The US Food and Drug Administration (FDA) has authorised 20 ZYN nicotine pouch products to be marketed as “modified risk” tobacco products, allowing them to tell adult smokers that switching completely from cigarettes reduces their risk of several serious diseases.
What ZYN is
ZYN pouches, made by Swedish Match, part of Philip Morris International, are small tobacco-free pouches containing nicotine that users place between the gum and the lip. They come in several flavours and strengths.
What the authorisation allows
The products can now carry a statement saying that using ZYN instead of cigarettes reduces the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
The authorisation covers ten flavours, each in 3 mg and 6 mg strengths: Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Menthol, Chill and Smooth.
Why the FDA agreed
Bret Koplow, acting director of the FDA’s Center for Tobacco Products, said the review aimed to give adult smokers clear, evidence-based information about the relative risks of different tobacco products, so they can make informed choices.
The key point is relative risk. The FDA is not saying nicotine pouches are safe — they are addictive and not risk-free — but that, for a smoker, switching completely to a product that does not involve burning tobacco exposes them to far fewer harmful chemicals.
Concerns about young people
The decision has been controversial because nicotine pouches have become popular among teenagers and young adults on social media. The FDA has attached conditions requiring the company to monitor use, particularly among young people, and says it can withdraw the authorisation if youth use rises significantly.
The situation in Spain
Nicotine pouches are sold in Spain, but the government has been working on rules to limit the nicotine content and restrict flavours in new tobacco and nicotine products. Health authorities stress that the best option for anyone who smokes is to stop using tobacco and nicotine altogether, and that help to quit is available through primary care.
