FDA Authorizes ZYN Nicotine Pouches, Citing Favorable Balance of Risks

In this photo illustration, ZYN nicotine cases and pouches are seen on a table in New York City, on Jan. 29, 2024. Michael M. Santiago/Getty Images

The Food and Drug Administration (FDA) has granted market authorization for over a dozen ZYN nicotine pouch products, with the agency cautioning that no tobacco product is safe and that the pouches’ risk to young people is outweighed by their benefits to adult cigarette smokers.

The FDA said in a Jan. 16 announcement that, following a scientific review, it concluded that these nicotine pouches contain fewer harmful chemicals than combustible cigarettes and traditional smokeless tobacco, potentially reducing risks of cancer and respiratory disease for adult users transitioning from more dangerous sources of nicotine.

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, said in a statement. “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

The FDA’s authorization was met with a sharply critical response from some public health advocates. Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement that the FDA is setting a “dangerous precedent that puts the nation’s kids at risk.” She said that the agency’s decision is “deeply troubling” given that flavored nicotine products like the newly authorized ZYN pouches have a well-documented history of appealing to youth and contributing to underage tobacco use.

Manufactured by Swedish Match, a subsidiary of Philip Morris International, ZYN pouches are intended for oral use and deliver nicotine without tobacco. The product consists of small synthetic pouches containing nicotine designed to be placed between the gum and lip. There, they slowly release low levels of nicotine that are absorbed into the bloodstream.

While the FDA said the product offers benefits to adult smokers switching from cigarettes, the agency underscored the importance of minimizing youth access and said it would closely monitor the marketplace to ensure these products are not marketed or sold in ways that appeal to underage users.

“While today’s actions permit these specific tobacco products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they ‘FDA approved,’” the FDA stated in the Jan. 16 announcement. “There is no safe tobacco product; youth should not use tobacco products, and adults who do not use tobacco products should not start.”

Nicotine exposure during adolescence can damage brain areas responsible for attention, learning, mood regulation, and impulse control, according to the U.S. Centers for Disease Control and Prevention (CDC).

The FDA’s decision to authorize ZYN pouches follows an announcement earlier this week of a plan to limit nicotine levels in order to make cigarettes and other tobacco non-addictive. The agency stated in its proposal that years of research indicate reducing nicotine levels could help around 13 million current smokers quit within a year while preventing an estimated 48 million people from starting to smoke by making cigarettes non-addictive.

Smoking is the leading preventable cause of disability, disease, and death in the United States, according to data from the CDC.