On 30 June 2026, the US Food and Drug Administration issued Modified Risk Tobacco Product (MRTP) orders for 20 ZYN nicotine pouch products manufactured by Swedish Match USA, a subsidiary of Philip Morris International. It is the first time any nicotine pouch brand has been authorised to market a reduced-risk claim compared with cigarettes.

The FDA-approved claim that ZYN can now carry on packaging and advertising:

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

That is six named diseases — and a regulatory green light no pouch competitor currently holds.

What happened

The MRTP orders cover 10 ZYN flavours — Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen — each in 3mg and 6mg nicotine strengths, per the FDA's official product page and Tobacco Reporter.

These same 20 products were already authorised for sale through the FDA's Premarket Tobacco Product Application (PMTA) pathway in January 2025. The June 2026 MRTP orders go further: they allow Swedish Match to actively communicate the reduced-risk profile to adult smokers — not just sell the products, but market them as lower-harm alternatives.

The FDA said its decision followed an extensive scientific review covering the products' relative health risks, consumer perception studies, youth-use data, public comments and recommendations from the Tobacco Products Scientific Advisory Committee, which met on 22 January 2026. The agency concluded that the modified-risk claim is scientifically supported, that consumers understand its meaning, and that allowing the claim is expected to benefit public health.

Bret Koplow, acting director of the FDA's Center for Tobacco Products, said the decision "allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products."

PMI US CEO Stacey Kennedy called it "an important moment for the more than 45 million legal-age nicotine consumers in America."

The orders come with conditions. Swedish Match must conduct post-market surveillance and behavioural studies, and the MRTP status expires after five years unless renewed. The FDA retained the authority to withdraw the orders if continued marketing no longer benefits public health — including if youth uptake increases.

Why doctors are alarmed

Five weeks after the MRTP orders, on 5 August 2026, CBS News reported that medical experts and public health groups were pushing back hard against the FDA's approach.

Dr. Brian King, executive vice president of US programs at the Campaign for Tobacco-Free Kids, called the products "a profound risk for a nicotine-naive person to get dependent and addicted." If pouches initiate new users rather than converting existing smokers, King said, "it could jeopardise the considerable public health progress we've made in addressing tobacco product use over the past several decades."

Dr. Purnima Kumar, chair of the Department of Periodontics, Oral Medicine and Dental Hygiene at the University of Michigan, pushed back on the idea that pouches are proven safe: "Just because we don't have evidence at this point doesn't mean that there's no harm."

Dr. Bonnie Halpern-Felsher, a professor of paediatrics at Stanford University, warned that youth nicotine use can prime the brain toward addictive behaviour: "You're changing your brain."

Dr. Aruni Bhatnagar, director of the American Heart Association's Tobacco Regulation and Addiction Center at the University of Louisville, flagged cardiovascular concerns: nicotine causes elevated heart rate and blood pressure and can constrict blood vessels. "We know that there's a strong link between [nicotine and] blood pressure and heart disease, and particularly heart attacks," Bhatnagar told CBS News.

The American Heart Association had already sued the FDA over its pouch enforcement policy on 14 July 2026, arguing the agency was allowing pouches to stay on the market without completing the scientific review required by federal law. We covered that lawsuit in detail: Health groups sue FDA over nicotine pouch enforcement policy.

The youth number that worries everyone

The latest National Youth Tobacco Survey found that approximately 460,000 middle and high school students reported using nicotine pouches in the past year, per CBS News. That makes pouches the second most commonly used tobacco product among young people in the US, behind e-cigarettes.

Meanwhile, CDC Foundation analysis found that monthly nicotine pouch sales increased 250% between January 2023 and August 2025. And the WHO reported in May 2026 that 160 countries still have no specific regulation for nicotine pouches, while 16 countries ban them outright — a gap we documented in our WHO nicotine pouch report coverage.

The political context

The MRTP designation landed during a period of industry-friendly policy under the Trump administration. President Trump promised during the 2024 campaign to "save vaping" and reversed his first-term restrictions on flavoured e-cigarettes. The White House TikTok account posted a video showcasing ZYN that included Joint Chiefs Chairman Dan Caine saying the US military consumes "a lot of nicotine," CBS News reported.

The Wall Street Journal reported that Health and Human Services Secretary Robert F. Kennedy Jr. uses nicotine pouches, and that Trump recently asked Kennedy which pouches he used after a lunch with tobacco executives. Former Fox News host Tucker Carlson, who helped popularise ZYN on the right, later launched his own competing brand, ALP.

The FDA's overall pouch authorisation count now stands at 30 products — 20 ZYN variants and 10 on! products from Altria — after four additional on! pouches were authorised on 4 August 2026.

What's next

The MRTP orders expire in five years unless renewed, and the FDA has made clear it will withdraw them if youth uptake rises. That means Swedish Match must demonstrate that the reduced-risk claim is reaching adult smokers — not recruiting new users — throughout the authorisation period.

Other pouch manufacturers now have a template. If a brand can demonstrate lower constituent levels and win consumer-perception studies, the FDA may grant similar MRTP orders. But the public health lawsuit, the youth-use data and the medical pushback mean the regulatory wind could shift before competitors get there.

The FDA continues to warn that "there is no safe tobacco product" and that non-users should not start. The MRTP designation does not mean ZYN is safe — it means the FDA has concluded that adults who completely switch from cigarettes to ZYN reduce their exposure to many harmful chemicals. The distinction between "safer than cigarettes" and "safe" is the one every regulator, doctor and investor is now watching.

Compare ZYN prices across retailers at PouchFinder.

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SOURCES:

• FDA: Swedish Match USA, Inc. Modified Risk Tobacco Product (MRTP) Applications for ZYN Products (official FDA page)
• Tobacco Reporter: FDA Issues MRTP Orders for 20 Zyn Products (30 June 2026)
• Nicotine Insider: FDA Grants ZYN 'Modified Risk' Marketing Orders (30 June 2026)
• CNBC: FDA allows Philip Morris-owned Zyn marketed as less harmful than cigarettes (30 June 2026)
• CBS News: As FDA approves new marketing for nicotine pouches, some doctors sound alarms (5 August 2026)
• Reuters: FDA allows Philip Morris to market Zyn as less harmful than cigarettes (30 June 2026)
• PMI press release: FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products (30 June 2026)