General Guidelines for the Regulation of Vapor Products and Heated Tobacco Products

This is to notify all concerned stakeholders and the general public that the following draft guidelines on the regulation of vapor products and heated tobacco products are now posted in the FDA Website for public comments:

1) General Guidelines

1.1 Annex A —Vapor Product Refill and Cartridge Standards 
1.2 Annex B — Heated Tobacco Product Refill and Cartridge Standard 
1.3 Annex C — Labeling Requirements for Vapor Product and Heated Tobacco Product Refills and Cartridge 
1.4 Annex D — Labeling Requirements for Vapor Product and Heated Tobacco Product Electronic Delivery Devices 
1.5 Annex E — Glossary

2) Licensing Guidelines 
3) Registration Guidelines 
4) Guidelines for the Preparation of a Product Information File
5) Batch Notification Guidelines 
6) Pre-Market Application

Kindly send your comments through email at [email protected] on or before 14 April 2020.

For your information and guidance.

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