The Food and Drug Administration (FDA) has authorized the marketing of four new nicotine pouch products through the premarket tobacco product application (PMTA) pathway. The products from Helix Innovations, sold under the “on!” brand name, include Rich Berry 2-milligram, Capuccino 2-milligram, Cappuccino 4-milligram and Autumn Spice 2-milligram.
“As part of its thorough scientific review of new tobacco products, the FDA considers the risks and benefits to the U.S. population as a whole — including the benefits to adults who currently use tobacco products and switch to a potentially lower-risk product, as well as the risks posed to youth and non-users of tobacco products,” the agency noted in a statement. “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.”
The review of these products was part of the agency’s nicotine pouch pilot program, which aims to increase efficiency and streamline the review process of nicotine pouches through the PMTA pathway.
The pilot has streamlined the FDA’s review processes, which has led to faster resolution of issues, decreased time needed for applicants to respond to deficiency letters and more efficient scientific reviews.
“The FDA’s evaluation found that these new products contain lower levels of most harmful and potentially harmful constituents (HPHCs) when compared to other oral and smokeless tobacco products, many of which were too low to be quantified in the new products,” the statement continued.
This move follows the FDA’s authorization of 20 Zyn pouch products in early July. The Zyn products were the first to receive modified risk tobacco product (MRTP) orders from the agency, allowing the company to market its nicotine pouches with the following claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”
“FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” said Stacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to Zyn reduces the risk of smoking-related diseases like heart disease and lung cancer. More broadly, it reinforces the agency’s science-based approach to evaluating products across the continuum of risk and communicating those findings transparently.”
In January 2025, Zyn was the first nicotine pouch authorized for sale in the U.S. following rigorous scientific review.
To date, the FDA has authorized 30 nicotine pouch products.
