Nicotine Pouch Regulations Explained: PMTAs and MGOs

The fast growth of the nicotine pouch market has led to a regulation crisis, with brands entering the market and seeking approval faster than the U.S. Food and Drug Administration (FDA) can decide whether to authorize them.

Pouch users might typically care more about getting their hands on their product of choice than understanding the complex regulations behind them. But with recent developments, like the pilot program to fast-track pouch approval, it's natural to have a little curiosity.

This article runs through the basics of nicotine pouch regulation, including the difference between PMTAs and MGOs.

Who Governs Nicotine Pouches?

In the US, the FDA is the ultimate authority over nicotine pouches. Although people sometimes describe nicotine pouches as being “tobacco-free” since they don’t contain tobacco leaves, the FDA considers them a “type of tobacco product”. This means they come under its domain; the same thing applies to other tobacco-leaf-free products, like e-cigarettes.

The US government passed the Family Smoking and Tobacco Control Act in 2009, giving the FDA control over the distribution, marketing, and manufacturing of tobacco products. For instance, it can dictate tobacco sponsorships and sales to those under the age of 21.

Synthetic nicotine once fell outside of the FDA’s authority. But in March 2022, the government passed the Consolidated Appropriations Act, which included products that use nicotine from any source as part of the Family Smoking Prevention and Tobacco Control Act.

However, it’s worth noting that the FDA doesn’t have control over every single decision related to tobacco products. There are some aspects that states or local authorities can control — we outlined a few of these in our 2025 nicotine pouch regulation roundup.

What is the PMTA?

Since the FDA has regulatory authority over nicotine pouches, they cannot go to market without its authority. Specifically, manufacturers must submit a Pre-Market Tobacco Application (PMTA) to legally sell a product in the USA. That includes all nicotine pouches we sell here on Prilla.

This process has public health at its center; the FDA determines whether the product is a better alternative to existing tobacco products. A product doesn’t have to be harmless or good for health — just better than what is currently available. 

Stages of the PMTA

The PMTA is a pathway with six stages:

1. Pre-meetings: A meeting between the FDA and the applicant (aka, the pouch manufacturer).
2. Acceptance: The first step of the review process, focused on whether a product meets the FDA’s statutory and regulatory requirements.
3. Filing: An evaluation of whether there is enough information to carry out the full review.
4. Review: An evaluation of all the scientific evidence, which determines whether an MGO can be granted. Evidence related to environmental considerations is also needed.
5. Action: The FDA either accepts or rejects marketing authorization.
6. Postmarket reporting: Even if the FDA authorizes a pouch, the manufacturer must continue its recordkeeping and reporting to the FDA (especially regarding youth exposure). If it fails to apply, the FDA may withdraw its authorization.

What the PMTA Evaluates

Since the PMTA is all about public health, it considers the following factors:

• Comparison of harm versus traditional tobacco products
• Impact on the behaviour of users, like whether it encourages smokers to stop smoking
• Influence on the youth
• Ingredients and chemistry
• Environmental impact
• Manufacturing controls

This evaluation requires hard data, clinical studies, and research, making it a lengthy process.

What is an MGO?

Confusion often arises between a PMTA and an MGO. Essentially, the final stage of a PMTA involves deciding whether to give a product the Marketing Granted Order (MGO).

Once a product has an MGO, a product is authorized for marketing. As outlined already, it must continue to submit reports to the FDA to monitor risks.

But the process has attracted some criticism (for instance, at the Global Tobacco & Nicotine Forum 2025) because of how complicated and lengthy it is. It takes years to receive an MGO, and a high volume of evidence.

In fact, currently, the 20 ZYN pouches on the market are the only nicotine pouches to be granted an MGO, and it took five years. Yet as of January 2025, the FDA has received almost 27 million applications and made decisions about 26 million of them (note this includes other oral tobacco products).

The status of a product can be found on the Searchable Tobacco Products Database.

FDA fast track

This process might be about to change, however. The FDA is carrying out a pilot process to test out a faster review of nicotine pouches, which involves the following brands:

• On!
• ZYN (a new range that is not yet on the market)
• ALP
• FRE
• VELO

It aims to streamline the process by improving communication and permitting the use of general research. 

Modified Risk Products

The FDA has an additional category, Modified Risk Tobacco Products (MRTP). This allows companies to claim their product reduces risks — for instance, they might say a product causes less harm than cigarettes.

To be classed as a MRTP, a product must already have an MGO, and the company must submit extensive evidence and research about consumers and behaviour. No nicotine pouch has yet earned this status.

Among the products with modified risk granted orders are Swedish Match’s General snus portions and the U.S Smokeless Tobacco Company’s Copenhagen Classic Snuff.