The U.S. Food and Drug Administration authorized four more flavored nicotine pouches this week – a move experts say flies in the face of “decades of evidence” about the tobacco industry’s marketing practices.
The authorized products from Virginia-based manufacturer Helix Innovations LLC are sold under the “on!” brand name and include cappuccino, autumn spice and rich berry flavors.
The pouches were approved as a part of a pilot program launched last year, which the FDA says has helped streamline the review process.
But the American Heart Association asserts the basis for the program was “never adequately explained to the public” and accused the agency of “allowing dangerous products on the market.”
Nicotine pouches don’t have tobacco – which is linked to cancer – but nicotine itself is a highly addictive chemical can harm brain development, the Centers for Disease Control and Prevention says. And long-term use can lead to permanent damage to lung tissue, stroke and heart disease, the American Lung Association explains.
“By authorizing these flavored nicotine pouch products while leaving key questions about the review process unanswered, the FDA appears to be ignoring decades of evidence that the tobacco industry has used flavored products and other tactics to attract and addict youth to its harmful products,” the American Heart Association said in a statement.
“Rather than allowing dangerous products on the market, the FDA should protect children’s health by prohibiting the sale of all flavored tobacco products, including menthol,” it urged.
Requests for comment from the FDA and Altria, the parent company of Helix Innovations LLC, were not immediately returned to The Independent.
The FDA’s authorization comes following a statement from the agency about how ZYN nicotine pouches – reportedly popular in the Trump administration – can be marketed.
The agency said it had issued modified risk granted orders to Swedish Match USA, Inc. for nearly two dozen products earlier this summer, and following “extensive” scientific review.
“With this issuance, these ZYN nicotine pouch products — which have been authorized for sale in the United States since January 2025 — may now be marketed with the following risk modification claim: ‘Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis,’” the FDA said.
That move was blasted by the American Lung Association, telling NBC News that the FDA’s decision was “appalling.”
“We must protect our children from a lifelong addition to nicotine,” Mike Seilback, assistant vice president of nationwide advocacy and state public policy at the American Lung Association, told the network.
A spokesperson for the company that makes ZYN said “everyone agrees that those under the legal age of purchase should never use nicotine.”
“That is why our U.S. businesses apply strict safeguards, including robust age verification, responsible marketing and ongoing monitoring to guard against access by those under the age of 21,” Corey Henry, Director Global Press Office & Issues Management for Philip Morris International, which owns ZYN, told The Independent.
The latest survey from the FDA shows that 1.7 percent of middle and high school students reported using the pouches last year.
