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.

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Table of contents

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

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