Haypp Welcomes FDA’s Clear Stance on Harm Reduction in ZYN Review

The Food and Drug Administration (FDA) has announced that it has moved forward with applications to classify certain ZYN nicotine pouches as Modified Risk Tobacco Products (MRTPs). Haypp welcomes this clarification, which aligns with the approach of national health authorities in countries like the UK, where alternative nicotine products are assessed by authorities to be around 95 percent less harmful than smoking cigarettes.

The FDA’s decision means that the agency will now conduct a thorough scientific review to determine whether these products may be marketed with claims that they are significantly less harmful than traditional cigarettes. The applications have been submitted by Swedish Match USA, but the issue is much broader than a single company — it concerns the entire principle of harm reduction within tobacco and nicotine policy.

Markus Lindblad, Head of Communications at Haypp Group, emphasizes the fundamental importance of this issue for public health:

“We hope and believe that the FDA’s final decision will align with what the UK’s National Health Service (NHS) — the UK counterpart to the FDA — has already concluded: that products such as e-cigarettes and nicotine pouches are significantly less harmful than cigarettes and can be an effective aid for smokers who otherwise struggle to quit.”

He continues: “Harm reduction is the most reasonable path forward if the goal is to reduce tobacco-related mortality.”

Nicotine pouches in the UK fall under general product safety regulations since they do not contain tobacco, resulting in less stringent oversight compared to other nicotine products (COT Statement). Specifically:

• There are currently no clear national NHS guidelines that include nicotine pouches in NHS stop-smoking support frameworks (e.g., RDaSH NHS Smoke-Free Policy).
• Some NHS Trusts do include nicotine pouches in local smoke-free and nicotine management policies, often acknowledging that they may be less harmful than smoking because they do not involve combustion — although they may not explicitly recommend their use (e.g., ELFT NHS Nicotine Policy).
• The Committee on Toxicity in Food, Consumer Products and the Environment (COT) advises that while nicotine pouches may pose lower risk than smoking, they are not risk-free, and the long-term health effects remain uncertain. NHS-related guidance reflects this cautious stance (COT Statement on the toxicological risk assessment of nicotine pouches).

Sweden is a country with extensive experience of nicotine pouches that also contain tobacco, known as snus. Swedes are on track to become the first smoke-free nation within the EU and the Western world.

“Merely referring to ‘limited evidence’ and taking an overly cautious approach when setting up a regulatory framework for these products is not enough,” says Markus Lindblad.

All available data shows that thanks to nicotine pouches, smoking rates are at record lows in Sweden. Studies also show that mortality and diseases related to nicotine use are significantly lower in Sweden than in other comparable countries. We hope the FDA will consider these findings so that the American population can experience similar — or even better — progress than what we have seen in parts of Scandinavia.

Markus Lindblad

Head of Communications

The FDA’s review now enters a substantial evaluation phase. At the same time, the application materials will be made publicly available on the Center for Tobacco Products (CTP) website, and anyone can submit comments via regulations.gov (Docket Number FDA-2025-N-0835). The comment period will remain open for at least 180 days following publication in the Federal Register and at least 30 days after final documents have been posted.