The Science of Oral Tobacco-Derived Nicotine
The Oral Tobacco-Derived Nicotine (OTDN) product category is one of the fastest growing tobacco product segments in the United States.
The OTDN category includes products that are non-combustible and intended for oral consumption. They do not contain cut, ground, powdered or leaf tobacco – a point of differentiation compared to smokeless tobacco products – and only contain tobacco-derived nicotine and non-tobacco ingredients.
In August 2019, we entered into an agreement with the Burger Group and now hold an 80% ownership stake of our Helix subsidiary, which manufactures the novel oral nicotine pouch product, on!®.
The product portfolio consists of seven flavors with each flavor offered in five nicotine levels (1.5 mg, 2 mg, 3.5 mg, 4 mg and 8 mg), each packaged in a can.
In May 2020, the company submitted Premarket Tobacco Product Applications 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, our research shows that when we compare the levels of HPHCs for the on! mint-flavored pouches containing 4 mg of tobacco-derived nicotine against the General snus products, which have been granted both market orders and authorization to be marketed with a reduced-risk claim, the on! product has significantly lower HPHCs versus the General products.
Altria has announced it intends to file an Modified Risk Tobacco Product Application for on!. We look forward to sharing the science supporting that application at upcoming conferences and in scientific publications, which we will also post on this site.