FDA CIRCULAR  
No.  ___________  
 
TO: ALL  VAPOR PRODUC TS AND HEATED TOBACCO PRODUCT 
MANUFACTURERS, TRADERS, AND IMPORTERS  
  
  
SUBJECT:  Guidelines for the Preparation of a Product Information File for 
Vapor Product and Heated Tobacco Product Refills and Cartridges, 
and Heated tobacco Product Electronic Delivery Devices   
 
I. BACKGROUND  
 
In 2005, the Philippines ratified the World Health Organization (WHO) Framework 
Convention on Tobacco Control (FCTC), implementing the comprehensive, effective, and 
practical tobacco control measures enshrined in the legally binding international treaty. T o 
minimize the  risk of harm inherent in such product s and develop product standards 
including restrictions on flavors and reduction of nicotine levels , Articles 9 and 10 of the 
WHO FCTC call on Parties to adopt measures for testing and regulating the conte nts and 
emissions of tobacco  and similar products  and to require disclosure of such information 
from regulators to the public.  
 
Pursuant to Republic Act No. 9711, otherwise known as the “FDA Act of 2009”, 
Section 144 of Republic Act No. 11467, and Section II of Executive Order No. 106, the 
Food and Drug Administration (FDA) shall periodically determine and regulate, consistent 
with evolving medical and scientific studies, the manufacture, importation, sale, 
packaging, advertising and distribution of vapor products and heated tobacco products. 
Thus, the FDA hereby implements this Circular for the  guidance and compliance of all 
concer ned establishments.  
  
II. OBJECTIVES  
 
This Circular is being issued to provide the vapor product and heated tobacco 
product (HTP) industry with the guidelines and a clear list of documents required for the 
preparation of a product information file (PIF).   
 
III. SCOPE  
 
This Circular shall apply to all FDA -licensed vapor product a nd HTP 
manufacturers, traders, and importers applying for a certificate of product registration 
(CPR)  for vapor prod uct and HTP refills and cart ridges, and HTP electronic delivery 
devices . 
 
 
  IV. GENERAL GUIDELINES  
 
1. Licensed manufacturers, traders, and importers, shall prepare an up -to-date PIF which will 
be submitted to the FDA as part of the application documents for a CPR . 
   
2. The FDA shall review and evaluate the submitted PIF together with other documentary 
requirements for the processing of applications for CPR issuance. However, this does not 
preclude the FDA from doing ad-hoc PIF audits when required which may occur with or  
without notice.   
 
3. Each brand and variant of vapor product  and HTP refills and cartr idges, and model of HTP 
electronic delivery device shall have its own PIF.   
 
4. Any changes in the information in the PIF shall constitute a new registration application 
for CPR .  
 
5. Electronic and/or hard copies of PIFs shall be readily accessible at the address of the 
marketing authorization holder (MAH) as declared in the CPR , consistent with the address 
indicated on the primary or secondary packaging of the  vapor product and HTP refills and 
cartridges and electronic delivery devices following FDA guidelines on the packaging and 
labeling of vapor products and HTPs.  
 
6. The PIF documents shall be written in English.  
  
7. The PIF shall be arranged according to the format provided under this Circular.  
 
8. The PIF shall be kept for a minimum of ten (10) years after the product has last been placed 
in the market (i.e. date when the inventory reaches 0 at retail level) or according to the 
company’s Standard Operating Procedure (SOP), whichever provides for a longer retention 
period.  
 
9. The FDA reserves the right to request for additional documents and product information, 
apart from the documents listed in the specific guidelines, needed during product 
evaluation. In such cases, the MAH shall be given a sufficient amount of time ranging from 
fifteen to sixty (15 -60) calendar days, depending on the type of document requested . 
 
10. Inconsistencies between the actual product and its corresponding PIF may result to the 
institution of a legal action directed towards the CPR  of the subject product which may 
lead to its cancellation and the corresponding product recall thereof when circumstances 
so warrant.  
 
V. SPECIFIC GUIDELINES  
 
The PIF shall be composed of the following documents:  
 
1. PIF Part I – Administrative Documents and Product Summary    
1.1 Administrative Documentation  
 
1.1.1 Copy of the valid License to Operate (LTO) of the MAH  
 
1.1.2 In case the MAH is a Trader  
 
1.1.2.1  Notarized Manufacturing Agreement with Local 
Manufacturer.  
 
1.1.2.2  Copy of the valid LTO of the local Manufacturer  
 
1.1.3 In case the MAH is an Importer:  
 
1.1.3.1  In case the Foreign Supplier is the manufacturer of the product, 
notarized contract of agreement  or notarized l etter of 
authorization from the manufacturer . 
 
1.1.3.2  In case the Foreign Supplier is not the manufacturer of the 
product:  
 
1.1.3.2.1  Notarized contract of agreement or notarized 
letter of authorization  from the Foreign Supplier 
and the Valid Supply Agreement between the 
Foreign Supplier and the Manufacturer; or  
 
1.1.3.2.2  Valid tripartite agreement between the MAH, 
Foreign Supplier and the Manufa cturer; and  
 
2. PIF Part II - Manufacturing Details  
 
2.1 Details of the Manufacturer:  
 
2.1.1 Company name  
 
2.1.2 Complete address of manufacturing plant  
 
2.1.3 Contact information  
 
2.1.4 Organizational chart of manufacturing plant  
 
2.1.5 Production line layout where the product will be manufactured  
 
2.1.6 List of equipment used for production  
 
2.2 Manufacturing Process/Procedure    
2.3 Copy of batch coding system for the product being registered  
 
3. PIF Part III – Quality Data of Raw Material  
 
3.1 Specifications and Test Methods of Raw Materials  
 
3.1.1 Technical specifications of each ingredient and/or components  
 
3.1.2 Method of analysis corresponding to the technical specifications 
including the identification test for each ingredient and/or component  
 
3.1.3 Signed Certificate of Analysis (COA) for each ingredient and/or 
component corresponding to its technical specifications  
 
3.1.4 Safety data of the ingredients (for refills and cartridge s) 
 
4. PIF Part IV – Quality Data of Finished Product  
 
4.1 Qualitative and Quantitative Disclosure of Ingredients and/or Components  
 
4.1.1 For HTP electronic delivery devices:  
4.1.1.1  Complete listing of components describing the type of 
materials and its function.  
 
4.1.2 For vapor product and HTP refills and cartridges  
 
4.1.2.1  Complete ingredient list of the  vapor product and HTP refills 
and cartridges  with their corresponding function and 
percentage (%) content. Ingredients shall be named using the 
nomenclatures from approved references, namely: (1) British 
Pharmacopeia; (2) United States Phar macopeia; (3) Chemical 
Abstract Service.  Botanical ingredients shall be identified by its 
genus and species.  
 
4.1.2.2  Complete listing of components describing the type of material 
and its function.  
 
4.1.2.3  Complete PMA documents  
 
4.2 Product Presentation  
 
4.2.1 Clear facsimile/layout of the immediate and/or secondary packaging 
and other informative materials that are used (i.e. inserts, leaflets, 
hangtags)  for the  product.  
  4.2.2 Clear photo of the actual product showing the principal display panel.  
 
4.3 Technical Specifications  of the Finished  Product and their Corresponding 
Test Methods  
  
4.3.1 Technical specifications of the finished product . 
 
4.3.2 Test methods used corresponding to the technical specifications of the 
finished product.  
 
4.3.3 Signed COA of the finished product corresponding to its technical 
specifications  
4.3.3.1  For HTP electronic delivery devices:  
4.3.3.1.1  Migration of Specific Metals  
 
4.3.3.2  For vapor products and HTP refills and cartridges:  
4.3.3.2.1  Nicotine content  
4.3.3.2.2  Test for harmful and potentially harmful 
constituents (HPHCs)  
4.3.3.2.3  Other chemical substances including trace 
elements  
 
4.4 Certificate of Analysis of Emission Testing  
 
4.5 Summary of the Risk Assessment of the Emission.  
 
4.5.1 Signed summary of the risk assessment  
 
4.5.2 Name and qualifications of the assessor together with the curriculum 
vitae. The assessor must have the appropriate qualifications for the 
assessment of the product.  
 
4.6 Summary of the Confirmed Undesirable Effects on Human Health  
 
4.6.1 The summary of confirmed undesirable effects on human health shall 
be updated monthly or according to the SOP of the establishment. The 
summary may be in any format easily understandable by the users.   
 
4.7 Product Safety Data Sheet following the Guidelines under the Globally 
Harmonized System for the Classification and Labelling of Chemicals (GHS) 
Annex 4 – Guidance on the Preparation of Safety Data Sheets (SDS) for refills 
and cartridges  
 
4.8 Product Stability   
  4.8.1 The stability study shall be part of the PIF to support the product’s 
claimed shelf -life. The stability study conducted on the product may be 
accelerated or long -term.  
 
4.8.1.1  Accelerated stability study; or  
 
4.8.1.2  Long -term stability study shall be provided.  
 
 
VI. SEPARABILITY CLAUSE  
 
If any part or term of provision of this Circular shall be declared invalid or 
unenforceable, the validity or enforceability of the remaining portions or provisions shall 
not be affected and this Circular shall be construed as if it did not contain the particular 
invalid or unenforceable part, term, or provision.  
 
VII. EFFECTIVITY DATE  
 
This Circular shall take effect immediately.  
 
 
 
 
ROLANDO ENRIQUE D. DOMINGO, MD  
                                                            Director -General