After years of dragging its feet—and running afoul of the law—on tobacco harm reduction (THR), the Food and Drug Administration (FDA) is finally reversing course. On August 21, Reuters reported that the FDA “authorized 11 [ZYN] nicotine pouch products recently launched by Philip Morris, citing lower levels of harmful constituents compared with other oral and smokeless tobacco products.”
The FDA noted that, in making its decision, it considered “the risks and benefits to the U.S. population as a whole — including the benefits to adults who currently use tobacco products and switch to a potentially lower-risk product, as well as the risks posed to youth and non-users of tobacco products.” Given that nicotine pouches are significantly less harmful than combustible tobacco products and are effective in helping smokers quit, the FDA’s decision was a sensible one. Hopefully, the FDA continues to allow smokers access to reduced-risk products such as pouches, vapes, and heat-not-burn devices. Millions of lives depend on this commonsense approach.
Roughly 30 million American adults smoke cigarettes, and there are few safe and legal options for quitting this deadly habit. Even relatively effective quit-smoking aids such as nicotine patches have a six-month success rate of approximately 20 percent. Fortunately, harm reduction products such as nicotine pouches offer users much of the satisfaction they gain from combustible tobacco products at a small fraction of the risk to their health.
Smokers looking to quit cigarettes often turn to reduced-risk products such as nicotine pouches. As Rutgers Institute for Nicotine and Tobacco Studies Director Cristine D. Delnevo, PhD, MPH notes, 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.” This substitution strategy is wise.
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.” Dr. Rees’ observations are well-supported by the available evidence. Blood and urine samples taken from nicotine pouch users contain markedly lower levels of harmful biomarkers compared to smokers’ samples. Evidence examining the oral lesions of tobacco and nicotine pouch users also demonstrates significant harm reduction.
The FDA is increasingly acknowledging this substantial body of evidence. In its June issuance of 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.”
Allowing the manufacturer to market these products with a modified risk claim (“Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis”) was a sensible move for the FDA that reflected all of the available evidence. The latest authorization of 11 new pouch products through the premarket tobacco product application pathway is the latest indication that the agency is starting to do right by consumers. For the sake of millions of smokers, the FDA needs to continue and expand on this light-touch approach.