The Food and Drug Administration (FDA) has historically made a terrible habit of curtailing access to products such as e-cigarettes and nicotine pouches, which can give adult smokers less harmful alternatives to cigarettes. But a sudden policy shift under the Trump administration suggests reality is finally breaking through the regulatory bureaucracy and red tape.
On August 21, the FDA authorized 11 new ZYN nicotine pouch products by Philip Morris International, noting lower levels of harmful constituents compared with other oral smokeless tobacco products. In its announcement, the agency said it weighed the “risks and benefits to the U.S. population as a whole.” This includes the substantial benefit to adults who want to switch to lower-risk options and are trying to quit smoking.
Cigarette smoking continues to cause more than 480,000 deaths annually in the United States and remains the leading preventable cause of disease, disability, and death. This decision to approve THR products gives the roughly 30 million American adults still smoke cigarettes an exit ramp off their deadly habit. Traditional aids, such as nicotine patches, have a six-month success rate of only about 20 percent, underscoring the need for better alternatives. Yet, for decades, the government’s response to these issues has been simple: make do with subpar cessation methods or suffer the consequences.
Tobacco Harm Reduction offers a far better and science-based approach to this broken status quo. Products like nicotine pouches and vapes give users an experience not far removed from smoking, but at a tiny fraction of the health risk of traditional cigarettes.
A 2025 Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) study analyzing and extrapolating data from the 2022 National Health Interview Survey found that, in all, approximately 2.9 million people successfully quit smoking for at least six months in the past year. The study highlights the increasingly pivotal role of nicotine products, especially e-cigarettes, in smoking cessation.
The authors note, “The most commonly reported listed methods were nicotine products (53.9%, 1.5 million US adults), primarily e-cigarettes used alone or in combination with other methods (40.8%, 1.2 million US adults). … However, a significant portion of adults still attempt to quit unaided, emphasizing the need for targeted interventions and promotion of evidence-based methods.”
And as Dr. Vaughan W. Rees, director of the Center for Global Tobacco Control at the Harvard T.H. Chan School of Public Health, notes, “Zyn has very low toxicity compared with smoking, so even without long-term studies we know that the long-term disease risk is likely to be lower than combusted cigarette products.” Similarly, government agencies such as Public Health England (replaced by the United Kingdom) Health Security Agency and Office for Health Improvement and Disparities have found that vapes are 95 percent less harmful than combustible tobacco products.
Furthermore, data from the Rutgers Institute for Nicotine and Tobacco Studies Director Cristine D. Delnevo, PhD, MPH, show that statistical analysis “suggest[s] that adults may be using nicotine pouches for harm reduction given that use is highest among those that have recently quit another tobacco product or e-cigarettes.” When individuals are free to choose, they naturally gravitate toward safer options.
Fortunately, the FDA has started to reverse course, publicly highlighting the benefits of harm reduction products and strategies. In June, the FDA issued modified risk granted orders for 20 ZYN nicotine pouch products. The agency stated, “FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices.” The latest authorizations are another step in the right direction.
Prohibiting products like pouches and vapes puts consumers at serious risk, but recent FDA efforts to approve products aligned with market needs are a positive step toward improved consumer safety. Hopefully, bureaucrats build on this progress by allowing consumers access to an array of reduced-risk products.
Christina Smith is the Director of the Taxpayers Protection Alliance’s Consumer Center