In September 2025, the U.S. Food and Drug Administration (FDA) announced a pilot program to streamline the review of nicotine pouches. This move comes after the Trump administration put pressure on the FDA to make the authorization process more efficient; currently, companies have to wait years for an authorization or rejection. In contrast, the pilot program aims to authorize the nicotine pouches participating by December 2025 (according to reporting from Reuters).
The pouches that will be part of the process are ZYN Ultra from Philip Morris International, On! And On! Plus from Altria, VELO Mini from Reynolds American, and FRE and ALP from Turning Point Brands.
Key Takeaways:
- To speed up the process of achieving FDA authorization, the Trump administration has introduced a pilot program with a new streamlined process.
- FDA authorization is required to market nicotine pouches in the USA and avoid enforcement issues.
- So far, the only nicotine pouches to have FDA authorization are 20 ZYNs.
- The nicotine pouches involved in the pilot program are ZYN, FRE, ALP, VELO, and On!
What’s the Big Deal about FDA Authorization?
When a company wants to launch a new nicotine pouch, it needs to go through something called a premarket tobacco product application (PMTA) to obtain marketing authorization. In this process, the FDA evaluates scientific evidence about the product, with a focus on manufacturing, ingredients, and its impact on public health.
This review process applies to all products that contain tobacco (while nicotine pouches are tobacco leaf-free, this is their legal classification as nicotine is derived from tobacco). Yet while traditional tobacco products can follow long-established regulatory processes, the same isn’t true of nicotine pouches.
As a new addition to the market, there aren’t the same precedents, and the approval process is proving onerous. It was big news in January 2025 when 20 ZYN pouches were authorized by the FDA, making them the first nicotine pouches to achieve this status. It was a landmark moment — but it took five years of waiting to get there.
What about Unauthorized Products?
The 20 ZYN pouches that obtained their PMTA are the only nicotine pouches on the market that the FDA has authorized. This means the FDA allows companies to market these products (but only to adults aged 21 and over, and the FDA closely monitors the adverts to prevent youth exposure).
No other nicotine pouches can be legally marketed in the US, and the FDA has continually cracked down on companies that have advertised their products illegally. However, companies can still sell their nicotine pouches as long as they have submitted a PMTA and are awaiting authorization — they are only prohibited from marketing.
Since most nicotine pouches do not have FDA authorization, any company that has its PMTA granted has a competitive advantage over brands awaiting a decision. As well as having the right to market their nicotine pouches, they no longer have to worry about facing problems related to enforcement or legality — a major concern considering legislation is changing so fast in the industry.
The Pilot Program: A Deep Dive
To grant a PMTA, the FDA must determine that a product offers more benefits than risks for public health. For instance, if a nicotine pouch encourages people to switch from cigarettes to a less harmful product, this is deemed beneficial for public health overall.
As part of the changes made to introduce the pilot program, Reuters has reported that the FDA plans to allow companies to use general nicotine pouch research in their application instead of requiring research on the specific nicotine pouches.
The pilot program also aims to improve communication between the FDA and the applicants to streamline the process.
Spotlight on the Pouches in the Pilot
Some of the brands going through the pilot program happen to be favorites here on Prilla. Let’s introduce the brands and look at what the future holds for them.
ZYN Ultra
ZYN pouches are the nicotine pouch market leader in the US, so it’s fitting that they were the first to receive FDA authorization. But while all ZYN products for sale in the US are now authorized, the brand isn’t stopping there.
It now wants to release a new range, ZYN Ultra, which is speculated to feature moist pouches (unlike its current collection of dry pouches).
The brand is currently keeping info on this exciting new collection under wraps, but Prilla will post an update when more information is available.
ALP
ALP pouches are a relative newcomer to the nicotine pouch market, launched by Tucker Carlson to compete with ZYN. But despite being fresh meat, their start has been far from slow. The brand is now hoping to take things from good to great with FDA approval as part of its mission to rival ZYN.
FRE
Like ALP, FRE pouches are made by Turning Point Brands. While the motto of the brand is to make customers “FRE to be wild,” the brand clearly wants that “FREdom” to be within the confines of the FDA’s authorization.
The pouches are slim and moist, with strength levels up to 15mg. This makes them a popular choice for those wanting a particularly intense experience.
VELO Mini
VELO pouches are already a market leader in Europe, and the brand is hoping to take the same level of success to the US. It has a few products on offer, from VELO Plus to VELO Max, but the company is focusing on the mini collection for FDA authorization.
On! (and On! Plus)
On! pouches are a popular choice on Prilla, and it submitted its application for On! Plus — a new collection designed to be extra-soft in the mouth — back in 2024. While these pouches are currently available in Europe, the company has been waiting for authorization in the USA.
The Trump Administration and Nicotine Pouches: A Background
While the announcement of the pilot program was a landmark moment, it is not the first time the current US government has expressed its support for nicotine pouches.
The administration has been vocal about its support for nicotine pouches. For instance, in an interview in August 2025, Health and Human Services Secretary Robert F. Kennedy Jr called nicotine pouches the “safest way to consume nicotine” in an interview.
So far, the FDA remains more cautious about other tobacco alternatives, like vapes.
Response to the Pilot Program
As would be expected, many manufacturers have responded positively to the news. For instance, Altria said the move was “encouraging” and good for harm reduction, while Turning Point Brands said it showed a commitment to transparency and effectiveness.
However, there has been some negative response. A group of various organizations, including the American Academy of Pediatrics and the American Heart Association, signed a letter to the FDA expressing their concerns that the new pilot program wouldn’t be scientifically rigorous enough.
