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.
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Table of contents
- How are all nicotine-containing tobacco-free products regulated?
- Are all types of nicotine-containing products regulated equally?
- Is there any specific rule for pouches, tobacco-free oral nicotine products?
- What about pouches, how are they regulated?
- Can pouches be sold as food products? If not, why not?
- Are pouches containing nicotine the same as dissolvable products?
- What is the difference, legally speaking, between tobacco-free (pouches) and tobacco-containing (snus) oral products?
- Do nicotine pouches require a PMTA?
- Are pouches on the market FDA-approved? Do they have PMTA/SEs?
- What about other tobacco-free oral products, do they require a PMTA?
- Do nicotine pouches require a health warning?
- Are there specific product restrictions for tobacco-free pouches?
- Do existing federal taxes apply to nicotine-containing tobacco-free pouches?
- Can they be described as less harmful?
- What about products that contain synthetic nicotine? Is all of the above applicable?
- Appendix: sources
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