Navigating Harm Reduction in Tobacco Dependence Treatment and Prevention

Clinical Perspectives in a Changing Regulatory Landscape

In the last year, the U.S. Food and Drug Administration began publicly acknowledging harm reduction as a legitimate principle within its regulatory framework. Through its Premarket Tobacco Product Application process, companies can gain authorization to sell their products in the U.S. Those seeking authorization must “provide scientific data that demonstrates a product is appropriate for the protection of public health,” according to FDA guidance. The current list of FDA authorized products includes some e-cigarettes and nicotine pouches. An important distinction here is that these products are not recognized by the FDA as being safe or approved for treatment of tobacco use disorder.

What does the FDA’s public shift on harm reduction mean for those who treat tobacco use and nicotine dependence? Our leadership team at the Duke-UNC Tobacco Treatment Training Program wanted to offer some guidance on this often-debated topic. We want to be clear that the best way to help people quit smoking is to offer FDA-approved medications for cessation (nicotine patch + nicotine gum or lozenges, varenicline, bupropion) along with behavioral counseling. This approach is evidence-based and will greatly increase a person’s chances of quitting.

Duke-UNC Tobacco Treatment Specialist Training Program Co-Founder, Adam Goldstein, MD, MPH, offers his insights as a clinician and public health expert.

Adam Goldstein, MD, MPH – Elizabeth and Oscar Goodwin Distinguished Professor and Director of Tobacco Intervention Program, UNC Chapel Hill

"I have watched tobacco harm reduction through products such as e-cigarettes move from a controversial concept to a central issue in tobacco regulatory science. For clinicians, this shift matters because our patients are increasingly using a wide range of nicotine products, and they expect honest, evidence-based conversations about risk.

Recent actions by the U.S. Food and Drug Administration reflect this evolving landscape. In 2025, the FDA authorized the marketing of 20 ZYN nicotine pouch products after determining they may benefit adults who completely switch away from combustible tobacco. The agency has also recently authorized certain flavored vaping products, including fruit flavors such as blueberry and mango, while emphasizing youth access restrictions and continued public health oversight.

"At the same time, these decisions raise legitimate concerns. Flavored products may help some adults move away from cigarettes, but they also risk increasing youth appeal and nicotine initiation. Groups such as Campaign for Tobacco-Free Kids have questioned whether the potential benefits for adults outweigh the risks for adolescents.

Effective harm reduction would not support marketing of any tobacco products in ways that attract non-tobacco users, create new or increased addiction, or delay people from quitting altogether.

"For providers delivering tobacco treatment, the message is not “quit entirely or fail.” Tobacco dependence is a chronic, relapsing condition, and most patients make multiple quit attempts before successfully stopping combustible tobacco use. Our role is to continue supporting cessation, encourage repeated quit attempts, and help patients move down the continuum of risk whenever possible.

"Harm reduction is not about declaring nicotine safe. It is about reducing disease and death while continuing to prioritize prevention, evidence-based treatment, and long-term cessation."

FDA Authorization vs. Approval

FDA authorized products that have gone through the Premarket Tobacco Product Application process are not “approved” as a form of treatment for tobacco use. They are tobacco products that are allowed to be sold in the U.S. The FDA requires that the applicants “provide scientific data that demonstrates a product is appropriate for the protection of public health.”

What About Modified Risk Tobacco Products?

The FDA also has a Modified Risk Tobacco Product (MRTP) application process. These products must show that “the product will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.” The current list of MRTPs includes some heat-not-burn products (IQOS), smokeless tobacco products, and very-low-nicotine cigarettes.

About the Author

Adam Goldstein, MD, MPH, is Elizabeth and Oscar Goodwin Distinguished Professor and Director of Departmental Advancement at the University of North Carolina (UNC) Department of Family Medicine. Dr. Goldstein is the Director of Tobacco Intervention Programs (Tobacco Treatment Program and Tobacco Prevention and Evaluation Program) at the UNC School of Medicine. Dr. Goldstein’s research has had extensive local, regional and national influence through print, radio, and television media, with over 200 articles, essays, book chapters, and books, featured in CNN, CBS Evening News, the New York Times, and the Wall Street Journal. Dr. Goldstein is a Co-Founder of the Duke-UNC Tobacco Treatment Specialist Training Program.

About the Duke-UNC Tobacco Treatment Specialist Training Program

Duke-UNC TTS provides interactive, evidence-based tobacco treatment training for medical, behavioral, and public health professionals. For more information about the Duke-UNC TTS Training Program, visit our website at www.dukeunctts.com.