Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

HOUSE BILL No. _ 3049

Introduced by: Hon. Angelina "Helen" D.L. Tan, MD.

AN ACT
PROVIDING REGULATIONS IN THE PACKAGING, USE, SALE, DISTRIBUTION AND
ADVERTISEMENTS OF ELECTRONIC NICOTINE DELIVERY SYSTEMS AND ELECTRONIC NON-
NICOTINE DELIVERY SYSTEMS (ENDS/ENNDS) AND HEATED TOBACCO PRODUCTS (HTPs) ; ~

EXPLANATORY NOTE

Electronic Nicotine and Non-Nicotine Delivery Systems (ENDS/ENNDS) and Heated Tobacco
Products (HTPs) are rapidly emerging and diversified product class that typically deliver nicotine via sy
inhaled aerosol.

These products have become an increasingly popular choice among smokers, either on the
assumption that such products pose less risk to conventional smoking-related diseases or that such
Products are smoking cessation aids. However, they are not completely harm-free. These products emit

Potentially harmful toxicants in the vapor if expressed at high levels.

The seventh World Health Organization (WHO) Report on the Global Tobacco Epidemic, 2019
has recently warned that “ENDS pose risks to users and non-users", while “HTPs produce toxic
emissions, many of which are similar to toxicants found in cigarette smoke” and must therefore be

AAs they are designed to mimic conventional cigarette smoking, initiation of non-smokers,
especially the youth, to nicotine-dependency is a cause for concem. The use of products containing
nicotine poses potential harm to youth with its addictive and teratogenic properties. Immediate action
therefore must be taken at the national level to prevent access to what is commonly referred to as

10 attract minors. This will take the form of restricting age sales, prohibiting minor use, and policing
marketing rules to ensure that promotions do not target minors as well as undermine smoking cessation
messages.

More importantly, it prohibits the use of e-cigarettes in all public places and provides regulation
on the sale distribution, and advertising of these products. This move is imperative in the face of reports
of exploding batteries or defective electrical system which need to be addressed.

This bill will require ENDS/ENNDS and HTPs manufacturers, distributors, importers, exporters,
and sellers to register with the Food and Drug Administration prior to market placement to ensure that
such products have sufficiently passed quality and safety requirements and avoid untoward incidents to
the public.

In the interest of public health and safety, immediate approval of this bill is earnestly sought.

ANGELINA le... M.D.

4th District, Quezon


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

HOUSE BILL NO. 3049

Introduced by: Hon. Angelina “Helen” D.L. Tan, M.D.

AN ACT
PROVIDING REGULATIONS IN THE PACKAGING, USE, SALE, DISTRIBUTION AND
ADVERTISEMENTS OF ELECTRONIC NICOTINE DELIVERY SYSTEMS AND ELECTRONIC NON-
NICOTINE DELIVERY SYSTEMS (ENDS/ENNDS) AND HEATED TOBACCO PRODUCTS (HTPs)

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-Cigarettes and HTPs Regulation

end, the State shall implement measures to promote the general welfare by protecting the public
against hazards to health and safety of electronic cigarettes, heated tobacco products, and cimilar
products.

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

(a) “Electronic cigarettes” refer to the most common Prototype of ENDS/ENNDS. They are
devices that do not burn or use tobacco leaves but instead vaporise a solution the user then inhales.

(0) “Electronic. Nicotine and Non-Nicotine Delivery Systems" refer to combinations of non-
obacco containing e-liquids or refills and an electronic delivery device to produce an aerosol:

(C) "Heated tobacco products” refer to a form of tobacco products that uses an electronic device
to heat processed tobacco leaves, and produces aerosols for inhalation by mimicking the behavior of
‘smoking conventional cigarettes;

(4) “Vaping” refers to the act of inhaling and exhaling the aerosol, often referred to as. vapor,
which is produced by an e-cigarette or similar device; and

(e) “Young person refers to any person below twenty-one (21) years old.

SEC. 4. Using ENDS/ENNDS and HTPs in Public Places. — Vaping or the use of Electronic
Nicotine, Non-Nicotine Delivery Systems, or electronic-cigarettes, and Heated Tobacco Products shall
be prohibited in all places where tobacco smoking or the use of cigarettes is prohibited by law,
executive order, or memorandum circular.

SEC. 5. Designated Areas for Using ENDS/ENNDS and HTPs. - In all enclosed places that are
open to the general public, private workplaces and other places not covered by the preceding section,
where the use of ENDS/ENNDS and HTPs may expose.a person other than their user/s, the owner,
Proprietor, operator, possessor, manager, or administrator of such places shall establish areas for the
use of ENDS/ENNDS and HTPs, which shall strictly comply with the following standards:

(1) There shall be no opening that will allow air to escape from such area to the prohibited area
of the building or conveyance, except for a single door equipped with an automatic door closer:
Provided, That if the area is not located in an open space, such door shall open directly towards a
buffer zone or ventilated area between the door of such area not located in an open space and the area
where the use of ENDS/ENNDS and HTPs are allowed;


(2) The area shall not be located in or within ten (10) meters from entrances, exits, or any place
where people pass or congregate, or in front of air intake ducts:

(3) The combined area of the designated area and the buffer zone shall not be larger than
twenty (20) percent of the total floor area of the building or conveyance; Provided, That inno case shall
such area be less than ten (10) square meters;

(4) No building or conveyance shall have more than one (1) area for the use of ENDS/ENNDS
or HTPs;

(5) The ventilation system for the area other than in an open space and for the buffer zone shall
be independent of all ventilation systems and the rest of the building or conveyance;

(6) Young persons and pregnant women shall not be allowed inside the area and the buffer
zone;

(7) The area shall have the following signages highly visible and prominently displayed:
(a) "ENDS/ENNDS/HTP Area” signage;
(b) Prohibition on the entry of persons below eighteen (18) years old and pregnant women,

However, there shall be no designated area for the use of ENDS/ENNDS and HTPs in the
following public places:

(1) Centers of youth activity such as playschools, preparatory schools, elementary schools, high
schools, colleges and universities, boarding houses, dormitories, youth hostels and recreational
facilities for young persons;

(2) Elevators and stairwells;

(3) Locations in which fire hazards are present;

(4) Within the buildings and premises of public and private hospitals, medical, dental, and
optical clinics, health centers, nursing homes, dispensaries and laboratories; and

(5) Food preparation areas

‘SEC. 6. Minimum Age Sales. ~ The following acts shall be prohibited:

(1) For any retailer to sell or distribute ENDS/ENNDS and HTPs to any young person;

(2) For any person to purchase ENDS/ENNDS and HTPs from a young person;

(3) For a young person to sell or buy ENDS/ENNDS or HTPs; and

(4) For a young person to use ENDS/ENNDS and HTPs.

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 young person. Neither shall it be a defense that he/she did not know nor
had any reason to believe that the ENDS/ENNDS or HTPs was for the consumption of a young person
to whom it was sold.

SEC. 7. Sale of ENDS/ENNDS and HTPs Within School Perimeters. - The sale or distribution of
ENDS/ENNDS and HTPs is prohibited within a minimum distance of one hundred (100) meters from
any point of the perimeter of a school, public playground or other facility frequented particularly by
young persons. Nothing in this provision or elsewhere in this Act shall be construed as limiting the
powers of local government units (LGUs) under the general welfare clause.

SEC. 8. Marketing Restrictions. — No establishment shall manufacture, distribute, import, export,

Sell, offer for sale, and transfer ENDS/ENNDS and HTPs without first securing the necessary marketing
authorization and License to Operate (LTO) from the Food and Drug Administration (FDA).


SEC. 9. Restrictions on e-Liquids. - The FDA shall set the appropriate standards and restrictions
on flavors and additives used in the manufacture of e-liquids and refills. The FDA shall impose a ban on
flavors and additives that are proven or Suspected to be toxic, harmful, addictive, sensitizing, or
appealing to young persons.

‘SEC. 10. Restriction on the Retail and Sale of Nicotine Shots. — The retail or use of nicotine
shots and/or concentrates shall be strictly prohibited.

SEC. 11. Restriction on Advertisement, Promotion, and Sponsorship. — Any form of advertising,
promotion, and sponsorship of ENDS/ENNDS and HTPs, including corporate social responsibiliy
campaigns by the industry, shall be prohibited. No person, establishment, or organization shall use the,
FDA logo, the words “Food and Drug Administration” or “Philippine FDA", or any imitation of euch
words, initials, or logo in print and other forms of broadcast, media, including the internet, in connection
wih any ENDS/ENNDS and HTPs, merchandize, impersonation, solicitation, or commercial activity in a
manner that convey that such use is approval, endorsement, or authorization by the FDA.

Placing, posting, or displaying ENDS/ENNDS and HTPs advertisements and promotion items
including ENDS/ENNDS and HTPs in any place, except for the placement of a single simple sign with
Wile background and black font and not exceeding twelve inches by eighteen inches (12"x18") in size
Stating only the following: ENDS/ENNDS/HTPs Available Here’ inside point-of-sale establishments,

Promoting, directly or indirectly, ENDS/ENNDS and HTPs in an event, activity, program or
Broject where ENDS/ENNDS and HTPs company is a participant as facilitator, sponsor, contributor,
donor or benefactor, whether or not the same is part of its corporate social responsibility activities.

Engaging in any form of ENDS/ENNDS and HTPs advertisement and promotion, including
advertising in social media, online media, and the internet.

SEC. 12. Waring on Packaging. - Containers and packages of ENDS/ENNDS, HTPs, e-liquids
and refil shall contain appropriate health warnings. 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 thity (30) percent of the lower part of the principal display
surface of the nicotine container.

SEC. 13. Role of the Department of Health and the Food and Drug Administration. — The
Department of Health, in consultation with the FDA, the Department of Trade and Industry, and
concemed agencies, shall promulgate rules, regulations, and standards on packaging, ingredients,
graphic health warnings, detailed information on the allowable nicotine-containing e-liquid, the ‘strength
of e-liquids, compliance with applicable electrical standards as well as with applicable industry
‘standards for batteries.

The FDA shall monitor closely the compliance of manufacturers, importers, distributors, and
retailers with this Act through surveillance inspections and investigations.

SEC. 14. Penalties. - The following penalties shall apply:

a. Violation of Sections 4 and 5, - On the first offense, a fine of not less than Two thousand
Pesos (PHP 2,000.00) but not more than Three thousand pesos (Php3,000.00).

On the second offense, a fine of not less than Three thousand pesos (PHP3,000.00) but not
more than Five thousand pesos (Php5,000.00) shall be imposed.

On the third offense, in addition to a fine of Ten thousand Pesos (Php10,000.00), the business
Permits and licenses to operate shall be cancelled or revoked.

. Violation of Sections 6 and 7. - On the first offense, any person or any business entity or
establishment selling to, distributing or purchasing ENDS/ENDDS or HTPs for a young person shall be
fined the amount of not less than Five thousand pesos (Php5,000.00) or an imprisonment of not more
than thirty (30) days, upon the discretion of the court. For succeeding offenses, both penalties shall
apply in addition to the revocation of business licenses or permits in the case of a business entity or


establishment.

If the violation is by an establishment of business entity, the owner, president, manager, or the
most senior officers thereof shall be held liable for the offense.

If'@ young person is caught selling, buying or using ENDS/ENNDS or HTPs, the provisions of
Article 189 of Presidential Decree No. 603 otherwise known as The Child and Youth Welfare Code, as
amended, shall apply.

c. Violation of Sections 8 to 12. - On the first offense, a fine of not more than One hundred
thousand pesos (Php100,000.00) or imprisonment of not more than one (1) year, or both, at the
discretion of the court shall be imposed.

On the second offense, a fine of Two hundred thousand pesos (Php200,000.00) or
imprisonment of not more than two (2) years, or both, at the discretion of the court shall be imposed.

On the third offense, in addition to a fine of not more than Four hundred thousand pesos
(Php400,000.00) or imprisonment of not more than three (3) years, or both, at the discretion of the
court, the business permits and licenses, in the case of a business entity or establishment, shall be
revoked or cancelled.

In the case of a business entity or establishment, the owner, president, manager or officials
thereof shall be liable.

If the guilty officer is an alien, he shall ‘summarily be deported after serving his sentence, and
Shall be forever barred from re-entering the Philippines.

SEC. 15. Implementing Rules and Regulations. - Within sixty (60) days from the approval of this
Act, the Secretary of Health, in consultation and coordination with appropriate government agencies
and other stakeholders, shall promulgate the necessary implementing rules and regulations for the
effective implementation of this Act.

SEC. 16. Separability Clause. - If any provision of this Act is held invalid or declared
unconstitutional, the other provisions which are not affected thereby shall remain valid and ‘subsisting.

SEC. 17. Repealing Clause. - All laws, decrees, presidential proclamations, executive orders,
tules and regulations or parts thereof inconsistent herewith, are hereby repealed or modified
accordingly.

SEC. 18. Effectivity. - This Act shall take effect fifteen (15) days after its publication in the
Official Gazette or in a newspaper of general circulation.

Approved,