EIGHTEENTH CONGRESS OF THE { 
REPUBLIC OF THE PHILIPPINES 
} 
F irst R e g u la r S essio n  
}
S E N A T E
S.B. No. 496
• in ■
'19 
JUL 15 All ••00
INTRODUCED BY SENATOR VICENTE C. SOTTO III
AN ACT
REGULATING VAPORIZED NICOTINE PRODUCTS
EXPLANATORY NOTE
Vaporized Nicotine Product System s (VNPs) arc battery-run products 
th at 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 m arket size was estim ated to be US$10 
billion and showing continued increase in prevalence of VNP use both 
globally and locally1 2. 
Such a trend threatens public health if the VNP 
m arket rem ains unregulated.
These VNPs are prom oted as cigarette alternatives and are designed to 
mimic both the form as well as the physical sensation delivered by 
cigarettes-*. Some VNPs claim in their m arketing labels that they are effective 
sm oking cessation tools as well as safer alternatives to smoking. Most of 
these health claim s 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.
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2 P h ilip p in e  C o lle g e  o f  C lic s l P h ysicians P o silio n  S la lcm cn l on C lc c d o n ic  C ig a ic llc s  (E -C ig a ic K c s )/ E lc c lro n ic  
N ic o tin e  D clivcr>- D e vice s (E N D D )
I


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 
form aldehyde, volatile organic com pounds, tobacco-specific nitrosam ines, 
m etals, silicate particles, polycyclic arom atic hydrocarbons, and other 
carcinogens -  albeit at m uch lower levels. At high levels, these substances 
are known to cause respiratoiy and vascular diseases apart from cancer. 
The VNP aerosol also contains nicotine, although not a carcinogen, is still an 
addictive substance.
One study also suggests that VNP use may initialize youth uptake3 4. 
The flavorings th at are present in e-juices, such as chocolate and candy-like 
flavors, may appeal to m inors and cause youth uptake. By perpetuating the 
behavior of smoking, VNP use have the potential to underm ine sm oking 
cessation efforts1.
The lack of a regulatory schem e to oversee product standards and 
safety has also led to the placem ent of inferior quality products in the 
Philippine m arket. In fact, m edia reports of exploding VNP products are 
becom ing increasingly common, with more than 200 reports of VNP-related 
explosions3 all over the world. These regrettable events could have been 
prevented had there been a proper regulatoiy schem e 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 Adm inistration (FDA), 
registration and product quality and safety are in line with the standards set 
by the D epartm ent of Trade and Industiy (DTI), sales and distribution to 
and from m inors are prohibited, and both public and environm ental 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 used. 
T hus, this m easure seeks to fill in the gap of Executive Order No. 26 issued 
by President Rodrigo D uterte on May 16, 2017 which prohibits sm oking in
3 D c p n rlm c n l o f  H c.'iK li W c b s ilc  lillp  / / \ \ \ \  w .(Joli.m )\ .i)li/iiu clc/(i4
4 P liilip p iiic  C o lle g e  o f  C lie sl P hysieians P o sitio n  S tatem ent on  E le e tio n ie  C ig a re tte s (E -C ig ;ite tte s )/ E le e tio n ie  
N ic o tin e  D c li\c r>  D c \ ices (E N D D )
' lUtpsV/www.i)icssieaclei.eoiii/oliilii)oiiics/tlie-oliilii)pii>e-siar/2UI()l21(»/2?<1'>22X7.^4^0134: 
littps://tliemo(liictlav\Aei^.coii\/e\Dlocliii’:-c-ciu'’c\i)losioii-linicliiK-/: littp:/'/eeiuaiettc- 
c.Nolosionelassiietion.coiii/tau/cMjlodinu-c-e ma ret les-in.iiiila-.ii-72142/


“enclosed public spaces and public conveyances except in certain designated 
sm oking areas” as the aforesaid executive order does not cover VNPs.
The im m ediate passage of this bill is earnestly requested.
VICENTE C. SOTTO III


EIGHTEENTH CONGRESS OF THE | 
REPUBLIC OF THE PHILIPPINES 
} 
F irs t R e g u la r S essio n  
}
t 
J ' dfli •* 
i **
*19 
JUL 15 
P11 :00
SENATE
S.B. No. 
4S6
R;:cnv-.
1
1
INTRODUCED BY SENATOR VICENTE C. SOTTO III
AN ACT
REGULATING VAPORIZED NICOTINE PRODUCTS
Be it enacted by the Senate and House of Representatives o f the 
Philippines in Congress assem bled:
1 
SECTION 1. S h o rt Title. -  This Act shall be known as the “Vaporized
2 
Nicotine Products Regulation Act.”
3 
SEC. 2. D e cla ra tio n  o f Policy. -  It is hereby declared the policy of
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the State to protect and promote the right to health of the people and instill
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health consciousness am ong them.
6 
It is further declared the policy of the State to discourage the use of
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cigarette products and to look for effective m easures in the fight against
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cigarette 
sm oking 
by 
encouraging 
the 
availability 
of well-regulated,
9 
significantly less harm ful alternatives to cigarettes for sm okers who do not
10 
or cannot quit smoking.
11 
SEC. 3. D efinitions. As used in this Act, the following term s shall
12 
m ean -
13 
(a) “Vaporized nicotine product” m eans a product with or w ithout
14 
tobacco that generates a nicotine-containing aerosol without
15 
com bustion, with or w ithout electronics or any com ponent of that
16 
product, this includes but is not limited to a cartridge, a  tank and
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the device w ithout a cartridge or tank.


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(b) “Ingredient” m eans any substance that is added to the tobacco or 
nicotine m ixture and present in the finished product.
(c) “Nicotine” m eans nicotinic alkaloids, including any salt or complex 
of 
nicotine 
w hether 
derived 
from 
tobacco 
or 
synthetically 
produced.
(d) “Nicotine m ixture” m eans the nicotine-containing liquid, solid or 
other non-tobacco substance in the product.
(e) “Refill container” m eans a receptacle for holding nicotine m ixture 
to refill certain vaporized nicotine products.
(1) “Em issions” m eans substances that are released when a product is 
consum ed 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 C onstituents (HPHCs)” shall 
refer to chem ical substances that pose potential health risks such 
as those identified by the World Health Organization.
(h) “Reduced exposure claim” m eans a com m unication to consum ers 
in the product label or m arketing m aterial that the product or its 
em issions 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” m eans a com m unication to consum ers in the 
product label or m arketing which represents explicitly or implicitly 
th at the product presents a lower risk or is less harm ful than 
continued cigarette smoking.
(j) “Package” shall refer to packs, boxes, cartons or containers of any 
kind in which the electronic com ponent of a  vaporized nicotine 
product is offered for sale to consum ers.
(k) “Nicotine receptacle” shall refer to bottles, boxes, cartons, or 
containers of any kind in which a nicotine-containing solution or


1 
vaporized tobacco or any related product is offered for sale to
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consum ers for use with a vaporized nicotine product system .
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(1) “Point-of-sale” shall refer to any location at which an individual
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can purchase or othem isc obtain vaporized nicotine products.
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(m) “Principal display surface” shall refer to the panel of the nicotine
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receptacle that faces the consum er when displayed for sale.
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(n) “Advertising” shall refer to the business of conceptualizing,
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presenting, m aking available and com m unicating to the public,
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through any form of m ass media, any fact, data, or information
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about the attributes, features, quality or availability of consum er
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products, services, or credit. 
For the purpose of this Act,
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advertising shall be understood as vaporized nicotine product
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advertising.
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SEC. 4. P a c k a g in g  C ontent. -  The packaging shall contain the
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following:
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(a) A list of all vaporized nicotine product device com ponents; and
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(b) A leaflet or insert containing instructions for handling, proper use,
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and m aintenance. It shall also include w arnings against im proper
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usage.
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SEC. 5. H e a lth  W arnings. -  Only nicotine receptacles shall bear
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textual health w arnings with the following specifications:
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(a) Unit packets and any outside wrapping of vaporized nicotine
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product nicotine receptacles such as e-juices, tobacco cartridges
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not intended for com bustion, and sim ilar products, shall carry the
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following health warning: T his product may dam age your health
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and is addictive’.
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(b) The health warning shall occupy 30% of the lower part of the
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principal display 
surface of the unit packet 
and 
any outside
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w rapping of the nicotine receptacle. The health w arning 
shall
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occupy a total area of not less than fifty percent (50%) of the total
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w arning frame.
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(c) Nothing shall be printed or applied on a location where it is likely
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to obscure or cover, in part or in whole, the health warning.


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(d) No part of the warning may he obliterated, obscured, folded,
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severed or become unreadable when the nicotine receptacle is
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opened or closed or when a w rapper on the receptacle is removed.
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Vaporized nicotine products shall not be covered by the Graphic
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Health W arnings Law.
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SEC. 6. M inim um  Age S ales a n d  P u rch ase. - The following acts
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shall be prohibited:
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(a) The sale and distribution, or transfer of vaporized nicotine
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products by any person to m inors (anyone below 18 years old);
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(b) Purchasing, or othem ise receiving vaporized nicotine products
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from a minor; and
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(c) The sale, purchase, and use of vaporized nicotine products by
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m inors.
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It shall not be a defense for the person selling or distributing the
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vaporized nicotine p ro d u ct/s that h e /sh e  did not know or w as not aware of
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the real age of the minor. Neither shall it be a defense that h e /sh e  did not
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know nor had any reason to believe that the product w as for the
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consum ption of the m inor to whom it was sold.
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SEC. 
7. 
Point-of-sale 
Signage. 
- 
Point-of-sale 
establishm ents
20 
offering, distributing, or selling vaporized nicotine products to consum ers
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shall post the following statem ent in a clear and conspicuous m anner;
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“SALE/DISTRIBUTION TO OR PURCHASE BY MINORS OF VAPORIZED
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NICOTINE 
PRODUCTS 
IS 
UNLAWFUL” 
or “IT 
IS 
UNLAWFUL 
FOR
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VAPORIZED NICOTINE PRODUCTS TO BE SOLD/DISTRIBUTED TO OR
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PURCHASED BY PERSONS UNDER 18 YEARS OF AGE.”
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SEC. 8. P ro o f o f Age V erification. - Retailers shall ascertain that no
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individual purchasing a vaporized nicotine product is below eighteen (18)
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years of age. 
In case of doubt, retailers shall verify the age of the buyer
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through any valid identification card exhibiting the buyer’s photograph and
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age or date of birth.
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SEC. 9. A d v ertisem en t R estrictio n s. -  Advertisem ents shall be
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allowed in points-of-sale, through diiect mm keting, and on the internet. The


1 
following 
restrictions 
shall 
apply 
to 
all 
vaporized 
nicotine 
product
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advertisem ents:
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(a) Advertisem ents shall not be aimed at or particularly appeal to
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persons under eighteen (18) years of age;
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(b) Advertisem ents shall not contain cartoon characters or subjects
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that depict hum ans or anim als with comically exaggerated
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features or that attribute hum an or unnatural characteristics to
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anim als, plants or other objects;
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(c) Advertisem ents shall only depict persons who are or who appear to
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be above twenty-five (25) years of age;
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(d) A dvertisem ents shall not show, portray or depict scenes where the
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actual use of, act of using, or puffing of vaporized nicotine
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products;
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(e) Advertisem ents should not underm ine quit-sm oking m essages and
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encourage non-tobacco or nicotine users to use the product;
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(f) A dvertisem ents do not contain any information or elem ent th at is
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un tru e or not scientifically substantiated, in particular with
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regards 
to product 
characteristics, 
health 
effects, 
risks or
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em issions;
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(g) Promotional com m unications shall allow for adult consum ers to
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learn about the availability of vaporized nicotine products, receive
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inform ation about how to use them , tiy them  before purchasing
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them , subject to proof of age and certification of sm oker status,
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and receive pre-sale and after-sales support;
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(h) Advertisem ents shall not appeEir in television, radio, and cinema;
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and
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(i) All 
allowable 
advertisem ents and 
prom otional 
m aterials 
for
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nicotine receptacles shall contain the health w arning T his product
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m ay dam age your health and is addictive.’ The health w arning
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shall occupy ten percent of the bottom area of the advertisem ent.
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SEC. 
10. 
R e stric tio n s on A dvertisem ent in  P rin t M edia. 
-
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Advertising and other prom otional com m unications of vaporized nicotine


1 
products shall be perm itted so long as the publication is not intended for
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m inors and generally has an adult readership or subscriber base.
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SEC. 11. P ublic P lace Use. - Use of vaporized nicotine products
4 
indoor is prohibited in places of worship, hospitals or other healthcare
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centers, 
public conveyances, governm ent offices, and educational or
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recreational facilities exclusively intended for minors. In all other enclosed
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places th at are open to the general public, private w orkplaces and those
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places not covered in the preceding enum eration, vaporized nicotine product
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use shall be allowed, provided that the owner, proprietor, operator,
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possessor, m anager or adm inistrator of such places shall post the following
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statem ent in a clear and conspicuous m anner at eveiy ingress point of the
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such places: “USE OF VAPORIZED NICOTINE PRODUCl'S IS ALLOWED
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INSIDE.”
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SEC. 12. P ro d u c t S ta n d a rd s  a n d  A ssessm ent. -  Vaporized nicotine
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products m ust comply with the following:
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(a) Vaporized nicotine products shall operate in such a way that no
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com bustion of the tobacco or nicotine m ixture occurs during the
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entire process of consum ption when used as intended;
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(b) All products m ust be m anufactured in accordance with an
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appropriate quality m anagem ent system. The quality m anagem ent
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system  m ust ensure batch-to-batch reproducibility of the products
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through quality control of both incoming m aterials and finished
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products; prevention of mix-ups; and traceability from raw
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m aterial supplier to distributor, with supporting docum ented
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evidence and a controlled change m anagem ent process;
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(c) The substances listed below may not be added in vaporized
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nicotine products:
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i. additives that have carcinogenic, m utagenic or reprotoxic
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properties in unburnt form;
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ii. respiratory sensitizers;
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iii. ethyleneglycol;
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iv. diethylene glycol;
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v. diacetyl; and


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vi. 2,3-pcnlanedione;
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(Cl) M anufacturers of electrical devices intended 
to be used in
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com bination with a vaporized nicotine product shall ensure that
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such devices comply with applicable electrical vSafety standards;
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and
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(e) B atteries m ust comply with applicable industry recjuirements.
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SEC. 13. T a m p e rp ro o f a n d  C hild-proof D esigns. - All receptacles
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containing nicotine m ixtures m ust be child-resistant, tam per-resistant and
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protected against breakage and leakage.
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SEC. 14. M ark et P lacing. -  M anufacturers and distributors m ust
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comply with the following;
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(a) Three (3) m onths prior to placing a vaporized nicotine product in
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the m arket, all m anufacturers and im porters m ust register their
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products with the D epartm ent of Trade and Industiy (DTI) and
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subm it 
information 
dem onstrating compliance 
with 
product
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stan d ard s and assessm ent requirem ents;
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(b) M anufacturers or im porters intending to present the product with
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any inform ation about the product’s health effects such as
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reduced exposure or reduced risk claims, m ust subm it scientific
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evidence supporting such consum er com m unication to the Food
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and Drug Adm inistration (FDA); and
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(c) For products th at are already in-m arket, they shall be given three
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m onths to register their products with the DTI and subm it
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inform ation dem onstrating compliance with product standards
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and assessm ent requirem ents. Any health claim s for in-m arket
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products shall also be subm itted to the FDA for approval.
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SEC. 15. H e a lth  C laim s. -  Notwithstanding the foregoing provisions,
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there are only two (2) claim s that vaporized nicotine product m anufacturers
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and distributors may make: (i) a reduced exposure claim and (ii) a reduced
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risk claim. The FDA shall be the responsible authority with respect to claim s
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of reduced exposure or reduced risk.
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(a) A reduced exposure claim may be mode only if:


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i. The m anufacturer characterizes the levels of nicotine 
uptake from vaporized nicotine products com pared to 
cigarette smoking based on clinical trials;
ii. The m anufacturer can support the claim with evidence 
from clinical trials conducted over a period of at least 
seven days dem onstrating that, com pared 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 
biom arkers 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 sm okers who switched to the product;
iii. The m anufacturer dem onstrates that the average user of 
tobacco product who is reasonably well-informed and 
reasonably 
observant 
and 
circum spect 
correctly 
com prehends the claim; and
iv. Clinical studies m ust be performed in accordance with 
ethical principles that have their origin in the Declaration 
of 
Helsinki 
and 
be 
consistent 
with 
reavsonable 
internationally accepted standards.
(b) A reduced risk claim may only be made if:
i. The m anufacturer m eets the requirem ents stipulated for 
reduced exposure claims;
ii. The m anufacturer can support the claim with clinical 
studies; and
iii. The m anufacturer can support 
the claim with evidence 
from clinical trials conducted over a period of at least 
ninety days dem onstrating that,
1. com pared 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 biom arker of exposure to HPHCs or


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th at the reductions are within 20% of the reduction
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obseiwed in sm okers who quit cigarette sm oking
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over the study period, and
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2. com pared to continued cigarette smoking, users
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who switch completely to the product in conditions
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of actual use show a reduction in risk of harm  or
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harm  com pared to continued smoking.
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Products substantiated as “reduced exposure” or “reduced risk”
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p u rsu an t to this Section may m ake such claim s on product
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packaging and nicotine receptacles.
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(c) To characterize risk reduction in the absence of epidemiological
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evidence, a m anufacturer may instead dem onstrate favorable
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biological and physiological changes in chosen clinical risk
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endpoints as com pared to continued smoking. These endpoints
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need to be effected by smoking, linked to sm oking related disease
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and reversible after smoking cessation. The majority of the
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assessed clinical risk endpoints m ust shift in the direction of
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sm oking cessation.
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(d) A reduced exposure, or reduced risk claim is perm issible only with
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regard to products for which adequate post-m arketing surveillance
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is in place. The notification m ust include the plans for such post-
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m arketing surveillance and studies to determ ine the im pact of the
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m arketing of the product on the population.
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SEC. 16. P e n a ltie s f o r  N oncom pliance. -  The following penalties
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shall individually apply to m anufacturers, im porters, distributors, and
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sellers of vaporized nicotine products as well as their agents/representatives
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for any violation of this Act:
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(a) 
On the first offense, a fine of not more than One hundred
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thousand pesos (P100,000.00);
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(b) 
On the second offense, a fine of not more than Five hundred
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thousand pesos (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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(P1,000,000.00) or im prisonm ent of not more than five (5) years, or both, at


1 
the discretion of the court: Provided, T hat the business perm its and
2 
licenses, in the case of a business entity or establishm ent shall be revoked
3 
or cancelled.
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Non-compliant vaporized nicotine products found in the m arket for
5 
sale or distribution shall be subject to confiscation.
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If the guilty officer is a foreign national, he shall be deported after
7 
service of sentence a n d /o r paym ent of applicable fines without need of
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further deportation proceedings and shall be perm anently barred from re-
9 
entering the Philippines.
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SEC. 17. C reatio n  o f a  C ongressional O versight C om m ittee. -  A
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Congressional Oversight Committee co-chaired by the Senate Com m ittees on
12 
Trade, Commerce, and E ntrepreneurship and Health and Demography and
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the House Com mittees on Trade and Health, is hereby constituted to
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m onitor and review the im plem entation of this Act.
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SEC. 18. Im p lem en tin g  R ules a n d  R egulations. -  Within six (6)
16 
m onths from the date of effectivity of this Act, the D'fl, in consultation with
17 
the FDA of the D epartm ent of Health, shall issue the im plem enting rules
18 
and regulations of this Act. The non-issuance of the IRR will not suspend
19 
the effectivity of this Act or the introduction of new vaporized nicotine
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products in the m arket.
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SEC. 19. S e p a ra b ility  C lause. -  If any provision or part hereof, is
22 
held invalid or unconstitutional, the rem ainder of the law or the provision
23 
not otherwise affected shall rem ain valid and subsisting.
24 
SEC. 20. R ep ealin g  C lause. -  Any law, presidential decree or
25 
issuance, executive order, letter of instruction, adm inistrative order, rule or
26 
regulation contrary to or is inconsistent with the provision of this Act is
27 
hereby repealed, modified, or am ended accordingly.
28 
SEC. 21. E ffectim ty  C lause. -  This Act shall take effect fifteen (15)
29 
days after its publication in at least two (2) new spapers of general
30 
circulation.
Approved,
10