ADMINISTRATIVE ORDER

No. ______________________

SUBJECT: Amendment to Administrative Order No. 2014-008

“Rules and Regulations on Electronic Nicotine Delivery
System (ENDS) or Electronic Cigarettes” dated 12 March
2014

I. BACKGROUND/RATIONALE

Under Section 3 of Republic Act No. (RA) 9711, otherwise known as The Food and
Drug Administration Act of 2009, “It is hereby declared a policy of the State to adopt,
support, establish, institutionalize, improve and maintain structures, processes, mechanisms
and initiatives that are aimed, directed and designed to: (a) protect and promote the right to
health of the Filipino people; and (b) help establish and maintain an effective health products
regulatory system and undertake appropriate health manpower development and research,
responsive to the country’s health needs and problems. Pursuant to this policy, the State
must enhance its regulatory capacity and strengthen its capability with regard to the
inspection, licensing and monitoring of establishments and the registration and monitoring
of health products.”

In line with the intent of RA 9711, the Department of Health (DOH) had 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
Order, electronic cigarettes (e-cigarettes) were classified as health or consumer products
under the jurisdiction of the FDA. The Order aimed to ensure the safety, efficacy and quality
of ENDS or E-cigarettes by providing pertinent guidelines in the licensing of e-cigarette
establishments and registration of their products.

E-cigarettes, which include both Electronic Nicotine Delivery Systems (ENDS) and
Electronic Non-nicotine Delivery Systems (ENNDS), are used to deliver aerosolized
solutions to the lungs, which is similar to the act of smoking. At present, the e-cigarette
industry are commonly marketing e-cigarettes as a “safer” or “less harmful” alternative to
conventional tobacco products despite the significant level of uncertainty surrounding its
safety. Although early studies suggest that e-cigarettes contain significantly lesser amounts
of toxic substances as compared to conventional tobacco products, these studies are not
enough to clearly and unequivocally conclude that the long-term use of e-cigarettes will not
have any harmful effect to human health. To be able to conclude that e-cigarettes are less
harmful than conventional smoking may require a series of long-term epidemiological and
peer-reviewed studies. “Less harmful” is not, however, synonymous to “safe” as 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.

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 Several years after A.O. 2014-0008 had been signed, e-cigarettes evolved into more
complex and diverse products with an array of different devices and mixtures offered to the
public, rendering the existing Order outdated. Thus, the DOH recognizes the exigency to
modernize its policy for the effective regulation of e-cigarettes.

II. OBJECTIVES

This Administrative Order is being issued to provide an updated policy on e-

cigarettes which will serve as a guide to all individuals, enterprises and businesses which
seek to manufacture, distribute, sell, offer for sale, advertise, promote, sponsor, and/or use
e-cigarettes; and other government units and offices, involved in the monitoring and
regulation of e-cigarette use and distribution.

III. SCOPE

This Administrative Order shall apply to all individuals and businesses, which seek
to manufacture, distribute, sell, offer for sale, advertise, promote, sponsor, and/or use e-
cigarettes in the Philippines.

This Order does not apply to heated tobacco products (HTPs) such as iQOS, Ploom,
and other similar innovations, which uses tobacco products.

IV. DEFINITION OF TERMS

a. Drugs means: (1) articles recognized in official pharmacopeias and

formularies, including official homeopathic pharmacopeias, or any
documentary supplement to any of them, which are recognized and
adopted by the FDA; (2) articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in man or other
animals; (3) articles (other than food) intended to affect the structure
of any function of the body of humans or animals; or (4) articles
intended for use as a component of any articles specified in clauses
(1), (2), or (3) but do not include devices or their components, parts
or accessories.

b. Electronic Is the combination of a non-tobacco-containing e-liquid or refill and

Cigarette a vaporizer to produce an aerosol that users inhale by mimicking the
(e-cigarette) act of smoking. This will include both electronic nicotine delivery
systems (ENDS) and electronic non-nicotine delivery systems
(ENNDS) and their components, whether sold separately or together.

c. Electronic- Are non-tobacco articles, which may or may not contain nicotine,
Liquid (e-liquid) designed to be used in conjunction with vaporizers for inhalation.
and Refill

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d. Harm Is an approach with the aim of managing or minimizing the negative
Reduction effects of a substance and/or behavior.

e. 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.

f. Health-Related Refers to any device not used in health care but has been determined
Device by the FDA to adversely affect the health of the people

g. Heated Tobacco Are a form of tobacco products that uses an electronic device to heat
Products (HTP) processed tobacco leaves, and produce aerosols for inhalation by
mimicking the behavior of smoking conventional cigarettes.

h. Household/ Any substance or mixture of substances intended for individual or

Urban Hazardous limited purposes and which is toxic, corrosive, an irritant, a strong
Substances sensitizer, is flammable or combustible, or generates pressure
(HUHS) 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

i. Minimum For the purpose of this AO, minimum allowable age shall refer to
Allowable Age 25 years of age.

j. Marketing Is a document that is issued by the FDA to a company, firm or non-

Authorization profit organization as an authorization to market health products in
the Philippines.

k. Marketing A company, firm or non-profit organization that has been granted

Authorization a marketing authorization.
Holder (MAH)

l. Smoking Refers to pharmacological aids to smoking cessation. Smoking

Cessation Aid cessation aids which are approved prescription or non-prescription
medication, which may form part of a comprehensive smoking
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 cessation program or strategy which includes counselling, behavior
change and/or various forms of support.

m. Vaporizer Is an electronic device that is used to heat and aerosolize/vaporize

non-tobacco-containing e-liquids or refills for inhalation. The device
is used in a manner similar to conventional cigarettes.

V. GUIDING PRINCIPLES

1. Precautionary Principle. With insufficient scientific evidences on the safety

profile of innovative products such as e-cigarettes, the DOH 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. Age Restriction. Scientific evidence show that the human brain, specifically the
prefrontal cortex, does not reach full maturity until the age of 25 and exposure
to nicotine increases the risk of developing psychiatric disorders and cognitive
impairment in later life. This, and the claim that e-cigarettes are intended for
smokers wanting to quit conventional cigarette use, led the DOH to determine
that the minimum allowable age for the purchase and sale of e-cigarettes is 25
years of age to protect the youth from initiating nicotine consumption and being
subjected to unnecessary risks resulting from nicotine addiction.

3. Protection of Vulnerable Populations. E-cigarettes have a wide variety of

flavors that are used to increase the palatability of these products and have
proven to become very popular amongst the youth. To minimize the appeal of
such products to the youth, the Department of Health shall impose a ban on all
flavors for e-liquids and refills.

4. Restriction on Use. Following the precautionary principle, exposure of the rest

of the population to the emissions of e-cigarettes should be minimized, if not
completely avoided, due to the limited scientific data on the effects of e-cigarette
emissions to human health. In this regard, the DOH deems it necessary that the
use of e-cigarettes banned in places where smoking is prohibited under E.O. 26
and other appropriate laws, rules, and regulations.

5. Classification of Product. E-liquids and refills, with or without the presence of

nicotine, but bears therapeutic or health claims such as but not limited to
cessation aide and/or harm reduction for smoking shall be classified as a drug
product. While e-liquids and refills, with or without the presence of nicotine, that
does not bear therapeutic or health claims shall be classified as Household/Urban
Hazardous Substances (HUHS). Vaporizers, including its components used for
modification, shall be classified as health-related device.

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 6. Capacity Building. Continuous study and analysis shall be conducted by the
DOH to increase its understanding of e-cigarettes, and assist in the development
of new and updating of existing policies on these products.

7. Protection of Public Health Policies. DOH-CSC Joint Memorandum Circular

(JMC) 2010-001 shall be strictly observed in the implementation of this Order.

VI. GENERAL GUIDELINES

1. All establishments engaged in the manufacture, distribution, importation,

exportation, sale, offering for sale, transfer, promotion, advertisement and/or
sponsorship of e-cigarettes shall secure a license to operate (LTO), following the
requirements stipulated under Administrative Order 2016-0003, prior to
operation.

2. Only establishments with a valid FDA-issued LTO can apply for a product
marketing authorization, such as Certificate of Product Registration (CPR) for
e-liquids and refills classified as drug products, Product Notification (NN) for e-
liquids and refills classified as HUHS and Certificate of Compliance (COC) for
vaporizers.

3. Establishments are required to secure the necessary product marketing

authorizations prior to manufacture, distribution, importation, exportation, sale,
offering for sale, transfer, promotion, advertisement and/or sponsorship of e-
cigarettes.

4. 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 e-cigarette 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 approved by the FDA”) unless with
written permission from the agency.

5. All e-cigarette establishments and products that are subject of promotional,

advertisement, sponsorship, marketing, or commercial materials shall use only
the License to Operate Number, Certificate of Product Registration Number,
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 Certificate of Notification Number, or Certificate of Compliance Number, to
reflect the authorization issued by the FDA.

6. A comprehensive ban on the advertising, promotion and sponsorship of

electronic cigarettes or any of its components, in any form including in quad-
media, shall be implemented, unless otherwise allowed by the FDA through a
written authorization.

7. Establishments shall be inspected by the FDA Field Regulatory Operations

Office (FROO) prior and/or after the issuance of the license. This does not
preclude the FDA Regulatory Enforcement Unit and inspectorates to conduct its
own inspection, surveillance, monitoring and/or investigation of e-cigarette
establishments.

8. The FDA shall adhere to and promote the applicable agreements under the
Framework Convention on Tobacco Control (FCTC) and other international
agreements.

VII. SPECIFIC GUIDELINES

A. Notification of HUHS e-liquids and refills

1. Ingredients classified as GHS Hazard Categories 1 and 2 in any of the health

hazard classes shall not be allowed to be part of the formulation of e-liquids and
refills for notification.

2. The application process will be through FDA’s current notification system for e-
cigarettes.

3. Notification will be per formulation and packaging presentation. Products

having the same ingredients but with varying in amount shall be notified
separately.

4. Administrative and technical product documents as listed in Annex A shall be

submitted as part of the notification process depending on the type of application.

5. Commercial product label shall follow the guidelines under Administrative

Order No. 311 “a” and the Globally Harmonized System of Classification and
Labeling of Chemicals.

6. Initial and renewal notification issued to HUHS e-liquids and refills shall have
an optional validity of 1 to 3 years.

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7. Changes in the status of the product shall either require an initial filing of
notification application or a variation application depending on the type of
variation. Below is a tabulation of these changes:

INITIAL VARIATION
Change in Manufacturer Change in Product Label
Change in Manufacturer’s Address Change in / Additional Pack Size or
Packaging Type
Change in Formulation Change in Supplier, if supplier is not
the manufacturer
Change in Marketing Authorization Change in GHS Category of
Holder (MAH) Ingredient

8. The establishment may apply for automatic renewal if a product does not have
any variation or pending application for variations.

9. For HUHS product with variation/s, regular renewal shall be filed together with
a duly accomplished application form, declaration and oath of undertaking for
regular renewal and the documentary requirement for the variation application.

10. Variations which require initial filing need not apply for renewal.

11. Applications are only approved or disapproved. 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.

12. Decision for the application, whether the issuance of CPR or Letter of
Disapproval (LOD) shall be sent through the FDA e-Portal system.

13. The MAH shall be responsible for ensuring the continuous compliance of their
products placed on the market to FDA-issued standards and guidelines.

B. Application of Certificate of Compliance (COC) for Vaporizers

1. Application process will be through FDA’s current registration system for e-

cigarettes.

2. All documentary requirements (Annex B) shall be submitted accordingly based

on the type of application.

3. Initial COC issued to vaporizers shall have a validity of 3 years and a renewed
COC shall be valid for 5 years.

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 4. Applications are only approved or disapproved. 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.

5. Decision for the application, whether the issuance of CPR or Letter of

Disapproval (LOD) shall be sent through the FDA e-Portal system.

6. The MAH shall be responsible for ensuring the continuous compliance of their
products placed on the market to FDA-issued standards and guidelines.

I. 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.

II. REPEALING CLAUSE

The provisions of other existing provisions or issuances found inconsistent or

contrary with this Order is hereby repealed or modified accordingly. .

III. EFFECTIVITY

This Order shall take effect fifteen (15) days after its publication on newspaper/s of
general circulation in the Philippines and filing ONAR.

Dr. Francisco Duque III

Secretary of Health

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