
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
Ski Resorts Universally: A Colder time of year Wonderland Guide - 2
What to know about new CDC deputy director who has been critical of COVID vaccines - 3
Doritos and Cheetos debut 'NKD' options, without artificial colors or flavors - 4
Astrophotographer captures spectacular photo of Antennae Galaxies dueling in deep space - 5
'Peaky Blinders: The Immortal Man' teaser trailer reveals Cillian Murphy's Tommy Shelby back in action
Nigeria warns its citizens in South Africa to be cautious after march turns violent
The 12 biggest space stories of 2025 — according to you
Vote in favor of the juice that you love for its medical advantages!
Czech Republic caps fuel prices amid Iran war energy crisis
Surging measles cases are 'fire alarm' warning that other diseases could be next
Kids with smartphones by age 12 are at higher risk of health issues, study finds
Thousands of ultra-orthodox protest in Jerusalem against conscription
Ocean side Locations for a Family Excursion
AI is providing emotional support for employees – but is it a valuable tool or privacy threat?












