Pursuant to Republic Act No. (RA) 11346 and RA 11467, the Food and Drug Administration (FDA) publishes the following revised draft guidelines on the regulation of Heated Tobacco Products (HTPs) for the second public consultation of the proposed policy:
1) General Guidelines for the Regulation of Heated Tobacco Products
1.1 Annex A – Heated Tobacco Product Refill/Cartridge and Device Standards
1.2 Annex B – Labeling Requirements for Heated Tobacco Product Refills and Cartridges
1.3 Annex C – Labeling Requirements for Heated Tobacco Product Electronic Delivery Devices
2.1 Annex A – Online User’s Registration Form
2.2 Annex B – Template for the Authorization Letter
2.3 Annex C – Documentary Requirements for LTO Application
2.4 Annex D – Fees and Charges for LTO Application
3) Product Marketing Authorization Guidelines for Heated Tobacco Products
3.1 Annex A – Guidelines for the Preparation of PIF for Heated Tobacco Products
3.2 Annex B – Schedule of Fees
4) Guidelines for the Issuance of Pre-Application Documentary Evaluation for Heated Tobacco Products
5) Batch Declaration of Heated Tobacco Products
Following the initial online posting of the draft guidelines dated 08 April 2020, the FDA had consolidated, discussed, and reviewed all received comments from 08 April to 30 June 2020, and had taken all submissions into consideration during the revision of the draft guidelines.
Kindly send your comments through email at [email protected] on or before 30 July 2020.
For your information and guidance.