
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
1,000-mile Saharan dust storm, from the sky and from the ground - 2
Clones of Stumpy, Washington D.C.'s beloved cherry blossom tree, have flowered for the first time - 3
Verdicts against social media companies carry consequences. But questions linger - 4
Canada cancels its 1st moon rover: 'It's hopefully not a lost cause' - 5
Twelve injured near Beit Shemesh, reports of shrapnel impact in Eilat as Iran targets Israel
The pinch at the pump continues on
ISS astronaut evacuation shouldn't interfere with upcoming Artemis 2 moon mission, NASA chief says
Instructions to Plan for Your Teeth Substitution Methodology
Study casts doubt on potential for life on Jupiter's moon Europa
Remote Headphones: Improve Your Sound Insight
What is the Significant Tech Expertise to Master Today?
With more Moon missions on the horizon, avoiding crowding and collisions will be a growing challenge
Amid growing bipartisan scrutiny of Pete Hegseth, Trump says he 'wouldn't have wanted … a second strike' on alleged Venezuelan drug boat survivors
The most effective method to Augment Benefits in Gold Speculation: Systems and Tips












