PR
REPRESEN

EIGHTEENTH CONGRESS )
REPUBLIC OF THE PHILIPPINES )
First Regular Session )

op DEC_0
ne
xv

HOUSE OF REPRESENTATIVES

Introduced by Representative Rufus B. Rodriguez
5702

House Bill No.
EXPLANATORY NOTE

In the Philippines, smoking persists as a prevalent threat to public health. A staggering 23%, or
16 million out of the 63 million adult Filipinos currently smoke ‘traditional’ combustible
cigarettes, thereby giving the Philippines one of the highest smoking rates in Asia

Given that smoking is the leading cause of preventable death in the country, the sheer
number of those affected by smoking combustible cigarettes raises grave concem. Thus, in the
interest of public welfare, it is imperative that the State address this health issue urgently and
effectively.

At the crux of this problem is the fact that many Filipino smokers in fact want to quit, but
due to the lack of viable alternatives to combustible cigarettes, find it extremely hard to do so.
According to the 2015 Global Tobacco Survey, of the estimated 16 million Filipinos who
currently smoke, at least 76% have planned or were thinking about quitting. Unfortunately, of
this number, only 4% were successful in their attempt.

Recognizing the need for a viable altemative to combustible cigarettes, governments
around the world and leading public health institutions have explored the concept of harm
reduction as a public health strategy to combat the smoking epidemic. Harm reduction is
grounded on the idea that people smoke for the nicotine but die from the tar. Hence, if there is a
way to deliver nicotine to those who smoke cigarettes without the associated harmful by-
products that are produced in a combustible cigarette, it would enable smokers to finally quit
smoking. The category of Electronic Nicotine Delivery Systems, Electronic Non-Nicotine
Delivery Systems ("ENDS/ ENNDS’) and Heated Tobacco Products ("HTPs”) were created as
an outcome of this insight. The fundamental difference versus that of a cigarette is that these
products do not combust and do not produce any smoke.

The entry of alternative products such as ENDS, ENNDS and HTPs in the market raises
the need for regulation primarily in the interest of public welfare. Furthermore, on top of public
health concems, regulation is needed to balance factors such as revenue generation; trade and
commerce; job creation; the protection of minors and non-smokers; public safety against sub-
standard/ malfunctioning products; the interest of tobacco farmers; the interests of industry; and
the interests of all other stakeholders who stand to be affected by the introduction of the said
category.

This Bill proposes a regulatory framework for ENDS, ENNDS and HTPs that takes into
consideration and balances the interests of the general public, along with the stakeholders most
interested in their use and sale.

‘The first crucial consideration is the protection of minors. Of primordial concer is that in
the absence of regulation, ENDS, ENNDS and HTPs may attract minors or be purchased by
and sold to minors, who are certainly not meant to be consumers of ENDS, ENNDS and HTPs.
Thus, apart from restricting access to persons below 18 years old, the Bill provides for
standards for communications materials on ENDS, ENNDS and HTPs, as well as penalties for
the violations ranging at least P100,000.00 to P500,000.00 and imprisonment.

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It is also important to ensure the safety and quality of ENDS, ENNDS and HTPs that are
available in the market to provide a viable altemative to combustible cigarettes. Thus, this Bill
proposes product standards, assessment parameters and product registration rules prior to
market placement. It also includes provisions on adequate wamings and packaging
specifications as applicable. As to use, this Bill proposes specific places where public ENDS,
ENNDS and HTP use may not be allowed.

While a growing body of scientific evidence increasingly show that ENDS, ENNDS and
HTPs provide for a less harmful altemative to combustible smoking, we are stil waiting to see if
in the long-term ENDS, ENNDS or HTP use may still pose some health risk to users. Moreover,
the vapor produced may still contain nicotine, which is an addictive substance

In view of the foregoing, immediate approval of this measure is earnestly requested



EIGHTEENTH CONGRESS
REPUBLIC OF THE PHILIPPINES ;
First Regular Session

HOUSE OF REPRESENTATIVES

Introduced by Representative Rufus B. Rodriguez
5702

House Bill No.

AN ACT
REGULATING THE TRADE OF ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY
SYSTEMS (ENDS/ ENNDS) AND HEATED TOBACCO PRODUCTS (HTPs),
PARTICULARLY, THE MANUFACTURING, USE, SALE, PACKAGING, DISTRIBUTION, AND
COMMUNICATIONS THEREOF AND FOR OTHER PURPOSES

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 “Electronic Nicotine Delivery System,
Electronic Non-Nicotine Delivery System ("ENDS/ENNDS") and Heated Tobacco Products
(‘HTPs") Regulation Act’.

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 to instill health consciousness among them.

It is further declared the policy of the State to promote harm reduction measures,
particularly in the fight against smoking, as a public health strategy by ensuring that non-
combustible alternatives to combustible cigarettes are properly regulated and readily made
available to smokers who cannot quit smoking
It is also the declared the policy of the State to protect the interests of the consumers and
implement measures on the provision of information and education to facilitate sound choice
and the proper exercise of rights by the consumer.

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

(a) “Combustion” means the act or process of buming or igniting a cigarette or any
article, usually for the purpose of causing the components of the said article to
smolder or produce smoke for oral inhalation.

() “Combustible Cigarette Product’ means any article, with or without tobacco, which
has any of its contents or components meant to be bumed or ignited in order to
produce smoke, for purposes of oral inhalation

(©) “E-commerce” means the activity of buying and selling products by electronic means,
such as but not limited to mobile applications and the Intemet. It refers to both online
retail as well as other electronic transactions.

(d) “E-liquid” means a solution, blend or gel, which may or may not contain nicotine,
designed to be used in conjunction with an electronic delivery device to be heated
and inhaled.

(@) “Electronic Nicotine and Non-Nicotine Delivery System” means any liquid solution or
gel, with or without tobacco, that may or may not generate a nicotine-containing
aerosol, without combustion, through the employment of a mechanical heating
element, battery or circuit that can be used to heat such solution or gel, and includes

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but is not limited to a cartridge, a tank, and the device without a cartridge or tank. It
is commonly known as “e-liquids” for “vapes.” It also includes combinations of non-
tobacco containing e-liquids or refills which contain up to sixty-five milligrams per
milliliter (65mg/ml) of nicotine in the e-liquid or refill and an electronic delivery device
to produce an aerosol, mist or vapor that adult users inhale by mimicking the act of
smoking

ENDS/ENNDS shall include nicotine salt/salt nicotine, and conventional
“freebase” nicotine, and other similar products as may be determined by the Inter
Agency Committee on ENDS/ ENDS.

() “Freebase nicotine” means e-liquid substances not falling under the definition of “salt
nicotine” or “nicotine salt.”

(g) ‘Harmful and Potentially Harmful Constituents (HPHCs)” shall refer to chemical
substances that pose potential health risks such as those identified by the World
Health Organization, the United States Food and Drugs Administration, and Health
Canada.

(h) Heated Tobacco Products - refer to tobacco products that may be consumed through
heating tobacco, either electrically or through other means sufficiently to release an
aerosol that can be inhaled.

(i) “Ingredient” shall refer to any substance that is added to the tobacco or nicotine
mixture and present in the finished product.

G) “Nicotine mixture” means the nicotine-containing e-liquid, solid or other non-tobacco
substance in the product.

(“Nicotine salt” or Salt Nicotine" means e-liquid substances compatible for use with
low-wattage devices, with a lower alkalinity due to the addition of substances such as
benzoic acid, or other similar substances.

() “Package” shall refer to packs, boxes, cartons or containers of any kind in which any
ENDS/ENNDS/HTPs device and e-liquids and refills are provided in and offered for
‘sale to consumers.

(m) “Reduced exposure claim” means a statement in the Principal display surface of a
product label that the product or its vapor contains a reduced level of, or are free of
HPHCs.

(n) “Reduced risk claim’ means a a statement in the Principal display surface of a
which represents explicitly or implicitly that the product presents a lower risk or is
less harmful than combustible smoking.

(0) “Nicotine Receptacle” shall refer to a pod, holder, vessel, bottles, boxes, cartons, or
containers of any kind in which a nicotine-containing solution or non-burning tobacco
or products that can be used for the consumption of a nicotine-containing vapors or
Nicotine Mixtures or any related product is offered for sale to consumers for use with
a Vaporized Nicotine Product system. “Point-of-sale” shall refer to any location,
including e-commerce, at which an individual can purchase or otherwise obtain
ENDS, ENNDS and HTPs devices and/or and/or e-liquids and/or refills

(p) ‘Principal display surface” shall refer to the panel of the secondary packaging of the
nicotine receptacle that faces the consumer when displayed for sale. For HTPs, in
the case of a package and carton that has at least two (2) equal sized sides or
surfaces, other than the top and bottom, that may be displayed or visible under
normal or customary conditions of sale or use, the areas of each of the two (2)
largest surface:

(q) ‘Communications” shall refer to conceptualizing, presenting, making available and
communicating to the public, through any form of mass media, any fact, data, or
information about the attributes, features, use, quality or availability of consumer

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products, services, or credit, sales support, after-sales support and product support
or credit, such as, but not limited to advertising, promotion, and sponsorships. For
the purpose of this Act, targeted communications shall be understood as
‘Communications on ENDS, ENNDS and HTPs.

(0) “Vapor” shall refer to substances that are released when a product is consumed as
intended, including the aerosol generated by ENDS, ENNDS and HTPs.

SEC. 4. Device Packaging Content. The device packaging of ENDS, ENNDS and HTPs shall
contain the following:
(a) The minimum labelling requirements for consumer products as required by the
Consumer Act of the Philippines; and
(b) A leaflet or insert containing instructions for handling, proper use, and maintenance.
It shall also include waming against improper usage of ENDS, ENNDS and HTPs
products.

SEC. 5. Health Warnings. - The packaging of ENDS, ENNDS and HTPs shall bear textual
health warnings with the following specifications:
(a) The Principal Display Surface of a package, carton, nicotine receptacles, e-liquid
pods and bottles shall carry the following health waming: “This product contains
nicotine which is a highly addictive substance

(b) The health warning frame shall occupy 20% of the lower part of the principal display
surface of the unit packet and any receptacle. The health waming shall occupy a
total area of not less than fifty percent (50%) of the total warning frame.

(©) Nothing shall be printed or applied on a location where it is likely to obscure or cover,
in part or in whole, the health waming.

(d) No part of the warming may be destroyed, obscured, folded, severed or become
unreadable when the nicotine receptacle is opened or closed or when a wrapper on
the receptacle is removed.

(€) No other printed wamings, except the textual health warning in Section 5 (a) shall be
placed on ENDS, ENNDS or HTPs packages.

ENDS, ENNDS and HTPs shall not be covered by Republic Act No. 10643 or the
Graphic Health Wamings and its implementing rules and regulations.

SEC. 6. Minimum Age for Sales, Distribution and Purchase. - The following acts shall be
prohibited:

(a) The sale, distribution, or transfer of ENDS, ENNDS or HTPs by any person to

minors, defined as anyone below eighteen (18) years old.

(b) Purchasing, or otherwise receiving ENDS, ENNDS or HTPs from a minor.

(c) The sale, purchase, distribution, transfer, or use of ENDS, ENNDS and HTPs by

minors, or on behalf of a minor.

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 of ENDS, ENNDS and HTPs were for the
consumption of the minor to whom it was sold.


SEC. 7. Point-of-Sale Signage. — Point-of-sale establishments offering, distributing, or selling
ENDS, ENNDS or HTPs shall post the following statement in a clear and conspicuous manner:
“SALE/DISTRIBUTION TO OR PURCHASE BY MINORS OF ELECTRONIC NICOTINE
DELIVERY SYSTEMS, ELECTRONIC NON-NICOTINE DELIVERY SYSTEMS, OR HEATED
TOBACCO PRODUCTS IS UNLAWFUL" or “IT IS UNLAWFUL FOR ELECTRONIC NICOTINE
DELIVERY SYSTEMS, ELECTRONIC NON-NICOTINE DELIVERY SYSTEMS, AND HEATED
TOBACCO PRODUCTS TO BE SOLD/DISTRIBUTED TO OR PURCHASED BY PERSONS
UNDER 18 YEARS OF AGE.”

SEC. 8. Proof of Age Verification. — Retailers shall ascertain that no individual purchasing an
ENDS, ENNDS or HTPs is below eighteen (18) years of age. In case of doubt, retailers shall
verify the age of the buyer through any valid identification document containing the buyer's
photograph and age or date of birth

At all times, retailers shall verify the age of the buyer by requiring the presentation of a
valid identification card exhibiting the buyer's photograph and age or date of birth.

In case of direct Communications conducted through digital media, the internet, social
media or social messaging applications or other similar forms, age-verification may be
conducted by self-deciaration by the consumer subject to confirmation by the seller upon
delivery of the product(s) either directly to the consumer's or through the consumer's authorized
agent.

SEC. 9. Online Trade. - The sale or distribution of ENDS, ENNDS or HTPs s through internet
websites or via e-commerce and/or other similar mediums, shall be allowed; provided that, the
seller or distributor shall adopt measures to ensure that access to the intemet website or via e-
commerce and/or other similar mediums shall be restricted to persons eighteen (18) years of
age or older and that the internet website shall bear the signage required under Section 5 of this,
Act. An intemet website or via e-commerce and/or other similar mediums is deemed restricted if
@ person cannot obtain access beyond the first page of the website, unless the person has self-
declared or otherwise established that he or she is at least eighteen (18) years of age.

SEC. 10. Requirements and Restrictions on Communications on Electronic Nicotine and
Non-Nicotine Delivery Systems and Heated Tobacco Products. — Communications
regarding ENDS, ENNDS or HTPs shall be subject to the following requirements and/or
restrictions:

(2) Communication shall be permitted in Points-of-sale or other places where use of
ENDS, ENNDS or HTPs allowed.

(b) Communication shall be allowed in print media; provided that, the publication is not
intended for or directed towards minors, and generally has seventy five (75%) adult
readership or adult subscriber base.

(c) Communication shall be allowed in electronic media, such as but not limited to digital
media, telecommunications, internet websites, social media, social messaging
applications and other similar forms to the foregoing; provided that for
Communication conducted through internet websites, the intemet website must be
restricted to persons eighteen (18) years of age or older; and provided, further, that
this limitation shall not prevent the use of company intemet websites or social media
or social media messaging applications or other similar applications or medium to
provide information regarding a company, its products and their use, services, sales
support, after-sales support and other product-related information. For avoidance of
doubt, an interet website or electronic media is deemed restricted if a person
cannot obtain access beyond the first page of the website or before actual
Communication is made to the user, unless the person has self-declared or

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otherwise established that he or she is at least eighteen (18) years of age in
accordance with Section 6 of this Act.

(4) Communication shall not appear in television, radio and billboards. However, for
cinema screenings which restrict and verify the age of its audience to at least 18
years old, Communications on ENDS, ENNDS or HTPs may be allowed.

(e) They shall not be aimed at or particularly appeal to persons under eighteen (18)
years of age.

(f) They shall not contain cartoon characters or subject that depict humans or animals
with comically exaggerated features or that attribute human or unnatural
characteristics to animals, plants or other objects.

(g) Communication by adult influencers, key-opinion leaders, experts, celebrities or
other similar individuals shall be allowed but Communication shall only depict
Persons who are or who appear to be above twenty-five (25) years of age.

(h) They shall not show, portray or depict the act of using or puffing ENDS, ENNDS or
HTPs.

(e) They should not undermine quit-smoking messages and encourage non-tobacco and
Non-nicotine users to use the product.

(f) They do not contain any information or element that is untrue or not scientifically
substantiated, in particular with regard to product characteristics or health effects.

(g) They shall allow for adult consumers to learn about the availability of ENDS, ENNDS
or HTPs, receive information about how to use them or product
demonstration/information and to receive samples, try them before purchasing them,
subject to proof of age and certification of smoker or usage status, and receive pre-
sale and after-sales support.

i) All Communications material for receptacles shall contain the health waming: “This
Product contains nicotine, which is a highly addictive substance.” The health waming
shall occupy ten percent of the bottom area of the communication.

(k) Communications on ENDS, ENNDS or HTPs. shall be permitted in print media
provided that, the publication is not intended for or directed towards minors, and
generally has seventy five (75%) adult readership or adult subscriber base

SEC. 11. Public Place Use. - The use of ENDS, ENNDS or HTPs indoors, in places of
worship, hospitals or other healthcare centers, public conveyances (unless in designated use
areas), and educational or recreational facilities exclusively intended for minors shall be
prohibited.

The use of ENDS, ENNDS or HTPs indoors, in all other enclosed places that are open to
the general public, private workplaces, and those places not covered in the preceding
enumeration shall be allowed, provided that the owner, proprietor, operator, possessor,
manager or administrator of such places shall post the following statement in a clear and
conspicuous manner or administrator of such places shall post the following statement in a clear
and conspicuous manner at every ingress point of such places: “USE OF ELECTRONIC
NICOTINE DELIVERY SYSTEMS, ELECTRONIC NON-NICOTINE DELIVERY SYSTEMS AND
HEATED TOBACCO PRODUCTS IS ALLOWED INSIDE.”

SEC. 12. Product Standards and Assessment. - ENDS, ENNDS or HTPs must comply with
the following:
(@) ENDS, ENNDS and HTPs shall operate in such a way that no combustion occurs
during the entire process of consumption when used as intended.
(b) All products must be manufactured in accordance with an appropriate quality
management system. The quality management system must ensure batch-to-batch


reproducibility of the products through quality control of both incoming materials and
finished products; and prevention of mix-ups.

© The substances listed below may not be added in ENDS, ENNDS or HTPs:

Additives that have carcinogenic, mutagenic or reprotoxic properties in
unbumt form;
ii, Vitamins or other additives that create the impression that the product has a
health benefit or presents reduced health risks;
iii, Caffeine, taurine, or other additives and stimulant compounds that are
associated with energy and vitality;
iv. Additives having coloring properties for emissions;
v. Ethylene glycol;
vi. Diethylene glycol;
vii. Diacetyl; and
vii. _ 2, 3-pentanedione

(d) Manufacturers of electrical devices intended to be used in combination with an
ENDS, ENNDS and HTPs shall ensure that such devices comply with applicable
electrical safety standards, as determined by the Department of Trade and Industry
(OT).

(€) Nicotine salt products shall have a maximum of two milliliter (2 ml) tank with a
maximum of sixty-five milligrams per milliliter (65mg/ml) of nicotine.

() Freebase products shall have a maximum of five milliliter (5 ml) tank with a maximum
of one hundred milliliters (100ml) refill package, and a maximum of sixty five
milligrams per milliliter (65 mg/ml) of nicotine

(g) Batteries must comply with applicable industry requirements as defined by DTI

SEC. 13. Tamper-proof and Child-proof Designs. — All nicotine receptacles containing
nicotine mixtures must be child-resistant, tamper-resistant and protected against breakage and
leakage.

SEC. 14, Market Placing. - All Manufacturers, distributors and importers must comply with the
following:

(@) Three (3) months prior to placing an ENDS, ENNDS and HTPs in the market, all

manufacturers and distributors must notify the Department of Trade and Industry
(OT), together with a submission of information demonstrating compliance with
Product standards and assessment requirements.
All manufacturers, distributors, and importers shall provide the DTI with written notice
of any modifications, improvements, adjustments, or redesigns of registered
Vaporized Nicotine Products or Nicotine Receptacles prior to placing such modified,
improved, adjusted, or redesigned Vaporized Nicotine Product or Nicotine
Receptacle in the market.

(b) Prior to the presentation of any information about reduced exposure or reduced risk
claims, the Inter-Agency Committee on Electronic Nicotine Delivery System,
Electronic Non-Nicotine Delivery System and Heated Tobacco Products (IAC-E) may
require manufacturers or importers to submit scientific evidence supporting such
health claims. Manufacturers and importers can also submit a regulatory approval or
authorization that was issued by a public health regulator of another country and the
same may be used by the IAC-E for allowing the use of a reduced- exposure or
reduced risk claims for a specific product.

(©) For ENDS, ENNDS and HTPs that are already in-market, all manufacturers,
distributors or importers shall be given six (6) months from the effectivity of this Act to
notify as well as submit information demonstrating compliance with product

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standards and assessment requirements in accordance with Sections 12 of this Act
to the Department of Trade and Industry (DT1).

SEC. 15. Reduced Exposure or Reduced Risk Claims. — There are two claims that ENDS,
ENNDS and HTPs may make: a reduced exposure claim and a reduced risk claim. The
Department of Health (DOH) shall be the responsible authority with respect to claims of reduced
exposure or reduced risk.

(a) A reduced exposure claim may be made only if:

i, The manufacturer characterized the levels of nicotine uptake from ENDS,
ENNDS and HTPs compared to cigarette smoking based on clinical trials;

ii, The manufacturer can support the claim with evidence from clinical trials
conducted over a period of at least seven days demonstrating that, compared
to continued cigarette smoking, users who switch completely to the product
show a significant reduction in exposure to one or more HPHCs based on
validated, scientifically-accepted biomarkers of exposure and that the
reductions in exposure are significant enough that a reasonable scientific or
medical expert would anticipate a reduction in risk of disease in smokers who
switched to the product.

il, The manufacturer demonstrates that the average user of a tobacco product,
who is reasonably well-informed and reasonably observant, correctly
‘comprehends the claim.

iv. Clinical studies must be performed in accordance with ethical principles that
have their origin in the Declaration of Helsinki and be consistent with
reasonable intemationally accepted standards.

(b) A reduced risk claim may only be made if:
i, The manufacturer meets the requirements stipulated for reduced
exposure claims; and
ii, The manufacturer can support the claim with clinical studies
() To characterize risk reduction in the absence of epidemiological evidence, a
manufacturer may instead demonstrate favorable biological and physiological
changes in chosen clinical risk endpoints as compared to continued cigarette
smoking. These endpoints need to be effected by smoking, linked to smoking
related disease and reversible after cigarette smoking cessation. The majority of the
assessed clinical risk endpoints must shift in the direction of cigarette smoking
cessation.

SEC. 16. Penalties for Non-compliance. — The following penalties shall individually apply to
manufacturers, importers, distributors, sellers and buyers found to be in violation of this Act, as
well as to their agents/representatives, as may be applicable:
(a) On the first offense, a fine of not more than One Hundred Thousand Pesos
(P100,000.00);
(b) On the second offense, a fine of not less than One Hundred Thousand Pesos
(P100,000.00) but not more than Five Hundred Thousand Pesos (P500,000.00); and
(©) On the third offense, a fine of not less than Five Hundred Thousand Pesos
(P500,000.00) but not more than One Million Pesos (P1,000,000.00) 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
(d) Violations of the provisions of this Act committed by minors shall be dealt with
accordingly by existing applicable laws without prejudice to any administrative


proceedings or sanctions that may be conducted or meted out by schools where the
said minors may be students of.
Non-compliant ENDS, ENNDS and HTPs products found in the market for sale or
distribution shall be subject to confiscation by the Philippine National Police
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. 17. Inter-Agency Committee. -An Inter-Agency Committee on Electronic Nicotine
Delivery Systems, Electronic Non-Nicotine Delivery Systems, and Heated Tobacco Products
(IAC-E), which shall have the exclusive power, jurisdiction and function to administer and
implement the provisions of this Act, is hereby created. The |AC-ENDS/ENNDS/HTPS shall be
co-chaired by the Secretary of the Department of Trade and Industry (DTI), in consultation with
the Secretary of the Department of Health (DOH). The |AC-ENDS/ENNDS/HTPS shall have the
following members:

(a) Secretary of the Department of Health

(b) Secretary of the Department of Agriculture

(c) Secretary of the Department of Justice

(d) Secretary of the Department of Finance (DOF);

(e) Secretary of the Department of Science and Technology (DOST);

(®) Secretary of the Department of Education (DepEd);

(g) Administrator of the National Tobacco Administration

(h) A representative from the ENDS/ENNDS/HTPS industry to be nominated by the

legitimate and recognized associations of the industry; and
(i) A representative from a nongovernment organization (NGO) involved in public health
promotion nominated by DOH in consultation with the concemed NGO's;

The Department Secretaries may designate their Undersecretaries as their authorized

representatives to the IAC.

SEC. 18. Creation of a Congressional Oversight Committee (COC). — A Congressional
Oversight Committee Co-chaired by the Senate Committee on Trade and the House Committee
on Trade shall be constituted to monitor and review the implementation of this Act. The
‘oversight committee shall be comprised of one representative from each of the following bodies:
(a) Senate
i. Committee on Health and Demography —

ii, Committee on Economic Affairs

iii, Committee on Science and Technology

iv. Committee on Ways and Means

v. Committee on Agriculture

(b) House of Representatives
i. Committee on Health —
ii. Committee on Economic Affairs
iii, Committee on Science and Technology
iv. Committee on Ways and Means
v. Committee on Agriculture

SEC. 19. Implementing Rules and Regulations. — Within six (6) months from the date of
effectivity of this Act, the DTI, in consultation with the IAC-E, shall issue the implementing rules
and regulations (IRR) of this Act. The non-issuance of the IRR will not suspend the effectivity of

10


this Act nor the introduction of New Electronic Nicotine and Non-Nicotine Delivery Systems and
Heated Tobacco Products in the market. Manufacturers, importers and distributors of the
products shall be given Eighteen (18) months after the effectivity of the IRR to fully comply with
the provisions of this Act as well as its IRR.

SEC. 20. Jurisdiction. - The DOH shall have jurisdiction over Section 15 of this Act. All other
Sections of this Act shall be under the general jurisdiction of the DTI.

SEC. 21. Separability Clause. - \f 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. 22. Repealing Clause. — The words “or heated” under Section 4 (d) of tobacco of
Republic Act No. 9211, Section 1.6 of Rule Ill of the Implementing Rules and Regulations of
Republic Act No. 9211, FDA Advisory No. 2013-008, and Department of Health Administrative
Order No. 0008-14 are hereby repealed.

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.

The provisions of RA 10643 or the Graphic Health Wamings Law shall not be applicable
to ENDS/ENNDS/HTPS

SEC. 23. Effectivity Clause. - This Act shall take effect fifteen (15) days after its publication in
at least two (2) newspapers of general circulation.

Approved,

n