Modern Oral Nicotine Pouches
The modern oral nicotine pouch category is one of the fastest growing smoke-free product segments in the United States. Nicotine pouches set themselves apart from smokeless tobacco products by excluding cut, ground, powdered, or leaf tobacco. Instead, nicotine pouches contain only tobacco-derived nicotine and non-tobacco ingredients, distinguishing them as a unique reduced-risk product.
Our modern oral nicotine pouch brands, on!® and on! PLUS™, are commercialized by Helix Innovation, LLC (Helix).
Designed for oral consumption, nicotine pouches provide a smoke-free alternative for adults seeking to transition away from cigarettes. And since nicotine pouches are smoke-free and tobacco leaf-free, most harmful and potentially harmful constituents (HPHCs) are not detectable or are significantly lower compared to cigarettes. Additionally, because no smoke is generated, nicotine pouches eliminate the harm of secondhand smoke exposure.
on!
In May 2020, Altria submitted Premarket Tobacco Product Applications (PMTAs) for 35 on! products to the Food and Drug Administration (FDA). We believe the applications make a compelling case to the FDA that the broad on! portfolio is appropriate for the protection of public health.
For example, when we compare the levels of HPHCs for the on! mint-flavored pouches containing 4 mg of tobacco-derived nicotine against General snus products, which have been granted PMTAs and Modified Risk Tobacco Product Applications (MRTPAs), the on! product has significantly lower HPHCs versus the General products. Additionally, our research demonstrates the ability of on! to transition adults who smoke from cigarettes. We’ve shared much of our research supporting the PMTA for on! at various scientific conferences through posters and presentations, which you can view here.
Below are highlights of the science and evidence submitted in support of the on! PMTA.
Constituent Reduction
Harmful and Potentially Harmful Constituents
Our research demonstrates that the HPHCs in on! nicotine pouches are absent or substantially reduced compared to combustible cigarettes.
Individual Risk Reduction
Biomarkers of Exposure
In a randomized control clinical trial, adults who smoke and switched to on!, showed substantially reduced levels of toxicants that are associated with many of smoking related diseases, with some levels comparable to abstinence.
Gingival Inflammation & Dental Staining
Our research shows that switching completely from combustible cigarettes to on! nicotine pouches significantly reduce levels of gingival inflammation (20+%) and dental staining (~70%) relative to continued cigarette smoking. Those who dual used on! while reducing cigarette consumption by >50%, show correspondingly lower levels of gingival inflammation and dental staining
Population Harm Reduction
Actual Use Study
At the end of a six-week Actual Use Study (AUS), 28% of adults who smoke and 72% of adults who dip switched completely to on!. The AUS also demonstrates that flavors are important to complete switching. For example, many adult tobacco consumers who switched used two or more flavors. These results are even more compelling because these adult tobacco consumers were not considering switching at the start of the study.
Nonuser & Youth Likelihood to Use
Data from the on! Perception and Behavioral Intentions Study (PBIS) and the National Youth Tobacco Survey (NYTS) shows a low likelihood of appeal and initiation of on! nicotine pouches among nonusers and youth.
on! PLUS
Commercialized by Helix Innovation, on! PLUS is a wet, spit-free tobacco-derived nicotine pouch product designed for adults who dip and dual users (i.e., adults who smoke and dip). Larger than any other tobacco-derived nicotine pouch in the U.S. market, on! PLUS is made from our proprietary “soft-feel” material to provide a more comfortable product experience.
on! PLUS is currently available in select international markets. While not currently available in the US, in June 2024 Helix submitted PMTAs to FDA for three distinct on! PLUS varieties: tobacco, mint and wintergreen. Each variety comes in three different nicotine strength options.
