Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

SIXTEENTH CONGRESS
Second Regular Session

5580

House Bill No. __

Introduced by Magdalo Party-List Representatives
Hon. Francisco Ashley L. Acedillo and Hon. Gary C. Alejano

EXPLANATORY NOTE

Republic Act No. 9211 or the “Tobacco Regulation Act of 2003” was signed into law on June
2003. The law aims to “protect the populace from hazardous products and promote the right to
health”, and “instill health consciousness among them”. Said Act effectively regulates the
package, use, sale, distribution, and advertisement of tobacco products. It also provided for the
prohibition of smoking in public places.

The passage of RA 9211 serves as a benchmark in implementing a stricter tobacco control
initiative in the country. The stricter implementation on tobacco contro! plus the imposition of
higher taxes in tobacco products paved the way for electronic cigarettes (e-cigs) to gain
popularity especially among the youth.

Electronic Nicotine Delivery System (ENDS) or more popularly known as e-cigarettes are
devices commonly made of plastic or metal that heats a liquid nicotine solution (e-juice) in a
disposable cartridge while creating a tiny light on the tip that glows like a real cigarette and
produces a vapour that stimulates the act of smoking. E-cigarettes have been promoted as a safer
alternative to traditional cigarettes and aids an individual to quit smoking.

Without formal studies on its real health effects on the user, a need for the government to
regulate its sale and promotion arises. This measure therefore aims to regulate the sale and use of
ENDS by amending various sections of RA 9211 or the “Tobacco Regulation Act of 2003” to
effectively regulate the use of e-cigarettes.

is earnestly requested.

In view of the foregoing, immediate approval of this bil

HON. PRANCISCO ASHLEY L, ACEDILLO IN. GARY C, ALEJANO-



Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

SIXTEENTH CONGRESS
Second Regular Session

House Bill No. 5580

~ Introduced by Magdalo Party-List Representatives
Francisco Ashley L. Acedillo and Hon. Gary C. Alejano

AN ACT
AMENDING REPUBLIC ACT NO. 9211 OTHERWISE KNOWN AS “AN ACT
REGULATING THE PACKAGING, USE, SALE, DISTRIBUTION AND
ADVERTISEMENTS OF TOBACCO PRODUCTS AND FOR OTHER PURPOSES”

Be it enacted by the Senate and House of Representatives of the Philippines in Congress
assembled:

SECTION 1. Title. This Act shall be known as the “Enhanced Tobacco Regulation Act
of 2014".

SEC. 2. Section 2 of Republic Act No. 9211 otherwise known as the “Tobacco
Regulation Act of 2003” is hereby amended to read as follows:

“Section 2. Policy - it is the policy of the State to protect the populace
from hazardous products and promote the right to health and instill health
consciousness among them, It is also the policy of the State, consistent with the
Constitutional ideal to promote the general welfare, to safeguard the Interests of
the workers and other stakeholders in the tobacco industry. For these purposes,
the government shall institute a balanced policy whereby the use, sale, and
advertisements of tobacco AND OTHER NICOTINE-CONTAINING products
shall be regulated in order to promote a healthful environment and protect the
citizens from the hazards of tobacco smoke AND NICOTINE USE, and at the
same time ensure that the interest of tobacco farmers, growers, workers and

stakeholders are not adversely compromised.”

SEC, 3. Section 3 of the same law is hereby amended to read as follows:
“Section 3. Purpose - It is the main thrust of this Act to:

a) Promote a healthful environment;


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b) Inform the public of the health risl sociated with cigarette
smoking and tobacco use, INCLUDING “ROLL-YOUR-OWN” TOBACCO,
AND NOVEL TOBACCO PRODUCTS;

c) Regulate and subsequently ban all tobacco advertisements and
sponsorships;

d) Regulate the labeling of tobacco products;

e) Protect the youth from being initiated to cigarette smoking and
tobacco use by prohibiting the sale of tobacco products to minors;

Assists and encourage Filipino tobacco farmers to cultivate
alternative agricultural crops to prevent economic dislocation; and

g) Create an Inter-Agency Committee on Tobacco (IAC-Tobacco) to
oversee the implementation of the provision of this Act.

h) EMPOWER THE FOOD AND DRUG ADMINISTRATION
TO REGULATE THE MANUFACTURE, IMPORTATION,
DISTRIBUTION, PROMOTON AND USE OF ELECTRONIC NICOTINE
DELIVERY SYSTEMS (ENDS).

IN ORDER TO CARRY OUT ITS REGULATORY TASKS, THE
STATE MUST REQUIRE COMPREHENSIVE INFORMATION ON THE
INGREDIENTS AND EMISSIONS FROM TOBACCO AND NICOTINE-
CONTAINING PRODUCTS TO ASSESS THE ATTRACTIVENESS,
ADDICTIVENESS AND TOXICITY OF TOBACCO PRODUCTS AND
THE HEALTH RISKS ASSOCIATED WITH THE CONSUMPTION OF
SUCH PRODUCTS, TO THIS END, THE REPORTING OBLIGATIONS
FOR INGREDIENTS AND EMISSIONS SHALL BE ESTABLISHED.
ADDITIONAL ENHANCED REPORTING OBLIGATIONS SHOULD BE
PROVIDED FOR IN RESPECT OF ADDITIVES INCLUDED IN A
PRIORITY LIST ISSUED BY THE IAC-TOBACCO IN ORDER TO
ASSESS THEIR TOXICITY, ADDICTIVENESS AND CARCINOGENIC,
MUTAGENIC OR REPROTOXIC PROPERTIES (‘CMR PROPERTIES’),
INCLUDING IN COMBUSTED FORM. THE BURDEN OF SUCH
ENHANCED REPORTING OBLIGATIONS FOR MICRO, SMALL, AND
MEDIUM ENTERPRISES (MSMES) SHOULD BE LIMITED TO THE
EXTENT POSSIBLE. SUCH REPORTING OBLIGATIONS SHALL BE
CONSISTENT WITH THE OBLIGATION PLACED ON THE STATE
UNDER EXISTING LAWS AND WITHIN THE FRAMEWORK OF THE
WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL


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(‘FCTC’) OF 2003 - TO ENSURE A HIGH LEVEL OF PROTECTION
FOR HUMAN HEALTH.

SEC. 4, Section 4 of the said law is hereby amended to read as follows:

“Section 4. Definition of Terms - As used in this Act:

a, "Advertisement" - refers to any visual and/or audible message
disseminated to the public about or on a particular product that promote and give
publicity by words, designs, images or any other means through broadcasts,
electronic, print or whatever form of mass media, including outdoor
advertisements, such as but no limited to signs and billboards. For the purpose of
this Act, advertisement shall be understood as tobacco advertisement.

b. "Advertising" - refers to the business of conceptualizing, presenting,
making available and communicating to the public, through any form of mass
media, any fact, data or information about the attributes, features, quality or
availability of consumers products, services or credit.

For the purpose of this Act, advertising shall be understood as tobacco
advertising. This shall specifically refer to any messages and images promoting
smoking; the purchase or use of cigarette or tobacco trademarks brand names,
design and manufacturer's names;

©. "Advertiser" - refers to a person or entity on whose account of for
whom an advertisement is prepared and disseminated by the advertising agency,
which is service established and operated for the purpose of counseling or
creating and producing and/or implementing advertising program in various forms
of media;

4d. "Cigarette" - refers to any roll or tubular construction, which contains
tobacco or its derivatives and is intended to be burned or heated under ordinary
conditions of use;

€. "Distributor" - refers to any person to whom a tobacco product is
delivered or sold for purposes of distribution in commerce, except that such terms
does not include a manufacturer or retailer or common carrier of such product;

F. “E-CIGARETTE” —~ REFERS TO A COMMON TYPE OF
ELECTRONIC NICOTINE DELIVERY SYSTEM THAT DELIVERS AN
AEROSOL BY HEATING A SOLUTION THAT USERS INHALE WHICH,
IN ADDITION TO NICOTINE WHEN NICOTINE IS PRESENT, ALSO
CONTAIN PROPYLENE GLYCOL (WITH OR WITHOUT GLYCEROL)
AND FLAVORING AGENTS, ARE SHAPED TO LOOK LIKE THEIR
CONVENTIONAL TOBACCO COUNTERPARTS (E.G. CIGARETTES,



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CIGARS, CIGARILLOS, PIPES, OR HOOKAHS), BUT ALSO TAKE THE
FORM OF EVERYDAY ITEMS SUCH AS PENS, USB MEMORY
STICKS, AND LARGER CYLINDRICAL OR RECTANGULAR
DEVI TC.

[£.]G. "Mass Media" - refers to any medium of communication designed

to reach a mass of people. For this purposes, mass media includes print media
such as, but not limited to, newspapers, magazines, and publications; broadcast
media such as, but not limited to, radio, television, cable television, and cinema;
electronic media such as but not limited to the internet;

[g.]H. "Minor" - refers to any person below eighteen (18) years old;

[hl "Manufacturer" - refers to any person entity, including a re-packer,
who makes, fabricates, assembles, processes, or labels a finished product;
J. “NICOTINE’—THE TERM “NICOTINE” MEANS THE
CHEMICAL SUBSTANCE NAMED 3-(1-METHYL-2-PYRROLIDINYL)
PYRIDINE OR C[10]H[14]N[2], INCLUDING ANY SALT OR COMPLEX
OF NICOTINE.

[i.JK. "Package" - refers to pack, boxes, cartons or containers of any kind

in which any tobacco product is offered for sale to consumers;

[j.]L "Persons" - refers to an individual, partnership, corporation or any
other business or legal entity;

[k.JM. "Point-of-sale" - refers to any location at which an individual can
purchase or otherwise obtain tobacco OR NICOTINE-CONTAINING products;

[LJN. "Promotions" - refers to an event or activity organized by or on
behalf of a tobacco manufacturer, distributor or retailer with the aim of promoting
a brand of tobacco product, which event or activity would not occur but for the
support given to it by or on behalf of the tobacco manufacturer's name, trademark,
logo, ete. on non-tobacco products. This includes the paid use of tobacco products
bearing the brand names, tradenames, logos, etc. In movies, television and other
forms of entertainment. For the purpose of this Act, promotion shall be
understood as tobacco promotion;

[m.JO. "Public Conveyance" - refers to mode of transportation servicing
the general population such as, but not limited to, elevators, airplanes, buses,
taxicabs, ships, jeepneys, light rail transits, tricycles, and similar vehicles;

[n.]P. "Public Places" - refer to enclose or confined areas of all hospitals,
medical clinics, schools, public transportation terminals and offices, and building
such as private and public offices, recreational places, shopping malls, movie

houses, hotels, restaurants, and the like’


Q. “ROLL-YOUR-OWN TOBACCO” — THE TERM “ROLL-
YOUR-OWN TOBACCO” MEANS ANY TOBACCO PRODUCT WHICH,
BECAUSE OF ITS APPEARANCE, TYPE, PACKAGING, OR
LABELING, IS SUITABLE FOR USE AND LIKELY TO BE OFFERED
TO, OR PURCHASED BY, CONSUMERS AS TOBACCO FOR MAKING
CIGARETTES;

[o.JR. "Retailer" - refers to any person who or entity that sells tobacco
products to individuals for personal consumption;

I[p.|S.
tobacco products, whether or not it is being inhale or smoked;

moking" - refers to the act of carrying a lighted cigarette or other

[a.IT. "Sponsorship" - refers to any public or private contribution to a
third party in relation to an event, team or activity made with the aim of
promoting a brand of tobacco product, which event, team or activity would still
exist or occur without such contribution. For the purpose of this Act, sponsorship
shall be understood as tobacco sponsorship;

[r.JU. "Tobacco" - refers to agricultural components derived from the
tobacco plant, which are processed for use in the manufacturing of cigarettes and
other tobacco products;

[s.JV. "Tobacco Products"
that contains nicotine and is intended for use in a cigarette, including any

refers to any product that consists of loose

tob:

product containing tobacco and intended smoking or oral or nasal use. Unless
stated otherwise, the requirements of this Act pertaining to cigarettes shall apply
to other tobacco AND NICOTINE-CONTAINING products;

[t]W. "Tobacco Grower" - refers to any person who plants tobacco before
the enactment of this Act and classified as such by the National Tobacco
Administration (NTA); and

[u.JX. "Warning" - refers to the notice printed on the tobacco produet or
its container and/or displayed in print or alert in broadcast or electronic media
including outdoor advertising and which shall bear information on the hazard of

tobacco use;

. Section 7 of the same law is hereby amended to read as follows:

“Section 7, Vending Machines, Self-Service Facilities - unless the vending
machine has a mechanism for age verification, the sale or distribution of tobacco
OR NICOTINE-CONTAINING products to minors by means of a vending
machine or any self-service facility or similar contraption or device is prohibited,
except at point-of-sale establishments WHERE THERE IS “FACE-TO-FACE”
CONTACT.”


SEC. 6, Section 9 of the said law is hereby amended to read as follows:

“Section 9. Minimum Age Sales - Under this Act, It shall be unlawful:

a. For any retailer of tobacco products to sell or distribute tobacco AND
OTHER NICOTINE-CONTAINING products to any minor;

b. For any person to purchase cigarettes, [or] tobacco AND OTHER
NICOTINE-CONTAINING products from a minor;

¢. For a minor to sell or buy cigarettes or any tobacco AND OTHER
NICOTINE-CONTAINING products; and

d. For a minor to smoke cigarettes, [or any other] tobacco AND OTHER

NICOTINE-CONTAINING products.

It shall not be a defense for the person selling or distributing that he/she
did not know or was aware of the real age of the minor. Neither shall it be a
defense that he/she did not know nor had any reason to believe that the cigarette
or [any other] tobacco AND OTHER NICOTINE-CONTAINING product was

for the consumption of the minor to whom it was sold.”

SEC. 7. Section 10 of the said law is hereby amended to read as follows:

“Section 10. Sale of Tobacco AND OTHER NICOTINE-CONTAINING
Products Within School Perimeters - The sale or distribution of tobacco AND
OTHER NICOTINE-CONTAINING products is prohibited within one hundred
(100) meters from any point of the perimeter of a school, public playground or

other facility frequented particularly by minors.”

SEC. 8. Section 11 of the said law is hereby amended to read as follows:

“Section 11. Signage - Point-of-Sale establishments offering, distributing
or selling tobaeco products to consumers, shall post the following statement in a
clear and conspicuous manner: "SALE/DISTRIBUTION TO OUR PURCHASE
BY MINORS OF TOBACCO AND OTHER NICOTINE-CONTAINING
PRODUCTS IS UNLAWFUL" or " IT IS LAWFUL FOR TOBACCO
PRODUCTS AND OTHER NICOTINE-CONTAINING TO BE
SOLD/DISTRIBUTED TO OR PURCHASED BY PERSONS UNDER 18
YEARS OF AGE".”



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SEC. 9. Section 12 of the same measure is hereby amended to read as follows:

“Section 12. Proof Of Age Verification - In case of doubt as to the age of
the buyer, retailers shall verify, by means of any valid from of photographic
identification containing the date of birth of the bearer, that no individual
purchasing a tobacco OR OTHER NICOTINE-CONTAINING PRODUCT is
below eighteen (18) years of age.”

SEC. 10. Section 13 of the same measure is hereby amended to read as follows:

“Section 13. Warning On Cigarette AND E-CIGARETTE Packages -
Under this Act:

a. All packages in which tobacco AND OTHER NICOTINE-
CONTAINING products are provided to consumers withdrawn from the
manufacturing facility of all manufacturers or imported into the Philippines
intended for sale to the market, starting 1 January 2004 JANUARY 1, 2015, shall

be printed, in either English or Filipino, on a rotating basis or separately and

simultaneously, the following health warnings:

“GOVERNMENT WARNING: Cigarette Smoking is Dangerous to your
Health;”

"GOVERNMENT WARNING; Cigarettes are Addictive";

["GOVERNMENT WARNING; Tobacco Can harm your Children";]

["GOVERNMENT WARNING; Smoking Kills;"]

“GOVERNMENT WARNING; NICOTINE IS HARMFUL TO
YOUR HEALTH”;

“GOVERNMENT WARNING; SMOKING CAUSES 9 OUT OF 10
LUNG CANCERS”

“GOVERNMENT WARNING; SMOKING CAUSES MOUTH AND
THROAT CANCER”

“GOVERNMENT WARNING; SMOKING DAMAGES YOUR
LUNGS”

“GOVERNMENT WARNING; SMOKING CAUSES HEART
ATTACKS”

“GOVERNMENT WARNING; SMOKING CAUSES STROKES
AND DISABILITY”

“GOVERNMENT WARNING; SMOKING CLOGS YOUR
ARTERIES”



“GOVERNMENT WARNING; SMOKING INCREASES THE RISK
OF BLINDNESS”

“GOVERNMENT WARNING; SMOKING DAMAGES YOUR
TEETH AND GUMS”

“GOVERNMENT WARNING; SMOKING CAN KILL YOUR
UNBORN CHILD”

“GOVERNMENT WARNING; YOUR SMOKE HARMS YOUR
CHILDREN, FAMILY AND FRIENDS”

“GOVERNMENT WARNING; SMOKERS' CHILDREN ARE
MORE LIKELY TO START SMOKING”

“GOVERNMENT WARNING; QUIT SMOKING — STAY ALIVE
FOR THOSE CLOSE TO YOU"

“GOVERNMENT WARNING; SMOKING REDUCES
FERTILITY”

“GOVERNMENT WARNING; SMOKING INCREASES THE RISK
OF IMPOTENCE”

b. Upon effectivity of this Act until 30June 2006, the health warning shall
be located on one side panel of every tobacco product package and occupy not
less than fifty percent (50%) of such side panel including any border of frame.

c. Beginning 1 July 2006, the health warning shall be on the bottom
portion of one (1) front panel of every tobacco product package and occupy not
less than thirty percent (30%) of such panel including any border or frame. The
text of the warning shall appear in clearly legible type in black text on a white
background with a black border and in contrasts by typography; layout or color to
the other printer materials on the package. The health warning shall occupy a total

area of less than fifty percent (50%) of the total warming frame,

d. The warning shall be rotated periodically, or separately and
simultaneously printed, so that within any [twenty-four (24)] SIXTY-FOUR (64)
month period, the [four (4)] SIXTEEN (16) variations of the warnings shall
appear with proportionate frequency.

e. The waming shall not be hidden or obscured by other printed
information or images, or printed in a location where tax or fiscal stamps are
likely to be applied to the package or placed in a location where it will be
damaged when the package is opened. If the warning to be printed on the package


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is likely to be obscured or obliterated by a wrapper on the package, the warning
must be printed on both the wrapper and the package.

£, In addition to the health warning all packages of tobacco AND OTHER
NICOTINE-CONTAINING products that are provided to consumers shall
contain, on one side panel the following statement in a clear, legible and
conspicuous manner; "NO SALE TO MINORS" or "NOT FOR SALE TO
MINORS." The statement shall occupied an area of not less than ten percent
(10%) of such side panel and shall appear in contrast by color, typography or
layout with all the other printed material on the side panel.

g. No other printed warnings, except the health warning and the message

required in this Section, paragraph F shall be placed on cigarette packages.”

SEC. 11. Section 14 of the same law is hereby amended to read as follows:

“Section 14. Warning On Advertising - Under this Act:

a. All tobacco AND NICOTINE PRODUCT advertising in mass media
shall contain either in English or Filipino, the following health warning;
"GOVERNMENT WARNING: Cigarette Smoking AND NICOTINE USE is
Dangerous to Your Health."

bx XX

«eX XX

aX X x”

SEC.12, Section 15 of the same law is hereby amended to read as follows:

“Section 15, Restrictions On Advertising - The following restrictions shall

apply to all tobacco advertising:

aX XX

bX XX

eX XX

d. Advertisement shall not show, portray or depict scenes where the actual
use of, or the act of using, puffing or lighting cigarettes or other tobacco AND
OTHER NICOTINE-CONTAINING products is presented to the public.”


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SEC. 13. Section 22 of the same law is hereby amended to read as follows:

“Section 22. Ban On Advertisements - Beginning 1 January [2007] 2015,
all tobacco NICOTINE-CONTAINING PRODUCT advertising on television,
cable television and radio shall be prohibited.

Beginning 1 July [2007] 2015, all cinema and outdoor advertising shall be
prohibited. No leaflets, posters and similar outdoor advertising materials be
posted, except inside the premises of point-of-sale retail establishments.

Beginning 1 July [2008] 2015, all forms of tobacco advertising in mass
media shall be prohibited except tobacco advertisements placed inside the

premises of point-of sale establishments.

SEC. 14, Section 23 of the same law is hereby amended to read as follows:

“Section 23. Restrictions on Tobacco AND NICOTINE-CONTAINING
PRODUCT Promotions - The following restrictions shall apply on all tobacco
promotions.

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SEC. 15. Section 29 of the same law is hereby amended to read as follows:

“Section 29. Implementing Agency. - An Inter-Agency Committee-
Tobacco (IAC-Tobacco), which shall have the exclusive power and function to
administer and implement the provisions of this Act, is hereby created. The IAC-
Tobacco shall be chaired by the Secretary of the Department of Trade and
Industry (DTI) with the Secretary of the Department of Health (DOH) as Vice
Chairperson. The IAC-Tobacco shall have the following members:

a. Secretary of the Department of Agriculture (DA);

b. Secretary of the Department of Justice (DOJ);

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c. Secretary of the Department of Environment and Natural Resources
(DENR);
d. Secretary of the Department of Science and Technology (DOST);

¢. Secretary of the Department of Education (DepEd);
£, Administrator of the National Tobacco Administration (NTA);
g. DIRECTOR GENERAL OF THE FOOD AND DRUG
ADMINISTRATION:
h. A representative from the Tobacco Industry to be nominated by the

legitimate and recognized associations of the industry; and

1. A representative from a nongovernment organization (NGO) involved in
public health promotion nominated by DOH in consultation with the concerned
NGO's;

The Department Secretaries may designate their Undersecretaries as their

authorized representatives to the IAC.”

SEC. 16. Section 30 of the same law is hereby amended to read as follows:

“Section 30, Application to Tobacco Products - This provision of this Act
shall apply to all tobacco products placed into commerce in the Philippines.

ALL TOBACCO PRODUCTS HAVE THE POTENTIAL TO
CAUSE MORTALITY, MORBIDITY AND DISABILITY, THEREFORE,
THEIR MANUFACTURE, DISTRIBUTION AND CONSUMPTION
SHOULD BE REGULATED. HENCE, IT IS IMPORTANT TO MONITOR
DEVELOPMENTS AS REGARDS NOVEL TOBACCO PRODUCTS.
MANUFACTURERS AND IMPORTERS MUST THEREFORE SUBMIT A
NOTIFICATION OF NOVEL TOBACCO PRODUCTS, WITHOUT
PREJUDICE TO THE POWER OF THE STATE TO BAN OR TO
AUTHORIZE SUCH NOVEL PRODUCTS.

THE STATE SHALL PROHIBIT THE PLACING ON THE
MARKET OF TOBACCO PRODUCTS WITH A CHARACTERIZING
FLAVOR. HOWEVER, IT SHALL NOT PROHIBIT THE USE OF
ADDITIVES WHICH ARE ESSENTIAL FOR THE MANUFACTURE OF
TOBACCO PRODUCTS, FOR EXAMPLE, SUGAR TO REPLACE
SUGAR THAT IS LOST DURING THE CURING PROCESS, PROVIDED
THOSE ADDITIVES DO NOT RESULT IN A PRODUCT WITH A
CHARACTERIZING FLAVOR AND DO NOT INCREASE TO A
SIGNIFICANT OR MEASUREABLE DEGREE THE ADDICTIVENESS,
TOXICITY OR THE CARCINOGENIC, MUTAGENIC OR
REPROTOXIC (CMR) PROPERTIES OF THE TOBACCO OR
NICOTINE-CONTAINING PRODUCT.

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Except as provided below, no provision of this Act shall apply to tobacco
products intended or offered by the manufacturer for export and not for (retail)
sale in the Philippines.

Tobacco products intended or offered for export shall be subject only to
the requirement that the shipping container shall be prominently marked on the
outside "Export Only": Provided, that tobacco products which are marked for
export, but are sold/traded or distributed in the Philippine market, shall be subject
to immediate confiscation and destruction.

THE FDA SHALL ESTABLISH MAXIMUM LIMITS FOR TAR,
NICOTINE AND CARBON MONOXIDE YIELDS OF CIGARETTES
THAT SHOULD ALSO BE APPLICABLE TO CIGARETTES WHICH
ARE EXPORTED FROM THE PHILIPPINES. FOR MEASURING THE
TAR, NICOTINE AND CARBON MONOXIDE YIELDS OF
CIGARETTES (REFERRED TO AS ‘EMISSION LEVELS’), REFERENCE
SHOULD BE MADE TO THE RELEVANT, INTERNATIONALLY-
RECOGNIZED ISO STANDARDS. THE VERIFICATION PROCESS
SHOULD BE PROTECTED FROM TOBACCO INDUSTRY INFLUENCE
BY USING INDEPENDENT LABORATORIES, INCLUDING
GOVERNMENT LABORATORIES. THE FDA SHOULD BE ABLE TO
USE LABORATORIES SITUATED IN OTHER COUNTRIES. FOR
OTHER EMISSIONS FROM TOBACCO PRODUCTS WHERE THERE
ARE NO INTERNATIONALLY AGREED STANDARDS OR TESTS FOR
QUANTIFYING MAXIMUM LEVELS, THE STATE SHALL MONITOR
ONGOING EFFORTS AT INTERNATIONAL LEVEL TO DEVELOP
SUCH STANDARDS OR TESTS SHOULD BE ENCOURAGED.

AS REGARDS ESTABLISHING MAXIMUM EMISSION LEVELS,
IT COULD BE NECESSARY AND APPROPRIATE AT A LATER DATE
TO REDUCE THE EMISSION LEVELS FOR TAR, NICOTINE AND
CARBON MONOXIDE OR TO ESTABLISH MAXIMUM LEVELS FOR
OTHER EMISSIONS FROM TOBACCO PRODUCTS, TAKING INTO
CONSIDERATION THEIR TOXICITY OR ADDICTIVENESS.”

SEC. 16. A new section is hereby inserted under the same law to be designated as

Section 30-A, to read as follows:

“SECTION 30-A. E-CIGARETTES. - THE FOOD AND DRUG
ADMINISTRATION (FDA) SHALL ENSURE THAT ELECTRONIC
CIGARETTES AND REFILL CONTAINERS COMPLY WITH THE
REQUIREMENTS OF THIS ACT. WHERE THE MANUFACTURER OF

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THE RELEVANT PRODUCT IS NOT ESTABLISHED IN THE
PHILIPPINES, THE IMPORTER OF THAT PRODUCT SHOULD BEAR
THE RESPONSIBILITIES RELATING TO THE COMPLIANCE OF
THOSE PRODUCTS WITH THIS ACT.

MANUFACTURERS AND IMPORTERS OF ELECTRONIC
CIGARETTES AND REFILL CONTAINERS SHALL SUBMIT A
NOTIFICATION TO THE FDA (FOR REGULATION PURPOSES) AND
THE DTI (FOR COMMERCIAL PURPOSES) OF ANY SUCH
PRODUCTS WHICH THEY INTEND TO PLACE ON THE MARKE’
THE NOTIFICATION SHALL BE SUBMITTED IN ELECTRONIC
FORM SIX MONTHS BEFORE THE INTENDED PLACING ON THE
MARKET. FOR ELECTRONIC CIGARETTES AND REFILL
CONTAINERS ALREADY PLACED ON THE MARKET BEFORE THE
EFFECTIVITY OF THIS PROVISION, THE NOTIFICATION SHALL BE
SUBMITTED WITHIN SIX MONTHS OF THAT DATE. A NEW
NOTIFICATION SHALL BE SUBMITTED FOR EACH SUBSTANTIAL
MODIFICATION OF THE PRODUCT, THE NOTIFICATION SHALL,
DEPENDING ON WHETHER THE PRODUCT IS AN ELECTRONIC
CIGARETTE OR A_ REFILL CONTAINER, CONTAIN THE
FOLLOWING INFORMATION:

(A) THE NAME AND CONTACT DETAILS OF THE
MANUFACTURER, A RESPONSIBLE LEGAL OR NATURAL PERSON
WITHIN THE PHILIPPINES, AND, IF APPLICABLE, THE IMPORTER
INTO THE PHILIPPINES;

(B) A LIST OF ALL INGREDIENTS CONTAINED IN, AND
EMISSIONS RESULTING FROM THE USE OF, THE PRODUCT, BY
BRAND NAME AND TYPE, INCLUDING QUANTITIES THEREOF;

(C) TOXICOLOGICAL DATA REGARDING THE PRODUCT'S
INGREDIENTS AND EMISSIONS, INCLUDING WHEN HEATED,
REFERRING IN PARTICULAR TO THEIR EFFECTS ON THE HEALTH
OF CONSUMERS WHEN INHALED AND TAKING INTO ACCOUNT,
INTER ALIA, ANY ADDICTIVE EFFECT;

(D) INFORMATION ON THE NICOTINE DOSES AND UPTAKE
WHEN CONSUMED UNDER NORMAL OR REASONABLY
FORESEEABLE CONDITIONS;

(E) A DESCRIPTION OF THE COMPONI OF THE
PRODUCT; INCLUDING, WHERE APPLICABLE, THE OPENING AND

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REFILL MECHANISM OF THE ELECTRONIC CIGARETTE OR
REFILL CONTAINERS;

(F) A DESCRIPTION OF THE PRODUCTION PROCESS,
INCLUDING WHETHER IT INVOLVES SERIES PRODUCTION, AND A
DECLARATION THAT THE PRODUCTION PROCESS ENSURES
CONFORMITY WITH THE REQUIREMENTS OF THIS ARTICLE;

(G) A DECLARATION THAT THE MANUFACTURER AND
IMPORTER BEAR FULL RESPONSIBILITY FOR THE QUALITY AND
SAFETY OF THE PRODUCT, WHEN PLACED ON THE MARKET AND
USED UNDER NORMAL OR REASONABLY FORESEEABLE
CONDITIONS,

NICOTINE-CONTAINING LIQUID SHOULD ONLY BE
ALLOWED TO BE PLACED ON THE MARKET WHERE THE
NICOTINE CONCENTRATION DOES NOT EXCEED 20 MG/ML. THIS
CONCENTRATION ALLOWS FOR A DELIVERY OF NICOTINE THAT
IS COMPARABLE TO THE PERMITTED DOSE OF NICOTINE
DERIVED FROM A STANDARD CIGARETTE DURING THE TIME
NEEDED TO SMOKE SUCH A CIGARETTE. IN ORDER TO LIMIT THE
RISKS ASSOCIATED WITH NICOTINE, MAXIMUM SIZES FOR
REFILL CONTAINERS, TANKS AND CARTRIDGES SHOULD BE SET
BY THE FDA.

ONLY E-CIGARETTES THAT DELIVER NICOTINE DOSES AT
CONSISTENT LEVELS SHOULD BE ALLOWED TO BE PLACED ON
THE MARKET UNDER THIS ACT. DELIVERY OF NICOTINE DOSES
AT CONSISTENT LEVELS UNDER NORMAL CONDITIONS OF USE IS
NECESSARY FOR HEALTH PROTECTION, SAFETY AND QUALITY
PURPOSES, INCLUDING TO AVOID THE RISK OF ACCIDENTAL
CONSUMPTION OF HIGH DOSES.

E-CIGARETTES AND REFILL CONTAINERS COULD CREATE
A HEALTH RISK WHEN IN THE HANDS OF CHILDREN.
THEREFORE, IT IS NECESSARY TO ENSURE THAT SUCH
PRODUCTS ARE CHILD- AND TAMPERPROOF, INCLUDING BY
MEANS OF CHILD-PROOF LABELLING, FASTENINGS AND
OPENING MECHANISMS.”

SEC. 17. Sunset Review. — As the need arises or within five (5) years after its effectivity,
the Congressional Oversight Committee shall conduct a sunset review of this Act. The term

“Sunset Review” shall mean a systematic evaluation of the accomplishments and impact of this

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Act as well as the performance and organizational structures of the implementing agencit

purpose of determining remedial legislation.

SEC. 18. Separability Clause. ~ If any provisions of this Act shall be held
unconstitutional or invalid, the other provisions not otherwise affected shall remain in full force

and effect.

\ SEC. 19. Repealing Clause. — All laws, executive orders, rules and regulation
inconsistent with or contrary to this Act, are hereby deemed accordingly repealed or amended.

SEC. 20. Effectivity Claus

publication in at least two (2) newspaper of national circulation.

This act shall take effect after fifteen (15) days from its

Approved,

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