Philip Morris Wins FDA Approval for ZYN ULTRA, Expanding Smoke-Free Lead

The U.S. Food and Drug Administration (FDA) granted marketing orders for 11 new Philip Morris International nicotine pouch products on August 21, 2026. This authorization covers the ZYN ULTRA brand, a line of moist oral nicotine pouches.

The approval includes ten varieties with a 9mg nicotine concentration. One additional variety features an 11mg nicotine concentration.

Swedish Match, the company’s U.S. affiliate, will legally market these tobacco-leaf-free products to adults. The FDA determined these authorizations are appropriate for the protection of public health.

This decision strengthens Philip Morris’s position in the growing U.S. smoke-free market. The new orders build on existing authorizations for the ZYN product line.