FDA approves marketing for Zyn, says health benefits outweigh harms for smokers

Today, the U.S. Food and Drug Administration (FDA) officially authorized 20 ZYN nicotine pouches to help adult smokers reduce or quit cigarette use, which marks the FDA’s first approval of nicotine pouches of any kind.

The authorization covers 10 flavors, including mint, coffee, and citrus, in two nicotine strengths. FDA officials said the pouches contain fewer harmful chemicals than cigarettes and smokeless tobacco, reducing risks of cancer and other diseases.

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products said.

“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 made it clear these products are not “FDA-approved” but do present a less-harmful option.

They determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

“An estimated 45 million Americans regularly consume nicotine and about 30 million of them smoke, the most harmful form of nicotine consumption,” said Tom Hayes, president of Swedish Match North America, LLC. “The FDA’s decision recognizes the role that ZYN can play in the protection of the public health by helping people switch from cigarettes and other traditional tobacco products.”

Strict marketing restrictions aim to prevent youth use, and federal data indicate fewer than 2% of U.S. teens currently use nicotine pouches.

Grayson Everett is the editor in chief of Yellowhammer News. You can follow him on X @Grayson270.