The Food and Drug Administration (FDA) is delaying the fast-track approval of nicotine pouches like Philip Morris International’s Zyn and British American Tobacco’s Velo due to concerns about youth use. They also are scrapping the pilot program aimed at expediting reviews of the growing $22 billion nicotine market. It is noble that the FDA is concerned about youth use, but denying adults access to safer alternatives under the banner of “caution” is exactly the kind of paternalism that keeps smokers hooked on more dangerous products.
Cigarette smoking costs the U.S. $600 billion annually in healthcare expenses and remains the leading cause of preventable death in the U.S. Nicotine itself is not the harmful component in tobacco products and can be helpful for adults trying to stop smoking. Ignoring the benefits of THR products like pouches and restricting access to consumers has both economic and humanitarian costs the FDA can’t ignore.
Due to the FDA backlog of product applications, companies face longer-than-necessary wait times, creating barriers to entry and limiting competition. Consumers are left with fewer options and often turn to black-market/illicit products to fill the gap. This puts vulnerable consumers at risk of dangerous products. The FDA is ignoring that tobacco harm reduction (THR) products exist on a continuum of risk, and less harmful products like pouches allow adult smokers to shift away from higher risk combustible cigarettes. This THR strategy is an evidence-based approach that millions of Americans have used, and more could benefit from to improve public health.
Many smokers trying to quit cigarettes find that reduced-risk products like nicotine pouches help them to successfully stop smoking. Rutgers Institute for Nicotine and Tobacco Studies Director Cristine D. Delnevo, PhD, MPH, states that statistical analysis “suggest[s] that adults may be using nicotine pouches for harm reduction given that use is highest among those who have recently quit another tobacco product.” This substitution approach is a smart way to reduce tobacco harm among adult smokers.
As Dr. Vaughan W. Rees, director of the Center for Global Tobacco Control at the Harvard 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 concern regarding youth use is legitimate and no one wants youth to use products they are legally banned from. Laws on the books must be enforced at the local, state, and federal levels to ensure youth are not gaining access to any products that have age restrictions. Signed into law in 2019, Tobacco 21 raised the legal age of tobacco and nicotine products to 21. The law also mandated retailers to verify the age of consumers attempting to purchase alcohol or nicotine products nationwide. Holding retailers accountable to enforce said laws is critical to reducing underage use. There must be a balance between restricting access for youth and increasing access to THR products for adults attempting to quit smoking.
The FDA frequently exhibits inconsistency, and the ongoing debate over nicotine pouches is a clear example. Nicotine pouches remain one of the least harmful ways to consume nicotine and have been successful in reducing smoking rates worldwide. Instead of limiting access, the FDA should promote consumer choice and let adult consumers decide which products are most effective for them. The FDA must take a balanced approach that supports using THR as a tool for quitting smoking to improve public health.
Christina Smith is the director of the Taxpayers Protection Alliance’s Consumer Center.
