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

EIGHTEENTH CONGRESS
First Regular Session

2862

House Bill No.

Introduced by Representatives Ron P. Salo and Juan Fidel F. Nograles

EXPLANATORY NOTE

Electronic cigarettes are a rapidly emerging and diversified product class that typically
deliver nicotine via an inhaled aerosol. They have become an increasingly popular choice among
smokers, either on the assumption that such products pose less risk to conventional smoking-
related diseases. It is marketed as a way to stop or cut down on smoking and provides a similar
sensation to inhaling tobacco smoke.

The impact of e-cigarettes on public health, however, remains 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 effects associated with their long-term use, as well as their potential to act as a
gateway to smoking among the youth.

As it stands today, there are already many e-cigarette users among our countrymen. Thus,
there is a cause for concern because it is still unregulated. E-cigarettes are not regulated in the
same manner as tobacco products because they do not contain tobacco- therefore falling outside
the ambit of the Tobacco Regulation Act. E-cigarettes are accessible to anyone who wishes to
use them, including minors.

In line with the policy of the State to protect and promote the right to health of the people
and instill health consciousness among them, this bill seeks to regulate the sale, distribution and
manufacture of e-cigarettes and similar devices. This will protect not only the welfare of the users,
but most especially the general public.

The proposed measure requires producers to register their e-cigarette products with the
Department of Trade and Industry prior to market placement to ensure that such products have
sufficiently passed quality and safety requirements and avoid untoward incidents to consumers
during use. Health warning is likewise mandated on nicotine containers of these products.

In view of the foregoing, the immediate passage of this Bill is earnestly sought.

Cu Z Ih Sag
RON P. SALO JUAN FIDEL F. FRALES
KABAYAN Partylist 2™ District, Rizal

Page 1 of 6


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

EIGHTEENTH CONGRESS
First Regular Session

House Bill No, 2862

Introduced by Representatives Ron P. Salo and Juan Fidel F. Nograles

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”.

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. Definitions. — As used in this Act, the following terms shall mean:

a) “E-cigarette" refers to a product that can be used for the consumption of a
nicotine-containing vapor;

b) "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;

d) "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;

Page 2 of 6


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 electronic 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;

i) "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, present, 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

|) "Vaping” shalll refer to the act of using an e-cigarette.

SEC. 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.

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

a) The sale, distribution, or transfer of 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

Page 3 of 6


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.

SEC. 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 IS UNLAWFUL" or "IT IS UNLAWFUL FOR E-CIGARETTES TO BE
SOLD/DISTRIBUTED TO OR PURCHASED BY PERSONS UNDER 18 YEARS OF
AGE".

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

SEC. 8. Product Communication Restrictions. — Advertisements shall be
allowed in retailer establishment, 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.

SEC. 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 or subscriber base.

SEC. 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."

SEC. 11. 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 5ml;

b) The maximum volume of nicotine-containing e-liquid for sale in one refill
container shall be limited to 30m;

c) E-liquids shall have a nicotine strength of no more than 20mg/mi;

d) Nicotine containers shall be child-resistant and tamper evident;

Page 4 of 6


e)

9)

hy

SEC.

following:

a)

b)

°)

Producers of electrical devices intended to be used in combination with an
e -cigarette shall ensure that such devices comply with 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;

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

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

12. Market Placing. — Producers and distributors must comply with the

Producers must submit information about their products to the DTI;

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;

This Act shall not cover nicotine-containing products that are authorized as
medicines and those that have health claims; d. Producers shall have six
months to register their products with the DTI and submit information
demonstrating compliance with product standards and assessment
requirements.

SEC. 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:

Page 5 of 6


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 (PhP 100,000.00); and

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 on 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 and/or payment of applicable fines without need of further deportation
proceedings and shall be permanently barred from re-entering the Philippines

SEC. 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 of the introduction of new e-cigarettes in the market.

SEC. 15. Separability Clause. — Should any provision herein be declared
unconstitutional, the same shall not affect the validity of the other provisions of this Act.

SEC. 16. Repealing Clause. — All laws, decrees, orders, rules, and regulations or
other issuances or parts inconsistent with the provisions of this Act are hereby repealed,
amended, or modified accordingly.

SEC. 17. Effectivity Clause. - This Act shall take effect in fifteen (15) days after
Publication in the Official Gazette or in one (1) newspaper of general circulation in the
Philippines.

Approved.

Page 6 of 6


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

EIGHTEENTH CONGRESS
First Regular Session

House Bill No._ 2862
——$ eee
Introduced by Representatives Ron P. Salo and Juan Fidel F. Nograles
a
EXPLANATORY NOTE

Electronic cigarettes are a rapidly emerging and diversified product class that typically
deliver nicotine via an inhaled aerosol. They have become an increasingly popular choice among
‘smokers, either on the assumption that such products pose less risk to conventional smoking-
related diseases. It is marketed as a way to stop or cut down on smoking and provides a similar
sensation to inhaling tobacco smoke.

The impact of e-cigarettes on public health, however, remains 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 effects associated with their long-term use, as well as their potential to act as a
gateway to smoking among the youth.

As it stands today, there are already many e-cigarette users among our countrymen. Thus,
there is a cause for concer because it is still unregulated. E-cigarettes are not regulated in the
same manner as tobacco products because they do not contain tobacco- therefore falling outside
the ambit of the Tobacco Regulation Act. E-cigarettes are accessible to anyone who wishes to
use them, including minors.

In line with the policy of the State to protect and promote the right to health of the people
and instill health consciousness among them, this bill seeks to regulate the sale, distribution and
manufacture of e-cigarettes and similar devices. This will protect not only the welfare of the users,
but most especially the general public.

The proposed measure requires producers to register their e-cigarette products with the
Department of Trade and Industry prior to market placement to ensure that such products have
sufficiently passed quality and safety requirements and avoid untoward incidents to consumers
during use. Health warning is likewise mandated on nicotine containers of these products.

In view of the foregoing, the immediate passage of this Bill is earnestly sought.

Gu é; ditdh Sag
RON P. SALO JUAN FIDEL F. NOGRALES
KABAYAN Partylist 2° District, Rizal

Page 1 of 6


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

EIGHTEENTH CONGRESS
First Regular Session

House Bill No. Oa

Introduced by Representatives Ron P. Salo and Juan Fidel F. Nograles

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”.

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. Definitions. — As used in this Act, the following terms shall mean:

“E-cigarette" refers to a product that can be used for the consumption of a
nicotine-containing vapor;

z=

"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;

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

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

Page 2 of 6


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 electronic 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;

i) "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, present, 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

|) "Vaping" shall refer to the act of using an e-cigarette.

SEC. 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.

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

a) The sale, distribution, or transfer of 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

Page 3 of 6


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.

SEC. 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 IS UNLAWFUL" or "IT IS UNLAWFUL FOR E-CIGARETTES TO BE
SOLD/DISTRIBUTED TO OR PURCHASED BY PERSONS UNDER 18 YEARS OF
AGE".

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

SEC. 8. Product Communication Restrictions. — Advertisements shall be
allowed in retailer establishment, 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.

SEC. 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 or subscriber base.

SEC. 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."

SEC. 11. 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 5ml;

b) The maximum volume of nicotine-containing e-liquid for sale in one refill
container shall be limited to 30ml;

c) E-liquids shall have a nicotine strength of no more than 20mg/ml;

d) Nicotine containers shall be child-resistant and tamper evident;

Page 4 of 6


e)

9)

h)

Producers of electrical devices intended to be used in combination with an
e -cigarette shall ensure that such devices comply with 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;

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

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

SEC. 12. Market Placing. — Producers and distributors must comply with the

following:

a)
b)

¢)

Producers must submit information about their products to the DTI;

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;

This Act shall not cover nicotine-containing products that are authorized as.
medicines and those that have health claims; d. Producers shall have six
months to register their products with the DTI and submit information
demonstrating compliance with product standards and assessment
requirements.

SEC. 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:

Page 5 of 6


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 (PhP 100,000.00); and

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 on 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 and/or payment of applicable fines without need of further deportation
proceedings and shall be permanently barred from re-entering the Philippines

SEC. 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 of the introduction of new e-cigarettes in the market.

SEC. 15. Separability Clause. - Should any provision herein be declared
unconstitutional, the same shall not affect the validity of the other provisions of this Act.

SEC. 16. Repealing Clause. — All laws, decrees, orders, rules, and regulations or
other issuances or parts inconsistent with the provisions of this Act are hereby repealed,
amended, or modified accordingly.

SEC. 17. Effectivity Clause. - This Act shall take effect in fifteen (15) days after
Publication in the Official Gazette or in one (1) newspaper of general circulation in the
Philippines.

Approved.

Page 6 of 6