Introduction of Nicotine Analogue-Containing Oral Pouch Products in the United States.

Background: In 2023, 6-methyl nicotine (6MN), a synthetic nicotine analogue, was introduced in US-marketed electronic cigarette products advertised as exempt from regulation. It is unknown whether the use of 6MN has spread to the oral nicotine pouch product category that has become increasingly popular. Methods: Industry reports and the USPTO database were searched for informationon 6-methyl nicotine products. The search terms "Metatine", "Nixotine", "Imotine" and "pouches" were shortlisted and used to identify US-marketed pouch products. Ingredient contents were compared to popular products, and safety warnings and regulatory statements assessed in context with US state and federal regulations. Results: Two US-based brands, "MG" and "Hippotine" pouches, were identified in August 2024, advertised to contain "Imotine"-trademarked 6MN. MG Pouches are marketed in four youth-appealing flavors. "Hippotine"-branded pouches are marketed in two flavors. 6MN contents ranged between 8mg - 25mg with almost identical ingredient lists otherwise. Products list extensive addiction and health warnings, including warnings not to operate vehicles. Vendors state that these are not a tobacco product, implicating that federal and state tobacco regulations do not apply. Conclusions: The spread of nicotine analogues to additional product categories such as oral pouches is concerning, especially given the high 6MN contents that exceed nicotine contents in popular US-marketed oral nicotine pouch products. Legislators and regulators need to provide certainty about the regulatory status of nicotine analogues to prevent further erosion of tobacco flavor bans and other regulations.