The U.S. Food and Drug Administration just gave Philip Morris International (Philip Morris (PM)) a big win. On Tuesday, the agency authorized the company's Swedish Match subsidiary to market 20 ZYN nicotine pouch products with a claim that could reshape how smokers think about their habit: using ZYN instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.

This is a big deal. It's the first time the FDA has allowed a nicotine pouch to be marketed with a reduced disease risk claim. The decision follows an extensive scientific review and applies only to the specific ZYN products that have been on sale in the U.S. since January 2025. The FDA was careful to note that this isn't a blanket approval for all nicotine pouches—just these 20.

So what exactly got the green light? The authorized products come in 10 flavors: Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen. Each flavor is available in two nicotine strengths: 3 milligrams and 6 milligrams. That's 20 products total, all now allowed to carry the reduced-risk claim.

But the FDA didn't just hand over the keys and walk away. As part of the authorization, Swedish Match has to conduct postmarket surveillance and research to see how consumers actually use the products and whether they understand the risk information. The orders expire in five years unless the company gets renewed authorization. And the FDA can pull the plug if continued marketing no longer benefits public health—for example, if youth uptake rises significantly. The agency reiterated that no tobacco product is safe and that non-users shouldn't start.

This is a milestone for the Zyn brand, which has been losing market share to competitors like Velo Plus in recent months. The FDA's decision could give Zyn a much-needed boost. As Bret Koplow, acting director of the FDA's Center for Tobacco Products, told Bloomberg, the decision lets consumers "make informed choices."

Philip Morris U.S. CEO Stacey Kennedy framed it as a victory for adult nicotine consumers. "FDA's decision is an important moment for the more than 45 million legal-age nicotine consumers in America," she told CNBC. "Today's news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer."

To date, the FDA has authorized 26 nicotine pouch products after determining they meet the statutory public health standard. But this is the first time a nicotine pouch has received the modified risk tobacco product (MRTP) designation. It's a significant step for harm reduction advocates who argue that nicotine pouches, while not risk-free, are far less harmful than combustible cigarettes.

As for Philip Morris stock, it was down 0.90% at $179.27 at the time of publication on Wednesday. But the long-term impact of this FDA decision could be substantial, giving the company a powerful marketing tool in a competitive market.