solely on merchant education) are uniformly ineffective at reducing youth smoking. Conversely, strategies that effectively reduce youths’ access to tobacco from commercial sources have been uniformly effective in reducing youth tobacco use (DiFranza, 2005b). The literature appears “mixed” in regard to effectiveness only when reviewers inexplicably mix studies of ineffective strategies that were abandoned years ago with those of current proven strategies and recommend throwing the baby out with the bath water (DiFranza, 2000; Fichtenberg & Glantz, 2002; Richardson et al., 2009; Stead & Lancaster, 2000).
National studies in the United States and Australia demonstrate that restricted access to tobacco has contributed to the historic reductions in youth smoking rates witnessed since the inception of youth access enforcement programs in these countries (DiFranza et al., 2009; Tutt et al., 2009). The only youth access strategy that has proven efficacy is proactive enforcement involving the routine inspection of retailers through the use of test purchases conducted by decoys, resulting in financial penalties (DiFranza, 2005a). The FDA’s intention to enforce its regulations using underage decoys is well grounded in public health science and legal precedent. The Synar initiative, with its requirement for routine inspections of merchants using test purchases, has resulted in marked improvement in merchant compliance with state laws in every state (Center for Substance Abuse Prevention, 2010). The observed improvement in merchant compliance has been linked to declining teen smoking in national surveys when controlled for other public health policies, such as taxation and clean indoor air regulations (DiFranza et al., 2009).
A major misconception in regard to youth access restrictions is that youths increase their attempts to purchase tobacco in response to restrictions, and social sources of tobacco expand to completely fill the void left by the removal of commercial sources (Castrucci, Gerlach, Kaufman, & Orleans, 2002; Friend, Carmona, Wilbur, & Levy, 2001; Ling, Landman, & Glantz, 2002). The scientific evidence soundly refutes both points. In Australia, enforcement resulted in a 75% decline in attempts by underage youth to purchase tobacco (Tutt et al., 2009). Since youths who buy cigarettes are more likely to supply other youths (Forster, Chen, Blaine, Perry, & Toomey, 2003), preventing them from purchasing cigarettes reduces the largest social source. By reducing the number of underage smokers, access restrictions also reduce the number of potential social sources. There is no evidence supporting the fear that black markets develop to provide youth with cigarettes (DiFranza & Coleman, 2001). For these reasons, youth access restrictions result in a net absolute decline in social sources.
Despite the success of the Synar program, additional attention from the FDA to the problem of illegal sales of tobacco to minors is welcome as there is room for improvement. Some states tolerate violation rates that are consistently three to four times higher than in other states (Center for Substance Abuse Prevention, 2010). Also, under the current Synar regulations, states need only to achieve a compliance rate of 80%, even though high-performing states like Florida and Maine have shown that merchant compliance rates can be maintained above 90% indefinitely (Center for Substance Abuse Prevention).
The Family Smoking Prevention and Tobacco Control Act reenacts the original FDA regulations on tobacco sales to minors. These include a minimum age of 18 years, a requirement for age verification, and a restriction on the location of vending machines and self-service displays to locations where minors are not allowed. Table 1 indicates the fine structure for violations of the prohibition on providing tobacco to minors. This fine structure is within the range of penalties that has proven to be effective in persuading retailers to obey the law. Many states have used license suspensions or the threat thereof as an effective tool (DiFranza, 2005a). The law does not provide for retailer licensing but does allow the FDA to issue “no tobacco sales” orders to retailers who violate the law.
The law provides that reliance on a forged government ID is a positive defense. This provision has been included in many local laws and has not been an obstacle to enforcement as the decoys never carry forged IDs.
The FDA regulations regarding sales to minors are well formulated and well supported by the scientific literature. Research should continue to determine if there are more effective ways of curtailing the sale of tobacco to minors.
After the Synar Regulation was adopted, about a dozen states that had no restriction on the sale of tobacco to minors established a minimum age of 18 years (DiFranza et al., 1987). Only three states have a minimum age of 19 years, the rest have 18 as the minimum age (Downey & Gardiner, 1996). Only states can raise the minimum age.
There are no studies that have evaluated the effect of actually raising the minimum age as this has not occurred in the United States. The impact of raising the minimum age for tobacco sales to 21 years has been considered in models (Ahmad, 2005a, 2005b; Ahmad & Billimek, 2007). There are many arguments in favor of raising the minimum age, foremost of which is that most youth turn 18 while they are still a junior or a senior in high school, which allows these youths to legally purchase tobacco and supply their classmates (Crane, Dunn, & Cocoran, 2003). Retailers argue that having the same minimum age for alcohol, lottery tickets, and cigarettes would make it easier for them to train clerks. It would also eliminate the need to have three license designs under 18, 18–20, and 21 years and over.
Section 104 requires a study of the effect of raising the minimum age but does not allow the FDA to raise this limit.
Several authors have calculated the dollar value of cigarettes consumed by minors and have called for the government to confiscate the profits manufacturers’ derive from the underage market as a way to discourage competition for the youth market (Cummings, Pechacek, & Shopland, 1994; DiFranza & Tye, 1990; Glantz, 1993). The proposed law would require the General Accounting Office (GAO) to study one such approach.
Section 919 apportions user fees to manufacturers and importers according to overall market share. It requires the GAO to conduct a study to determine (a) brand preferences of minors, (b) the feasibility of reapportioning the user fees on the basis of market share among minors, and (c) the likely impact on the marketing of tobacco products to youth if user fees were apportioned according to youth market share.
Published studies establish that (a) youth brand preferences do not match those of adults, (b) youth brand preference varies by region, and (c) brand preference is not an exact match for market share because youth cannot always afford their preferred brands (DiFranza, Eddy, Brown, Ryan, & Bogojavlensky, 1994; DiFranza et al., 1991b).
All states prohibit the distribution of free samples to minors. Many states and municipalities prohibit the distribution of free samples entirely and do not make exceptions for adults.
When free sampling of adults has been allowed, there has been very poor compliance with the prohibition of distribution to minors. Historically, youth have had little difficulty obtaining free samples when they are available.
Title I. Bill Section 102 prohibits the distribution of free samples of cigarettes, smokeless, or tobacco but provides for a limited exception for smokeless tobacco in Section 919 that allows for the distribution of free samples of smokeless tobacco to adults under very restricted circumstances.
There are no existing regulations specific to Indian territory.
No studies have been published regarding the adequacy of enforcement on Indian lands. In some states, enforcement programs have covered tribal territories but not in others. To the extent that the tribes have prevented or neglected enforcement, Indian youth are being deprived of the proven public health benefits of this intervention.
Section 102 requires the Secretary of the Department of Health and Human Services to ensure that the provisions of this Act are enforced with respect to the United States and Indian tribes.
The Federal Trade Commission considers advertising of cigarettes to minors to be an unfair trade practice as reflected in their decision regarding Joe Camel and a few prior decisions (Federal Trade Commission, 1997). It might be possible to prosecute companies for soliciting illegal sales but that would have to be proved on a case-by-case basis. The companies agreed to limited restrictions on their ability to advertise to children as part of the Master Settlement Agreement but that is a negotiated agreement with the states and not a regulation (National Association of Attorneys General, 1989). Violations are handled through civil litigation, not through prosecution.
Efforts in other countries to prohibit advertising have been circumvented by the tobacco companies through the exploitation of loopholes, such as advertising in imported publications and by using tobacco brand logos and colors on other products and services. Ongoing vigilance and rapid reactions will be the price of imposing restrictions on the advertising of tobacco.
Title I. Bill Section 103 provides that the Secretary shall publish an action plan to enforce restrictions on promotion and advertising of menthol and other cigarettes to youth. The action plan shall be developed in consultation with public health organizations and other stakeholders with demonstrated expertise and experience in serving minority communities.
The research question is whether the proposed restrictions are adequate to protect minors and minority youth from tobacco advertising. This can be assessed through ongoing monitoring.
An important question is whether generic packaging is required to protect youth.
The passage of the Family Smoking Prevention and Tobacco Control Act provides a number of research opportunities and challenges. Some of these can be best addressed by the FDA, some by researchers in the public sector, and some by a collaboration between the FDA and academic researchers.
Funding for this project was provided by the National Cancer Institute through a contract (HHSN261200900423P) to the Society for Research on Nicotine and Tobacco.