republic of the philippines } f irst r egular session

13
EIGHTEENTH CONGRESS OF THE { REPUBLIC OF THE PHILIPPINES } First Regular Session } SENATE 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 Systems (VNPs) arc 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 locally12 . 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 cigarettes-*. 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. 1 Conference of tlic Panics to llic WHO Framework Comcnlion on Tobacco Conlrol 7"' session ieix)rt 2 Philippine College of Clicsl Physicians Posilion Slalcmcnl on Clccdonic Cigaicllcs (E-CigaicKcs)/ Elcclronic Nicotine Dclivcr>- Devices (ENDD) I

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Page 1: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

EIGHTEENTH CONGRESS OF THE { REPUBLIC OF THE PHILIPPINES } F i r s t R e g u la r S e ss io n }

S E N A T ES.B. No. 496

• in ■

'19 JUL 15 All ••00

INTRODUCED BY SENATOR VICENTE C. SOTTO III

AN ACTREGULATING VAPORIZED NICOTINE PRODUCTS

EXPLANATORY NOTE

Vaporized Nicotine Product System s (VNPs) arc b a tte ry -run p roducts

th a t h ea t a solution (e-juice) to generate vapor th a t usually co n sis ts of

vegetable glycerin, propylene glycol, flavorants, and nicotine. They

com m only consist of an atom izer, which h ea ts the e-juice; a cartridge, which

serves a s the e-juice carrier; and a power source or battery.

As of 2015, the global VNP m arket size w as estim ated to be US$10

billion and show ing con tinued increase in prevalence of VNP use both

globally and locally1 2. Such a trend th rea ten s public health if the VNP

m arke t rem ains unregulated .

These VNPs are prom oted a s cigarette a lternatives and are designed to

m im ic both the form a s well a s the physical sensation delivered by

cigarettes-*. Some VNPs claim in their m arketing labels th a t they are effective

sm oking cessation tools a s well a s safer a lternatives to sm oking. Most of

these health claim s are yet to be proven by concrete scientific evidence. In

fact, the World H ealth O rganizations (WHO) h a s sta ted concerns on its

safety an d its su s ta inab ility a s a qu itting aid.

1 C o n fe re n ce o f t l ic P a n ics to l l ic W H O F ra m e w o rk C o m c n lio n o n T o b a cco C o n lro l 7"' session ie ix )r t2 P h ilip p in e C o lle g e o f C lic s l P h ys ic ia n s P o s ilio n S la lc m c n 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 t in e D c livc r> - D e v ice s (E N D D )

I

Page 2: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

VNP use m ay still pose a health risk to u se rs. The vapor generated

still co n ta in s the u su a l tox ican ts th a t are found in cigarette sm oke such a s

form aldehyde, volatile organic com pounds, tobacco-specific n itrosam ines,

m etals, silicate particles, polycyclic arom atic hydrocarbons, and o ther

carcinogens - albeit a t m uch lower levels. At high levels, these su b s ta n c e s

are know n to cause resp ira to iy and vascu lar d iseases a p a r t from cancer.

The VNP aerosol also con ta in s nicotine, a lthough no t a carcinogen, is still an

addictive su b stan ce .

One study also suggests th a t VNP use m ay initialize youth u p tak e 3 4.

The flavorings th a t a re p resen t in e-juices, such a s chocolate an d candy-like

flavors, m ay appeal to m inors and cause youth up take. By perpe tua ting the

behavior of sm oking, VNP use have the potential to underm ine sm oking

cessa tion effo rts1.

The lack of a regulatory schem e to oversee p roduct s ta n d a rd s and

safety h a s also led to the placem ent of inferior quality p roducts in the

Philippine m arket. In fact, m edia repo rts of exploding VNP p ro d u cts are

becom ing increasingly com m on, with more th an 200 reports of VNP-related

explosions3 all over the world. These regrettable even ts could have been

prevented had there been a proper regulatoiy schem e in place.

T his bill p roposes th a t VNP p roducts be regulated in su ch a way th a t

any h ea lth claim is assessed by the Food and D rug A dm inistration (FDA),

reg istra tion and p roduct quality and safety are in line w ith the s ta n d a rd s set

by the D epartm en t of T rade and In d u stiy (DTI), sa les and d istribu tion to

an d from m inors are prohibited, and both public and environm ental hea lth

are protected.

Moreover, contained in th is proposed bill is a provision on “public

p lace u se”, which specifies the places w here VNPs m ay be validly used.

T hus, th is m easu re seeks to fill in the gap of Executive O rder No. 26 issued

by P residen t Rodrigo D uterte on May 16, 2017 which p roh ib its sm oking in

3 D c p n r lm c n l o f H c .'iK li W c b s ilc l i l lp / / \ \ \ \ w .(Jo li.m )\ . i) li/ iiu c lc /( i4

4 P l i i l ip p i i ic C o lle g e o f C lie s l P h ys ie ians P o s it io n S ta tem en t o n E le e tio n ie C ig a re tte s (E -C ig ; ite tte s ) / E le e t io n ie N ic o t in 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/

Page 3: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

“enclosed public spaces and public conveyances except in certa in designated

sm oking a re a s” a s the aforesaid executive order does not cover VNPs.

The im m ediate passage of th is bill is earnestly requested .

VICENTE C. SOTTO III

Page 4: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

EIGHTEENTH CONGRESS OF THE |

REPUBLIC OF THE PHILIPPINES }

F i r s t R e g u la r S e ss io n }

t J ' dfli •* i **

*19 JUL 15 P11 :00

SENATE

S.B. No. 4S6 R;:cnv-. 11

INTRODUCED BY SENATOR VICENTE C. SOTTO III

AN ACT

REGULATING VAPORIZED NICOTINE PRODUCTS

Be it enac ted by the Senate a n d H ouse o f R epresentatives o f the

Philippines in C ongress assem bled:

1 SECTION 1. S h o r t T itle . - This Act shall be known a s the “Vaporized

2 Nicotine Products Regulation Act.”

3 SEC. 2. D e c la ra t io n o f Policy . - It is hereby declared the policy of

4 th e S ta te to p ro tect and prom ote the right to health of the people and instill

5 health co n sc io u sn ess am ong them .

6 It is fu rth er declared the policy of the S ta te to d iscourage the use of

7 cigarette p ro d u c ts and to look for effective m easu res in the fight aga in st

8 c igarette sm oking by encouraging the availability of w ell-regulated,

9 significantly less harm ful a lternatives to cigarettes for sm okers who do not

10 or can n o t qu it sm oking.

11 SEC. 3. D e fin itio n s . As used in th is Act, the following term s shall

12 m ean -

13 (a) “Vaporized nicotine p roduct” m eans a p roduct w ith or w ithout

14 tobacco th a t generates a n icotine-contain ing aerosol w ithout

15 com bustion , w ith or w ithout electronics or any com ponent of th a t

16 p roduct, th is includes b u t is not limited to a cartridge, a tan k and

17 the device w ithout a cartridge or tank.

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1 (b) “Ingred ien t” m eans any su b s tan ce th a t is added to the tobacco or

nicotine m ixture and p resen t in the finished product.

(c) “Nicotine” m eans nicotinic alkaloids, including any sa lt or com plex

of nicotine w hether derived from tobacco or synthetically

produced.

(d) “Nicotine m ix ture” m eans the nicotine-contain ing liquid, solid or

o th er non-tobacco su b stan ce in the product.

(e) “Refill co n ta in e r” m eans a receptacle for holding nicotine m ixture

to refill certa in vaporized nicotine p roducts.

(1) “E m issions” m eans su b s ta n c es th a t a re released w hen a p roduct is

consum ed a s in tended, such a s su b s ta n c es found in cigarette

sm oke, or the aerosol generated by a vaporized nicotine p roducts,

or su b s ta n c es released during the process of u sing vaporized

nicotine p roducts.

(g) “H arm ful and Potentially Harm ful C o n stitu en ts (HPHCs)” shall

refer to chem ical su b s ta n c es th a t pose potential health risk s such

a s those identified by the World Health O rganization.

(h) “Reduced exposure claim ” m eans a com m unication to co n su m ers

in the p roduct label or m arketing m aterial th a t the p roduct or its

em issions contain a reduced level of, or are free of, a su b s tan ce or

su b s ta n c e s or p resen t a reduced exposure to a su b s ta n c e or

su b s tan ces , such a s HPHCs.

(i) “Reduced risk claim ” m eans a com m unication to co n su m ers in the

p roduct label or m arketing which rep resen ts explicitly or implicitly

th a t the p roduct p resen ts a lower risk or is less harm ful th an

con tinued cigarette sm oking.

(j) “Package” shall refer to packs, boxes, ca rto n s or co n ta in ers of any

k ind in w hich the electronic com ponent of a vaporized nicotine

p roduct is offered for sale to consum ers.

(k) “Nicotine receptacle” shall refer to bottles, boxes, cartons, or

co n ta in ers of any kind in which a n icotine-contain ing solution or

Page 6: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

1 vaporized tobacco or any related p roduct is offered for sale to

2 co n su m ers for u se w ith a vaporized nicotine p roduct system .

3 (1) “Point-of-sale” shall refer to any location a t w hich an individual

4 can p u rch ase or o th em isc obtain vaporized nicotine p roducts.

5 (m) “Principal display surface” shall refer to the panel of the nicotine

6 receptacle th a t faces the consum er w hen displayed for sale.

7 (n) “A dvertising” shall refer to the b u s in ess of conceptualizing,

8 p resen ting , m aking available and com m unicating to the public,

9 th rough any form of m ass m edia, any fact, d a ta , or inform ation

10 ab o u t the a ttr ib u te s , features, quality or availability of consum er

11 p roducts , services, or credit. For the pu rpose of th is Act,

12 advertising shall be understood a s vaporized nicotine p roduct

13 advertising.

14 SEC. 4 . P a c k a g in g C on ten t. - The packaging shall con ta in the

15 following:

16 (a) A list of all vaporized nicotine p roduct device com ponents; and

17 (b) A leaflet or in sert contain ing in stru c tio n s for handling, proper use ,

18 and m ain tenance . It shall also include w arn ings again st im proper

19 usage.

20 SEC. 5. H e a lth W arn in g s. - Only nicotine recep tacles shall bear

21 tex tual health w arn ings with the following specifications:

22 (a) Unit packe ts and any outside w rapping of vaporized nicotine

23 p roduct nicotine receptacles such a s e-juices, tobacco cartridges

24 not in tended for com bustion , and sim ilar p roducts, shall carry the

25 following health warning: T h is p roduct m ay dam age your health

26 and is addictive’.

27 (b) The health w arning shall occupy 30% of the lower p a rt of the

28 principal display surface of the un it packet and any ou tside

29 w rapping of the nicotine receptacle. The health w arn ing shall

30 occupy a total a rea of not less th an fifty percen t (50%) of the total

31 w arn ing frame.

32 (c) Nothing shall be prin ted or applied on a location w here it is likely

33 to obscure or cover, in p a rt or in whole, the health w arning.

Page 7: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

1 (d) No p a rt of the w arning m ay he obliterated, obscured , folded,

2 severed or becom e un readab le w hen the nicotine receptacle is

3 opened or closed or w hen a w rapper on the receptacle is removed.

4 Vaporized nicotine p roducts shall not be covered by the G raphic

5 H ealth W arnings Law.

6 SEC. 6 . M in im um Age S a le s a n d P u rc h a s e . - The following ac ts

7 shall be prohibited:

8 (a) The sale and d istribu tion , or tran sfe r of vaporized nicotine

9 p ro d u c ts by any person to m inors (anyone below 18 years old);

10 (b) Purchasing , or o th em ise receiving vaporized nicotine p ro d u cts

11 from a m inor; and

12 (c) The sale, p u rchase , and use of vaporized nicotine p ro d u c ts by

13 m inors.

14 It shall not be a defense for the person selling or d is tribu ting the

15 vaporized nicotine p ro d u c t/s th a t h e /s h e did not know or w as not aw are of

16 the real age of the m inor. Neither shall it be a defense th a t h e /s h e did not

17 know nor had any reason to believe th a t the product w as for the

18 consum ption of the m inor to whom it w as sold.

19 SEC. 7. P o in t-o f-sa le S ig n a g e . - Point-of-sale estab lish m en ts

20 offering, d istribu ting , or selling vaporized nicotine p ro d u cts to con su m ers

21 shall post the following sta tem en t in a clear and consp icuous m anner;

22 “SALE/DISTRIBUTION TO OR PURCHASE BY MINORS OF VAPORIZED

23 NICOTINE PRODUCTS IS UNLAWFUL” or “IT IS UNLAWFUL FOR

24 VAPORIZED NICOTINE PRODUCTS TO BE SOLD/DISTRIBUTED TO OR

25 PURCHASED BY PERSONS UNDER 18 YEARS OF AGE.”

26 SEC. 8. P ro o f o f Age V erifica tio n . - Retailers shall a scerta in th a t no

27 individual p u rch asin g a vaporized nicotine p roduct is below eighteen (18)

28 years of age. In case of doubt, re ta ilers shall verify the age of the buyer

29 th rough any valid identification card exhibiting the buyer’s photograph and

30 age or d a te of b irth .

31 SEC. 9 . A d v e rtis e m e n t R e s tr ic tio n s . - A dvertisem ents shall be

32 allowed in points-of-sale, through diiect mm keting, and on the in te rnet. The

Page 8: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

1 following restric tions shall apply to all vaporized nicotine p roduct

2 advertisem ents:

3 (a) A dvertisem ents shall not be aim ed a t or particu larly appeal to

4 persons u n d e r eighteen (18) years of age;

5 (b) A dvertisem ents shall not contain cartoon ch a rac te rs or sub jec ts

6 th a t depict h u m an s or an im als with comically exaggerated

7 fea tu res or th a t a ttr ib u te h u m an or u n n a tu ra l ch arac te ris tic s to

8 an im als, p lan ts or o ther objects;

9 (c) A dvertisem ents shall only depict persons who are or who a p p ea r to

10 be above twenty-five (25) years of age;

11 (d) A dvertisem ents shall no t show, portray or depict scenes w here the

12 ac tu a l u se of, act of using, or puffing of vaporized nicotine

13 products;

14 (e) A dvertisem ents should not underm ine quit-sm oking m essages and

15 encourage non-tobacco or nicotine u se rs to use the product;

16 (f) A dvertisem ents do not con tain any inform ation or elem ent th a t is

17 u n tru e or no t scientifically su b s tan tia ted , in p a rticu la r w ith

18 regards to p roduct charac teristics, health effects, risk s or

19 em issions;

20 (g) Prom otional com m unications shall allow for ad u lt co n su m ers to

21 learn ab o u t the availability of vaporized nicotine p roducts, receive

22 inform ation ab o u t how to use them , tiy them before p u rch asin g

23 them , sub ject to proof of age and certification of sm oker s ta tu s ,

24 an d receive pre-sale and after-sales support;

25 (h) A dvertisem ents shall not appeEir in television, radio, an d cinem a;26 and

27 (i) All allowable advertisem ents and prom otional m ateria ls for

28 nicotine receptacles shall contain the health w arning T h is p roduct

29 m ay dam age your health and is addictive.’ The health w arning

30 shall occupy ten percen t of the bottom a rea of the advertisem ent.

31 SEC. 10. R e s tr ic t io n s o n A d v e rtise m e n t in P r in t M edia . -

32 A dvertising and o ther prom otional com m unications of vaporized nicotine

Page 9: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

1 p ro d u c ts shall be perm itted so long a s the publication is not in tended for

2 m inors and generally h a s an ad u lt readersh ip or su b scrib er base.

3 SEC. 11. P u b lic P la c e Use. - Use of vaporized nicotine p ro d u cts

4 indoor is prohibited in places of worship, hosp ita ls or o ther healthcare

5 cen ters , public conveyances, governm ent offices, and educational or

6 recreational facilities exclusively in tended for m inors. In all o ther enclosed

7 p laces th a t a re open to the general public, private w orkplaces an d those

8 p laces not covered in the preceding enum eration , vaporized nicotine p roduct

9 u se shall be allowed, provided th a t the owner, proprietor, operator,

10 possesso r, m anager or ad m in is tra to r of such places shall post the following

11 s ta te m e n t in a c lear and consp icuous m an n er a t eveiy ingress point of the

12 su ch places: “USE OF VAPORIZED NICOTINE PRODUCl'S IS ALLOWED

13 INSIDE.”

14 SEC. 12. P ro d u c t S ta n d a r d s a n d A sse ssm e n t. - Vaporized nicotine

15 p ro d u c ts m u st comply with the following:

16 (a) Vaporized nicotine p roducts shall operate in su ch a way th a t no

17 com bustion of the tobacco or nicotine m ixture occu rs du ring the

18 en tire process of consum ption when used a s in tended;

19 (b) All p ro d u cts m u st be m anufactu red in accordance w ith an

20 appropria te quality m anagem ent system . The quality m anagem ent

21 system m u st en su re ba tch-to -batch reproducibility of the p roducts

22 th rough quality control of both incom ing m ateria ls an d finished

23 p roducts ; prevention of m ix-ups; and traceability from raw

24 m ateria l supplier to d istribu to r, with supporting docum ented

25 evidence and a controlled change m anagem ent process;

26 (c) The su b s ta n c es listed below m ay not be added in vaporized

27 nicotine products:

28 i. additives th a t have carcinogenic, m utagenic o r reprotoxic

29 properties in u n b u rn t form;

30 ii. resp ira to ry sensitizers;

31 iii. ethyleneglycol;

32 iv. diethylene glycol;

33 v. diacetyl; and

Page 10: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

1 vi. 2 ,3 -pcn laned ione;

2 (Cl) M anufac tu rers of electrical devices in tended to be used in

3 com bination with a vaporized nicotine p roduct shall en su re th a t

4 such devices comply with applicable electrical vSafety standards;5 and

6 (e) B atteries m u st comply with applicable industry recjuirem ents.

7 SEC. 13. T a m p e rp ro o f a n d C h ild -p ro o f D esigns. - All recep tacles

8 con ta in ing nicotine m ix tu res m u st be ch ild -resis tan t, tam p er-re s is tan t and

9 pro tected ag a in st breakage and leakage.

10 SEC. 14. M a rk e t P la c in g . - M anufactu rers and d is tr ib u to rs m ust

11 com ply w ith the following;

12 (a) Three (3) m on ths prior to placing a vaporized nicotine p roduct in

13 the m arket, all m an u fac tu re rs and im porters m ust reg ister their

14 p ro d u c ts w ith the D epartm ent of T rade and In d u stiy (DTI) and

15 su b m it inform ation dem onstra ting com pliance w ith product

16 s ta n d a rd s and a sse ssm en t requirem ents;

17 (b) M anufactu rers or im porters in tending to present the p roduct with

18 any inform ation ab o u t the p ro d u c t’s health effects su ch as

19 reduced exposure or reduced risk claim s, m u st subm it scientific

20 evidence supporting such consum er com m unication to the Food

21 an d D rug A dm inistration (FDA); and

22 (c) For p ro d u cts th a t are already in -m arket, they shall be given three

23 m o n th s to register their p roducts with the DTI and subm it

24 inform ation dem onstra ting com pliance with p roduct s ta n d a rd s

25 and a sse ssm en t requirem ents. Any health claim s for in -m arket

26 p roducts shall also be subm itted to the FDA for approval.

27 SEC. 15. H e a l th C la im s. - N otw ithstanding the foregoing provisions,

28 there are only two (2) claim s th a t vaporized nicotine p roduct m an u fac tu re rs

29 and d is tr ib u to rs may m ake: (i) a reduced exposure claim and (ii) a reduced

30 risk claim . The FDA shall be the responsible au tho rity w ith respect to claim s

31 of reduced exposure or reduced risk.

32 (a) A reduced exposure claim m ay be m ode only if:

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i. The m an u fac tu re r characterizes the levels of nicotine

u p tak e from vaporized nicotine p ro d u cts com pared to

cigarette sm oking based on clinical trials;

ii. The m an u fac tu re r can suppo rt the claim w ith evidence

from clinical tria ls conducted over a period of a t least

seven days dem onstra ting th a t, com pared to con tinued

cigarette sm oking, u se rs who switch com pletely to the

p roduct show a significant reduction in exposure to one

or more HPHCs based on validated, scientifically-accepted

b iom arkers of exposure and th a t the reduc tions in

exposure are significant enough th a t a reasonable

scientific or m edical expert would an tic ipa te a reduction

in risk of d isease in sm okers who sw itched to the product;

iii. The m an u fac tu re r d em o n stra tes th a t the average u se r of

tobacco product who is reasonably well-informed and

reasonably observan t and c ircum spect correctly

com prehends the claim; and

iv. Clinical s tud ies m u st be perform ed in accordance w ith

ethical principles th a t have their origin in the D eclaration

of Helsinki and be consisten t w ith reavsonable

in ternationally accepted s tan d ard s.

(b) A reduced risk claim m ay only be m ade if:

i. The m an u fac tu re r m eets the requ irem en ts s tipu la ted for

reduced exposure claim s;

ii. The m an u fac tu re r can suppo rt the claim with clinical

stud ies; and

iii. The m an u fac tu rer can sup p o rt the claim with evidence

from clinical tria ls conducted over a period of a t least

n inety days dem onstra ting tha t,

1. com pared to continued cigarette sm oking, u se rs

who sw itch completely to the product in conditions

of ac tual use show a significant reduction in the

level of each biom arker of exposure to HPHCs or

Page 12: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

1 th a t the reductions are w ithin 20% of the reduction

2 obseiwed in sm okers who qu it c igarette sm oking

3 over the study period, and

4 2. com pared to con tinued cigarette sm oking, u se rs

5 who sw itch com pletely to the p roduct in conditions

6 of ac tu a l use show a reduction in risk of harm or

7 harm com pared to con tinued sm oking.

8 P roducts su b s tan tia ted a s “reduced exposure” or “reduced risk ”

9 p u rsu a n t to th is Section m ay m ake such claim s on p roduct

10 packaging and nicotine receptacles.

11 (c) To characterize risk reduction in the absence of epidemiological

12 evidence, a m an u fac tu re r m ay in stead dem onstra te favorable

13 biological and physiological changes in chosen clinical risk

14 endpo in ts a s com pared to con tinued sm oking. These endpo in ts

15 need to be effected by sm oking, linked to sm oking related d isease

16 and reversible after sm oking cessation . The m ajority of the

17 a sse ssed clinical risk endpo in ts m u st shift in the direction of

18 sm oking cessation .

19 (d) A reduced exposure, or reduced risk claim is perm issible only w ith

20 regard to p roducts for which adequate post-m arketing surveillance

21 is in place. The notification m u st include the p lans for su ch post-

22 m arketing surveillance and s tud ies to determ ine the im pact of the

23 m arketing of the p roduct on the population.

24 SEC. 16. P e n a l t ie s f o r N oncom pliance . - The following penalties

25 shall individually apply to m anu factu rers , im porters, d is trib u to rs , and

26 sellers of vaporized nicotine p roducts a s well a s their a g en ts /rep re se n ta tiv e s

27 for any violation of th is Act:

28 (a) On the first offense, a fine of not m ore th an One h u n d red

29 th o u sa n d pesos (P100,000.00);

30 (b) On the second offense, a fine of not more th an Five h u n d red

31 th o u sa n d pesos (P500,000.00); and

32 (c) On the th ird offense, a fine of not more than One million pesos

33 (P1,000,000.00) or im prisonm ent of not more th an five (5) years, or both, a t

Page 13: REPUBLIC OF THE PHILIPPINES } F irst R egular Session

1 the d iscretion of the court: Provided, T hat the b u sin ess perm its and

2 licenses, in the case of a b u sin ess entity or estab lish m en t shall be revoked

3 or cancelled.

4 N on-com pliant vaporized nicotine p roducts found in the m arke t for

5 sale or d istribu tion shall be sub ject to confiscation.

6 If the guilty officer is a foreign national, he shall be deported after

7 service of sen tence a n d /o r paym ent of applicable fines w ithout need of

8 fu rth e r deporta tion proceedings and shall be perm anently barred from re-

9 en tering the Philippines.

10 SEC. 17. C re a tio n o f a C o n g re ss io n a l O v e rs ig h t C om m ittee . - A

11 C ongressional Oversight Com m ittee co-chaired by the Senate C om m ittees on

12 T rade, Com m erce, and E n trep reneu rsh ip and Health and D em ography and

13 the H ouse C om m ittees on Trade and Health, is hereby co n stitu ted to

14 m onitor and review the im plem entation of th is Act.

15 SEC. 18. Im p le m e n tin g R u le s a n d R e g u la tio n s . - W ithin six (6)

16 m o n th s from the date of effectivity of th is Act, the D'fl, in consu lta tion with

17 the FDA of the D epartm ent of Health, shall issue the im plem enting ru les

18 and regu la tions of th is Act. The non -issuance of the IRR will not su sp en d

19 the effectivity of th is Act or the in troduction of new vaporized nicotine

20 p ro d u c ts in the m arket.

21 SEC. 19. S e p a ra b i l i ty C lause . - If any provision or p a rt hereof, is

22 held invalid or unconstitu tiona l, the rem ainder of the law or the provision

23 no t otherw ise affected shall rem ain valid and subsisting .

24 SEC. 2 0 . R e p e a lin g C lause . - Any law, p residen tia l decree or

25 issu an ce , executive order, letter of instruction , adm in istrative order, ru le or

26 regulation con trary to or is inconsisten t with the provision of th is Act is

27 hereby repealed, modified, or am ended accordingly.

28 SEC. 2 1 . E ffe c tim ty C lau se . - This Act shall take effect fifteen (15)

29 days a fte r its publication in a t least two (2) new spapers of general

30 c irculation .

Approved,

10