Richard Crosby 29 June 2025

 

Swedish Match USA Inc., the company behind the popular nicotine pouch ZYN, has asked the U.S. Food and Drug Administration (FDA) for special permission to say their products are less risky than regular tobacco. The FDA unequivocally admitted this is true in January, but the question now is whether ZYN is allowed to state this truth.

FDA pouch approval

In January 2025, Swedish Match submitted a successful Premarket Tobacco Product Application (PMTA) for 20 ZYN products. The products were 10 different flavours of 3mg and 6mg strengths:

Drawing on an extensive scientific review that examined chemistry, microbiology, and toxicology data, the evaluation compared ZYN pouches to combustible cigarettes and other smokeless tobacco products, such as snus. The FDA found that ZYN pouches have substantially lower levels of what the federal agency terms harmful and potentially harmful constituents (HPHCs).

During the FDA’s investigation into the potential harm of ZYN, it found that “of 42 HPHCs analysed, 36 were below quantifiable levels.” To put it another way, the amount present in the product was so minuscule that it was either undetectable or too low for scientific instruments to measure with any degree of accuracy.

Of the other 6 HPCHs, which were Acetaldehyde, Coumarin, Formaldehyde, Naphthalene

Nicotine and Nornicotine, the FDA states that the exposure from ZYN pouches is low and considered acceptable from a toxicology perspective. In layman’s terms, that means the levels are below what is believed to cause health risks if used daily over a lifetime.

The next step

January’s decision meant that these 20 ZYN products were authorised for sale in the US. However, this application centres around whether ZYN can say that their products are less risky than regular tobacco. The mechanism to do this is through a “Modified Risk Tobacco Product” (MRTP) application.

Part of the MRTP process is that data on pouches is made available to the public, and the public is allowed to express their views on the relative risks of the product. The comment period will last at least 180 days after the official notice is issued and at least 30 days after all documents are posted.

Why does this matter?

The outcome of this application is crucial for several reasons. One of the most critical reasons, from a health perspective at least, is that if ZYN is successful, it will be allowed to state that using ZYN is less risky than using combustible cigarettes.

Instead of a steady diet of innuendo, misinformation, and disinformation about ZYN, the public will have factual, evidence-based information about pouches. If the FDA makes the right decision, smokers cannot be gaslit in the same ways as they have been about vaping.

All the Mike Bloomberg-sponsored “thinkpieces” in the world won’t make a difference because smokers will be empowered to evaluate which product is the best for their health based on robust scientific data.

Final thoughts

The call for evidence is open. Pouch users and evidence-based scientists can submit their thoughts and opinions by:

  • Going to www.regulations.gov
  • Searching for the docket number: FDA-2025-N-0835
  • Clicking on the ZYN Modified Risk Tobacco Product (MRTP) applications page
  • Selecting the button or link to “Submit a Comment.”
  • Sharing any information they want the FDA to consider.

Remember, you don’t need to be a scientist or expert to have your voice heard. Anyone can comment. So, if pouches have helped you or someone you love quit smoking, make sure the FDA knows it.

The comment period started on the 18th of June, 2025. While the window will be open for a while, get on it now. Smokers deserve to know the truth about pouches. And perhaps more importantly, ZYN should be allowed to tell the truth.