FDA Authorizes ZYN Pouches as Lower-Risk Alternatives to Cigarettes

On June 30, the US Food and Drug Administration (FDA) authorized 20 ZYN nicotine pouch products to make a specific “modified risk” claim. This allows ZYN to assert that “using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” However, this ruling does not imply that nicotine pouches are safe or approved smoking cessation products.

The decision enables Swedish Match, the manufacturer of ZYN, to market these products as a less harmful alternative for adults who completely switch from cigarettes. The regulatory approval arrives amidst a significant boom in nicotine pouches, which have rapidly reshaped the market for smoking alternatives.

Growth of Nicotine Pouches

Nicotine pouches have surged in popularity, becoming one of the fastest-growing nicotine categories worldwide. According to a recent report by the World Health Organization (WHO), global retail sales of nicotine pouches reached 23.4 billion units in 2024, marking a more than 50% increase from the previous year. This growth illustrates the changing perceptions of nicotine consumption, as many view pouches as a “cleaner” alternative.

The FDA's announcement coincides with WHO's warnings regarding the rapid spread of nicotine pouches, which are often marketed through social media and youth-oriented campaigns. This marks the first time regulators have formally endorsed the notion that these products can be a lower-risk option for smokers.

Regulatory Insights on ZYN

Public health officials remain cautious about nicotine pouches. The WHO has expressed concerns about their increasing popularity among young adults due to their “strong youth appeal and high addiction potential.” The FDA’s Modified Risk Tobacco Product (MRTP) order applies to 10 ZYN flavors at two strengths: 3 milligrams and 6 milligrams.

This ruling is significant for the tobacco industry, but there are critical limitations. It is applicable only to the 20 authorized products and specifically for smokers who fully switch to these pouches. The FDA advises non-tobacco users against using nicotine pouches, emphasizing that there is no safe tobacco product.

Implications for Public Health

The FDA's review aims to provide adult users with clear, science-based information about the relative harms of tobacco products. “FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products.

While the FDA acknowledges that adults who smoke and switch completely to ZYN pouches may reduce their health risks compared to continuing with cigarettes, it also stresses that quitting all tobacco and nicotine products is the healthiest option. The MRTP order is valid for five years, after which it may be renewed or withdrawn.

As nicotine pouches gain traction, questions remain regarding their ultimate user demographics and potential to create a new generation of nicotine users.