US: nicotine pouches – PMTA status Q&A, July 2022

While synthetic nicotine products have been in a legal limbo for a while – including uncertainty as to whether PMTAs were actually necessary for them – now they have been put under the FDA’s regulatory authority. This is quite a different scenario from the one for tobacco-derived nicotine pouches, which have always been under the FDA’s regulatory authority, as they are derived from tobacco, and thus considered a “new tobacco product”.

This report asks and answers questions regarding US federal regulation on nicotine pouches, reviewing current law, looking at what stands to change, and clearing up what could happen if state and federal legislation clash.

 

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Table of contents

  1. Executive summary
  2. Current regulatory framework – summary
  3. What’s the status of products on the market?
  4. What impact, if any, will the menthol ban for combustible cigarettes have on nicotine pouches?
  5. Will the nicotine-reduction policy for cigarettes affect nicotine pouches?
  6. If nicotine pouches fit into a pre-existing tobacco category, will this change if they are specifically regulated?
  7. Are there any manufacturing or product restrictions at the federal level?
  8. Can states regulate nicotine pouches once the federal government has done so?
  9. What if state and federal laws clash?

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