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The Changing Cigarette

New Oversight of Tobacco Products

On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act (Public Law 111-31). The Tobacco Control Act grants the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products to protect the public’s health and recognizes FDA as the primary federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products. Key elements of the act include, among other things, creation of a new Center for Tobacco Products, prohibition of the sale of cigarettes containing certain characterizing flavors, the requirement that manufacturers and importers report to FDA the ingredients and additives in their products, strengthened warning labels with graphic images of the adverse effects of cigarette use, and oversight of the tobacco industry’s efforts to develop and market potential reduced-exposure tobacco products. The Tobacco Control Act also requires FDA to reissue the agency’s 1996 regulation aimed at reducing young people’s access to tobacco products and curbing the appeal of tobacco to the young. Although some provisions of the act went into effect shortly after the statute was enacted, such as the ban on flavored cigarettes, others will be implemented over time.

Sections 910 and 911 of the Tobacco Control Act provide that premarket review of certain tobacco products by FDA is required before the products may be marketed. Section 910 requires manufacturers of new tobacco products (those not commercially marketed as of February 15, 2007, or modified after that date) to submit an application containing specified manufacturing and ingredient information, as well as studies of the product’s health risks, for FDA review. After reviewing the application, the agency will issue an order either permitting the product to be marketed or denying its marketing according to specified bases for its action. New tobacco products determined by FDA to be substantially equivalent to products already on the market as of February 15, 2007, are not required to undergo premarket review.

Section 911 provides that “modified risk tobacco products” may only be marketed if FDA determines, after reviewing a product application, that the product will significantly reduce the risk of tobacco-related disease to individual users, and benefit the health of the population as a whole, taking into account the impact on both users and nonusers of tobacco products. Section 911 recognizes so-called special rule products, which also require pre-market approval. Such products may be marketed for up to five years (subject to renewal) if the agency determines that the applicant has met specified criteria, the applicant agrees to conduct certain postmarket surveillance and studies, and other specified findings regarding the relative harm of the product are made. Under this section, FDA must issue guidance or regulations on the scientific evidence required for the assessment and ongoing review of modified-risk tobacco products in consultation with IOM.

Summary

To reduce smoking-attributable death and disease, public health efforts since the 1964 Surgeon General’s report on smoking and health have focused on reducing the prevalence of tobacco use. Reduced prevalence has been achieved through efforts to prevent tobacco use and promote cessation; this effort has been termed one of the “ten great public health achievements of the twentieth century” (CDC 1999). At the time the adverse effects of smoking were being recognized, the tobacco industry developed cigarettes with low machine-measured yields of tar and nicotine, and public health authorities encouraged consumers to select them (Peeler 1996; Shopland 2001). Unfortunately, it took public health researchers and federal authorities many years to discover what the tobacco industry knew much earlier: the health benefits of reductions of tar and nicotine intakes were negligible at best for persons using these products (Federal Register 1995, 1996; NCI 2001; WHO 2001; U.S. v. Philip Morris No. 449 F. Supp. 2d 1, 430–75 [D.D.C. 2006]). In 2001, an NCI report concluded: “There is no convincing evidence that changes in cigarette design between 1950 and the mid 1980s have resulted in an important decrease in the disease burden caused by cigarette use either for smokers as a group or for the entire population” (NCI 2001, p. 146). Thus, by the twenty-first century, it was apparent that five decades of evolving cigarette design had not reduced overall disease risk among smokers, and new designs were used by the tobacco industry as a tool to undermine prevention and cessation efforts (NCI 2001; Stratton et al. 2001; WHO 2001, 2003a,b,c; USDHHS 2004).

Similarly, informative and comprehensive scientific evaluations do not exist for any of the other new products developed ostensibly to reduce toxicants in cigarette smoke. This lack of data limits any conclusions that can be drawn about potential health risks or benefits.

The well-documented risks of cigarette design changes must be weighed against any potential benefits (Stratton et al. 2001). As this chapter makes clear, substantial risks may be associated with new tobacco products: (1) smokers who might have otherwise stopped smoking may continue to smoke because of perceived reduction in risk with use of new products; (2) former smokers may resume smoking because of perceived reduction in risk with use of new products; and (3) nonsmokers, particularly youth, may start to use new products because of their perceived safety. The theoretical benefit of cigarette design changes is to reduce exposure to toxicants sufficiently to reduce the risk of disease and death. However, if these products are used by persons otherwise unlikely to use a tobacco product, which would undermine efforts to prevent tobacco use, or if the products delay cessation among persons who would otherwise stop using tobacco, the overall health of the population would be harmed.

There is little doubt that new tobacco products will continue to be developed. Consequently, there is a critical need to conduct independent research on the design, composition, and health effects of new cigarette products and to put in place a comprehensive surveillance system to understand consumers’ knowledge, attitudes, and behaviors regarding these products.

Conclusions

1. The evidence indicates that changing cigarette designs over the last five decades, including filtered, low-tar, and “light” variations, have not reduced overall disease risk among smokers and may have hindered prevention and cessation efforts.

2. There is insufficient evidence to determine whether novel tobacco products reduce individual and population health risks.

3. The overall health of the public could be harmed if the introduction of novel tobacco products encourages tobacco use among people who would otherwise be unlikely to use a tobacco product or delays cessation among persons who would otherwise quit using tobacco altogether.

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Filters and harm

Despite being labelled the “deadliest fraud in the history of human civilisation”,1 filter tips now feature on almost every mass-produced cigarette smoked across the globe.2 After filters first appeared in the 1860s as an attempt to protect against tobacco flakes entering the mouth,3 the tobacco industry introduced modern cellulose acetate cigarette filters in the 1950s to alleviate public concerns about smoking-related lung cancer.4 Filters and innovations to filters have been consistently marketed as a means to reduce smoking-related health risks,5 with the very name ‘filter’ suggesting reduced harm.6 For instance, filter perforations introduced in the 1970s and 1980s to create ‘light’ and ‘mild’ cigarettes produced lower machine-tested yields of tar and nicotine. When smoking, however, the perforations are blocked by smokers’ fingers,7 8 serving to increase rather than decrease harm as smokers take more frequent and deeper puffs to satisfy nicotine cravings.9 The overwhelming majority of independent research shows that filters do not reduce the harms associated with smoking7–9—a fact understood by tobacco industry scientists in the 1960s.4 In fact, filters may increase the harms caused by smoking by enabling smokers to inhale smoke more deeply into their lungs.8 Furthermore, toxic fibres shed from the cut end of the filter are inhaled and ingested by smokers.3 A recent research letter reporting a study with contradictory findings10 has been criticised for a non-representative sample11 and failing to take into account confounding factors such as socioeconomic status.12

In addition, cigarette filters are an environmental hazard and are among the 10 most common plastics in the world’s oceans. Every year, an estimated 4.5 trillion cigarette filters are deposited into the environment. Discarded filters are commonly made of cellulose acetate, a plastic13 losing on average only 38% mass in two years of decomposition,14 and contain a number of toxic substances which may leach into the environment.15 16 In 2019, many single use plastics were banned in the EU. However, early proposals for Member States to reduce plastic waste from cigarettes by 50% by 2025 and 80% by 2030 were rejected in favour of weaker measures.17 Instead, tobacco companies must help raise public awareness of the plastic in their cigarette filters and contribute to the costs of clean-up, collection and waste treatment of disposed filters.18 Even these measures were resisted by the tobacco industry and its associates.19

Now tobacco companies are exploring the possibility of biodegradable filters. However, this should be regarded with caution. First, biodegradable filters would still leach harmful chemicals into the environment if discarded improperly16 and second, it is likely that the tobacco industry will use biodegradable filters as both a Corporate Social Responsibility and a marketing opportunity. The potential unintended consequences would be reputation rehabilitation and consumers and non-consumers alike believing that filtered cigarettes are less harmful without plastic in their filters. Given that we know that tobacco companies are already marketing their filter innovations to retailers in a way that connotates health benefits, biodegradable filters are likely to be no exception and the filter fraud will be enabled to adapt and persist once more.