Republic of the Philippines  
Department of Health  
OFFICE OF THE SECRETARY  
 
 
 
 
Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila  Trunk Li ne 651 -7800 Local 1113, 1108, 1 135 
Direct Line: / 711 —9502; 711 -9503 Fax: 743 -1829  URL: http://www.doh.gov.ph; e -mail: ftduque@doh.gov.ph  
ADMINISTRATIVE ORDER  
No. ______________________  
  
  
SUBJECT:  Revised  Rules and Regulations on Electr onic Nicotine and Non -   
Nicotine Delivery System (ENDS/ENNDS)   
  
 
I. BACKGROUND/RATIONALE  
  
Executive Order No. 102, Redirecting the Functions and Operations of the 
Department of Health (DOH), mandated the agency  to be the over -all technical 
authority on health  in the provision of the national policy direction and develop 
national plans, technical standards and guidelines on health.  Furthermore, the DOH 
shall pursue and assure promotion of the health and well -being for every Filipino , 
prevention and control of diseases among population at risk and protection of 
individuals,  families and communities exposed to health hazards & risks.  
Republic Act No. (RA) 9711, otherwise known as The Food and Drug 
Administration Act (FDA) of 2009 , declares as a policy that the State shall  protect and 
promote the right to health of the Filipin o 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 enhance its regulatory capacity and strengthen its 
capacity for the regulation of health products and its industry.  
 In line with the intent of RA 9711, the Department of Health (DOH) issued 
Administrative Order (A.O.) 2014 -0008 entitled “Rules and Regulations on Electronic 
Nicotine Delivery System (ENDS) or Electronic Cigarettes” on 12 March 2014. 
Under the A.O. , electronic  cigarettes (e -cigarettes) were classified as health or 
consumer products under the jurisdic tion of the FDA. The Order aims  to ensure the 
safety and quality of ENDS or E -cigarettes by providing pertinent guidelines in the 
licensing of e -cigarette establishments and registration/notification of their products.  
  
 E-cigarettes , including  both Electronic Nicotine and Non -nicotine  Delivery 
Systems ( ENDS/ ENNDS) , are used to deliver aerosolized solutions to the lungs, 
which is similar to the act of smoking.  At present, the industry is commonly 
marketing ENDS/ENNDS  as a “safer” or “less harmful” alternative to conventional 
tobacco pr oducts despite the significant level of uncertainty surrounding its safety. 
The available studies are not enough to clearly and unequivocally conclude that the 
long-term use of ENDS/ENNDS  will not have any harmful effect to human health. 
There may still be  undue harm to health that may be brought about by the use of these 
products thus, precautionary measures such as regulation by a competent authority is 
necessary for the protection of public health.  Thus, the DOH reco gnizes the exigency 
to strengthen  its policy for the effective regulation of ENDS/ENNDS products .  
 
 
Page 2 of 9 
 II. OBJECTIVES  
This Order is being issued to provide an updated policy on ENDS/ENNDS  
which sha ll serve as a guide to all individuals, enterprises and businesses which seek 
to manufacture, di stribute, import, export, sell, offer for sale , and/or use these 
products . It shall also guide  other government units and offices, involved in the 
monitoring and regulation of ENDS/ENNDS use and distribution.  
 
   
III. SCOPE  
 
This Order shall apply to all individuals and the busines s sector , which intend 
to manufacture, distribute,  import, export,  sell, offer for sale, and/or use 
ENDS/ENNDS in the Philippines.  
  
This Order does not apply to heated tobacco products (HTPs) and other  similar 
innovations, which use  tobacco products.  
 
 
IV. DEFINITION OF TERMS  
 
1. Designated Vaping Area refers to an area of a buil ding or conveyance where 
vaping  may be allowed, which may be in an open space or separate area with 
proper ventilation subject to the specific standards provided in this order.  
 
2. Drugs refer  to (a) articles recognized in official pharmacopeias and formularies, 
including official homeopat hic pharmacopeias, or any documentary supplement 
to any of them, which are recognized and adopted by the FDA; (b) articles 
intended for use in the diagnosis, cure, mitigation, treatment, or prevention of 
disease in man or other animals; (c) articles (other  than food) intended to affect 
the structure of any function of the body of humans or  animals; or (d) articles 
intended for use as a  component of any articles specified in clauses (a), (b), or (c) 
but do not include devices or their components, parts or ac cessories.  
 
3. Electronic Nicotine and Non -Nicotine Delivery Systems (ENDS/ENNDS) are 
combination s of non-tobacco -containing e -liquid s or refill s and an electronic 
delive ry device to produce an aerosol, mist, or vapor that users inhale by 
mimicking the act of  smoking .  
 
4. FDA Electronic Registration Number (FERN) shall refer to the product 
certification issued by the FDA to a company, firm or non -profit organization as 
an authorization to market specific ENDS/ENNDS products in the Philippines . 
 
5. Globally Harmoniz ed System of Classification and Labelling of Chemicals 
(GHS) refers to the system developed by the United Nations for standardizing 
and harmonizing the classification and labeling of chemicals.   
 
 
Page 3 of 9 
  
6. Health Claims refers to the relationship between the use of E NDS/ENNDS 
products and reduced risk of disease or health -related condition.  
 
7. Health Products means food, drugs, cosmetics, devices, biologicals, vaccines, 
in-vitro diagnostic reagents and household urban hazardous substances and/or a 
combination of and or a derivative thereof. It shall also refer to products that may 
have an effect on health which require regulations as determined by the FDA.  
 
8. Health -Related Device refers to any device not used in health care but has been 
determined by the FDA to adversely affect the health of the people.  
 
9. Heated Tobacco Products (HTPs) refers to a form of tobacco products that uses 
an electronic device to heat processed tobacco leaves, and produces aerosols for 
inhalation by mimicking the behavior of smoking conventional ci garettes . 
 
10. Household/Urban Hazardous Substances (HUHS) refers to any substance or 
mixture of substances intended for individual or limited purposes and which is 
toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or 
generates pressure through decomposition , heat or other means, if such substance 
or mixture of substances may cause substantial injury or substantial illness during 
or as a proximate result of any customary or reasonably foreseeable ingestion by 
children, but shall not include agricultural fertilizer, pesticide, and insecticide, 
and other economic poisons, radioactive substance, or substances intended for use 
as fuels, coolants, refrigerants and the like.  
 
11. Minimum Allowable Age shall refer to 21  years of age for the purpose of this 
Order.  
 
12. Marketing Authorization shall refer to the document(s) that is issued by the 
FDA to a company, firm or non -profit organization as an authorization to market 
health products in the Philippines . 
 
13. Marketing Authorization Holder (MAH) refers to a company, firm or non -
profit organization that has been granted a marketing authorization by the FDA . 
 
14. Nicotine Shots/Concentrates refers to high strength preparations of flavorless 
nicotine designed to be added to e -liquid preparations to incre ase its  nicotine 
content . 
 
15. 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.  
  
 
 
Page 4 of 9 
 16. Smoking Cessation Aid refers to pharmacological aids to smoking cessation; 
Smoking cessation aids which are approved prescription or non -prescription 
medication, which may form part of a comprehens ive smoking cessation program 
or strategy which includes counselling, behavior change and/or various forms of 
support.  
 
 
V. GUIDING PRINCIPLES  
  
1. Precautionary Principle.  The principle that the introduction of a new product or 
process whose ultimate effects are disputed or unknown should be treated with 
precaution . With insufficient scientific evidences on the safety profile of 
innovative products such as ENDS/ENNDS, the DO H shall take precautionary 
measures to ensure the protection of the right to health of the public. In this 
regard, e -cigarettes shall be classified as a health product and shall be regulated 
accordingly.  
 
2. Classification of Product.  E-liquids and refills, with or without the  presence of 
nicotine, but bear  therapeutic or health claims such as but not limited to cessation 
aide and/or harm reduction for smoking, or are marketed as such shall be 
classified as a drug product. E -liquids an d refills, with or without the  presence of 
nicotine, that do  not bear therapeutic or health claims shall be classified as 
Household/Urban Hazardous Substances (HUHS). The electronic delivery 
devices, including its components used for modification shall be classified as 
health -related device.  
 
3. Research and Development . Continuous research study and analysis shall be 
conducted by the DOH on ENDS/ENNDS , including emerging and novel tobacco 
products , to increase its competency for the development of new and existing 
policies for these products . 
 
4. Protection of the Bureaucracy Against Tobacco Industry Interference . DOH -
CSC Joint Memorandum Circular (JMC) 2010 -001 shall be strictly observed in 
the implem entation of this Order.  
 
5. WHO Framework Convention on Tobacco Control.  The FDA shall adhere to 
and promote the applicable agreements under the Framework Convention on 
Tobacco Control (FCTC) and other pertinent international agreements.  
 
  
VI. GENERAL GUIDELINES  
  
1. All establishments engaged in the manufacture, distribution, importation, 
exportation, sale including online sal e, offering for sale, and transfer of 
ENDS/ENNDS  products shall first secure a License to O perate (LTO), following  
 
 
Page 5 of 9 
 the procedure stipulated u nder Administrative Order 2016 -0003  and its 
amendments .  
 
2. Only establishments with a valid FDA -issued LTO can apply for a product 
marketing authorization, such as Certificate of Product Registration (CPR)  or 
FDA Electronic Registration Number (FER N). 
 
3. Establishments seeking to market e -liquids and refills classified as drug products 
shall comply with the regulatory requirements for pharmaceutical products under 
the Center for Drugs Regulation and Research.  
 
4. No establishment shall engage in the manufactu re, distribution, importation, 
exportation, sale, offering for sale, and transfer of ENDS/ENNDS  products 
without first securing the necessary marketing authorizations.  
 
5. 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 ENDS/ENNDS  products, 
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 app roved by the FDA”) unless with written 
permission from the agency.  
 
6. All refills and devices  shall be child -resistant, tamper resistant, and  shall be  
protected against breakage and leakage.  
 
7. Containers and packages of electronic delivery devices, e -liquids and r efill sh all 
contain appropriate health warnings, whose content, format, and specifications, 
are designated by the FDA, based on the declaration of ingredients or components 
of the same product.  (see Annex D)  
 
8. The FDA shall set standards and necessary restrictions on flavors and additives 
used in the manufacture  of e-liquids and refills. The FDA shall  also impose a ban 
on flavors and additives that are proven or suspected to be appealing to the youth, 
toxic, harmful, addictive , or sensitizing  
 
9. The retail sale of nicotine shots  and/or concentrates shall be  strictly prohibited.  
 
10. A comprehensive ban on  any form  of advertis ing, promotion and sponsorship, 
including corporate social responsibility campaigns  by the industry,  of 
ENDS/ENNDS  products , shall be implemented upon approval of this Order.  
 
11. Establishments shall be inspected by the FDA prior and/or aft er the issuance of 
the license.   
 
 
Page 6 of 9 
  
12. The minimum  allowable age for purchase, sale, and use  of ENDS/ENNDS  shall 
be set at 21  years old.  
 
13. The distribution, sale and offering for sale  and use  of ENDS/ENNDS  shall be 
strictly pr ohibited in places where sale and use  of cigarettes are  prohibited.  
 
14. The use of ENDS/ENNDS  shall be banned in places where smoking is prohibited.  
 
15. Designated vaping areas (D VAs), including vaping lounges and the like, shall 
follow the same guidelines and requirements set for DSAs  as provided under 
section 4 of Executive Order No. 26 s. 2017 . 
 
16. Local Government Units (LGUs), and other government units and offices 
involved in the monitoring and regulation of ENDS/ENNDS  use, sale and 
distribution are en joined to observe and implement  the guidelines provided under 
this Order.  LGUs shall have the aut hority to adopt or enact more stringent 
measures to exercise their power under the General W elfare clause.  
 
17. The FDA shall not be precluded from the iss uance of subsequent regulations or 
regulatory actions   for the protection of public health .  
 
 
VII. SPECIFIC GUIDELINES  
 
  
A. Industry Application of FDA Electronic Registration Number (FERN) for 
HUHS E -liquids and R efills  
  
1. The application process shall be through FDA’s current licensing and registration 
system for ENDS/ENNDS products.  
 
2. Application for FERN  of e-liquids and refills shall be per formulation.  
 
3. E-liquid and refills  with Hazard Categories 1 and 2 in  any of the health and 
environmental hazard classes under the prevailing GHS revision shall not be 
allowed for FERN application .  
 
4. The maximum allowable nicotine content for e -liquids and refills shall be ten (10) 
mg/mL.  
 
5. E-liquid and refill containers, with or without nicotine, shall only be allowed to 
have a maximum volume of thirty ( 30) mL. 
  
 
 
Page 7 of 9 
 6. Administrative and technical product documents as listed in Annex A  shall be 
submitted as part of the FERN application  process depending on the type of 
application.  
 
7. Commercial product label shall follow the guidelines  and requirements for 
labelling of hazardous substances stated  under Administrative Order No. 311 s. 
1977  and Republic Act 7394  s. 1992,  while  the Globally Harmonized System of 
Classification and Labeling of Chemicals  shall be optional . 
 
8. Schedule of fees i s provided under Annex C  of this Order.  
 
9. Applications determined to have complied with FDA’s requirements and 
standards shall be approved while applications deemed to be incomplete, 
inconsistent or incorrect shall automatically be disapproved.  
 
10. Decision for the application , whether for the issuance of a FERN  or Letter of 
Disapproval (LOD) shall be sent through FDA’s current licensing and registration 
system , as may be applicable.  
 
11. The MAH shall be responsible for ensuring the continuous compliance of thei r 
products placed on the market to FDA -issued standards and guidelines.  
  
 
B. Industry Application of FDA Electronic Registration Number (FERN)  for 
Electronic Delivery Devices  
  
1. Application process will be through FDA’s current licensing and registration 
system  for ENDS/ENNDS products.  
 
2. Tanks of electronic delivery devices shall only be allowed to have a maximum 
capacity of two (2) mL.  
 
3. All documentary and technical requirements (Annex B)  shall be submitted 
accordingly based on the type of application.  
 
4. Schedule of fees is provided under Annex C  of this Order.  
 
5. Applications determined to have complied with FDA’s requirements and 
standards shall be approved while applications deemed to be incomplete or 
incorrect shall automatically be disapproved.  
 
6. Decision for the application, whether for the issuance of a FERN  or Letter of 
Disapproval (LOD) shall be sent through FDA’s current licensing and registration 
system . 
  
 
 
Page 8 of 9 
 7. The MAH shall be responsible for ensuring the continuous compliance of their 
products placed on the market to FDA -issued standards and guidelines.  
 
 
VIII.  CREATION OF THE FDA EXECUTIVE COUNCIL ON ENDS/ENNDS  
 
The FDA shall  create an  Executive Council on ENDS/ENDDS which will 
exercise oversight functions  on the regulation of ENDS/ENNDS . 
 
IX. LEGAL FUND  
 
In the event that any legal action, suit, or proceeding arising from or related to 
this AO is initiated against the FDA or its officials a nd employees in the course of the 
exercise of their official functions and duties, the costs and expenses incurred in 
connection with such action, suit, or proceeding, including attorney’s fees, shall be 
paid from the Legal Fund [pursuant to Section 18 of RA 9711 and Article II.B, 
Section 8 of its Implementing Rules and Regulations].  
 
X. PENALT IES 
 
Violation to any of the provisions of this Order 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, and other penalties provided by other applicable  laws.  
 
 
XI. TRANSITORY PERIOD  
 
A transitory period of not more than  three (3) months from the date of 
effectivity of this Order shall be provided to allow all covered establishments to 
comply with the new guidelines.  
ENDS/ENNDS products  verified to be unregistered after the given grace period 
shall be subject to seizure , and persons, establishments  including the officers and 
directors,  responsible for their distribution or introduction in the Philippines shall be 
subject to the imposition of appropriate regulatory actions after due process.  
 
 
XII. SEPARABILITY CLAUSE  
  
If, for any reason, any section or provision of this Order is declared invalid, 
illegal or unconstitutional, such invalidity or unconstitutionally shall not affect the 
other provisions of this Order, which will remain in full force and effect.  
 
   
 
 
Page 9 of 9 
 XIII.  REPEALING CLAUSE  
  
This policy repeals A.O. 2014 -0008 entitled “Rules and Regulations on 
Electronic Nicotine Delivery System (ENDS) or Electronic Cigarettes.” Provisions of 
other existing Orders or issuances found inconsistent or contrary with this Order are 
hereby amended acc ordingly.  
 
  
XIV. EFFECTIVITY  
  
This Order shall take effect fifteen (15) days after its publication on newspaper/s 
of general circulation in the Philippines and filing with the Office of the National 
Administrative Register.  
 
 
 
 
 
Office  FDA  HRT  HPDPB/OHS  OSEC  
 
 
 
Initial   
 
 
NELA CHARADE G. 
PUNO, RPh.  
Director General   
 
 
ROLANDO ENRIQUE D. 
DOMINGO, MD, DPBO  
Undersecretary   
 
 
MAYLENE M. BELTRAN, 
MPA, CESO III  
Director IV   
 
 
ATTY. FATIMA P. 
LAPERAL  
Head Executive Assistant  
Date      
 
 
 
 
 FRANCISCO T. DUQUE III, MD, MSc  
Secretary of Health  
Keywords  Electronic Nicotine Delivery System, Electronic Non -Nicotine Delivery System, ENDS/ENNDS, 
Vape, E -Cigarettes, E -Liquids  
Related Issuances, Laws, Directives  RA 9711 , AO 20 14-0008