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Bolstering FDA Pathways for Reducing Death and Disease from Tobacco

Scott Gottlieb Nicotene Article
Thought Leader: Scott Gottlieb
April 11, 2024
Source: JAMA
Written by: Scott Gottlieb, M.D.

In the decade since passage of the Family Smoking Prevention and Tobacco Control Act (TCA) in 2009, overall cigarette use has declined by 26%.1 There is little doubt that the Food and Drug Administration’s (FDA) efforts to implement the law have contributed to these public health gains. However, there are indications that the rate of decline in smoking has started to slow in recent years. Even if these observations do not mark the beginning of a trend, maintaining the historical rate of decline in smoking and smoking-related death and disease may grow more difficult. Adults who continue to smoke despite its obvious health risks, high cost, and growing societal restrictions may be more committed to the habit, potentially have a worse addiction to nicotine, and, therefore, find it more difficult to transition away from tobacco products. For these currently nicotine-addicted adult smokers, the opportunity to convert to noncombustible products offering nicotine delivery without the combustion-related health risks should be a renewed part of the US public health agenda.

A safer way for addicted adult smokers to access nicotine is through FDA-approved medicinal products like gums and patches. The agency issued new guidance last year aiming to advance the development of additional products that demonstrate evidence to help smokers quit and to reduce their risk of relapse.2 The FDA should embrace new forms of medicinal nicotine through new routes of delivery to make the products more appealing to adult smokers, such as electronic nicotine delivery systems (ENDS), that could undergo the scrutiny of the new drug approval process to evaluate their safety profile and demonstrate their efficacy in helping smokers achieve tobacco cessation.

Products that lower the risk of harm compared with traditional tobacco products like cigarettes and can be used by adults as alternatives to smoking can also be approved through the Modified Risk Tobacco Product (MRTP) pathway created by the TCA. The MRTP pathway recognizes that even if there are some risks to individual users of noncombustible forms of nicotine delivery, these risks can be outweighed by the potential benefits of reduced risk for tobacco users who switch to the new product and a decreased likelihood of initiation for nonsmokers. The criteria also require that a product must benefit the overall health of the population, considering both tobacco users and nonusers.

The MRTP pathway reflects a modern, bipartisan approach to tobacco regulation within the TCA framework. Congress recognized that nicotine itself would not be banned, and that the deadliest aspects of smoking stemmed from combustion, not nicotine. Although nicotine is responsible for sustaining the addiction to cigarettes, Congress understood that some adults would still seek it. One intent of the law was to incentivize manufacturers to develop less harmful alternatives for adult smokers by offering nicotine without combustion. The MRTP pathway approach aims to compel manufacturers to shift toward developing and marketing products that reduce smoking and its harms.

Implementing the MRTP’s risk-benefit framework for the sale of modified risk products has long presented a dilemma for the FDA and the public health community. Although alternative nicotine delivery systems might reduce harm for existing smokers, they also carry the risk of initiating new nicotine users, some of whom may eventually transition to combustible tobacco. These concerns are especially heightened for children.3 The experience with Juul, a vaping product that was inappropriately marketed and fueled a youth vaping crisis in 2018, without MRTP authorization, underscores the risks associated with these products.4

Reflecting these concerns, the FDA has been cautious in granting MRTP authorizations, and the pathway for demonstrating that a product meets the strict standards is challenging. To date, the FDA has authorized the sale of only 3 brands of modified risk tobacco products: Swedish Match snus products authorized in 2019; IQOS Tobacco Heating System, which heats tobacco rather than burning it, in 2020; and U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff that was authorized in 2023.5

The tension between enabling new products that can help some adult smokers quit and that do not rely on combustion and inhalation, and the concerns over diversion to youth, is exemplified by the recent backlash against Zyn, a brand of nicotine pouches that, although derived from tobacco, contain no tobacco leaf. Zyn is available for adult tobacco users, and presently, overall youth use of nicotine pouches appears to remain low.6 However, Zyn’s growing popularity on social media platforms like TikTok, where influencers with young audiences promote it, sparks concern. There is a fear of a repeat of the rapid spike seen with Juul use among youth in 2018, which would be difficult to curb. More generally, even though products that could make claims that they pose less health risks than cigarettes continue to face understandable skepticism, the marketplace continues to be dominated by both combustible and noncombustible products such as ENDS that have been introduced to the market after passage of the TCA and that have undergone no review at all, 15 years after the TCA was first passed.

After implementation of the TCA, tobacco products such as ENDS and nicotine pouches that were newly deemed to be subject to the FDA’s regulations, have been allowed to remain on the market while manufacturers filed Premarket Tobacco Product Applications (PMTA) and awaited the FDA’s decision. PMTA is a second pathway in the TCA, in addition to the MRTP, that ensures the FDA has the information to assess the health risks and public health impact of a new tobacco product. Unlike the MRTP pathway, however, which focuses on reduced risk compared with existing products, the PMTA process centers on overall safety and public health implications. The FDA faces hundreds of thousands of pending PMTA applications that it has not acted on, reflecting the enormous challenge of reviewing so many applications. Many companies that introduced products after passage of the TCA have taken advantage of the regulatory backlog to remain on the US market while the FDA works through its application bottleneck.

Although the MRTP and PMTA application processes are distinct, both pathways grant the FDA greater authority to restrict sales and marketing practices that could promote smoking or entice youth use of tobacco products. The public would benefit from additional guidance on the implementation of these pathways, and greater ability of the FDA to work through the application backlog. Once the FDA can make more active and regular use of the MRTP and PMTA pathways, with authorizations or denials under either pathway, it would have a stronger legal basis to enforce regulations, including restrictions on how products may be marketed.

Congress is considering a user fee program to bolster the FDA’s tobacco center. These additional resources, tied to a mandate for the agency to address its application backlog promptly, should be combined with expanded enforcement activities. Prioritizing enforcement actions is likely to have the most impact on public health. Full implementation of the MRTP and PMTA pathway, including enforcement actions based on clear regulatory principles for reducing health risks, would strengthen the FDA’s hand in shifting the market away from combustible tobacco.

Addressing the PMTA backlog would facilitate the FDA’s efforts to remove unauthorized products from the market. For example, there is evidence that youth vaping has shifted to illegally marketed disposable vaping products like Puff Bar. However, without final decisions on all vaping products, stores wishing to comply with FDA regulations, as well as state and federal inspectors who interdict illegal products, argue that it can be harder for them to distinguish between legal and illegal devices, including most disposable vaping products currently being sold.7

Finally, in conjunction with these steps, the FDA should advance its proposed rule to regulate nicotine in combustible cigarettes to render them minimally addictive or nonaddictive. If cigarettes could no longer create and sustain addiction, it would be easier to migrate smokers away from these products altogether.

Passage of the TCA was a watershed moment that contributed to declines in smoking rates that seemed unthinkable just decades prior, but maintaining this momentum will require further steps to harness the full potential of this groundbreaking legislation, including its innovative approach to risk reduction. Implementing the full authority of the TCA offers the best opportunity for a multipronged approach against nicotine addiction and smoking-related harm. Like a final, grueling stretch of a marathon, this push requires an intelligent use of all the tools of the TCA at our disposal.

Article Information

Published: April 11, 2024. doi:10.1001/jamahealthforum.2024.1233

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2024 Gottlieb S et al. JAMA Health Forum.

Corresponding Author: Scott M. Gottlieb, MD, American Enterprise Institute, 1789 Massachusetts Ave NW, Washington, DC 20036 (scott.gottlieb@gmail.com).

Conflict of Interest Disclosures: Dr McClellan reported receiving personal fees from Cigna Health, Alignment Health Care, Johnson & Johnson, Arsenal Capital, Blackstone Life Sciences, MITRE, CRG, and Washington Speakers Bureau outside the submitted work. No other disclosures were reported.

References

1. American Lung Association. State of tobacco control, tobacco facts, 2024. January 19, 2024. Accessed March 19, 2024. https://www.lung.org/research/sotc/facts

2. US Food and Drug Administration. Smoking cessation and related indications: developing nicotine replacement therapy drug products. May 2023. Accessed March 19, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/smoking-cessation-and-related-indications-developing-nicotine-replacement-therapy-drug-products

3. Piper  ME, Mermelstein  R, Baker  TB.  Progress in treating youth smoking: imperative, difficult, slow.   JAMA Pediatr. 2019;173(12):1131-1132. doi:10.1001/jamapediatrics.2019.3541
ArticlePubMedGoogle ScholarCrossref

4. US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use. September 11, 2018. Accessed March 19, 2024. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-address-epidemic-youth-e-cigarette-use

5. US Food and Drug Administration. Modified risk granted orders. Accessed March 19, 2024. https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-granted-orders

6. Centers for Disease Control and Prevention. Fast facts and fact sheets: youth and tobacco use. Accessed March 19, 2024. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm

7. Jewett  C. Illicit e-cigarettes flood stores as F.D.A. struggles to combat imports. The New York Times. October 10, 2023. Accessed April 3, 2024. https://www.nytimes.com/2023/10/10/health/illegal-vapes-ecigarettes-fda.html

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