Republic of the Philippines
HOUSE OF REPRESENTATIVES

Quezon City

EIGHTEENTH CONGRESS.
First Regular Session

HOUSE BILL No. !793

Introduced by HONORABLE LUIS RAYMUND F. VILLAFUERTE, JR.

EXPLANATORY NOTE

The passage of the Sin Tax Reform Law substantially raised excise taxes on tobacco
products, intending to lower the smoking rate in the country. This prompted a
number of smokers to switch to e-cigarettes, or "vaping", on the assumption that it is
less harmful than smoking. E-cigarettes use battery power to ignite an electric coil,
juice" and generate the vapor that the

heat liquid in small juice, commonly called "e
user inhales. The solution of the e-juice is usually composed of propylene glycol,

glycerol, and food grade flavor. It also contains nicotine, albeit in smaller amounts

than regular cigarettes.

The rise of e-cigarettes in the country is fairly young, but the Department of Health
has recognized its popularity and issued and Administrative Order mandating all
manufacturers or distributors of vapes to apply for a Certificate of Product
Registration with the Food and Drug Administration. As of June 2018, nobody has yet
applied 'and the debate on its effects. whether harmful or otherwise, is still ongoing.
However, steps must be taken to ensure that the e-cigarette products being sold in
the market poses no threat to public health and safety.

This bill intends to require producers to follow the product standard requirements in
order to register their e-cigarette products with the Department of Trade and
Industry to ensure that the products have passed quality and safety standards. The

bill also


hitps://www. philstar.com/nation201 8106/0 I / 1 820466 'Illa-no-e-ciuarettes-registered-philippines
proposes to prohibit the sale and distribution of such products to anyone below 18
years old and require buyers to present a proof of age.

Further, this bill intends to ensure that the public is well-informed of the products
they are exposed to with health warnings on nicotine containers and a restriction on
advertisement in print media. Use of e-cigarettes indoors is prohibited in most
establishments, or otherwise shall bear clear signage of its allowed use.

The approval of this bill is earnestly sought.

Ly) D F. VILLAFUERTE, JR.


Republic of the Philippines
HOUSE OF REPRESENTATIVES

Quezon City

EIGHTEENTH CONGRESS
First Regular Session

HOUSE BILL No. 1703

Introduced by HONORABLE LUIS RAYMUND F. VILLAFUERTE, JR.

AN ACT
REGULATING ELECTRONIC CIGARETTES

Be it enacted by the Senate and 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. 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 nontobacco
substance in the product;

e. ‘Refill container’ means a container for holding nicotine mixture 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 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;

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, 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;

|. "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 warming: "This product may damage your health and is
addictive.

The health warning shall occupy 30% of the lower pan of the principal display surface

of the nicotine container. No other health waming shall be required for ecigarette
products

SECTION 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 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 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.

SECTION 8. 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.

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 the such places: "USE OF ECIGARETTES 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, E-cigarette tanks shall have a capacity of no more than ml,
b. The maximum volume of nicotine-containing e-liquid for sale in one refill
container shall be limited to 30m; ¢, E-liquids shall have a nicotine strength of no
more than 20mg/ml;
d. Nicotine containers shall be child-resistant end tamper evident,
€, 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


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

8. 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 notifications through
the DTI;

i, Packs shalll 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:

j. 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. market Placing. — Producers and distributors must comply with the
following

a. Producers 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 have six months to register their products with the DTI and

submit information demonstrating compliance with product standards and
assessment requirements.

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

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

SECTION 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.

SECTION 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,