Pilot Program Update: FDA Authorizes 4 New Nicotine Pouches
Today, the U.S. Food and Drug Administration (FDA) authorized the marketing of four new nicotine pouch products through the premarket tobacco product application (PMTA) pathway: Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg. The authorized products, made by Helix Innovations LLC, are sold under the “on!” brand name.
As part of its thorough scientific review of new tobacco products, the FDA considers the risks and benefits to the U.S. population as a whole — including the benefits to adults who currently use tobacco products and switch to a potentially lower-risk product, as well as the risks posed to youth and non-users of tobacco products. To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.
|
