Regulatory report: Q&A – US federal regulation of oral nicotine products

As defined by the Federal Food, Drug, and Cosmetic Act (FDCA) (section 101), a tobacco product is “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)”. According to federal laws, nicotine-containing tobacco-free products are generally defined as tobacco products, which means any tobacco-containing or tobacco-derived product – such as oral tobacco products that contain tobacco (for example, snus) and tobacco-free nicotine-containing pouches (if nicotine is derived from tobacco). This report provides a detailed Q&A about the current regulations in place in the US for these type of products.