G/TBT/N/PHL/331  
14 May 2024  
(24-3751) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  PHILIPPINES  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
DR. SAMUEL A. ZACATE  
Director General  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notifi cation shall be indicated if different from above:   
Engr. Ana Trinidad F. Rivera, MSc  
Director IV  
Center for Cosmetics and Household/Urban  
Hazardous Substances Regulation and Research  
DEPARTMENT OF HEALTH  
Email: cchuhsrr@fda.gov.ph ; cchuhsrr -policy@fda.gov.ph ; ntru@fda.gov .ph; 
bps@dti.gov.ph  
www.fda.gov.ph   
3. Notified under Article 2.9.2 [X], 2.1 0.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  (ICS 
code(s): 65.160)  
5. Title, number of pages and language(s) of the notified document:  Guidelines for 
the Authorization of Vaporized Nicot ine and Non -Nicotine Products and Novel Tobacco 
Products with Medicinal or Therapeutic Claims or Reduced -Risk Statements Pursuant to 
Sections 12 (k), 12 (l), and 13 (c) of Republic Act No. 11900; (6 page(s), in English)  
6. Description of content:  The prop osed issuance aims to provide the authorization 
process of the FDA for VNNPs and NTPs with medicinal or therapeutic claims or reduced -
risk statements.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Under Sections 12 (k), 12 (l), and 13 (c) of RA No. 11900  and its 
implementing rules and regulations (IRR), through Department Administrative Order No. 
22-16, VNNPs and NTPs bearing explicit medicinal or therapeutic claims, or reduced -risk 
statements shall require approval from the Food and Drug Administration (FDA) pursuant 
to RA No. 9711 otherwise known as the "Food and Drug Regulation Act of 2009".  
In view of the foregoing, the FDA hereby issues the guidelines for the authorization of 
VNNPs or NTPs intending to make medic inal or therapeutic claims on its marketing G/TBT/N/PHL/331  
 
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  materials or packaging, or explicit reduced -risk statements pursuant to RA No. 11900 and 
its IRR.  
This issuance aims to provide the guidelines on the FDA's regulatory framework for the 
issuance of authorizations for VNNPs and NTPs that are marketed with medicinal or 
therapeutic claims on its marketing materials or packaging, and/or explicit reduced -risk 
statements pursuant to RA No. 11900 and its IRR. ; Protection of human health or safety  
8. Relevant documents:   
• Republic Act (RA) No 11900 and its Implementing Rules and Regulations (IRR): 
Vaporized Nicotine and Non -Nicotine Product Regulations Act  
• RA No. 9711 and its Implementing Rules and Regulations (IRR): The Food and 
Drug Administration (FDA) Act of  2009 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  This issuance shall take effect fifteen (15) days 
after publication to the Official Gazette or a newspaper of general circulation, with three 
(3) copies to be filed with the U.P. Law Center pursuant to Section 3, Chapter 3, Book VII 
of Executive Order No. 292, Series of 1987 through this Department's records officer or 
its equivalent functionary.  
10. Final date for comments:  27 May 2024  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Mr. Neil P. Catajay  
Director  
Bureau of Philippine Standards  
Department of Trade and Industry  
3F Trade and Industry Building  
361 Sen. Gil Puyat Avenue  
Makat i City 
Philippines  
1200 
Tel: (632) 751 4700; (632) 7913128  
Email: bps@dti.gov.ph  
Website: http://www.bps.dti.gov.ph  
https://members.wto.org/crnattachments/2024/TBT/PHL/24_03208_00_e.pdf