The FDA authorized four flavored on! nicotine pouches: Rich Berry 2 mg, Autumn Spice 2 mg, and Cappuccino in 2 mg and 4 mg strengths.
Regulators said the products contain lower levels of most harmful constituents than cigarettes and traditional smokeless tobacco, but stressed that they are addictive and not safe.
Public-health groups criticized the decision, warning that flavored nicotine products could attract young people.
The U.S. Food and Drug Administration has authorized four new flavored nicotine pouches for sale in the United States, expanding the number of legally marketed products in a rapidly growing segment of the tobacco industry.
The agency this week granted marketing authorization to Rich Berry 2 mg, Autumn Spice 2 mg, Cappuccino 2 mg and Cappuccino 4 mg pouches manufactured by Helix Innovations LLC and sold under the on! brand. Helix is an Altria Group subsidiary.
The decision brings the number of nicotine pouch products authorized by the FDA to 30. It was made through the agency’s premarket tobacco product application pathway and formed part of a pilot program launched in September 2025 to make reviews more efficient. The FDA said applicants must demonstrate that a new product’s expected population-level benefits outweigh its risks.
Following its scientific review, the agency found that the four pouches contain lower levels of most harmful and potentially harmful constituents than cigarettes and traditional oral or smokeless tobacco products. Adults who smoke or use smokeless tobacco could therefore reduce their exposure to harmful chemicals by switching completely to authorized nicotine pouches, according to the FDA.
Using pouches alongside cigarettes, however, would not produce the same reduction in exposure.
What the approval means
The authorization does not mean the products are safe or “FDA approved,” a distinction the agency makes for tobacco products. Nicotine is highly addictive, and people who do not currently use tobacco products are generally advised not to begin using the pouches. The orders also do not allow Helix to advertise the products as carrying a reduced risk of disease.
Public-health advocates condemned the inclusion of flavors they say could appeal to children.
The American Heart Association said nicotine pouches are already the second-most commonly used tobacco product among young people and questioned the transparency of the FDA’s pilot review program.
The American Lung Association offered similar criticism.
“Every new flavored tobacco product authorized by FDA is another gamble with kids’ health,” Ranjana Caple, the group’s director of federal advocacy, said in a statement reported by KFF Health News.
The FDA evaluates tobacco applications by weighing possible benefits for adults who already use tobacco against risks to young people and nonusers. It can withdraw a marketing order if later evidence shows that a product no longer meets the federal public-health standard.