The U.S. Food and Drug Administration (FDA) has given the core ZYN collection a modified risk granted order. As a result, manufacturer Swedish Match can market ZYNs as being lower-risk than tobacco products. The FDA issued this authorization on 30 June, 2026, and it applies to ZYN products with nicotine strengths of 3mg or 6mg.
In this article, we’ll break down what modified risk tobacco products are, explain what the decision really means, and outline the difference between modified risk tobacco products and other regulation categories. Don’t be scared by the jargon — this is all simpler than it sounds!
Key Takeaways:
- 20 ZYNs can now be marketed as being a lower-risk alternative to tobacco products.
- To earn their status as a modified risk tobacco product, the pouches have been through a rigorous application.
- This is part of ZYN’s positive trajectory in recent years, as the pouches have gone from marketing authorization to now modified risk products.
What is a Modified Risk Tobacco Product?
A modified risk tobacco product (MRTP) is a product that the FDA deems to be significantly lower-risk than other tobacco products, such as cigarettes. To earn this status, products have to go through a rigorous application process to earn an FDA modified risk order.
This includes a comprehensive scientific review, which weighs up whether a product reduces harm (both for individual tobacco users and the wider population). It does this by considering:
- The health risks of the tobacco product
- The chance of tobacco users switching to the tobacco product instead of quitting using tobacco
- The chance of non-tobacco users starting to use the tobacco product
- How the use of the tobacco product compares to the use of approved smoking cessation products
The FDA regulates this under Section 911 of the Federal Food, Drug, and Cosmetic (FD&C) Act.
ZYNs are currently the only nicotine pouches to have a modified risk granted order. However, other tobacco alternatives are on the list, including Marlboro heatsticks, General snus, and IQOS devices.
Which ZYNs are Modified Risk Tobacco Products?
The brand’s original lineup of 20 pouches are now modified risk tobacco products. Specifically, those with 3mg and 6mg strengths, across the following flavors:
- ZYN Peppermint
- ZYN Menthol
- ZYN Spearmint
- ZYN Cool Mint
- ZYN Wintergreen
- ZYN Smooth
- ZYN Chill
- ZYN Citrus
- ZYN Coffee
- ZYN Cinnamon
The new ZYN Ultra range, limited edition pouches, and any ZYN products in other flavors or strength levels do not have status as modified risk products. This could change in the future if Swedish Match successfully submits MRTP applications for these pouches too.
Modified Risk Tobacco Products vs Other Regulation Categories
Anyone who has spent time browsing the Prilla blog before has likely come across some other regulation categories. So it’s only natural to wonder how they compare to a modified risk order.
The Pre-Market Tobacco Application (PMTA) is the process that companies must go through to sell nicotine pouches in the USA. It functions as a pathway with multiple steps, and the final one involves a product being granted a marketing authorization. While the FDA has recently eased restrictions on unauthorized nicotine products, it remains a crucial process.
In January 2025, 20 ZYN products became the first nicotine pouches to be granted this authorization. Other nicotine pouches, including on! pouches, followed — partly thanks to the new pilot program to fast-track authorization.
To gain both marketing authorization and a modified risk order, companies need to submit significant evidence about the product, including health information. But the focus is different, with the MRP process focusing on the behavior of tobacco users and how tobacco products affect their decisions related to tobacco usage. Meanwhile, the PMTA has a more general assessment that covers youth influence, product ingredients, environmental impact, and more.
As a result, while a PMTA only gives companies authorization for general sale, the MRP allows them to make a specific claim about reducing risk.
What ZYN’s Modified Risk Status Means
ZYN has been America’s leader for a while now, and becoming the country’s best-known brand early on offered a clear advantage. But as new nicotine pouches emerge and become popular, the brand cannot afford to take its position for granted.
The new modified risk status is the latest in a series of moves to help ZYN maintain its bestselling status. It was also the first nicotine pouch brand to earn a PMTA, and the collection recently expanded to include ZYN Ultra and new flavor profiles.
But we may also see other pouch brands seeking out their own modified risk granted orders. So watch this space.
