
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
Saturn shines with the waxing moon at sunset on Nov. 29 - 2
75% of US adults may meet criteria for obesity under new definition, study finds - 3
Brazil approves law strengthening protective measures for female victims of gender-based violence - 4
A 'Stranger Things' documentary covering the final season is on its way: Watch the trailer - 5
From Exemplary to Current: Famous Rings Available
Watch the Geminid meteor shower peak tonight from the comfort of home with this free livestream
Figure out How to Adjust Your Handshake to Various Societies
2024 Style: The It-Things You Want in Your Closet
IDF kills senior PIJ Gaza City Brigade cmdr. who infiltrated Kibbutz Nahal Oz on Oct. 7
Fake new headlights rule steer Australian drivers astray
Slims down for Maintainable Weight reduction
Dr. Vinay Prasad's memo raises concerns about COVID-19 vaccines and pediatric mortality
Check out the exclusive pitch deck Valerie Health used to raise $30 million from Redpoint Ventures to automate healthcare faxes
Figure out How to Use Your Nursing Abilities for Better Compensation













