
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
Young Muslims in Germany feel left out of Mideast debate, experts say - 2
Accor signs agreement to transform El Gouna resort as Sofitel - 3
Study shows no clear link between low-fat dairy and dementia risk - 4
Kremlin: Russian troops conquer Pokrovsk after year of intense combat - 5
Metropolitan Greatness: The 6 Urban areas for Quality Living in 2024
As her kidneys fail and time runs short, this activist fights to decriminalize euthanasia in Mexico
San Francisco mayor says city in talks to bring pandas back to zoo ahead of trip to Asia
More than 3 million eye drops have been recalled from CVS, Walgreens and other national retailers. How to check if yours are safe
Blue Origin launches huge rocket carrying twin NASA spacecraft to Mars
Watch India launch advanced military satellite on rocket's 1st flight since May 2025 failure
A Manual for Nations to Head out To
Doctor's orders? ‘Belly laugh at least two to five days a week'
A Past filled with Old Civilizations: The World's Most established Societies
Why home maintenance deserves a spot in the annual health and budget plans













