ANNEX C  
 
Labeling Requirements for Vapor Product and  
Heated Tobacco Product Refills and Cartridges  
 
 
GUIDELINES  
 
1. Packaging Materials for Refills and Cartridges  
 
1.1. The packaging material for refills and cartridges shall not release toxic substances 
and mixtures into the product, by migration, leaching or dissolution, which are 
liable to constitute a human health hazard.  
 
1.2. For vapor product and heated tobacco product refills and cartridges, in order to 
minimize the risks of migration, leaching, dissolution  and owing to the potential 
toxicity of their monomers and additives, these materials are prohibited in the 
manufacture of refill containers:  
 
1.2.1.  polyvinyl chloride (PVC) (CAS No. 9002 -86-2) 
1.2.2.  polystyrene (PS) (CAS No. 9003 -53-6) 
1.2.3.  polycarbonate (PC) (CAS No. 25037 -45-0) 
1.2.4.  acrylonitrile -butadiene -styrene (ABS) (CAS No. 9003 -56-9) 
1.2.5.  styrene -acrylonitrile (SAN) (CAS No. 9003 -54-7) 
1.2.6.  polyoxymethylene (POM) (CAS No. 9002 -81-7) 
 
2. Child -Resistant/Tamper -Proof Vapor Product  and Heated Tobacco Product 
Refill Solution Containers  
 
2.1. Refills of vapor product and heated tobacco product solutions in reclosable 
containers shall at least comply with ISO 8317:2015 standards.  
 
2.2. The sole use of non -resealable containers for vapor product and heated tobacco 
product refill solutions is not allowed.  
 
2.3. Single -use vapor products, heated tobacco products, and proprietary refill 
cartridges must follow the same restrictions on content by volume as provided by 
the FDA.  
 
3. Product Labels  
 
3.1. The labels of vapor products and heated tobacco products  registered as 
Household/Urban Hazardous Substances shall not contain any health, therapeutic, 
nutritional, or functional claims.  
 3.2. Misleading phrases shall not be allowed in vapor product and  heated tobacco 
products. The following is a non -exhaustive list of misleading words or phrases 
that shall not be allowed:  
 
3.2.1.  Light; Lites; Ultra Lite  
3.2.2.  Supreme  
3.2.3.  Safer  
3.2.4.  No.1  
3.2.5.  Leading  
3.2.6.  Most  
3.2.7.  Finest  
3.2.8.  Clean  
 
3.3. No claims of FDA endorsement shall be allowed on the packaging, such as 
placement of the FDA logo or the inscription of the words “Food and Drug 
Administration,” or “Philippine FDA,” the initials “FDA,” or any imitation of such 
words, initials, or logo.  
 
3.4. All information on the product label must only be written in either English or 
Filipino.  
 
3.5. The following information should be available and printed legibly on the primary 
packaging of vapor product and heated tobacco product  refills and cartridges.  
 
3.5.1.  Brand name  
3.5.2.  Name of Product Variant  
3.5.3.  Nicotine concentration per unit refill, expressed in mg nicotine/mL of 
solution or mg, or the words “nicotine -free,” as applicable  
3.5.4.  Net volume or weight, as applicable  
3.5.5.  The term “Vapor Product Refill” OR “Heated Tobacco Product Refill” as 
applicable, to describe the product.  
3.5.6.  The exact statements “Do not swallow” and “Keep out of the reach of 
children.”  
3.5.7.  Graphic Health Warning  
3.5.8.  Batch/Lot number  
3.5.9.  Expiry date  
3.5.10.  FDA Electronic Registration Number [FERN] or Certificate of Product 
Registration (CPR) number.  
 
3.6. If possible, the following information should also be printed on the primary 
packaging. However, in cases where the required information does not fit in the 
primary package, a secondary packaging shall be provided to reflect the following 
information in addit ion to the information already provided above:  
 
3.6.1.  Marketing Authorization Holder Information  
 3.6.1.1.  Company Name  
3.6.1.2.  Company Address  
3.6.1.3.  Company Contact Details  
3.6.1.4.  LTO Number  
 
3.6.2.  Country of Origin  
3.6.3.  List of ingredients contained in the product, in descending order of 
concentration, with potential allergens emphasized in bold characters.  
3.6.4.  Instructions on the handling, use, and storage of the vapor product and 
heated tobacco product solutions  
3.6.5.  Usage cases to be avoided (in the context of current medications, health 
conditi ons, and interactions with other drugs and other substances)  
3.6.6.  Instructions for the disposal of the vapor product and heated tobacco 
product solutions and containers  
3.6.7.  Directions in case of ingestion or skin contact  
3.6.8.  GHS Pictogram, Signal Word, and Hazard State ment  
3.6.9.  Undesirable adverse health effects  
3.6.10.  Warning statements:  
 
3.6.10.1.  Do not swallow  
3.6.10.2.  Keep out of the reach of children  
3.6.10.3.  Avoid prolonged contact with the skin  
3.6.10.4.  Nicotine is an addictive substance  
3.6.10.5.  Not suitable for pregnant women, nursing mothers, children, 
persons with respiratory or cardiovascular diseases  
3.6.10.6.  Call the poison center or the hospital near you in case of accidents, 
injury, or illness arising from the use of this product.  
 
3.6.11.  The updated contact information of the Philippine General Hospital, 
National  Management and Control Center, as of the time of manufacture  
3.6.12.  The exact statement: “For complaints or reports on product quality and 
safety, please contact the Food and Drug Administration by email: 
ntru@fda.gov.ph .” 
 
4. Graphic Health Warnings  
 
4.1. Heated tobacco products , both refills and electronic delivery devices,  shall comply 
with the current graphic health warning templates and specifications, as provided 
under Republic Act No. 10643, otherwise known as “The Graphic Health Warning 
Law”, and its subsequent issuances.  
 
4.2. A separate set of templates  and specifications  shall be issued by the Department of 
Health as prescribed by the FDA, applicable for vapor products in terms of its 
content and health effects .