Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

House Bill No, _ 500

Introduced by Representative ROBERT ACE S. BARBERS

Explanatory Note
AN ACT REGULATING ELECTRONIC CIGARETTES

An electronic cigarette or e-cigarette is marketed as a way to stop or cut down on
smoking. It is a battery-operated device that emits doses of vaporized nicotine, on non-
nicotine solutions, for the user to inhale. It provides a similar sensation to inhaling
tobacco smoke.

The impact of e-cigarettes on public health is unclear. Science and public policy have
bounced back and forth for over a decade, as different studies produce different—and
sometimes contradictory—results. It is surrounded by debate, focusing on the lack of
evidence regarding the harm associated with their long-term use, as well as their
potential to act as a gateway to smoking among teens

This gives rise to the concer of lack of regulation over e-cigarettes and similar devices.
E-cigarettes are not regulated in the same manner as tobacco products because they do
not contain tobacco—thus falling outside the ambit of the Tobacco Begulation Act. Thus,
e-cigarettes are accessible to anyone who wishes to use them—jrCluding minors.

In line with the policy of the State to protect and promote the pight to haalth of the people
and instill health consciousness among them, this bill speks to regulate the sale,

2" \istrict| Surigao del Norte


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

House Bill No:__509

Introduced by Representative ROBERT ACE S. BARBERS

AN ACT REGULATING ELECTRONIC CIGARETTES

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

2018"

SECTION 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.

SECTION 3. Definition of Terms. As used in this Act, the following terms shall mean:

a

b.

c.

d.

“E-cigarette” refers to a product that can be used for the consumption of a
nicotine-containing vapour,

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

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

“Nicotine mixture” means the nicotine-containing liquid, solid or other non-
tobacco substance in the product;

“Refill container” means a container for holding nicotine mixture to refill certain
e-cigarettes;

“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;

. “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;

._ “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;

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

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

“Advertising” shall refer to the business of conceptualizing, presenting, making
available and communication 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;

|. “Vaping” shall refer to the act of using an e-cigarette

SECTION 4. Health Warnings. Only nicotine containers shall bear textual health
warnings with the following warning: “This product may damage your health and is
addictive.”

The health warning shall occupy 30% of the lower part of the principal display
surface of the nicotine container. No other health warning shall be required for e-
cigarette products.

SECTION 5. Minimum Age Sales and Purchase. The following acts shall be
prohibited:

a. The sale, distribution, or transfer or e-cigarettes by any person to minors (anyone
below 18 years old);

b. Purchasing, or otherwise receiving e-cigarettes from a minor;

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

It shall not be a defense for the person selling or distributing that he/she did not know
or was not 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 product was for the consumption of
the minor to whom it was sold.

SECTION 6. Retailer Signage. Producer establishments offering, distributing, or selling
e-cigarettes to consumers shall post the following statement in a clear and conspicuous
manner: “SALE/DISTRIBUTION TO OR PURCHASE BY MINORS OF E-CIGARETTES
1S UNLAWFUL" or “IT IS UNLAWFUL FOR E-CIGARETTES TO BE
SOLD/DISTRIBUTED TO OR PURCHASED BY PERSONS UNDER 18 YEARS OF
AGE”

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

SECTION 8. Product Communication Restrictions. Advertisements shall be allowed
in retailer establishments, through direct marketing, and on the internet. These shall not
be aimed at or particularly appeal to persons under eighteen (18) years of age. These
should not undermine quit-smoking messages and encourage non-tobacco or nicotine
users to use the product. These should not contain any information that is untrue or not
scientifically substantiated, in particular with regards to product characteristics, health
effects, risks or emissions.

SECTION 9. Restrictions on Advertisement in Print Media. Advertising and other
promotional communications of e-cigarettes shall be permitted so long as the publication
is not intended for minors and generally has an adult readership of subscriber base.

SECTION 10. Public Place Use. Use of e-cigarettes indoors is prohibited in schools,
hospitals, government offices, and facilities intended particularly for minors. In all other
enclosed places open to the general public, e-cigarette use shall be allowed, provided


that the owner of such places shall post the following statement in a clear manner at
every entrance point of such places: “USE OF E-CIGARETTES IS ALLOWED INSIDE.”
For places that do not allow e-cigarette use indoors, the owner of such places shall post
the following statement at every entrance: “NO VAPING INSIDE.”

SECTION 11. Product Standard Requirements. The following shall be required for all
e-cigarettes sold in the Philippines:

a.
b,

c

go

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

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

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

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;

|. 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;

A full list of ingredients in the flavoring must be included in notifications through
the DTI;

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;

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;

All e-cigarettes and e-liquids shall be notified to the Department of Trade and
Industry before they can be sold in the market.

SECTION 12. Marketing Placing. Producers and distributors must comply with the

following:

a. Products must submit information about their products to the DTI;

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

c. This Act shall not cover nicotine-containing products that are authorized as
medicines and those that have health claims;

d. 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;


e. 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.

SECTION 13. Penalties for Noncompliance. 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
(P50,000.00);

b. On the second offense, a fine of not more than ONE HUNDRED THOUSAND
PESOS (P100,000.00),

c. On the third offense, a fine of not more than FIVE HUNDRED THOUSAND
PESOS (P500,000.00) 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-complaint 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
and/or payment of applicable fines without need of further deportation proceedings and
shall be permanently barred from re-entering the Philippines.

SECTION 14. 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.

SECTION 15. 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.

SECTION 16. Repealing Clause. Any law, presidential decree or issuance, executive
order, letter of instruction, administrative order, rule or regulation contrary to or is
inconsistent with the provision of this Act is hereby repealed, modified, or amended
accordingly

SECTION 17. Effectivity Clause. This Act shall take effect fifteen (15) days after its
publication in at least two (2) newspapers of general circulation.

Approved.