Does Modified Risk Need to Be Modified?

Rich Berry. Autumn Spice. Cappuccino. Citrus. Cinnamon. These aren’t drinks at Starbucks, but flavors of ZYN nicotine pouches recently authorized by the U.S. Food and Drug Administration (FDA) for marketing under the favorable new designation as a “Modified Risk Tobacco Product.”  As of June, ZYN is the first brand to be able to market their products under this labeling.  The new flavors that dropped on August 5th were the newest to be greenlit under this label, bringing the number of FDA-approved nicotine brands on the market to 30.  According to the FDA’s Pilot Program Update (this is a new program that expedites the procedure to pass approval) on August 4th, there was enough “sufficient evidence that the new products offer greater benefits to population health than risks.” In order to receive marketing authorizations like this, they must consider the impact of public health. The FDA claims they do thorough scientific review of all products and do consider the risks and benefits of the U.S. population as a whole “including the benefits to adults who currently use tobacco products and switch to a potentially lower risk products, as well as the risks posed to youth and non-users of tobacco products.”

Their evaluations consider the fact that those adults, 21 and older who use e-cigarettes or smoke traditional cigarettes, who switch to a nicotine pouch will reduce their harm from harmful chemicals found either of those.  They must completely switch and not be dual users.  This might be true; however, this does not consider nicotine, which is addictive in all tobacco products.  They are considering health risk reduction for present cigarette smokers as outweighing the risk of initiating first-time use in the youth by presenting them with flavors that are appealing to their demographic.

A recent CBS article by Callie Teitelbaum, Jamie Korenblat, and Max Moore, discusses both sides of the issue with interviews and quotes from the manufacturers who believe they are helping current smokers from lower risk of heart disease, stroke, lung cancer, chronic bronchitis, emphysema, and mouth cancer, and doctors like Dr. Brian King, executive vice president of U.S. programs at the Campaign for Tobacco-Free Kids, who states that “pouches create a profound risk for a nicotine-naïve person to get dependent and addicted.” A ZYN (owned by Philip Morris International) spokesperson countered by throwing in, once again, the age restriction component, telling CBS News that their pouches are intended only for legal-age current nicotine consumers who would already be smoking or using other traditional tobacco products. The problem we see with this, at least in Ulster County, is that teens are able to acquire nicotine pouches without being the legal age to purchase them.  In theory, yes, the law restricts them from being able to use and/or purchase them (and in correlation, be able to use them), but with marketing in places where youth and young adults spend time online and person, music events, and social media platforms, they are surrounded by the influence and ideation.  In turn, ease of access and price point makes nicotine pouches appealing.

Who wouldn’t be tempted to get their hands on something with a candy flavor or mint flavor? ZYN is the most commonly used, with approximately 84% of users indicating use of the brand and most commonly among youth (according to the TEEN+ study—a nationally representative, longitudinal study of tobacco product use among over 10,000 youth and young adults in the United States that is funded by the Bloomberg Initiative to Reduce Tobacco Use through the CDC Foundation with a grant from Bloomberg Philanthropies).  This is the problem that we are encountering.  The approval of more and more nicotine flavors, albeit useful for the cessation of smoking of current adult smokers, leads to an increase in teen users. In reducing usage by older generations, we could be exposing a new generation to the dangers of nicotine addiction.

It seems contradictory that the FDA, an agency within the U.S. Department of Health and Human Services, that protects the public health by assuring safety, effectiveness, and security of regulating tobacco products (among many other things like our nation’s food supply, human drugs, biological products for human use, cosmetics, veterinary drugs, etc.), is allowing the health of youth to be at risk. The extremely rapid increase in nicotine pouch use causes a serious public health risk, raising concern over the long-term impacts on teens’ health that we do not know until more research has been done.  The FDA does admit that their authorization “does not mean these products are safe or risk free.”  However, do teens know this?  Do they know that the minty pouch of nicotine salts they are putting in their mouth causes nicotine to cross the blood-brain barrier easier, making higher doses of nicotine more palatable, says Dr. King.  Dr. Bonnie Halpern-Felsher, Stanford University’s professor of pediatrics, warns that the use of nicotine by young people can “prime the brain toward addictive behavior.”

The numbers don’t lie. Nicotine pouches, like those marketed and sold by ZYN and on!, are the second most commonly used form of tobacco used by the youth, behind vapes.  In monitoring nicotine pouch trends in their TEEN+ report from February 2020 to December 2025, 2.3% of U.S. high school students and 0.9% of middle school students currently use nicotine pouches. This extrapolates that in the past three years the use of nicotine pouches has quadrupled!  Even though the FDA is requiring Philip Morris International, owner of ZYN, to conduct studies and post-market surveillance in order to keep its status as an MRTP (Modified Risk Tobacco Product), this will not stop the inevitable and statistically proven increase in usage by teens. This label will expire in five years if at any point the FDA determines that any marketing no longer benefits the health of the population as a whole “such as if there is a significant increase in youth uptake.” They will withdraw their orders.  If we look at what the last three years’ number show in terms of increase in youth usage, the National Youth Development Survey (a survey that provides national benchmark data on commercial tobacco use, behaviors and related risk factors among youth in the United States) should show a heavy increase in usage.  The long-term effects that could happen in five years’ time could be detrimental to our county’s youth. This may be too late for our current middle- and high schoolers!

Thankfully we are able to implement programs like Maximizing Life (formerly Too Good for Drugs) in the elementary, middle, and high schools and Vaping Crash Courses in the high schools, in order to educate students on the dangers of all tobacco products. Maximizing Life talks about making good decisions, resisting peer pressure, the health risks as well as marketing and social media influence. Vaping Crash Courses discuss everything related to tobacco products, but specifically focusing on vaping as that is the number one used nicotine product used by the youth. Ulster Prevention Council programs and offers programming to all nine school districts in Ulster County and will be starting our fall cohort on September 14th.

It is interesting that 16 countries have banned sales of pouches while we are approving more and more! Until we can advocate for the banning of flavored nicotine pouches in New York State and have stricter fines and punishments for retail establishments who sell to underage youth, we have to do what we can to educate our youth in the schools while parents, caregivers, and guardians begin talking to their children early and often. We have to be the change!

Sources

Center for Disease and Prevention. September 17, 2025.

Teitelbaum, Callie, Jamie Korenblat, and Max Moore. “As FDA approves new marketing for nicotine pouches, some doctors sound alarms” August 5, 2026.

Tobacco Epidemic Evaluation Network (TEEN+) Study. September 2025.

FDA Website. “Pilot Program Update:  FDA Authorizes 4 New Nicotine Pouches.” August 4, 2025.

FDA Website. “FDA Launches Program to More Efficiently Review Nicotine Pouch Application. September 18, 2025.

FDA Website. Nicotine Pouch Products Authorized by the FDA.

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