DOH Administrative Order required graphic health information on tobacco product packages

1. Republic of rhe Phil ippincs
Department oI Heallh
OF'FICE OF THE SECRETARY
12 r4ay 20I0
ADMINISTR.ATI,8 ORDER
No.2010 - /0/?
SIIBJEC'I: RtrOUIRING GRAPHIC IIEALTII INFORMATION ON TOBACCO
PRODUCT PACKAGES, ANOPTING IVIEASURES TO ENSURE
THAT TOBACCO PRODUCT PACKAGING AND LABELLING DO
NOT PROMOTE TOBACCO BY ANY MEANS TIAAT ARE FALSE.
MISLEADING. DECEPTI'E OR LIKELY TO CREATE AN
ERRONEOUS IMPRESSION. AND MATTERS RNLATtrD TIIDRETO
I. RATIONALE/BACKGROTINI)
The right to health is one ol lhe lindamental rights enshrined in Afiicle ll of the Constitution.
Section 15 stales that "the State shall prolect and promote the righl to health ofthe people and
instilt health consoiousness among them." Likewise, under Repubiic Act No. 7394 or the
ConsLrmer Protection Act, llilipinos have the tight to obtain accurate infornation as k) lhe naturc,
qualily and quantity of the contents of consumer products, as well as the dghl lo be protccied
lrom deceptive, unfair and unconscionable sales acts or practices.
As a State-Party lo the International Covenant on Economic, Social and Cullural Rights, the
Philippines recognized the right of everyone lo the enjoyment of the highesl attainable standard
of physical and mental health. . The right to health in'cludes the right to health-teitted e.lucation
and information. Access to information, including the right to seek, receive and impart
information arrd ideas conceming health issues is considered an integral componellt of the right
Lo health.
There is unequivocal scientific evidence establishing lhat dealh, disease and disability result
fiom tobacco consurnplion and exposurc to tobacco smoke. At present, thete are about 5 million
deaths a year worldwide dircctly related to tobacco and WHO estimates this to double by 2020'
if present trends continue unchecked. By then, 70% of mortaLity would be taking place in
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2. developing counfties. In the Philippines, 240 Filipinos die cveryday or over 87,000 a year ltom
what is clearly a preventable disease. Tobacco products contain toxic compounds and over fony
carcinoggns, including carbon monoxide, arsenic, benzene, butane, lormaldchyde, lead, toluene,
and nicotine, among others. Nicotine, a by-ploduct uniqLre only to tobacco, is tltc substance that
eventually leads the smoker to addiction.
Recogrizing the magnitude of the lobacco €pidemic. the Philippines. along wrth other States,
signed the Framework Convention on Tobacoo Control (FCTC)
- the only public health treaty
initiated by the World Health Organization (WHO), The FCIC requires State parties to adopt a
comprehensive range ol measures designed to reduce the devaslating health ard economic
impacts oftobacco.
On 4 September 2005, follou'ing its ratitication through the conou(ence of twolhirds of the
Philippine Senate in accordance with the Constitution, the FCTC was lransformed into municipal
law. As such, the FCTC became legally binding upon state organs.
As a State Party to thc FCTC, the Phiiippines is duly-bound 10 comply with FCTC provisions in
good lbith, in observance of the principle of pacta sullt serJan.la, srch tha1, the failure of the
Philippines to perform its treaty obligations unde. the FCTC constitutes an intemationally
$'rongflrl act under the doctrine of state rcsponsibility, a norln of EeDeral international law lhat
every internatjonally wrongful act of a Siate entails lnternational lcsponsibility ofthat State.
Articlc I I ofthe within three years after cntry into fbrce oflhc
FCTCI provides that Parties shall,
treaty, adopt, and implement eflective measures lo ensure that €ach unit packet and package of
tobacco products and any outside packaging and labelling of such products (i) catay rolatirrg
health warnings that shall, among othets, cover 500/n or mote but no less than 30u% of the
principal display area, placed in the principal janguage or languuges and may be in the lorm of
pictures or pictograms, and approved by the competent national authority: and (ii) do not
promolg tobacco products by means that are false, misleading, deceptive or likely to create an
erroneous imprcssioll abollt its characteristics, health efl'ects, hazards, or emissions. The
inclusion of a speoific timelrame of three years in Afiicle li underscores the mandatory ahd
prescriptive nature, as well as the exigency. of the Philippines' obligation to adopt ond
implement effective measures in compliance with said provision.
Article 5.2 of the ICTC mandates Pa ies to adopt and implement not just effective legislative,
but also executive, administrative and/or other measll.es in developing appropriate policies lbr
preventing and reducing tobacco consumption, nicotine addiction and cxposure to tobacco
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3. Under the Constitution and the Administrative Code of 1987, the Depaftnenl of lleallll
(Department) is the compctent national authority mandated to ensure the propagation of heahh
information. In its disoussion ofthe Department's power to regulale pdvate indusfies in the area
of health information, the Supreme Court held that "lh]ealth is a legitimdte subject matter for
regulation by the DOll (and certain otber adminislrative agencics) in exercisc of police powers
delegated to it. The sheer span ofjurisprudence on that matter precludes the need to further
discuss it." The Supreme Cou , in its examination of the naturc, puqose, and depth of the
regulatory powers ef the Department, cited the Administrative Codc, which tasked the
Department to carry oul the state policy pronounced under Section 15, Afiicle II olthe 1987
Constitution, which is "to protect and promote the right to health olthe people and instill heallh
oonsciousness among them." To this end, the Department was "granted under Section 3 of tlre
Admhistrative Code the porver to propagate health information and educate the poplllation or1
important health, medical and environmental matters which have heallh implications."
The Department is likewise mandated, under the Consumer Protection Act, to protect the
interests of the consumgr, promote his general welfare, and establish standards of conduct for
business and industry. To this end, the Department has the duty to implcment measures that
ensure the provision of inlormation necessary for the protection of public health alld the
protection of consumers against deceptive pmcticas.
Evidcnce shows that health infonnation with picturos communioates health risks better especially
to children and young people as well as the illitsrate, and inctease the motivation ol lobacco
users to quit and to decrcase their tobacco consumltion.
Pursuant 10 DepartmeDt Order 2009-01 16, th€ Depaftment may promulgale an Administrative
Order (Ordcr) lhat prescdbes policies, tules and regulations, and procedtrres in accordance with
or pursuant to la4, 10 supplemenf plovisions ol the law or provides means lol carlying thenl out,
and is primarily applicable to individuals and organizations ouiside the Department.
Through this Order, tlre Philippines, through the l)epartment, is laking a definitive step towards
complying with its binding inlernational obligations under the FC'fC
Through this Ordet thc Depaftment underscorcs the Primacy of public health and al'firms its
primary function to pl omote, prolect, preserve, and restore the heahh olthe people
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4. . OBJtrCTI'ES
It is the policy ofthe State to promote the right ro bealth ofall the people
and instill health
conscior.isness among them. TIle State affirms this as oneof the fimdarnental rights of a human
beihg. Towards this end, the State shall implement effective measures to achieye the following
objcctives:
a. irovide necessary information abou! the health consequences, addictive
nature, and mortal threat posed by tobacco consumption and exposure to
tobacco smoke through measurcs that aLe scientifioally pfoven to be elfective
in iroreasing public awareness of the hgalth eflects of tobacco use and in
reducinS tobacco consumption;
b. Protect consumers from deceptjve labels, packaging, descriptions and
prdclices related to tobacco use;
c. lmplement measures to prohibit means that are lalse, misleading, deceptive or
likely (o creatc an erroneous impression about $e characteristics of tobaoco,
its heahh effects, hazards or emissions, so as to promote tobacco producls in
lohacco product pilckages.
To achieve these objeolivcs, the Depattmcnt shall ensure that effective, distincf, and highly
visible graphic health information is placed on tobacco product packages.
MoLeovcr, the DepaftmeDt shall ensute that tobacco product packaging and labelling do nol
promole a tobacco product by any mcans that are false, mislcading, deceptive, or likely to create
an erroneous impression abont the product and its characteristics, health effects, hazards ot
enrissions.
IN. SCOPE AND COVERAGE
lhese policies and guidelines shall apply to all tobacco products and to all tobacco
manufacture$, importers, exporters, wholesalers, distributors, retailers, concessionaires, and
other sellers oftobacco products, as well as thejr'agents and representatives, which are operating,
existing, and/or found rvithin the Republio ofthe Philippincs,
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5. tv. DEFINITION OF ]'ERMS
c, "Gtttphlc Health Infomatio " means statements, and/or other information,
accompanied by related fuli-color pictures or pictograms, which inform about the
contenls and subst4nces, in descriptive form, of tobacco products as rvell as inform
against health dangers and other problems lelated to tobacco producls, tobacco
consumption, exposure to lobacco smoke, or other effects oftobacco use,
b. "Tobacco Proaluct Pocrtdge" means the packet and package oftobacco products and any
outside packagiDg and labelliDg of tobacco prodlrcts for sale, distribution, exportation,
importation, tmde, exchange, or exhibition, srch as, but not limited to, packs, tins, boxes,
pouches, flip.lops, slide and shcll packages, cadons, transparclt wrappers: clcar
packaging, packages containing one product unit, master cases, ot olher containels oF
tobacco products.
"Tabucco Ptoducts" means prodLlcts entitely or pafily made of leaf tobacco as taw
haterial, lvhich are nanufhctured to be used for smoking, sucking, chewing or snulting,
or by an1 other means ofconsLllnption.
d. "Irr.sel" means any communication inside an individual packagc and/or carton purchased
at ejther lvholesale or retajl by consumcrs, such as a leaflet or broohure.
e. "Onse "
means any commLrnication affixed to the outside of an individual packag€
and/or carton prrchased at either wlrolesale or rctail by consumers, such as a brochure
benealh the outer cellophane wrapping or glued to the olLtside ofthe cigarette package.
v. ipncrnc pnovrsloNs
The Departmeht hereby promulgates the fbllowing rules and regulations govcrning packaging
and labelling of tobacco products:
A. Gyaphic Health Irfotmation
1. Scope of Graphic llealth Infoftdtioh. - Each unit packet and package of
tobacco
products, ilrcluding paokage insefts and onserls, and any outside packaging and
labellilg of such products for sale, distribulion or importation wifiin the country,
shall bear large, clear, visible, and legible full color graphic heallh information, :ls
attached in ,4nhex l.
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6. 2. Size oni Posltion qfG tphic Hednh lttfotmfltion. -1he gtaphic health infonration
shall occupy the upper portions oi each tobacco product packet or package and no
lgss thanthidy perceni (30olo) of the front pane! and sixty peroent (600lo) of the back
panel (or all coresponding panels of the unit packet or package if in non-standard
packaging) in a manner that ensures maxirnum visibility.
3. nohtioa. - lhere shall be a minimum of eight (8) variations of graphic health
information that shall appear concurrently within a twenty four (24) month period.
The variations shall appear on an equal number of l etaiL tob.Lcco product packages lor
each brand and tbr each paokage sizc and t5,pe.
4, Transilioas. - During transition periods, when an old sct graphic health of
iuformation is being replaced by a new set, there shall be a phase-in pe(iod of sixty
(60) days between sets of graphic health information, during which time both sets
may be used concurrently.
5. Tehpldes. - The templates of graphic health intbrmation, which conlain specilic
printing and othet requircmenls, shall be issucd by the Department on its own, or
upon consultation with organizations with established track record of, and expertise in
public health policies and duly recognized by the Depaltment as such. The
template(s) shalL be approved by the Secretary within thi(y (30) days lrom its
submission and shall be deemcd automatically apprcved ifnol acted upon thereafter.
These templates shall be issued by the Depadment e!eD, two (2) years ot as the need
for it a ses.
6. Slrict A.lhercttce. - The tobacco manufaclurers, imponers. exporters, wholcsalers.
clistributors, retailers, concessionaires, and other sellers, sball sfictly lbllow lhe
templates and shall submit theil packagings and iabclings for approval to the
Department no later than three (3) months bcfore they are to be used- The Department
shall act on the packaging and labeling of the unit packet and package of tobacco
prodlLcts within thjriy (30) days from its submission and shall be deemed
automatically approved if not acted upon thercalier.
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7. B. Misleading Descriptors
l. Genelal Prohibitior. - Each unit packel and package of tobacco prodncts, including
' package inserts and onsefis, and any outside packagirg and labelling ofsuch products
for sale, distribution or importation wilhin the country shall not promote a lobacco
product by any means that are false, misleading, deceptive or likety to create an
erron€ous imp.ession about the product's characteristics, health effects, hazards or
. emissior,s, including any term, descriptor, tradenark, figurative or any olher sign
(including colors, imagcs, or nunhers) or any package or product design t'eature that
directLy or indirectLy create or are liksly to create the false inpression that a particular
iobacco product or brand is less hamlt'll thall any otLler tobacco prodrlct or brand.
Usc of nrisleading descriptors on tobacoo produot packages such as, but not iirnited
to, "low tar", "light", "ultra-1ight," 'l11ild," "extra," "ullm," and similar terms in any
language that might mislead consumers, is prohibited. Use olcorresponding synbols
ol colors sigrifying the same is also pmhibitcd. No misleadirlg descriptor shall be
used as part of a brand name ot rmdemark for tobacco products introduced afler the
efl'ectivity of this Order-
Z. Prohibition Mislea.ling Infomation. - Irfomation that may imply that one
o
variant or brand is safer than the other is prollibited, such as statements indicating that
the tobacco product contains "leduced levels" ofcontenls, substances, and cm;ssirnrs.
Figures lor emission yi€lds, such as for tar, nicotine end carbon monoxide, shall be
prohibited, including when used Bs part ofa brand name or trademark
VI. COMMON PROVISIONS
L Compliance. - Tobacco prodrrcL facluges tlat do not comply lvitb this Order shall be
frohibited after ninety (90 days) ftom the elfectivity o[ t]ris Order'
Non-compliant
products must be withdrawn no later than such date Absolutely no extcnsions of time to
cornply with the provisions oftlris Order slrall be gEnted to tobacco manufactuters or any
other aflected parly.
Imported tobacco products mealt to be sold in the Philippines, even ifthey are iD product
packages thal carry graphic health infolnration compliant !ith the country ofo
gin shall
comply with this Order within thirty (30) days from lhis order's effectivity-
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8. 2. DutJ) Not to SelyDispla! Non-cohplianl Prcducts, -
Manufacturers, importers,
exporters, wholesalers, distlibrLtor.s, retaiiers, concessionaires and other sellers shall not
sgli and,/or display iobacco products that do not comply with this Order.
1. Bunleh of Costs oh Tobacco Companier, - All costs relative to the packaging and
labelling of tobacco products shall be borne by the respective tobacco manufacturers,
importers, and/or exporters responsible forpackaging and labelliog ofthe products.
4. Monltoting Te.rns. - Therc shall be Monitoring Teams at the national, rcgional,
provincial, city, municipal, and barangay levels (in coordinatiou with respective Local
Governhent Uoits), as well as in civil society, to ensure compliance with, and
implementation of, this Ordcr.
Monitoring Tdams shall be coftposed oi
a, National Level:
i, National Center for Healih Promolion (NCllP)
ii. Non-Govemment Organizations (NGOS) as deputized by thc Department.
iii, Any other office/agency designated by the Departrnent.
b, Ilegional/Provincial/City/Municipal/Barangay Level:
i. Centers for Health Developmcnt (CllDs)
ii. Provincial Health OfTlces
iii. City l{ealfi Offices
iv. Municipal Health Offices/ Rural llealth Units
v. Bamngay Health Oflices
vi, NGOS as deputized by the Department
vii. Any other office/agency designated by the Departmcnt.
5. Moniloring Teqmt; Fanclions ond Resaonsibililies, - Monitoring teams shall have the
following responsibilities:
a. Monitor compliance with, as $'ell as problems encountered in, the implementation
ofthis Order and submit timely reports thereon;
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9. b. Monitor labels and packages of tobacco products within thc scope of the Order
and marketing practices in various disiribution centeN and points of sale
estoblishments;
c. V€rify repons ofviolations of this ordcr;
d. Submit tinely repofts on their monitoring ard verification and follow-up on the
actions and/or resolutions rvith the concerned olllce/agency; and
e. Such other hlnctions and responsibilities .!s may be assigned by the Depafment.
6. Conlents of Wolation -Repolrs. - Rcports of alleged violafions shall include: (i) the
specific location where the violation was fbltnd and lhc corresponding daie; (ii) a pictlLre
or sarnple of the violative label or pacleging; (iii) as mllch as possible, a picture of ihe
violativo product as displaycd in the point ol sale/distribution outlet; and (iv) such other
information as the Departmcnt may later require. Monitoring Teams shall keep proper
documentation ofall repoft€d violations, which documentation may be made availahie lo
the publ;c.
7. Coopelation/Cootdhtotion vith Otganizntions. - 'fhe Department and official
Monitorins Teans may engage olher civiL society organizations, individuals, and otlrer
agenqies, to closely monitor impLementatioD of and oompliance with this ordet ilr their
respective areas of jurisdiction, and submit timely reports to the l)epartment or the
monitoring teams ofany alleged violation.
8 Pubtic Vigilance. -The l)epaflment, lnoniloring teams, other ageDcies, and stakeholders,
shall encourage the public to report what they deem to be violations under this order.
9. lyherc to Repofi, -lileports olviolations shall be submitled to rhe Olfice oltLre Secretaly,
or any othel offioe/agency designated by tlle Secretary, at the nalional level, and io ihc
CHDS at the local level. The concemcd olfice/agency shall provide immediate feedback
within five (5) working days on actions talien based on the receivcd reports of alleged
violations.
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10. 1I. VIOLATIONF
The Department, or any office desiguated by the Seqetart' of Health, shall investigale any
rcported violations of this Order, and affer due notice and hearing, if found responsible thereof,
apply such adminisualive sanctiorls and penaltiss, including scizure, recall and condemnation,
wh€re approp ate, on the concerned nranufacturers, importeN, expo ers, wholesalers,
distributors, retajlers, co$cessioDaires, selle!s, or other concemed iudivjduals/cntities,
VXI. SEPARABILITY
, CLAUSE
If, for any rcason: any section or provision of this Order is declared iuvalid, illegal or
rmconstitutional, such invalidity or uncoDstitutionality shall not aff€ct the other provisioDs ofthis
Order, which shall remain in full force and effect.
IX. REPDALING CLAUStr
The provisions of other existing provisions or issuances found inconsisteut or contrary with this
Order are hereby repealed or modifieil accordingly.
X. EFFECTIVITY
This Order shalLtake elfect fifteen (15) days follo1!-irg the date ofits pLrblication in a newspcper
of general oiroulalion,
RANZA I. CABRAL, MD
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