SEVENTEHNTI1 CONGRESS OE T1 IE 
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REPUBLIC OF THE PI IILIPPINES 
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Second Regular Session 
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SENAU:
S.B. No. 
lO O O
■f ’■ 4' • 1:' •
■'’’r  O' 1 
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.'.III'
’17 
AUG-2  
P3 5 7
S E C : !
INTRODUCED BY SENATOR VICENTE C. SOTTO III
EXPLANATORY NOTE
Vaporized Nicotine Product Systems (VNPs) are battery-run products that heat a 
solution (e-juice) to generate vapor that usually consists of vegetable glycerin, propylene 
glycol, flavorants, and nicotine. They commonly consist of an atomizer, which heats the e- 
juice; a cartridge, which serves as the e-Juice carrier; and a power source or battery.
As of 2015, the global VNP market size was estimated to be US$10 billion and 
showing continued increase in prevalence of VNP use both globally and locally1. Such a 
trend threatens public health if the VNP market remains unregulated.
These VNPs are promoted as cigarette alternatives and are designed to mimic both the 
form as well as the physical sensation delivered by cigarettes2. Some VNPs claim in their 
marketing labels that they are effective smoking cessation tools as well as safer alternatives to 
smoking. Most of these health claims are yet to be proven by concrete scientific evidence. In 
fact, the World Health Organizations (WHO) has stated concerns on its safety and its 
sustainability as a quitting aid.
VNP use may still pose a health risk to users. The vapor generated still contains the 
usual toxicants that are found in cigarette smoke such as formaldehyde, volatile organic 
compounds, tobacco-specific nitrosamines, metals, silicate particles, polycyclic aromatic 
hydrocarbons, and other carcinogens -  albeit at much lower levels. At high levels, these 
substances are known to cause respiratory and vascular diseases apart from cancer. The VNP 
aerosol also contains nicotine, although not a carcinogen, is still an addictive substance.
^ Conference of the Parties to the WHO Framework Convention on Tobacco Control 7,h session report
Philippine College of Chest Physicians Position Statement on Electronic Cigarettes (E-Cigarettes)/ Electronic 
Nicotine Delivery' Devices (ENDD)
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One study also suggests that VNP use may initialize youth uptake3. The flavorings 
that are present in e-juices, such as chocolate and candy-like flavors, may appeal to minors 
and cause youth uptake. By perpetuating the behavior of smoking, VNP use have the 
potential to undermine smoking cessation efforts4.
The lack of a regulatory scheme to oversee product standards and safety has also led 
to the placement of inferior quality products in the Philippine market. In fact, media reports 
of exploding VNP products are becoming increasingly common, with more than 200 reports 
of VNP-related explosions5 all over the world. These regrettable events could have been 
prevented had there been a proper regulatory scheme in place.
This bill proposes that VNP products be regulated in such a way that any health claim 
is assessed by the Food and Drug Administration (FDA), registration and product quality and 
safety are in line with the standards set by the Department of Trade and Industry (DTI), sales 
and distribution to and from minors are prohibited, and both public and environmental health 
are protected.
Moreover, contained in this proposed bill is a provision on ^public place use"\ which 
specifies the places where VNPs may be validly u.sed. Thus, this measure seeks to fill in the 
gap of Executive Order No. 26 issued by President Rodrigo Duterte on May 16, 2017 which 
prohibits smoking in “enclosed publie spaces and public conveyances exeept in certain 
designated smoking areas'' as the aforesaid executive order does not cover VNPs.
The immediate passage of this bill is earnestly requested.
CENTE C. SOTTO III
■* Department of Health Website http://\v\v'\v.doli.uov.ph/node/(>4 
Philippine College of Chest Physicians Position Statement on Electronic Cigarettes (E-Cigarettes)/ Electronic
Nicotine Delivery Devices (ENDD)
5 hltps:;/\v\vw.prcssrcadcr.com/philippincs/lhc-philippinc-star/2016 12 16/281822873440154: 
hllps://thcproductlawvers.com/cxplodim;-c-ciR/cxplosion-limeline/: h11p://ecigarcttc- 
C2yilosiojiclassaction.aimtagcxploding-c-cigarcttes-manila-ar-72442/


SEVENTEENTH CONGRESS OF THE 
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REPUBEIC OF THE PHILIPPINES 
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Second Regular Session 
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SENATE ,
S.B. No. 
1538
of ii|r 
I r t a t p
’17 
AU6-2 
P3 5 7
RCCc.
INTRODUCED BY SENATOR VICENTE C. SOTTO III
AN ACT
REGULATING VAPORIZED NICOTINE PRODUCTS
Be it enacted by the Senate and House of Representatives of the Philippines in 
Congress assembled:
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SECTION 1. Short Title. -  This Act shall be known as the ""Vaporized Nicotine 
Products 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 instill health consciousness among 
them.
It is further declared the policy of the State to discourage the use of cigarette products 
and to look for effective measures in the fight against cigarette smoking by encouraging the 
availability of well-regulated, significantly less harmful alternatives to cigarettes for smokers 
who do not or cannot quit smoking.
SEC. 3. Definitions. As used in this Act. the following terms shall mean -
(a) “Vaporized nicotine product" means a product with or without tobacco that 
generates a nicotine-containing aerosol without combustion, with or without 
electronics or any component of that product, this includes but is not limited to a 
cartridge, a tank and the device without a cartridge or tank.
(b) “Ingredient" means any substance that is added to the tobacco or nicotine mixture 
and present in the finished product.
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(c) “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 receptacle for holding nicotine mixture to refill certain 
vaporized nicotine products.
(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 a vaporized nicotine products, or substances released during the process of 
using vaporized nicotine products.
(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.
(h) “Reduced exposure claim” means a communication to consumers in the product 
label or marketing material that tlie product or its emissions contain a reduced 
level of, or are free of, a substance or substances or present a reduced exposure to 
a substance or substances, such as HPHCs.
(i) “Reduced risk claim” means a communication to consumers in the product label 
or marketing which represents explicitly or implicitly that the product presents a 
lower risk or is less harmful than continued cigarette smoking.
(j) “Package” shall refer to packs, boxes, cartons or containers of any kind in which 
the electronic component of a vaporized nicotine product is offered for sale to 
consumers.
(k) “Nicotine receptacle” shall refer to bottles, boxes, cartons, or containers of any 
kind in which a nicotine-containing solution or vaporized tobacco or any related


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product is offered for sale to consumers for use with a vaporized nicotine product 
system.
(l) “Point-of-sale" shall refer to any location at which an individual can purchase or 
otherwise obtain vaporized nicotine products.
(m) “Principal display surface" shall refer to the panel of the nicotine receptacle that 
faces the consumer when displayed for sale.
(n) “Advertising” shall refer to the business of conceptualizing, presenting, 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 vaporized nicotine product advertising.
SEC. 4. Packaging Content. - The packaging shall contain the following:
(a) A list of all vaporized nicotine product device components; and
(b) A leaflet or insert containing instructions for handling, proper use, and 
maintenance. It shall also include warnings against improper usage.
SEC. 5. Health Warnings. -  Only nicotine receptacles shall bear textual health 
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warnings with the following specifications:
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(a) Unit packets and any outside wrapping of vaporized nicotine product nicotine
receptacles such as e-juices, tobacco cartridges not intended for combustion, and 
similar products, shall carry the following health warning: This product may 
damage your health and is addictive’.
(b) The health warning shall occupy 30% of the lower part of the principal display 
surface of the unit packet and any outside wrapping of the nicotine receptacle. 
The health warning shall occupy a total area of not less than fifty percent (50%) 
of the total warning frame.


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(c) Nothing shall be printed or applied on a loeation where it is likely to obscure or 
cover, in part or in whole, the health warning.
(d) No part of the warning may be obliterated, obscured, folded, severed or become 
unreadable when the nicotine receptacle is opened or closed or when a wrapper 
on the receptacle is removed.
Vaporized nicotine products shall not be covered by the Graphic Health Warnings
Law.
SEC. 6. Minimum A^e Sales and Purchase. - The following acts shall be prohibited:
(a) The sale and distribution, or transfer of vaporized nicotine products by any person 
to minors (anyone below 18 years old);
(b) Purchasing, or otherwise receiving vaporized nicotine products from a minor; and
(c) The sale, purchase, and use of vaporized nicotine products by minors.
It shall not be a defense for the person selling or distributing the vaporized nicotine
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product/s that he/she did not know or was not aware of the real age of the minor. Neither
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shall it be a defense that he/she did not know nor had any reason to believe that the product
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was for the consumption of the minor to whom it was sold.
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SEC. 7. Point-of-sale Signage. - Point-of-sale establishments offering, distributing,
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or selling vaporized nicotine products to consumers shall post the following statement in a
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clear and conspicuous manner: “SALE/DISTRIBUTION TO OR PURCHASE BY MINORS
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OF VAPORIZED NICOTINE PRODUCTS IS UNLAWFUL" or “IT IS UNLAWFUL FOR
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VAPORIZED 
NICOTINE 
PRODUCTS 
TO 
BE 
SOLD/DI STRl BUTED 
TO 
OR
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PURCHASED BY PERSONS UNDER 18 YEARS OF AGE."
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SEC. 8. Proof of Age Verification. - Retailers shall ascertain that no individual
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purchasing a vaporized nicotine product is below eighteen (18) years of age. In case of


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doubt, retailers shall verify the age of the buyer through any valid identification card
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exhibiting the buyer's photograph and age or date of birth.
SEC. 9. Advertisement Restrictions. - Advertisements shall be allowed in points-of- 
sale. through direct marketing, and on the internet. The following restrictions shall apply to 
all vaporized nicotine product advertisements:
(a) Advertisements shall not be aimed at or particularly appeal to persons under 
eighteen (18) years of age;
(b) Advertisements shall not contain cartoon characters or subjects that depict 
humans or animals with comically exaggerated features or that attribute human or 
unnatural characteristics to animals, plants or other objects;
(c) Advcrti.scmcnts shall only depict persons who are or who appear to be above 
twenty-five (25) years of age;
(d) Advertisements shall not show, portray or depict scenes where the actual use of, 
act of using, or puffing of vaporized nicotine products;
(e) Advertisements should not undermine quit-smoking messages and encourage 
non-tobacco or nicotine users to use the product;
(f) Advertisements do not contain any information or element that is untrue or not 
scientifically substantiated, in particular with regards to product characteristics, 
health effects, risks or emissions;
(g) Promotional communications shall allow for adult consumers to learn about the 
availability of vaporized nicotine products, receive information about how to use 
them, try them before purchasing them, subject to proof of age and certification 
of smoker status, and receive pre-sale and after-sales support;
(h) Advertisements shall not appear in television, radio, and cinema; and


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(i) All allowable advertisements and promotional materials for nicotine receptacles
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shall contain the health warning ‘This product may damage your health and is
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addictive.’ The health warning shall occupy ten percent of the bottom area of the
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advertisement.
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SEC. 10. Restrictions on Advertisement in Print Media. - Advertising and other
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promotional communications of vaporized nicotine products shall be permitted so long as the
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publication is not intended for minors and generally has an adult readership or subscriber
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base.
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SEC. 11. Public Place Use. - Use of vaporized nicotine products indoor is prohibited
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in places of worship, hospitals or other healthcare centers, public conveyances, government
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offices, and educational or recreational facilities exclusively intended for minors. In all other
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enclosed places that are open to the general public, private workplaces and those places not
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covered in the preceding enumeration, vaporized nicotine product use shall be allowed,
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provided that the owner, proprietor, operator, possessor, manager or administrator of such
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places shall post the lollowing statement in a clear and conspicuous manner at every ingress
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point of the such places: “USE OF VAPORIZED NICOTINE PRODUCTS IS ALLOWED
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INSIDE.”
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SEC. 12. Product Standards and Assessment. -  Vaporized nicotine products must 
comply with the following:
(a) Vaporized nicotine products shall operate in such a way that no combustion of the 
tobacco or nicotine mixture 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


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and finished products; prevention of mix-ups; and traceability from raw material 
supplier to distributor, with supporting documented evidence and a controlled 
change management process;
(c) The substances listed below may not be added in vaporized nicotine products:
i. additives that have carcinogenic, mutagenic or rcprotoxic properties in 
unburnt form;
ii. respiratory sensitizers;
iii. ethylene glycol;
iv. diethylene glycol;
V. diacetyl; and 
vi. 2,3-pentanedione;
(d) Manufacturers of electrical devices intended to be used in combination with a 
vaporized nicotine product shall ensure that such devices comply with applicable 
electrical safety standards; and
(e) Batteries must comply with applicable industry requirements.
SEC. 13. Tamper-proof and Child-proof Designs. - All receptacles containing
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nicotine mixtures must be child-resistant, tamper-resistant and protected against breakage and
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leakage.
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SEC. 14. Market Placing. -  Manufacturers and distributors must comply with the
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following;
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(a) Three (3) months prior to placing a vaporized nicotine product in the market, all 
manufacturers and importers must register their products with the Department of 
Trade and Industry (DTI) and submit information demonstrating compliance with 
product standards and assessment requirements;


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(b) Manufacturers or importers intending to present tlie product with any information 
about the product's health effects such as reduced exposure or reduced risk 
claims, 
must 
submit 
scientific 
evidence 
supporting 
such 
consumer 
communication to the Food and Drug Administration (FDA); and
(c) For products that are already in-market, they shall be given three months to 
register their products with the DTI and submit information demonstrating 
compliance with product standards and assessment requirements. Any health 
claims for in-market products shall also be submitted to the FDA for approval.
SEC. 15. Health Claims. — Notwithstanding the foregoing provisions, there are only 
two (2) claims that vaporized nicotine product manufacturers and distributors may make: (i) a 
reduced exposure claim and (ii) a reduced risk claim. The FDA shall be the responsible 
authority with respect to claims of reduced expo.surc or reduced risk.
(a) A reduced exposure claim may be made only if:
i. The manufacturer characterizes the levels of nicotine uptake from 
vaporized nicotine products 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 FIPHCs based on validated, scientifically-accepted 
biomarkers of exposure and that the reductions in exposure arc 
significant enough that a reasonable scientific or medical expert would 
anticipate a reduction in risk of disease in smokers who switched to the 
product;


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iii. The manufacturer demonstrates that the average user of tobacco 
product who is reasonably well-informed and reasonably observant and 
circumspect correctly comprehends the claim; and
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 internationally accepted standards.
(b) A reduced risk claim may only be made if:
i. The manufacturer meets the requirements stipulated for reduced 
exposure claims;
ii. The manufacturer can support the claim with clinical studies; and
iii. The manufacturer can support the claim with evidence from clinical 
trials conducted over a period of at least ninety days demonstrating 
that,
1. compared to continued cigarette smoking, users who switch 
completely to the product in conditions of actual use show a 
significant reduction in the level of each biomarker of exposure 
to HPHCs or that the reductions are within 20% of the 
reduction observed in smokers who quit cigarette smoking over 
the study period, and
2. compared to continued cigarette smoking, users who switch 
completely to the product in conditions of actual use show a 
reduction in risk of harm or harm compared to continued 
smoking.
Products substantiated as “reduced exposure” or “reduced risk” pursuant to this 
Section may make such claims on product packaging and nicotine receptacles.


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(c) To characterize risk reduction in the absence of epidemiological evidence, a
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manufacturer may instead demonstrate favorable biological and physiological
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changes in chosen clinical risk endpoints as compared to continued smoking.
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These endpoints need to be effected by smoking, linked to smoking related
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disease and reversible after smoking cessation. The majority of the assessed
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clinical risk endpoints must shift in the direction of smoking cessation.
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(d) A reduced exposure, or reduced risk claim is permissible only with regard to
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products for which adequate po.st-marketing surveillance is in place. The
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notification must include the plans for such post-marketing surveillance and
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studies to determine the impact of the marketing of the product on the population.
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SEC. 16. Penalties for Noncompliance. -  The following penalties shall individually
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apply to manufacturers, importers, distributors, and sellers of vaporized nicotine products as
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well as their agents/representatives for any violation of this Act:
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(a) 
On the first offense, a fine of not more than One hundred thousand pesos
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(PI 00.000.00);
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(b) 
On the second offense, a fine of not more than Five hundred thousand pesos
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(P500.000.00); and
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(c) 
On the third offense, a fine of not more than One million 
pesos
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(PI.000.000.00) or imprisonment of not more than five (5) years, or both, at the discretion of
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the court: Provided, That the business permits and licenses, in the case of a business entity or
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establishment shall be revoked or cancelled.
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Non-compliant vaporized nicotine products found in the market for sale or
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distribution shall be subject to confiscation.
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If the guilty officer is a foreign national, he shall be deported after service of sentence
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and/or payment of applicable lines without need of further deportation proceedings and shall
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be permanently barred from re-entering the Philippines.
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SEC. 17. Creation of a Congressional Oversight Committee. -  A Congressional
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Oversight Committee co-chaired by the Senate Committees on Trade, Commerce, and
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Entrepreneurship and Health and Demography and the House Committees on Trade and
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1 lealth, is hereby constituted to monitor and review the implementation of this Act.
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SEC. 18. Implementing Rules and Regulations. -  Within six (6) months from the
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date of effcctivity of this Act, the DTI, in consultation with the FDA of the Department of
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Health, shall issue the implementing rules and regulations of this Act. The non-issuance of
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the IRR will not suspend the effcctivity of this Act or the introduction of new vaporized
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nicotine products in the market.
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SEC. 19. Separability Clause. -  If any provision or part hereof, is held invalid or
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unconstitutional, the remainder of the law or the provision not otherwise affected shall remain
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valid and subsisting.
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SEC. 20. Repealing Clause. -  Any law. presidential decree or issuance, executive
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order, letter of instruction, administrative order, rule or regulation contrary to or is
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inconsistent with the provision of this Act is hereby repealed, modified, or amended
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accordingly.
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SEC. 21. Effectivity Clause. -  This Act shall take effect fifteen (15) days after its
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publication in at least two (2) newspapers of general circulation.
Approved.
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