Achievements in Tobacco Regulation Over the Past Decade and Beyond

By: Ned Sharpless, M.D., Acting Commissioner, and Mitch Zeller, J.D., Director, Center for Tobacco Products

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Ned Sharpless, M.D.

When Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA) 10 years ago, it gave the U.S. Food and Drug Administration (FDA) new authorities to protect people, particularly youth, from the harms of tobacco use. The law authorized the FDA to create its Center for Tobacco Products (CTP), with the mission to reduce the death and disease toll caused by tobacco. Tobacco product regulation represents one of the FDA’s greatest opportunities to save lives.

In the decade since the TCA was passed, CTP has established a science-based approach to the regulation of tobacco products; vigorously enforced our authorities to target manufacturers and retailers that violate the law, such as through illegal sales to minors; and designed innovative education campaigns to educate youth on the dangers of tobacco use. We developed a multi-year roadmap that places nicotine, and the issue of addiction, at the center of our tobacco regulation efforts. CTP has also expanded its focus and authorities to address new challenges posed by products such as e-cigarettes.

CTP continues to evolve and meet the challenge of regulating a complex and rapidly changing tobacco landscape by focusing on research, regulatory oversight, public health education, and compliance with federal laws.

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Funding Scientific Research Relevant to Tobacco Control

Mitch Zeller, J.D.

The FDA funds a wide range of research projects to add to our knowledge base and assess the public health impact of our regulatory actions. In October 2011, the FDA and the National Institutes of Health (NIH) launched the Population Assessment of Tobacco and Health (PATH) Study. This long-term, ongoing study follows tens of thousands of adults and teens over time, helping scientists learn how and why people start using tobacco, quit using it, and start using it again after they’ve quit. The PATH Study asks crucial questions not often seen in other surveys, such as why consumers use tobacco products. For instance, the PATH Study found that flavor was a primary reason for youth to use a tobacco product.¹ This finding has informed our policies about flavored products moving forward. Recent PATH Study findings have also shed light on important topics such as the health effects of chemicals in e-cigarettes and cigars, and patterns of adult hookah use.

In 2011, the FDA also began to collaborate with the Centers for Disease Control and Prevention (CDC) on the National Youth Tobacco Survey, an ongoing nationally representative survey of middle and high school students. This survey provides annual data on current tobacco product use that helps us understand the changing tobacco landscape and informs our policy development. For instance, the most recent survey identified unprecedented increases in youth use of e-cigarettes — namely, that e-cigarette use rose by 78 percent among high school students and 48 percent among middle school students from 2017 to 2018² — and formed the basis for the FDA’s data-driven policy approaches to curb youth use of these products.

In 2013, the FDA and NIH awarded money to 14 Tobacco Centers of Regulatory Science. These grants fund research on topics critical to the future of regulation, such as flavors in e-cigarettes, the effects of reducing nicotine in cigarettes, consumer perceptions of tobacco products, and addiction. CTP awarded 9 more grants in 2018 to fund further research on topics such as toxicity of tobacco smoke and aerosol, addiction, and the influences of tobacco marketing.

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Extending the FDA’s Authority to All Tobacco Products

Since 2009, the FDA has regulated cigarettes, smokeless tobacco, cigarette tobacco and roll-your-own tobacco. Consistent with the TCA, such products can only be sold to customers aged 18 years and older. In 2016, the FDA published the deeming final rule. The deeming rule extended the FDA’s authorities to include all tobacco products, except accessories of newly deemed products. This historic final rule also included prohibitions on the sale of covered tobacco products to individuals under 18 years of age, among other sales and distribution requirements. Like originally regulated tobacco products, all new, deemed tobacco products must undergo a comprehensive scientific review before they may receive marketing authorization. Lastly, the rule established new warning requirements for deemed tobacco products.

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Public Education Preventing Up to 587,000 Kids from Starting to Smoke Cigarettes

Note: The statistics in this section were updated on August 20, 2019.

Because almost 90 percent of adult daily smokers started by the age of 18,³ the FDA launched its first tobacco prevention campaign, “The Real Cost,” in 2014 to educate at-risk teens on the harmful effects of cigarette smoking. Research shows that between February 2014 and November 2016 the campaign prevented up to 587,000 youth, ages 11 to 19, from initiating smoking, half of whom might have gone on to become established adult smokers.⁴ Ultimately, the campaign will save these kids, their families, and the country more than $53 billion by reducing smoking-related costs, like early loss of life, costly medical care, lost wages, lower productivity, and increased disability.⁵ In 2016, “The Real Cost” expanded messaging to prevent smokeless tobacco use and then evolved again in 2018 to tackle the epidemic of youth vaping. The FDA has launched two additional youth and young adult campaigns — “Fresh Empire” and “This Free Life” — as well as an adult-focused cessation campaign, “Every Try Counts.” These innovative campaigns, grounded in science, use messages that resonate with each target audience and cause people to think and act differently toward tobacco use.

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Enforcing Rules to Save Lives

An important part of fulfilling our mission is enforcing rules that protect the public health from disease and death caused by tobacco. We hold manufacturers, distributors, and importers accountable for making sure all tobacco products sold in interstate commerce comply with the law and are not misbranded or adulterated. In addition, we conduct compliance check inspections of tobacco retailers to ensure they uphold the law, most critically that they do not sell tobacco products to youth. Our robust retailer education program, This is Our Watch, provides educational resources and tools to help retailers comply with tobacco regulations. We also host a series of webinars designed to provide the FDA tobacco compliance education and information to retailers and to small business manufacturers.

Today, 10 years since CTP opened its doors, the agency has conducted more than a million compliance check inspections and issued nearly 88,000 Warning Letters, 22,000 Civil Money Penalties, and 160 No Tobacco Sale Orders.

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Making Tobacco Less Addictive, Less Appealing, and Less Deadly

The FDA has unique power to set standards that make tobacco products less deadly, less addictive, and less appealing.

Because a robust science base shows that flavored tobacco products are especially appealing to youth, the TCA immediately banned cigarettes with all characterizing flavors except tobacco flavor or menthol. This flavor ban went into effect on September 22, 2009. The FDA also has the authority to create additional product standards. In January 2017 the FDA issued a proposed rule to limit the levels of a carcinogen, N-nitrosonornicotine or NNN, in smokeless tobacco products, which would reduce disease caused by smokeless tobacco.

We have a comprehensive framework to regulate nicotine to reduce the harm to society of tobacco use. In July 2017, the FDA announced a groundbreaking plan for tobacco and nicotine regulation. This plan acknowledges that some forms of nicotine delivery are potentially less harmful than others, with approved nicotine replacement therapies like patches or gum being the least harmful and combustible cigarettes being the deadliest.

Then in March 2018, the FDA issued an Advance Notice of Proposed Rulemaking for a product standard to lower nicotine levels in combusted cigarettes to minimally or non-addictive levels. This historic product standard could potentially prevent future generations from ever becoming addicted to the deadliest tobacco product, while making it easier for currently addicted cigarette smokers to quit.

In March 2018, the FDA issued an Advance Notice of Proposed Rulemaking seeking public comment on flavors in tobacco products. We are taking a closer look at flavors in tobacco products to better understand their appeal to youth and level of impact on youth initiation. And as a public health agency, it’s important that we also explore whether or not and how flavors, under a proper regulatory framework that protects youth, may have the potential to help some currently addicted adult cigarette smokers transition completely away from cigarettes. We plan to take action on flavored cigars and continue to explore other issues related to flavored tobacco products.

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Appreciating Progress, Accepting Challenges and Opportunities Ahead

Over the last decade, current adult cigarette smoking rates have fallen from nearly 21 percent to 14 percent,⁶ and teen cigarette smoking rates are at an all-time low.⁷ There is much to commemorate, yet we have significant important work ahead of us.

Recent National Youth Tobacco Survey statistics show a concerning rise in e-cigarette use among middle- and high-school students.² As we continue to make progress with reductions in cigarette use, we cannot allow the next generation to become addicted to nicotine in other forms of delivery. Our path forward must involve a comprehensive approach to the flavors in tobacco that many, particularly young people, find appealing. If the 2019 National Youth Tobacco Survey continues to show sharp increases in youth use of tobacco products, the FDA will consider additional measures to address this crisis. We’ll take all appropriate actions necessary to stop these rates from increasing, including changing our enforcement policies for products on the market without authorization.

It is not easy to navigate the complexities of the shifting tobacco landscape, one where products reside on a continuum of risk with deadly combustible products on one end of the continuum and safe and effective medicines on the other. However, we are more than up for the task. CTP, which began with just a dozen people, has grown to about 800 employees working hard to protect public health by utilizing the powerful authorities afforded to the FDA under the TCA and Federal Food, Drug, and Cosmetic Act. We have the committed and expert staff, authority, and science base to continue taking effective action to end the tobacco epidemic. The FDA has made significant progress over the past decade and will continue to work towards a future when death and disease from tobacco usage are a thing of the past.

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References

1. Villanti et al. Flavored tobacco product use in youth and adults: findings from the first wave of the PATH study (2013-2014). Am J Prev Med. 2017;53(2). https://doi.org/10.1016/j.amepre.2017.01.026. Accessed December 27, 2018.
2. Cullen KA, Ambrose BK, Gentzke AS, Apelberg BJ, Jamal A, King BA. Notes from the Field: Increase in use of electronic cigarettes and any tobacco product among middle and high school students — United States, 2011—2018. MMWR Morbid Mortal Wkly Rep. 2018;67(45).
3. U.S. Department of Health and Human Services (USDHHS). The Health Consequences of Smoking - 50 Years of Progress. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.
4. Farrelly MC, Duke JC, Nonnemaker J, et al. Association Between The Real Cost Media Campaign and Smoking Initiation Among Youths — United States, 2014—2016. MMWR Morb Mortal Wkly Rep 2017;66:47—50. DOI: http://dx.doi.org/10.15585/mmwr.mm6602a2.htm. Accessed March 21, 2019.
5. MacMonegle AJ, Nonnemaker J, Duke JC, et al. Cost-Effectiveness Analysis of The Real Cost Campaign's Effect on Smoking Prevention. Am J Prev Med. 2018;55(3). DOI: https://doi.org/10.1016/j.amepre.2018.05.006. Accessed March 21, 2019.
6. Wang TW, Asman K, Gentzke AS, et al. Tobacco Product Use Among Adults — United States,-2017. MMWR Morb Mortal Wkly Rep 2018:67:1125—32.
7. Wang TW, Gentzke A, Sharapova S, et al. Tobacco Product Use Among Middle and High School Students — United States, 2011-2017. MMWR Morb Mortal Wkly Rep. 2018; 67:629—33.