Is Zyn FDA Approved?

As its popularity grows, you may be wondering is Zyn FDA approved...

Key findings

As of January 2025, the U.S. Food and Drug Administration (FDA) has authorised the sale of Zyn nicotine pouches. While not entirely risk free, they acknowledged their potential benefits for adult smokers looking for alternatives to traditional tobacco products, and considers Zyn pouches less harmful than cigarettes and some smokeless tobacco products. The FDA emphasises that Zyn nicotine pouches are intended for adults aged 21 and over and should be marketed responsibly to prevent youth usage.

Introduction: What is Zyn?

Zyn is a brand of nicotine pouches that launched in the US over 10 years ago. They’re small sachets filled with plant fibers, nicotine and flavourings that you place under your lip in between your gums and cheek, where nicotine enters your body through the lining of your mouth.

A single Zyn nicotine pouch lasts for about 25 to 30 minutes and you get 20 pouches per tub. They’re tobacco-free, much cheaper than smoking and vaping, lung friendly as you don’t have to inhale anything.

Nicotine pouches are made entirely out of food grade products and are completely bio-degradable, so they're an excellent option if you're eco-conscious. Zyn nicotine pouches are also very discreet and can be used indoors, making them a popular choice for office workers and frequent travellers.

Zyn’s parent company is Swedish Match, a European enterprise that was bought out by Philip Morris International in 2022 for $16B. Since then, Zyn’s shipments have doubled from 238m units in 2022 to 570m units in 2024, hitting $1.3 billion in sales in 2023.

Philip Morris says their aim is to phase out tobacco products altogether, and Zyn appears to be spearheading this ambition; they currently control more than 70% of the US nicotine pouch market, which earns them six times more money than their international cigarette business.

By 2030 Philip Morris International predicts that their sales of Zyn will hit $3.5 billion.

Let’s explore whether Zyn is FDA approved and dive into the legal status of Zyn nicotine pouches in the US.

Is Zyn FDA approved?

No, Zyn is not FDA approved; it is authorised for sale based on certain conditions.

On the 16th January 2025, the FDA announced that it was authorising the sale of 20 Zyn nicotine pouch flavours and two nicotine strengths. The review followed official calls for an investigation into the safety and use of these products, with concerns raised by Senator Chuck Schumer that nicotine pouches could be abused by students.

After an extensive scientific study, the FDA believes that Zyn nicotine pouches offer more benefits to the smoking population than health risks.(1) They also concluded that youth nicotine pouch use remains low, citing a CDC Survey in 2023 that showed that 1.2% of students used oral nicotine products.(2)

What’s the difference between FDA approval and authorisation?

FDA Authorisation means that a product, like Zyn nicotine pouches, can legally be sold under specific conditions. In the case of Zyn nicotine pouches, it means that they can be sold to adults as a nicotine alternative or a safer alternative to tobacco. This does not imply they are completely safe, they must not be marketed to children, and only certain flavours and strengths have been authorised. Authorisation under Premarket Tobacco Product Application (PMTA) is specific to tobacco and nicotine products, but it is not a step towards approval in the pharmaceutical sense.

FDA Approval, on the other hand, applies to drugs, medical devices, and treatments that the FDA has decided are safe and effective. Products like nicotine patches or gum are FDA-approved because they are classed as medical aids for smoking cessation. Nicotine pouches like Zyn are not eligible for FDA approval because they are regulated as tobacco products.

What does FDA authorisation of Zyn mean?

Zyn FDA authorisation means that they can be sold to adults over the age of 21. It does not mean that Zyn nicotine pouches are officially FDA approved for smoking cessation, only that they appear less harmful than existing tobacco products and alternatives like e-cigarettes.

Here are the highlights:

• FDA authorises the sale of 20 Zyn products, including Chill, Cinnamon, Citrus, Coffee, Cool Mint & Menthol.

• Marketing is granted for two nicotine strengths - 3mg & 6mg.

• Strict advertising restrictions are to be implemented to restrict youth access, e.g. ads to target audiences of 21 years or older & no mass-marketing on radio or TV.

• Zyn nicotine pouches are not approved for smoking cessation. Adults who wish to quit smoking should use FDA approved nicotine patches, gum or prescription medications.

What flavours of Zyn are available?

While the FDA authorised 20 Zyn products, this includes variations in strengths across 10 core flavours.

What are the ingredients in Zyn?

Nicotine salt: Zyn nicotine pouches do not contain any tobacco, nicotine is isolated from tobacco leaf and blended with benzoic acid to create a fast acting experience that feels comfortable.

Fillers: cellulose; organic plant fibers used as a base to absorb the rest of the ingredients.

Stabilisers: food grade additives used to keep Zyn pouches fresh on the shelf.

pH adjusters: additives like sodium carbonate are used to ensure Zyn pouches work in harmony with your mouth's pH.

Sweeteners: calorie free sweeteners like sucralose and Acesulfame K.

Flavourings: used to add a dynamic level of enjoyment to your experience.

How does Zyn compare to other nicotine pouches?

Nicotine Strength

Zyn offers a wide range of nicotine strengths to suit all preferences. The low strength 3mg is great for beginners and people with mild cravings, while 6mg, 9.5mg and 12.5mg options provide solutions for more experienced users and people with strong cravings. At the moment the FDA has approved the sale of the 3mg and 6mg Zyn nicotine strengths. Compared to other brands like VELO or Nordic Spirit, which offer similar strength ranges, Zyn provides more balanced nicotine options that cater to both light and heavy users.

Flavour Variety

Flavour plays a huge role in Zyn's popularity. They showcase an exciting array of flavours that range from classic mints like Cool Mint and Peppermint to more unique options like Citrus, Coffee, and Cinnamon. This diverse flavour range rivals competitors such as V&YOU and Nordic Spirit, which also offer a broad selection but tend to focus more on traditional Scandinavian flavours. Zyn’s flavours are known for their subtlety and smoothness, making them a good choice if you don’t like overpowering tastes.

Comfort

Zyn pouches are designed with comfort in mind. Their slim, discreet size makes them easy to use without causing noticeable bulges under your lip. Zyn’s slim format provides a less intrusive experience that is great if you’re just starting and prefer prolonged and discreet use throughout the day.

pH Balance

Zyn pouches have a carefully controlled pH level that optimises nicotine absorption while minimising mouth irritation. Their use of benzoic acid helps to stabilise the pH, ensuring a smoother, less harsh experience. Some competing brands may cause a stronger “tingling” sensation under the lip due to higher pH levels, this can be uncomfortable for sensitive users, whereas Zyn strikes a balance between efficient nicotine delivery and comfort.

Texture

The texture of Zyn pouches is smooth and soft, thanks to the high-quality plant-based fibres used as fillers. Unlike some competitors, whose pouches may feel grainy or rough, Zyn’s pouches sit comfortably under your lip without causing dryness or irritation. This smooth texture, combined with a consistent release of flavour and nicotine, is what makes Zyn’s reputation for quality.

Is Zyn safer than smoking or vaping?

The FDA announced that nicotine pouches pose a lower risk of cancer than tobacco and other nicotine replacement products and they cited evidence that they can be used by tobacco consumers and vapers as a harm reduction tool.

Zyn’s main active ingredient, nicotine, is a stimulant with no history of carcinogenic risk. Sweden provides a good example of how oral nicotine products can lower the risk of smoking related cancers. They use a product called snus, which is actually a precursor to nicotine pouches. Snus is a small envelope that contains a pasteurised moist tobacco leaf, which is also placed under the lip.

Since its inception in the 1970s, Sweden's smoking rates have plummeted and its instances of tobacco related cancers are some of the lowest in Europe. (3) Nicotine pouches go one step further by removing tobacco completely. Because Zyn contains no tobacco, it removes all the harmful toxins associated with it. The other ingredients found in nicotine pouches are also found in chewing gum, toothpaste and other food grade products.

Zyn is also lung-friendly and removes the need to inhale smoke or any other type of nicotine carrier into the lungs. This is great news for people with COPD or any breathing issues, the nicotine from Zyn enters your bloodstream in the same way that FDA approved nicotine gum does. There’s no tar and none of the cancer related chemicals associated with tobacco.

Does Zyn help with quitting smoking?

It is important to make the distinction between tobacco and nicotine. One is a delivery method, the other is an addictive drug. If you smoke you have a nicotine addiction, not a tobacco addiction. Tobacco is merely the nicotine carrier and is extremely harmful and responsible for many types of cardiovascular diseases including multiple forms of cancer. While Zyn is not FDA-approved for smoking cessation, it offers a less harmful alternative to tobacco.

Additional advantages include:

• Improvements to the way you smell.

• A massive reduction in your spending.

• Privacy, you can use Zyn nicotine pouches privately in any social setting.

You can also customise your experience to suit your needs. Nicotine pouches offer a choice of strengths that cater to a variety of preferences, as well as different flavours and sizes that make the experience enjoyable and comfortable.

All of these factors combined, make nicotine pouches an attractive alternative that offers not only harm reduction perks but also enhancements to your overall quality of life.

How does Zyn work?

Nicotine pouches like Zyn use the buccal absorption method, where the soft tissue of the mouth is used to transport nicotine directly to the bloodstream. Lozenges, nicotine gum and a lot of children's medications use this delivery method because it takes effect quickly and ensures that the body receives the medicine before it's broken down by the stomach.

Buccal absorption works really well with nicotine because the effect is rapid and long lasting and doesn’t require you to do anything once the pouch is in place. People who use nicotine pouches can enjoy a nicotine buzz for up to an hour or more during and after use, opposed to minutes with cigarettes and vapes.

Here are some nicotine pouch top tips from experienced Zyn users:

• Roll your Zyn nicotine pouch between your fingers to loosen it.

• Tuck it under your lip and push it into place with your tongue.

• Keep your Zyn in for at least 10 minutes to ensure nicotine release.

• If the tingle of your Zyn pouch feels too uncomfortable, drop to a lower nicotine strength.

What strength of Zyn should I use?

You should start with a low strength if you’ve never used a nicotine pouch before. It takes a while for your mouth to adapt to absorbing nicotine through the lining of your mouth, and if you start with too much nicotine, it could cause irritation. Start low and work your way up until you find a nicotine strength that matches your cravings.

Where to buy Zyn online?

Buy your next tub of Zyn at Alternix, we stock the best selling Zyn flavours like Black Cherry, Cool Mint and Espressino. Buying online is secure, discreet and fast. We offer:

• 10% off your first order

• Free delivery on orders over £15

• Same Day Dispatch before 4pm

• 5% cashback

• Price Match Promise

Zyn price comparison – best deals & discounts

Zyns are cheaper than tobacco and vaping, and you can save even more if you buy in bulk. At Alternix our Zyns start from £3.50 a tub when you buy 10 cans - saving you over 40%. We offer a variety of multi-buy deals for Zyn, the more you buy, the more you save.

FAQs

Summary

Zyn is not FDA approved but has been authorised for sale under specific conditions. While not entirely risk-free, it poses fewer health risks than smoking and vaping. Nicotine pouches should only be used by people trying to quit smoking or anyone who already makes use of other nicotine products like vapes or gum. Zyn’s discreet design, variety of flavours, and availability online make it a popular choice for nicotine users seeking a safer alternative. Explore the Full Range of Zyn Flavours at Alternix and take advantage of huge discounts.

Sources

(1,4) fda.gov - FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review

(2) cdc.gov - Tobacco Product Use Among U.S. Middle and High School Students — National Youth Tobacco Survey, 2023

(3) harmreductionjournal.biomedcentral.com - If there had been no snus in Sweden: the impact of snus on mortality attributable to smoking