FDA Circular No. __________________  
 
 
SUBJECT: General Guidelines for the Regulation of Vapor Products and Heated Tobacco 
Products  
  
  
I. BACKGROUND/RATIONALE  
Republic Act No. (RA) 9711, otherwise known as The Food and Drug 
Administration Act of 2009, declares as a policy that the State shall protect and promote 
the right to health of the Filipino people and help establish and maintain an effective health 
product regulatory system based on the country’s health needs and problems. Thus, the 
State must en hance its regulatory capacity and strengthen its capacity for the regulation of 
health products and its industry  
Under Sec. 144(C) of Act No. (RA) 11467 entitled “An Act Amending Sections 
109, 141, 142, 143, 144, 147, 152, 263, 263 -A, 265, and 288 -A, and A dding a New Section 
290-A to Republic Act No. 8424, as Amended, Otherwise Known as the National Internal 
Revenue Code of 1997, and For Other Purposes” , the Food and Drug Administration 
(FDA) is mandated to periodically determine and regulate, consistent wi th evolving 
medical and scientific studies, the manufacture, importation, sale, packaging, advertising, 
and distribution of vapor products and heated tobacco products (HTPs), including banning 
of flavors, and the sale to nonsmokers or persons below twenty -one (21) years old.  
Likewise, Executive Order No. 106 (EO 106) entitled “Prohibiting the 
Manufacture, Distribution, Marketing, and Sale of Unregistered and/or Adulterated 
Electronic Nicotine/Non -Nicotine Delivery Systems, Heated Tobacco Products, and Other  
Novel Tobacco Products, Amending Executive Order No. 26 (EO 26 s. 2017) and for Other 
Purposes, ” mandates the Philippine FDA to (a) develop the regulatory framework for 
ENDS/ENNDS and HTPs and their components  (b) issuance of license to operate (LTO) 
to establishments; (c) guidelines in the importation of these products and (d) pertinent rules, 
regulations and standards thereto in the implementing guidelines.  
Vapor products, including Electronic Nicotine and Non -nicotine Delivery Systems 
(ENDS/ENNDS), and  HTPs are a form of health products used to deliver aerosolized 
substances to the lungs by mimicking the act of smoking. Vapor products and HTPs are not 
likely to be risk free, and may expose users to chemicals and toxins at levels that have the 
potential to cause health effects. Presented by the industry as an alternative to conventional 
tobacco products, these products still contain and produce harmful and potentially harmful 
substances. There is currently insufficient evidence to demonstrate that vapor p roducts or  
HTPs are effective in assisting people to quit smoking and no brand of these products have 
been approved by the World Health Organization (WHO) or any National Regulatory 
Agency (NRA) for this purpose. The scientific evidence regarding the effec tiveness of 
vapor products or HTPs as a smoking cessation aid is scant and of low certainty, making it 
difficult to draw credible inferences. Furthermore, current studies are not yet enough to 
conclude that the long -term use of vapor products and HTPs will  not have any effect on 
human health. Concerns have been raised on the possibility that novel tobacco products 
may provide a gateway to nicotine addiction or tobacco product use, or that they may 
renormalize smoking. To ensure the protection of public heal th, the FDA shall establish 
science -based policies and regulations that limit youth access to vapor products and HTPs.  
II. OBJECTIVES  
This Memorandum is being issued to stipulate FDA’s regulatory framework to all 
individuals, enterprises and businesses seeking to manufacture, distribute, import, export, 
sell, offer for sale, advertise, and/or use vapor products and heated tobacco products 
(HTPs) in the Philippines.  
 
III. SCOPE  
  
This issuance shall apply to all entities within the industry, which i ntend to 
manufacture, distribute, import, export, sell, offer for sale, and advertise vapor products, 
and HTPs in the Philippines.  
 
IV. GUIDELINES  
  
1. Market Authorization of Vapor Products and HTPs  
 
1.1. All establishments engaged in the manufacture, distribution, importation, exportation, 
retail sale of vapor products and HTPs shall first secure a License to Operate (LTO) from 
the Center for Cosmetics Regulation and Research (CCRR).  
 
1.2. No establishment shall engage in activities beyond what was approved  by the FDA in its 
issued LTO.  
 
1.3. Only establishments with a valid FDA -issued LTO can apply for a product marketing 
authorization, such as Certificate of Product Registration (CPR), FDA Electronic 
Registration Number (FERN) and/or Batch Notification.  
  
1.4. No establishment shall engage in the manufacture, distribution, importation, exportation, 
sale, offering for sale, and advertising of vapor products and HTPs without first securing 
the necessary authorizations from the FDA.  
 
1.5. HTP refills and cartridges, and its electronic delivery device shall be required to undergo 
Pre-Market Authorization (PMA) at least three (3) months prior to applying for a CPR. 
A CPR will be issued after compliance to set requirements.  
 
1.6. Vapor product ref ills, and cartridges with or without the presence of nicotine, bearing 
therapeutic or health claims, such as but not limited to tobacco cessation claims, reduced 
risk/tobacco harm reduction claims, and/or nicotine concentrations  above 20 mg/mL but 
not mor e than 65 mg/mL in its formulation shall be subject to PMA three (3) months 
prior to submission for CPR. A CPR will be issued after compliance to set requirements.  
 
1.7. Vapor product refills, and cartridges with or without the presence of nicotine, that are no t 
marketed with therapeutic or health claims, with nicotine content not exceeding 20 
mg/mL, an FDA Electronic Registration Number (FERN) shall be issued upon 
compliance to set requirements.  
 
1.8. Vapor product electronic delivery devices, shall be issued a FERN  upon compliance to 
set requirements including the certificate of conformity issued by the Department of 
Trade and Industry (DTI).  
 
1.9. No establishment shall operate and distribute/sell its products in the Philippines without 
the appropriate market authorizations from the FDA.  
 
2. Product Standards  
 
2.1. All vapor products and HTPs must be compliant with the set standards provided under 
Annex A  - “Vapor Product Refill and Cartridge Standards” , and Annex B - “Heated 
Tobacco Product Refill and Cartridge Standards”  prior to release for distribution 
and/or sale in the Philippines.  
 
2.2. The FDA shall set and issue pertinent standards on vapor product and HTP refills and 
collaborate with the DTI for the issuance of standards on the electronic delivery 
devices, guided by current available scientific evidence and international standards.  
 
3. Labelling and Packaging  
  
3.1. All containers and packages of vapor product and HTP refills and cartridges and 
electronic delivery devices shall contain appropriate information and health warnings 
compliant with the guidelines provided under Annex C - “Labelling Requirements for 
Vapor Product and Heated Tobacco Product Refills and Cartridges” , and Annex D - 
“Labelling Requirements for Vapor Product and Heated Tobacco Product Electronic 
Delivery Devices” . 
 
4. Sale, Use, and Access Restrictions  
 
4.1. Online sale of vapor products and HTPs shall not be allowed.  
 
4.2. Retail sale of pure nicotine and nicotine shots/concentrates shall be strictly prohibited.  
 
4.3. No manufacturer, retailer, distributor, importer, exporter, or retailer of vapor products 
and HTPs shall sell to individuals under twent y-one (21) years of age.  
 
4.4. The distribution, sale, offering for sale and use of vapor products and HTPs shall be 
strictly prohibited in places provided by Executive Order No. 26 s. 2017 as amended by 
Executive Order No. 106 s. 2020.  
 
4.5. The testing and use of vapor products and HTPs shall be prohibited inside the premises 
of retail outlets and in other enclosed public places, except in Designated vaping areas 
(DVAs).  
 
4.6. Designated vaping areas (DVAs), including vaping lounges and the like, shall follow the 
same guidelines and requirements provided under this circular and section 4 of EO 26 s. 
2017 as amended by EO 106 s. 2020.  
  
5. Advertising, Promotion, and Sponsorship  
 
5.1. No person, establishment or organization, shall use the FDA logo, the words “Food and 
Drug Administration” or “Philippine FDA”, the initials “FDA”, or any imitation of such 
words, initials, or logo in print and other forms of broadcast media, including the internet, 
in connection with any vapor products and HTPs merchandise, impersonation, 
solicitation, or commercial activity in a manner that convey that such use is approval, 
endorsement, or authorization by the FDA (e.g. “FDA approved” or “This product is 
approved by the FDA”).  
 
5.2. Advertising activities shall be strictly prohibited except in FDA -licensed retail outlets for 
vapor products and HTPs.   
 
5.3. Marketing materials shall not bear markings or characters that are likely to promote youth 
use such as the use of cartoons, anim é, manga, animated characters or the likes.  
 
5.4. Only print medi a on fixed locations, within the premises of retail establishments shall be 
allowed. Free product samples, hand -outs, flyers, and other print media for distribution 
to store patrons and passers -by, shall be strictly prohibited.  
 
5.5. Placing, posting, or displa ying vapor products, HTPs, and its advertising materials in any 
place of retail outlets that is open and visible to the general public, especially the youth, 
such as but not limited to stalls, kiosks, booths, or stands is strictly prohibited. For such 
retail outlets, only the use of a signage displaying the name of the establishment, menu 
cards for the list of products offered (to be presented to verified customers), and 
placement of a single simple sign with white background and black font and not 
exceedin g twelve inches by eighteen inches (12"x18”) in size stating only the following: 
Vapor products/HTPs Available Here" shall be allowed.  
 
5.6. Promotion and sponsorship, including corporate social responsibility 
campaigns/activities by the vapor product and HTP i ndustry shall be strictly prohibited.  
 
5.7. Other products and merchandises, such as but not limited to clothing, bags, accessories, 
toys, foods, and beverages, especially those generally intended for the consumption of 
children and the youth shall not bear nam es, logos, or other indicia of vapor product 
and/or HTP brand nor shall it be presented in such a way that it resembles vapor products 
or HTPs shall be strictly prohibited.  
                        
6. Enforcement  
 
6.1. The FDA, through a subsequent Order, shall form a specialized unit under the Center for 
Cosmetics Regulation and Research, to implement and co -develop the provisions of this 
policy.  
 
6.2. The FDA shall conduct post market surveillance (PMS) activities for verification of 
industry compliance and en forcement of FDA rules and regulations.  
 
6.3. The DILG through the LGUs, PNP, and MMDA, shall enforce the minimum allowable 
age for the use of vapor products and HTPs. Sale of vapor products and HTPs, shall be 
made only to an individual who demonstrates that he/she is more than 21 years of age, 
throug h (a) any valid government ID; (b) a valid passport issued by the Department of  
Foreign Affairs or any other country; or (c) an identification card issued by the FDA for 
the use of such products.  
 
6.4. The local government units (LGU), and other government age ncies and offices involved 
in the monitoring and regulation of the use, sale and distribution of vapor products and 
HTPs are enjoined to observe and implement the guidelines provided.  
  
V. EFFECTIVITY  
 
         This Circular shall take effect immediately.   
 
VI. PENALTIES  
 
Violation to any provisions of this Circular shall be subject to the penalties/sanctions 
provided under Book III, Article XI of the Rules and Regulations Implementing Republic Act 
No. 9711, The Food and Drug Administration Act of 2009, Republic Act No. 11346, Republic 
Act No. 11467, Executive Order No. 106 and other penalties provided by other applicable 
laws.  
 
VII. SEPARABILITY CLAUSE  
 
If any provision in this Circular, or application of such provision to any circumstances, is 
held inv alid, the remainder of the provisions in this Circular shall not be affected.  
 
  
  
ROLANDO ENRIQUE D. DOMINGO, MD  
Director General, Food and Drug Administration  
  
Keywords  Implementing Guidelines, Vapor Products, Heated Tobacco Products, HTP, Heat -Not-
Burn, Electronic Nicotine Delivery System, Electronic Non -Nicotine Delivery System, 
ENDS/ENNDS, Vape, E -Cigarettes, E -Liquids, Vapor Products  
Related Issuances, Laws, Directives  RA 9711, RA 11346, RA 11467, EO 106 s.2020  
 
    
ANNEX E  
GLOSSARY  
  
1. Advertising  shall refer to the conceptualizing, presenting, making available and 
communication to the public, through any form of media platforms, any fact, data, 
or information about the attributes, features, quality or availability of consumer  
products, services, or credit.  
  
2. Authorization  means a permission embodied in a document granted by the FDA 
to a natural or juridical person who has submitted an application to implement the 
manufacture, importation, exportation, sale, offer for sale, dis tribution, and/or, 
where appropriate, the use, testing, promotion, advertising, or sponsorship of 
health products. The authorization can take the form of a permit, a license, a 
certificate of registration, of accreditation, of compliance, or of exemption, or any 
similar document.  
  
3. Designated Vaping Area shall refer to an area where the use of vapor products 
shall be allowed . 
 
4. FDA Electronic Registration Number (FERN) shall refer to the product 
authorization issued by the FDA to FDA -licensed companies, firms or non -profit 
organizations to market specific vapor products classified as HUHS and health -
related devices in the Philippines.  
  
5. Health Claims shall refer to the beneficial effects to promote good health by 
enhancing/improving body functi on, improving a function, enhancing or 
preserving health and/or reducing the risk of health -related conditions of diseases.  
 
6. Heated Tobacco Products (HTPs) refer to tobacco products that may be 
consumed through heating tobacco, either electrically or throu gh other means 
sufficiently to release an aerosol that can be inhaled without burning or any 
combustion of the tobacco. Heated tobacco products include liquid solutions and 
gels that are part of the product and are heated to generate an aerosol.  
  
7. Industry  refers to manufacturers, traders, distributors (importer, exporter, 
wholesaler), and retailers of vapor products and/or heated tobacco products . 
 
8. Ingredient  means any substance that is added to the mixture and present in the 
finished product   
  
9. Marketing Authorization Holder (MAH) refers to a company, firm or non -profit 
organization that has been granted an authorization by the FDA.  
 
10. Nicotine Shots  refer to nicotine in liquid or any other form/substances that is added 
to or mixed with vapor produ ct refills or cartridges that has the effect of increasing 
the dosage or nicotine concentration in a refill or cartridge.  
  
11. Package  shall refer to packs, boxes, cartons, or containers of any kind used on 
vapor products, which is offered for sale to consume rs. 
  
12. Post-Marketing Surveillance (PMS) refers to activities involved in safety, 
efficacy, and quality monitoring of health products. This shall also include, among 
others, adverse events reporting, product safety update reporting, collection and 
testing of health products in the market.  
  
13. Promotion  shall refer to an event or activity organized by or on behalf of an vapor 
product manufacturer, distributors (importer, exporter, wholesaler), seller or 
retailer with the aim of promoting vapor products , which event or activity would 
not occur but for the support given to it by or on behalf of the vapor product 
manufacturer, distributor (importer, exporter, wholesaler), seller or retailer. It may 
also refer to the display of vapor products or the manufac turer’s name, trademark, 
logo, and the like on non -vapor products. This includes the paid use of vapor 
products bearing the brand names, trademarks, logos, and the like in movies, 
television, and other forms of entertainment.  
  
14. Refills and Cartridges  are a rticles, which may or may not contain nicotine, 
designed to be used in conjunction with vapor product or HTP electronic delivery 
devices for inhalation;  
  
15. Sponsorship  shall refer to any public or private contribution from vapor product 
industry in relation  to an event, team or activity made with the aim of promoting a 
brand of vapor products, which event, team or activity would still exist or occur 
with or without contribution. This shall also include corporate social responsibility 
(CSR) activities by the vapor product industry.  
  
16. Vapor Products  shall mean any liquid solution or gel which contains nicotine that 
transforms into an aerosol without combustion through employment of a 
mechanical heating element, battery or circuit that can be used to heat such s olution 
or gel, and includes but is not limited to, a cartridge, a tank, and a device without  
a cartridge or tank. It is commonly known as ‘e -liquids’ or ‘e -cigarettes’. It also 
includes electronic nicotine and non -nicotine delivery systems (ENDS/ENNDS) 
which are combinations of non -tobacco containing e -liquids or refills which 
contain up to sixty -five milligrams per milliliter (65mg/mL) of nicotine in the e -
liquid or refill and an electronic delivery device to produce an aerosol, mist or 
vapor that users i nhale by mimicking the act of smoking.