Yes, ZYN has been FDA-authorized in the US since January 16, 2025. The FDA issued a press release to regularize ZYN nicotine pouches in the US market, surprising many manufacturers and users. The products had previously been pulled from online sales because of a lawsuit and underage sale.
While the product is not "FDA approved" because it contains nicotine, ZYN can now be marketed and sold in the US under a legal banner. ZYN has become the first nicotine pouch product to gain FDA authorization, marking its spot in the US.
What Does FDA Authorization Mean for ZYN?
In short, the Food and Drug Administration (FDA) authorization means ZYN can now be marketed freely in the US. Previously, ZYN nicotine pouches were in a gray area because they were available in stores but not completely authorized. ZYN applied for a Pre-Market Tobacco Application in 2020.
Now, marketing and sales of ZYN nicotine pouches are authorized across the states. However, the legal decorum around these pouches still stands. For example, anyone under the age of 21 cannot buy these products, and certain states, like California, have still enforced a flavored ZYN ban since 2024.
Surprise ZYN Nicotine Pouch Authorization: Whys and How
The surprise decision came on 16 January 2025, when the FDA announced ZYN authorization. It came as a shock to many because ZYN had ceased online sales across the states previously. The reason cited was the rampant youth use of ZYNs.
People were speculating a complete ban, but the FDA did the opposite. Now, the FDA authorizes the marketing of ZYN products after conducting extensive market and health research for four years. The FDA determined that ZYN had significant value as an alternative to cigarettes, vapes, and e-cigs.
Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products, stated, “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”
Why Did The FDA Authorize Nicotine Pouches?
According to the FDA, they authorized ZYN nicotine pouches because of three reasons:
- ZYN nicotine pouches have a positive impact on public health for users who want to quit cigarettes.
- Extensive scientific review shows that using nicotine pouches is better than cigarettes.
- ZYN has clarified its stance and the integrity of its products.
The National Youth Tobacco Survey showed that 1.4% of High and Middle School students were using ZYN pouches. Philip Morris International has also stated its intention of doubling down on retailers who sell ZYNs to youth.
While the sale of underage ZYNs is limited, the FDA hasn't shied away. They clarified their intentions by saying:
“While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”
How Many ZYN Products Were Authorized?
Initially, 20 ZYN nicotine pouch products were authorized for sale and marketing in the US. These products include:
- ZYN Chill
- ZYN Cinnamon
- ZYN Citrus
- ZYN Coffee
- ZYN Cool Mint
- ZYN Menthol
- ZYN Peppermint
- ZYN Smooth
- ZYN Spearmint
- ZYN Wintergreen
Each flavored product will be available in ZYN 3 and 6 mg variations, which means 10 (flavors) × 2 (nicotine concentrations).
Other flavors and products might be authorized later after more scientific review. Right now, we'll have to do with the 10 standard flavors. The FDA is still overseeing the addition and regularization of flavors due to the increasing risk of youth use of nicotine pouches.
If you are looking for ZYN nicotine pouches, here are the three top-selling products we recommend.
What Does FDA Authorization Mean For Snus?
Surprisingly, the FDA also added information about snus in the new press release. According to the release:
"Among several key considerations, the agency’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products pose a lower risk of cancer and other serious health conditions than such products."
It implies that authorized snus flavors will also be readily available in the US. While snus and nicotine pouches were already available in the US, most of them were limited because of their semi-legal status. Now, users can enjoy their favorite products without any worries.
Are ZYN Nicotine Pouches FDA Approved or Authorized?
Products like ZYN can never be approved because nicotine products are pernicious. The FDA has never approved cigarettes, CBCs, or other products that are addictive. However, the FDA, like any other organization, looks at products that have exceeding demand and their effects.
If a product offers a solution to problems and it checks all the marks for safety, the FDA authorizes it. It gives the product legal status to operate in the jurisdiction. Based on that, ZYN has never been FDA-approved; however, it is authorized to operate in the US.
According to ZYN and the FDA's current agreement, ZYN cannot market its products to anyone under the age of 21. They also have to be careful about their marketing campaigns. Here's what the FDA said specifically:
"the authorizations impose stringent marketing restrictions for digital, TV, and radio, including measures to ensure ads are carefully targeted to adults ages 21 and older and the demographics of the audiences reached by the ads are tracked and measured by the manufacturer."
FAQs - ZYN and FDA Authorization
Is ZYN approved as an NRT?
No, ZYN is not an approved NRT like nicotine gum or lozenges. However, according to the FDA, the product has been identified as less harmful than cigarettes. It still has risks like nicotine addiction, which the users have to consider.
Will ZYN be available in stores across the US?
Yes, ZYN is now legally available for consumers across the US. You can find them in shops or order online from retailers like Snusdaddy. However, you need to be at least 21 years old to buy ZYN nicotine pouches.
Are ZYN considered tobacco products?
Yes, ZYN nicotine pouches are considered as tobacco products. While the pouches don't contain tobacco, the nicotine powder is refined from tobacco. Naturally, these products are considered tobacco products.
Conclusion: ZYNs Are FDA Authorized Now
On January 16, 2025, the FDA authorized ZYN nicotine pouches. These pouches are now available across the US in shops and online websites. ZYN is the first authorized nicotine pouch brand in the US, and anyone above the age of 21 can use it.
If you want your favorite products, order them online today. We give you the best nicotine pouches at the best prices and sweetest discounts. Order your favorite FDA authorized ZYN nicotine pouches today with Snusdaddy.
