RECEIVED
pare,OCT_0 2 2019

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

EIGHTEENTH CONGRESS
First Regular Session

5072

House Bill No.

Introduced by Representative GERALDINE B. ROMAN

EXPLANATORY NOTE

‘The Philippine Constitution provides that the State shall protect and promote
the right to health of the people and instill health consciousness among them, The
Constitution further states that the State shall promote the general welfare and mandates that
the State adopt an integrated and comprehensive approach to health development. As a
result, the State has an interest in protecting citizens from hazardous products.

In the recent months, several news items have been published on deaths and various
serious illnesses that have been linked to smoking e-cigarettes, U.S. health officials through
CNN have announced recently that they are now aware of at least 450 possible cases of
severe lung diseases and several deaths that could be caused by vaping. There are many
similar reports in many countries all over the world.

Although the original intention of e-cigarettes was to provide an alternative to
tobacco smoking, pulmonary experts here and abroad have now come out in the open
advocating the banning of the advertisement, sale, and use of e-cigarettes. Health experts
declare that these e-cigarettes contain harmful and toxic chemicals that have led to serious
pulmonary problems and even deaths. Vaping patients have landed in in the Intensive Care
Units of hospitals needing intubation and mechanical support to breathe. Even those who
appeared young and healthy suffered shortness of breath, asthma, gastrointestinal symptoms,
and all had general symptoms of fever, fatigue and weight loss. Lung scans showed
“different mechanisms of injury.” Lipoid pneumonia cases linked to vaping have also been
reported,

A major area of concern in our country is the youth who are attracted to these
smoking devices because of the various flavors that are offered and inviting packaging.
Because of easy access and peer influence, smoking e-cigarettes is now very popular even
among Filipino teenagers and college students. There are even sightings of pre-teens
vaping. For them, e-cigarettes are harmless because this is what they have been told. For
the older ones, vaping isthe _—safest_— substitute for smoking.


‘he public must be informed of the dangers of smoking e-cigaretes. The State must also
provect the Public from harmful products. Accordingly, I eamestly seek the immediae
Pissage OF this Bill to regulate the use, sale, distribution, labeling, and advertisement of =

cigarettes.
(SRV ILO» Ae
GERALDINE B. ROMAN


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

EIGHTEENTH CONGRESS
First Regular Session

House Bill No,_ 5072

Introduced by Representative GERALDINE B. ROMAN

AN ACT
REGULATING THE PACKAGING, USE, SALE, DISTRIBUTION,
LABELING, AND ADVERTISEMENT OF ELECTRONIC CIGARETTES
AND FOR OTHER PURPOSES

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

SECTION 1. Short Title. - This Act shall be known as the “E-Cigarette Regulation Act
of 2019",

SEC. 2. Declaration of Policy. - It is hereby declared the policy of the State to protect
and promote the right to health of the people and instill health consciousness among them.

SEC. 3. Definition of Terms. - As used in this Act, the following terms shall be
defined in the matter set forth below:

a. E-cigarettes, also known as electronic cigarettes, e-vaporizers, or electronic nicotine
delivery systems, are battery-operated devices that people use to inhale an aerosol,
which typically contains nicotine (though not always), flavorings, and other chemicals.
They can resemble traditional tobacco cigarettes(cig-a-likes), cigars, or pipes, or even
everyday items like pens or USB memory sticks. Some common nicknames for e-

cigarettes are:


e-cigs
e-hookahs

hookah pens

vapes

vape pens

mods (customizable, more powerful vaporizers)

b. Ingredient means any substance that is added to the mixture and present in the
finished product;

c. Nicotine means nicotinic alkaloids, including any salt or complex of nicotine,
whether derived from tobacco or synthetically produced;

d. Nicotine mixture means the nicotine-containing liquid, solid or other non-tobacco
substance in the product; it is also sometimes called liquid solution (e-liquid or e-juice)
which is a solution containing varying amounts of nicotine, flavorings, and other
chemicals;

©. Refill container means a container, a cartridge or reservoir for holding nicotine
mixture or liquid solution (e-liquid or e-juice) to refill certain e-cigarettes;

f. Emissions means substances that are released when a product is consumed as
intended, such as substances found in cigarette smoke, or the aerosol generated by an
e-cigarette;

g. Package shall refer to packs, boxes, cartons or containers of any kind in which the
electric component of an e-cigarette is offered for sale to consumers;

h. Nicotine container shall refer to bottles, boxes, cartons, or containers of any kind in
which a nicotine-containing product is offered for sale to consumers for use with an e-

cigarette product system;

i, Producer shall refer to any location at which an individual can purchase or
otherwise obtain e-cigarette products;


j, Principal display surface shall refer to the panel of the nicotine container that faces
the consumer when displayed for sale;

k. Advertising shall refer 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 consumer
products, services, or credit. For the purpose of this Act, advertising shall be
understood as e-cigarette advertising; and

1. Vaping shall refer to the act of using an e-cigarette.
SEC. 4. Health Warnings. - Nicotine containers and packages of e-cigarettes shall

bear graphic health warnings that shall have two (2) components: photographic picture
warnings and textual warnings, The textual health warnings shall bear the following:

product is dangerous to your health and is addictive.”

The health warnings shall occupy 30% of the lower part of the principal display
surface of the nicotine containers and packages of _—_e-cigarettes,

SEC. 5. Minimum Age Sales and Purchases. - The following acts shall be prohibited:
a. The sale, distribution, or transfer of e-cigarettes by any person to minors;

b. Purchasing, or otherwise receiving e-cigarettes from minors; and

. The sale, purchase, and use of e-cigarettes by minors.

It shall not be a defense for the person selling or distributing that the seller or
distributor did not know or was not aware of the real age of the minor. Neither shall it be a
defense that the seller or distributor did not know nor had any reason to believe that the

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


SEC. 6, Retailer Signage. - Establishments offering, distributing, or selling e-
cigarettes to consumers shall post the following statement in a clear and conspicuous
manner; "THE SALE AND DISTRIBUTION TO OR PURCHASE BY MINORS OF E-
CIGARETTES IS UNLAWFUL" or "IT IS UNLAWFUL FOR E-CIGARETTES TO BE
SOLD AND DISTRIBUTED TO OR PURCHASED BY PERSONS UNDER 18 YEARS
OLD".

SEC. 7. Proof of Age Verification. - Retailers shall ascertain that no individual
purchasing an e-cigarette is below eighteen (18) years old.

SEC. 8. Access Restriction.-The sale or distribution of e-cigarette products is
prohibited within one hundred (100) meters from any point of the perimeter of a school,
playground or other facility frequented by minors.

SEC. 9. Product Communication Restrictions. - The following restrictions shall apply
to all e-cigarette advertising:

a. Advertisements shall not be aimed at or particularly appeal to persons under

eighteen (18) years old.

b, Advertisements shall not feature a celebrity or contain an endorsement, implied or

express by a celebrity,

c. Advertisements shall not contain cartoon characters or subjects that depict humans
or animals with comically exaggerated features or that attribute human or unnatural

characteristics to animals, plants or other objects.

d. Advertisements shall not show, portray or depict scenes where the actual use of, or

the act of using, or puffing e-cigarettes is presented to the public.


SEC. 10. Restrictions on Advertisement in Print Media. The following restrictions
shall apply to all print media e-cigarette advertisements:

a. Advertisements shall not be placed in any printed publication unless there is a

reasonable basis to believe that at least seventy-five percent (75%) of the readers of
such publication are eighteen (18) years of age and above, and the number of youth
who read it constitutes less than ten percent (10%) of all youth in the Philippines.

b. Advertisements shall not be placed on the packaging or outside covers (front and
back) of a magazine, newspaper, journal or other publication printed for general
circulation

SEC. 11. Restrictions on Outdoor Advertising — The following restrictions shall apply
to all e-cigarette advertisements:

a. Outdoor advertisements shall not be placed on billboards, wall murals, or ‘transport
Stops or stations which are within the one hundred (100) meters from any point of the

Perimeter of a school, public playground or other facility frequented particularly by

persons below eighteen (18) years of age.

b. Outdoor advertisements shall not be placed on taxis, buses, trains or other public
conveyance or in stations, terminals or platforms thereof, except point-of-sale

establishments.

SEC. 12, Restrictions on Advertising in Cinemas. - E-cigarette advertisements are
Prohibited in connection with the showing of any film where persons below eighteen (18)

years old are permitted admission.


SEC. 13. Restrictions on Television. — Advertisements shall not be broadcast on
television, cable television, and radio between seven o'clock in the morning and seven o'
clock at night.

SEC. 14. Restriction on Advertising in Audio, Video and Computer Cassettes/discs
and Similar Medium. —No electronic advertisements shall be incorporated within any video
or audio cassette, videogame machine, optical disc or any similar medium, unless access to
the item is restricted to persons eighteen (18) years of age or older. For the purpose of this
Section, video game includes any electronic amusement device that utilizes a computer,
microprocessor, or similar electronic circuitry and its own cathode ray tube, or is designed to

be used with a television set or monitor that interacts with the user of the device.

SEC. 15. Restrictions on Advertising on the Internet and Similar Medium. -
Advertisements are prohibited on the internet and other similar medium unless that Internet
site is restricted to persons eighteen (18) years of age or older. A site will be deemed
restricted if a person cannot obtain access beyond the first page of the website unless the
person has established that he or she is at least eighteen (18) years old. This Section shall
prohibit business-to-business transactions conducted on the Internet, and other similar

medium between e-cigarette manufactures, retailers and distributors.

SEC. 16. Ban on Advertisements. - Implementing Rules and Regulations shall be
issued to absolutely prohibit all e-cigarette advertising on television, cable television and
radio. Implementing Rules and Regulations shall also be issued to absolutely prohibit all
cinema and outdoor e-cigarette advertising. No leaflets, posters and similar outdoor
advertising materials shall be posted, except inside the premises of point-of-sale retail
establishments. Implementing Rules and Regulations shall also be issued that will absolutely
prohibit all forms of e-cigarette advertising in mass media except those advertisements

placed inside the premises of point-of sale establishments.


SEC. 17. Restrictions in Public Conveyances and Places. -Vaping ot use of ¢
cigarettes is prohibited in all forms of public conveyances, government-owned vehicles,
accommodations and entertainment establishments, workplaces, enclosed or partially
enclosed public places, public buildings and public outdoor spaces, except in duly
designated vaping areas, as will be defined in the Implementing Rules and Regulations.

SEC. 18. Product Standard Requirements. - The following shall be required for all e-
cigarettes sold in the Philippines:

a. E-cigarette tanks shall have a capacity of no more than 5 ml;

b. The maximum volume of nicotine-containing e-liquid for sale in one refill container
shall be limited to 10 ml;

¢. E-liquids used for refill containers shall have a nicotine strength of no more than 20
mg/ml;

d. E-cigarette containers/Nicotine containers shall be child- resistant and tamper
evident;

€. Producers of electrical devices intended to be used in combination with an e
cigarette shall ensure that such devices comply with the applicable electrical safety
standards as may be determined by the Bureau of Product Standards of the Department
of Trade and Industry;

£. Batteries must comply with applicable industry requirements as may be determined
by the Bureau of Product Standards of the Department of Trade and Industry;

g. All ingredients in the product should be listed on the label where they are used in
quantities of 0.1 % or more of the final formulation of the e-liquid. Where a flavor
ingredient contains several component chemicals, it can be described on the label by
the name of the flavor. For confidentiality reasons, companies may choose to describe
individual ingredients used in quantities below 0.1 % of the final formulation by
category;

h. A full list of ingredients in the flavoring must be included in the notifications
through the DTI,


i. Nicotine, propylene glycol and glycerol used in the manufacture of the e-liquids
shall meet the requirements of either the European or American Pharmacopoeia and
other ingredients in the manufacture of the e-liquids, such as flavors, shall be of food
grade; and

j. Packs shall include an information leaflet about safe use of the product. This shall
also include appropriate advice on product storage, particularly on how to ensure the
battery does not malfunction.

SEC.19. Market Placing. - Producers and distributors must comply with the
following:

a. E-cigarette producers shall register their products with the DTI and submit
information demonstrating compliance with product standards and assessment
requirements before all e-cigarettes and e-liquids can be sold in the market;

b. E-cigarette retailers do not need to submit information for any products they sell
unless they also qualify as producers. Retailers shall have six (6) months from the
date of effectivity of this Act to sell through the stock of e-cigarette products that do
not comply with the labeling, and product composition requirements of this Act; and

¢. A new notification shall be submitted for each substantial modification of the
product, such as, but not limited to new ingredients introduced in e-liquids.

SEC. 20. Penalties for Non-Compliance. - The following penalties shall individually
apply to producers, importers, distributors, and sellers of e-cigarettes as well as their
agents for any violation of this Act:

a. On the first offense, a fine of not more than Fifty thousand pesos (Php 50,000.00);

b. On the second offense, a fine of not more than One hundred thousand pesos (Php
100,000.00);

c. On the third offense, a fine of not more than Five hundred thousand pesos (Php
500,000.00) or imprisonment of not more than five (5) years, or both, at the
discretion of the court: Provided, That the business permits and licenses, in the case
of a business entity or establishment shall be revoked or cancelled.


Non-compliant e-cigarettes found in the market for sale or distribution shall be subject to
confiscation.

If the guilty officer is a foreign national, he shall be deported after service of
sentence or payment of applicable fines without need of further deportation proceedings and
shall be permanently barred from re-entering the Philippines

SEC. 21. Implementing Rules and Regulations. - Within three (3) months from the
date of effectivity of this Act, the DTI shall issue the Implementing Rules and Regulations
for this Act. The non-issuance of the IRR will not suspend the effectivity of this Act or the
introduction of new e-cigarettes in the market.

SEC. 22. Separability Clause. - If any provision or part hereof is held invalid or
unconstitutional, the remainder of the law or the provision not otherwise affected shall
remain valid and subsisting

SEC. 23. Repealing Clause. - Any law, presidential decree or issuance, executive
order, letter of instruction, administrative order, rule or regulation contrary to or inconsistent
with the provisions of this Act is hereby repealed, modified, or amended accordingly.

SEC. 24. Effectivity Clause. - This Act shall take effect fifteen (15) days after its
complete publication in the Official Gazette or in two (2) newspapers of general circulation.

Approved,