Regulation · 29 October 2026 · Stefan Bensmo

ZYN Can Claim “Lower Risk Than Cigarettes” – What FDA’s MRTP Order Means

Short answer: on June 30, 2026, the US FDA allowed 20 ZYN products to be marketed with a claim of lower risk compared with cigarettes. It is the first time a nicotine pouch has received such an order, known as an MRTP (modified risk tobacco product) order. The orders last five years, can be withdrawn if youth use rises, and do not mean ZYN is approved as safe or as a smoking cessation product.

What FDA decided

FDA issued the orders to Swedish Match USA, a wholly owned subsidiary of Philip Morris International. They cover 20 products: ten flavours (Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen) in 3 mg and 6 mg strengths (FDA). This is the claim that may be used, verbatim:

“Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

The conditions

• Five years: the orders expire after five years unless the company applies for and receives renewal.
• Follow-up: the company must run postmarket surveillance and studies, including how users behave and whether they understand the risk information.
• Can be withdrawn: FDA can withdraw the orders if the marketing no longer benefits population health, for example if youth uptake rises significantly.
• No safety certificate: according to law firm Keller and Heckman, the orders do not mean FDA has “approved” ZYN, that the product is safe, or that it may be marketed as a smoking cessation treatment (Keller and Heckman). FDA itself says there is no safe tobacco product.

What the order does not cover

The claim applies only to the 20 named products. They first received marketing authorisation through the PMTA pathway on January 16, 2025. Since then PMI has received authorisation for more variants, including eleven ZYN Ultra products in August 2026, and ZYN now has 31 authorised variants in total (PMI). ZYN Ultra, new flavours and new strengths are therefore not covered by the reduced-risk claim. Reading the order as an approval for the whole brand is a common mistake.

Why there is nothing equivalent in the EU

We have not found any equivalent procedure in EU law or in Swedish law through which a manufacturer can have a reduced-risk claim for nicotine pouches assessed and authorised. In Sweden, all marketing of tobacco-free nicotine products must show particular moderation (Act 2022:1257).

The EU debate is also moving the other way. EU Commissioner Olivér Várhelyi reportedly told Euractiv he is “one hundred per cent convinced” that vapes, nicotine pouches and heated tobacco are as harmful as cigarettes. The quote is relayed in an opinion piece by the World Vapers’ Alliance and should be read as advocacy (The Parliament Magazine).

What it means for the industry

Our read The MRTP order is a regulatory asset for PMI in the US, but it also sets a clear bar: FDA requires extensive scientific evidence, exact wording and postmarket follow-up. For other US brands it shows the path exists, but that it is long and expensive. In Europe the effect is mainly political. The US regulator and the European Commission are now drawing opposite conclusions about the same type of product, and both sides will use that in the negotiations over new EU rules.

• Do not use the order in European marketing. A US MRTP order gives no right to make health claims in Sweden or the EU.
• Separate PMTA from MRTP. PMTA means a product may be sold. MRTP means it may be marketed with a specific risk claim.
• Watch US youth data. If youth use rises, the orders can be withdrawn, which would shift the whole debate.

See also the PMTA process in the US, who owns ZYN, ZYN Ultra and the eight EU countries and TPD3.