
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
Most loved Amusement Park Firecrackers Show: Which One Lights Up Your Evening? - 2
IDF drops over 80 explosives on Tehran weapon production sites in latest strike - 3
NASA's Artemis 2 moon launch may be visible from Florida and southern Georgia today. Here's when to look - 4
Abbott issues US device correction for some glucose monitors over faulty readings risk - 5
See the 'amazing' photos of Earth taken on historic Artemis II moon mission
Most loved Seared Chicken: Which Chain Rules?
Selena Quintanilla documentary 'Selena y Los Dinos: A Family's Legacy' is coming to Netflix
Russia provided Iran with list of Israeli energy targets, Ukrainian intelligence finds
The race to mine the moon is on – and it urgently needs some clear international rules
5 Critical Rules For Business Regulation Chiefs
Changes to CDC website spark debate over autism and vaccine misinformation
Smooth countdown continues for Artemis II moon mission
She was the supermodel dubbed 'The Face' in the '80s. Joining OnlyFans in her 60s taught her a lot.
RFK Jr.'s handpicked vaccine panel just voted to stop recommending hepatitis B shots for all newborns. Why experts object.












