
Dec 19 (Reuters) - The U.S. Food and Drug Administration said on Friday it has authorized the marketing of six Altria-owned on! PLUS nicotine pouch products, through a pilot program aimed to fast-track reviews of such products.
The authorization was the first under the pilot program that the FDA launched in September, and applies to six on! PLUS nicotine pouches, which are manufactured by Helix Innovations LLC, an Altria joint venture for the global on! PLUS nicotine pouch portfolio.
The company had applied for premarket authorization for the products in June 2024.
The decision allows the mint, tobacco and wintergreen-flavored pouches, offered in 6 mg and 9 mg nicotine strengths, to be legally sold to adults in the United States.
The FDA said its decision was based on evidence that the products contain lower levels of harmful chemicals, posing a lower risk of cancer and other serious health conditions compared to other smokeless tobacco products. The authorization applies only to the specified products and not to other Helix offerings.
Nicotine pouches, which users insert under the lip, are the fastest-growing category of tobacco products in the U.S., and are generally considered among the lowest-risk smoking alternatives given they do not involve inhalation and do not contain tobacco.
Earlier this year, 20 Zyn products, owned by Philip Morris became the first in the nicotine pouch category to receive market authorization from the FDA in the U.S.
Zyn products were approved in January, more than five years after the company first submitted its application.
Tobacco companies have invested heavily in developing and marketing alternatives to cigarettes as demand for these products grows.
"on! PLUS will resume taking new orders for retail accounts in Florida, North Carolina and Texas and on e-commerce soon," Altria said to Reuters.
Nicotine in adolescence can harm the parts of the brain that control attention, learning, mood and impulse control, according to the U.S. Centers for Disease Control and Prevention.
(Reporting by Sanskriti Shekhar and Juveria Tabassum in Bengaluru; Editing by Alan Barona)
LATEST POSTS
- 1
Kiefer Sutherland arrested after allegedly assaulting a ride-share driver in L.A. - 2
Iran steps up executions as experts warn state killing being used to suppress political dissent - 3
Dancing through the crackdown: The satirical song soundtracking post-Khamenei Iran - 4
Italian police hold suspected boss of Naples Mafia's Mazzarella Clan - 5
Vote in favor of your Favored kind of pasta
FOX8 Meteorologist Charles Ewing makes his 2025-26 winter weather predictions!
Journalists killed by Israeli strike in southern Lebanon
Smooth out Your Funds: Cash The board Simplified
NASA's Artemis 2 pilot Victor Glover listens to 'Whitey on the Moon' every Monday. This is why.
Sahel coups push Africa to top of global democratic declines, report finds
$1,000 bribes, Mormon momfluencer mixers and making content to get plastic surgery: The wildest things I learned reporting my book
A 3-limbed Kemp's ridley sea turtle is now being tracked at sea by satellite
SpaceX shatters its rocket launch record yet again — 165 orbital flights in 2025
Figure out How to Function Successfully with Your Auto Collision Legal advisor for the Best Result













