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
Instructions to Safeguard Your Speculations In the midst of Changing Disc Rates - 2PFAS in pregnant women’s drinking water puts their babies at higher risk, study finds
- 3Fireballs and a full moon. Here’s how to see two celestial events this week
- 4Venezuelan President Maduro arrives in New York following U.S. capture: Full coverage
- 5Watch SpaceX launch NASA's Pandora exoplanet-studying satellite on Jan. 11
- Hilary Duff's husband responds to Ashley Tisdale's 'toxic' mom group claims: The drama, explained
- Unwinding History's Secrets: Looking for the Response to Antiquated Human advancements
- African Forests Have Become a Source of Carbon Emissions
- Arctic sea ice hits lowest winter level as unprecedented heat hits smashes records all over Earth
- Violence 'never part' of break-in plan, court told
- Activists Took BMW and Mercedes to Court Over Gas Cars. It Didn’t Stick
- Which European countries have mandatory or voluntary military service
- Rights group: At least 2,500 deaths during protest crackdown in Iran
- What to watch for as NASA’s historic Artemis II crew prepares to lift off toward the moon
