Introduction of nicotine analogue-containing oral pouch products in the United States.

Abstract

In 2023, 6-methyl nicotine (6MN), a synthetic nicotine analog, was introduced in US-marketed electronic cigarette products advertised as exempt from regulation. It is unknown whether the use of 6MN has spread to other product categories. Industry reports, patent and trademark databases were searched for 6-methyl nicotine products. Identified trademarks 'Metatine', 'Nixotine', 'Imotine' were used to search for US-marketed products. Ingredient information was compared to US market-leading products, and safety warnings and regulatory statements were assessed in context with US state and federal regulations. Two US-based oral pouch brands, 'MG' and 'Hippotine' pouches, were identified in August 2024, advertised to contain 'Imotine'-trademarked 6MN. MG Pouches are marketed in four flavors, and 'Hippotine'-branded pouches are marketed in two flavors, likely representing banned flavor characterization in US state jurisdictions such as California. 6MN contents range 8-25 mg. Otherwise, the ingredient lists were almost identical across both product lines. Products list extensive addiction and health warnings, including warnings not to operate vehicles. Vendors state that these are not tobacco products, which implies that federal and state tobacco regulations do not apply. The spread of nicotine analogs to additional product categories, such as oral pouches, is concerning, especially given the high declared 6MN contents exceeding nicotine in popular US-marketed oral nicotine pouch products. Legislators and regulators need to provide certainty about the regulatory status of nicotine analogs to prevent further erosion of tobacco flavor bans and other regulations.