A former FDA scientist says the agency approved ZYN nicotine pouches for sale without knowing what the pouches were actually made of. In internal emails obtained by investigative journalists, Eija Leppanen, a former environmental scientist at the FDA's Center for Tobacco Products, wrote that she was "flabbergasted" to learn her superiors did not know the composition of ZYN's pouch material. Her concern: the pouches might contain microplastics, and the FDA's environmental assessment failed to address this possibility.
This revelation comes just weeks after the FDA granted ZYN a modified risk claim, allowing the product to state it poses lower risk than cigarettes for certain diseases. The timing has intensified scrutiny of both the product and the regulatory process behind it.
What Leppanen Actually Found
Leppanen's concerns center on the pouch itself, the small teabag-like container that holds the nicotine and flavoring. In her January 2025 email to Brian King, then director of the Center for Tobacco Products, she questioned why the environmental assessment did not include research on microplastic exposure, even if that research was inconclusive.
The FDA updated its ZYN authorization in March 2025 to note that Leppanen did not sign the "finding of no significant impact." This is notable. When a scientist refuses to sign off on environmental clearance, it usually signals unresolved concerns that the agency chose to override.
Philip Morris International, ZYN's parent company, has not publicly disclosed the full material composition of the pouches. The company states that the product is "tobacco-free" and emphasizes the nicotine content, but the physical pouch material remains proprietary.
Why Microplastics in Nicotine Pouches Matter
Microplastics are plastic particles smaller than 5 millimeters. They have been found in human blood, lungs, placentas, and even brain tissue. Research on health effects is still developing, but studies have linked microplastic exposure to inflammation, cellular damage, and disruption of endocrine function.
The concern with nicotine pouches is specific: users hold the pouch against their gum for extended periods, sometimes hours at a time. This creates a direct route for any microplastic particles to enter the bloodstream through the oral mucosa. Unlike swallowing a particle, which might pass through the digestive system, buccal absorption bypasses first-pass metabolism and delivers substances directly into circulation.
A 2024 study in the journal Toxicological Sciences found that microplastics can penetrate human tissue barriers more easily than previously thought. Another study, published in Environmental Health Perspectives, linked microplastic accumulation to increased markers of oxidative stress in human cells.
The research is not conclusive enough to establish safe exposure limits. But that is precisely Leppanen's point: the FDA approved a product for widespread use without understanding whether it introduces a new vector for microplastic exposure.
The Modified Risk Claim Controversy
On June 30, 2026, the FDA authorized 20 ZYN products to carry a modified risk claim. The label now states that switching from cigarettes to ZYN "puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."
This authorization has drawn criticism from public health advocates who argue it will attract new users, particularly young people, rather than just helping existing smokers switch. The timing of Leppanen's revelations, coming just days after the modified risk authorization, has amplified these concerns.
Dr. Stanton Glantz, a tobacco control researcher at UCSF, told Medical Xpress that the FDA's decision "may hook a new generation" on nicotine. The modified risk claim, he argues, creates a perception of safety that could lead non-smokers to start using the product.
What We Actually Know About the Pouches
Philip Morris International has disclosed that ZYN contains nicotine salts, food-grade flavorings, and plant-based filler materials. The company has not specified what the pouch material itself is made of.
Industry analysts speculate that the pouches likely contain some form of cellulose or non-woven synthetic fiber. These materials are common in similar products. But without disclosure, users cannot know whether they are being exposed to microplastics or other synthetic compounds.
The FDA's environmental assessment, which Leppanen criticized, is supposed to evaluate whether a product poses risks to the environment or human health beyond its intended use. In this case, the assessment appears to have focused on disposal and manufacturing impacts rather than the direct exposure question Leppanen raised.
What This Means If You Use ZYN
If you currently use ZYN or are considering switching from cigarettes, this controversy introduces uncertainty that did not exist a month ago. The modified risk claim compares ZYN to cigarettes, not to abstinence from nicotine entirely. It does not address the microplastic question because that question was not fully investigated.
For current users, the practical options are limited. There is no tested method to determine whether a specific ZYN pouch contains microplastics. There is no alternative nicotine pouch product that has been fully vetted for microplastic content either. The entire category exists in a disclosure gap.
Some users have switched to nicotine gum or patches, which use different delivery mechanisms and have longer safety records. Others have used the controversy as motivation to quit nicotine entirely. Neither choice is simple, and both involve trade-offs that depend on individual circumstances.
The Bigger Picture: Regulation Lagging Behind Products
This controversy illustrates a broader pattern in nicotine product regulation. New products reach the market, gain popularity, and only later face serious scrutiny of their ingredients and long-term effects. The FDA's modified risk pathway was designed to encourage smokers to switch to less harmful products, but critics argue it has created a system where products are approved based on incomplete information.
The microplastic question is particularly vexing because it sits at the intersection of multiple regulatory gaps. The FDA regulates nicotine products. The EPA regulates environmental contaminants. Neither agency has clear authority over microplastics in consumer products held in the mouth for extended periods.
Philip Morris International has invested over $1 billion in U.S. nicotine pouch manufacturing capacity, according to industry reports. The company is clearly betting on continued growth in this product category. Whether that growth continues may depend on how regulators and consumers respond to the questions Leppanen raised.
What Happens Next
The FDA has not indicated whether it will revisit its ZYN authorization in light of Leppanen's concerns. Congressional oversight is possible, given the attention the issue has received. Several state attorneys general have already taken independent action against nicotine pouch marketing, and the microplastic revelation could fuel additional state-level scrutiny.
For individual users, the most immediate impact may be psychological. The modified risk claim created a sense that ZYN was "FDA approved" in a comprehensive sense. The Leppanen emails reveal that this approval was narrower and more contested than the marketing suggested.
Frequently Asked Questions
Does ZYN contain microplastics?
We do not know. The pouch material composition has not been fully disclosed, and the FDA's environmental assessment did not address microplastic exposure. The former FDA scientist who raised this concern refused to sign off on the environmental clearance.
Is ZYN still FDA approved?
Yes. The FDA has authorized ZYN for sale and granted a modified risk claim for 20 specific products. However, this approval has been revealed to be more limited and contested than initial marketing suggested.
What are the health risks of microplastics?
Research is ongoing. Studies have linked microplastic exposure to inflammation, cellular damage, and endocrine disruption. Microplastics have been found in human blood, lungs, and brain tissue, but long-term health effects are not yet fully understood.
Should I stop using ZYN because of this?
This is a personal decision that depends on your circumstances. If you switched from cigarettes, you have already reduced certain risks. If you started using ZYN without a smoking history, the risk calculation is different. The microplastic concern adds uncertainty that did not exist when many users started.
Are other nicotine pouches safer?
Other nicotine pouch brands have not been tested for microplastic content either. The entire product category lacks disclosure standards for pouch materials. Nicotine gum and patches have longer safety records and different delivery mechanisms.
What is the modified risk claim?
The FDA authorized ZYN to state that switching from cigarettes to ZYN "puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis." This claim compares ZYN to cigarettes, not to abstaining from nicotine entirely.
The ZYN microplastics controversy is not going away. As more journalists dig into the FDA's approval process and as researchers continue studying microplastic health effects, users will face increasing pressure to make informed decisions about their nicotine use.
For those considering quitting, this moment offers clarity that did not exist before. The modified risk claim always compared ZYN to cigarettes, not to quitting entirely. The microplastic question adds another variable to consider.
Download PouchOut for structured support in reducing or quitting your nicotine pouch use. The app tracks your progress, manages cravings, and provides evidence-based strategies for breaking the habit.
Related Articles
- How to Quit ZYN: Complete 2026 Guide
- ZYN Withdrawal Symptoms: Complete List
- Nicotine Pouch Withdrawal Timeline: Day by Day
- Quitting ZYN Without Gaining Weight
- How to Quit ZYN Without Withdrawal Symptoms
- ZYN vs VELO vs ON vs Lyft: Which Is Easiest to Quit
- Reasons to Quit ZYN: Motivation Guide
- How to Support a Partner Quitting ZYN