
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
Journalists killed by Israeli strike in southern Lebanon - 2
How to watch NASA's Artemis 2 astronauts launch to the moon on April 1 - 3
'The best gift ever': Baby is born after the rarest of pregnancies, defying all odds - 4
Artemis 2 astronaut Victor Glover delivers inspiring Easter message on the way to the moon (video) - 5
5 Morning Schedules That Stimulate Your Day
A definitive Manual for the 5 Off-road Bicycles Available
'Something Very Bad Is Going to Happen' is the Duffer Brothers' first project since 'Stranger Things.' It's also 'wildly insane.'
Watching ‘Home Alone’ with the kids this holiday season? Brace yourself for '6-7.'
Sean 'Diddy' Combs faces new sexual assault allegations, currently under investigation by Los Angeles Sheriff's Department
The most effective method to Boost Eco-friendliness in Your Volvo XC40
Which European palace do you fantasy about visiting? Vote!
What is colostrum? And should you be taking it?
Who was Haytham Ali Tabatabai, Hezbollah's military leader killed by Israel?
Find the Future of Outsourcing: Exploring the Gig Economy












