Since the responsibilities of the US Food and Drug Administration (FDA) extend to Puerto Rico, we understand that new tobacco and nicotine products intended to be marketed within Puerto Rico will need to go through the FDA’s premarket tobacco application (PMTA) process.

Nicotine pouches are not subject to any retail, advertising or public place usage restrictions.

Unlike nicotine pouches, oral tobacco is taxed in Puerto Rico.

This report provides a summary of the current regulatory framework in place for oral tobacco and nicotine pouches in Puerto Rico, covering all policy areas from taxation and advertising to labelling, notification and retail channels.

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Table of contents

  1. Executive summary
  2. Outlook
  3. Puerto Rico: the basics
  4. National regulatory framework
  5. Age restrictions
  6. Product restrictions
  7. Labelling and packaging
  8. Obligation to notify
  9. Retail channel restrictions
  10. Public usage
  11. Advertising
  12. Taxation
  13. Sanctions
  14. Relevant laws
  15. Relevant bodies

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“ Puerto Rico: oral tobacco and nicotine pouch regulation, September 2022 ”





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