New Strategy for Tobacco Regulation

By Erik J. MacLaren, PhD

On July 28, 2017, the U.S. Food and Drug Administration (FDA) announced a new, multi-year strategy intended to reduce tobacco-related disease and mortality. As part of this new strategy, the agency will begin developing a plan to reduce nicotine in combustible cigarettes to non-addictive levels and delay implementation of some new product regulations.1 The primary goals of these actions are to make it easier for current smokers to quit, to reduce the risk of nicotine addiction in new smokers, and to gather more evidence for the benefits and risks newer nicotine-delivery methods, such as e-cigarettes, might pose for addicted smokers.

In a speech to employees of the FDA in May, Scott Gottlieb, MD, the FDA Commissioner, identified reducing smoking rates as a key goal in the agency’s mission to protect public health.2 The new strategy announced at the end of July is intended to focus on nicotine as the underlying cause of tobacco addiction and to recognize differences in the health risks posed by combustible cigarettes versus electronic devices such as e-cigarettes. Writing in the New England Journal of Medicine,3 Dr. Gottlieb and Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, provided more details about this strategy, explaining that the ultimate goals are to reduce the addictiveness of cigarettes while exploring how potentially less harmful nicotinedelivery devices should be regulated to maximize harm reduction among smokers.

To reduce the addictiveness of combustible cigarettes, the FDA will seek to regulate nicotine yields in combustible cigarettes using authority granted by the Family Smoking Prevention and Tobacco Control Act of 2009. This legislation empowered the agency to set product standards, including standards for nicotine yields, in the interest of public health. Although the FDA cannot require the complete removal of nicotine from cigarettes, it can limit nicotine to levels that are non-addictive or minimally addictive.

To begin creating new nicotine standards, the FDA will first issue an Advance Notice of Proposed Rulemaking seeking stakeholder input on the potential public health benefits and possible unintended consequences of lowering nicotine in cigarettes. Dr. Gottlieb and Mr. Zeller wrote that the FDA will consider data from peer-reviewed studies of verylow- nicotine cigarettes in setting any potential standard. Scientific evidence about possible adverse effects of decreasing nicotine levels, such as compensatory smoking, the migration of smokers to other tobacco products, or the emergence of a black market for high-nicotine cigarettes, will also be explored.

In concert with developing new regulations regarding nicotine yields, the FDA will delay the deadline for manufacturers of newly regulated products such as cigars and e-cigarettes to submit tobacco product review applications until 2021 or 2022, respectively. Current requirements for cigarettes and smokeless tobacco, and all other requirements for cigars and e-cigarettes, will be unaffected.

In their editorial, Dr. Gottlieb and Mr. Zeller explained the need for the postponement by noting that there is Scott Gottlieb, MD, Commissioner of the U.S. Food and Drug Administration, said in a recent speech, “There’s probably no single intervention or product we’re likely to create in the near future that can have as profound an impact on reducing illness and death from disease as our ability to increase the rate of decline in smoking.”1 One of the many ways the National Cancer Institute (NCI) contributes to the goal of reducing smoking is through its Tobacco Control Research Branch (TCRB), which leads and collaborates on research, and disseminates evidence-based findings to prevent, treat, and control tobacco use.

In collaboration with other Federal organizations, TCRB created and maintains the Smokefree.gov Initiative (www.smokefree.gov), the largest Federal mobile behavioral health intervention program. Smokefree.gov offers free, accurate, evidence-based smoking cessation treatment and professional assistance to help individuals, including specific vulnerable populations such as teens, women of reproductive age, Spanish speakers, military/veterans, and older adults.A wealth of consumer-friendly articles on key smoking cessation topics— including preparing to quit, managing withdrawal, and choosing cessation support methods—serves as the foundation of Smokefree.gov. In addition, Smokefree.gov offers digital tools for those wishing to quit, such as a Create My Quit Plan builder and quizzes that assess topics like nicotine dependence or stress levels. QuitGuide (for adults) and quitSTART (for teens), are smartphone apps that conform to US Clinical Practice Guidelines. They each provide 24/7 on-demand support and skills building to improve users’ chances of successfully quitting. They also allow users to tag specific locations and times of day to get support when they need it most.

The Initiative also maintains SmokefreeTXT, a 6–8 week text messaging intervention that provides smoking cessation treatment and includes advice and encouragement to smokers attempting to quit. Eleven other smoking cessation text programs have been modeled from SmokefreeTXT to help vulnerable smoking populations. Two recently developed programs assist smokers in practicing quitting and building skills and confidence for quitting permanently. HealthyYouTXT offers 3 tailored programs for smokers interested in addressing related health behaviors around eating healthier, increasing physical activity, and managing their weight.

The NCI’s Cancer Information Service supports a smoking quit line (1-877-44U-QUIT), a national service with trained information specialists who offer multiple resources to quit smoking, including information, counseling, and referrals. As a complement to this, the NCI also offers access to state-run programs via 1-800-QUIT-NOW, which automatically redirects callers to a local quit line.

Erik Augustson, PhD, MPH, a Behavioral Scientist and Program Director in the TCRB, spoke with IASLC Lung Cancer News about the future of digital tools for smoking cessation, including mobile health (mHealth) treatments such as smartphone apps. “One primary area in which I expect to see improvement is in our ability to maintain engagement in mHealth treatments with smokers across time, which will improve outcomes,” said Dr. Augustson. He explained that several research groups around the country, including his own, are working on integrating natural language processing and artificial intelligence into mHealth treatments to achieve this goal.

Another key direction identified by Dr. Augustson is improvement in the integration between digital resources and those delivered by real people. One possibility, he said, would be “providing the counselor with data summaries collected within the mHealth platforms to improve the ability of the counselor and smoker to work collaboratively in developing and implementing quit plans.” The goal of such integration would not be to reduce the active role of real people in delivering treatment but to allow the greater personalization of treatment plans and improve outcomes. ✦

References

1. Gottlieb, S. Dr. Gottlieb’s first remarks to FDA staff. 2017 May 15. Available at: https://www. fda.gov/NewsEvents/Speeches/ucm558566. htm.