
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
Trump announces 'Patriot Games' with 2 competitors from every state and territory: What we know - 2
6 Web-based Lawful Administrations: Extensive Surveys and Elements - 3
Eli Lilly to build $6 billion Alabama plant as part of US manufacturing push - 4
The Craft of Do-It-Yourself Home Stylistic layout: Change Your Space - 5
Which Breakfast Enraptures Your Taste Buds? Vote
UN rights chief says Israeli policy in West Bank 'resembles apartheid system'
Lilly becomes first healthcare firm to join trillion-dollar club, Wall Street reacts
Misjudged Objections For Solo Voyagers
‘The White Lotus’ sparked online interest in risky anxiety pills, study says
Affordable Care Act enrollment is slightly ahead of last year, despite expiring subsidies
Invigorating Spots To Go Kayaking All over The Planet
What is the Insurrection Act? Can Trump really use the military to 'put an end' to Minneapolis ICE protests?
SpaceX shatters its rocket launch record yet again — 165 orbital flights in 2025
Winter storms blanket the East, while the U.S. West is wondering: Where’s the snow?












