Republicof the Philippines

Department of Health
OFFICE OF THE SECRETARY

ACT 27 Wn
ADMINISTRATIVE ORDER
No.2021- 005]
SUBJECT: Guidelines on Graphic Health Warnings on Vapor Products,
Heated Tobacco Products and Other Similar Products

I. RATIONALE

In the 2015 Global Adult Tobacco Survey in the Philippines, the overall prevalence of
ever use and current use of electronic cigarettes among all adults is at 2.8% and 0.8%
respectively, with higher prevalence of electronic cigarette use among men and those
living in urban areas. Among adolescents aged 13-15 years, the 2019 Global Youth
Tobacco Survey shows a more alarming 14.1% of students who are currently electronic
cigarette users. While the negative effects of vapor products and heated tobacco
products (HTPs) are not yet fully known, evidence of their potential and long-term
harmful effects are accumulating and evolving to include increased nicotine addiction,
fatal respiratory problems, mucosa, poisoning, among others. Injuries from explosion
have also occurred world-wide.

In relation to these emerging adverse health effects, a decision was adopted in 2014 by
the Conference of Parties (COP) to the World Health Organization (WHO) Framework
Convention on Tobacco Control (FCTC) which states that vapor products are harmful,
and that sale and marketing of vapor products should be prohibited or regulated. For
HTPs, an FCTC/COP decision was again adopted in 2018 which recognizes novel or
emerging tobacco products, including HTPs, as tobacco products and therefore subject
to the provisions of the FCTC.

Consistent with the WHO-FCTC’s decisions and recommendations as well as the policy
of the state to protect and promote the right to health of the people and instill health
consciousness as enshrined in the 1987 Philippine Constitution, the use of vapor, HTPs,
and other similar products or devices are regulated by the Department of Health (DOH)
and the Food and Drug Administration (FDA) pursuant to Republic Act Nos. 11346 and
11467; and Executive Order No. 106, series of 2020.

RA No. 11346 and its Implementing Rules and Regulations, through Joint Memorandum
Circular (JMC) No. 003-2020, mandated the DOH to issue guidelines on the effective
implementation of the application of graphic health warnings (GHW) on the packaging
of vapor products, HTPs, and other similar products compliant with RA No. 10643 or
the “Graphic Health Warnings (GHW) Law”. This expansion in the application of GHW
seeks to effectively inform and educate the public regarding some of the health risks and
dangers associated with the use of vapor products, HTPs, and other novel or similar
products or devices.

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 local 1108, 1111, 1112, 1113 {
Direct Line: 711-9502; 711-9503 Fax: 743-1829 # URL: http://www.doh.gov.ph; e-mail: ftduque@doh.gov.ph
 OBJECTIVES

This Order aims to provide guidelines on the placement and use of GHWs on vapor
products, heated tobacco products (HTPs), and other similar products, and define the
roles and responsibilities of the DOH, FDA, and other relevant agencies, offices, and
stakeholders of vapor products, HTPs, and other similar products.

IIL. SCOPE OF APPLICATION

This Order shall apply to all manufacturers, importers, distributors of vapor products,
HTPs and other similar products. It shall also cover all the DOH Central Office Bureaus
and Services, Centers for Health Development (CHDs), including the Bangsamoro
Autonomous Region in Muslim Mindanao (BARMM) subject to the applicable
provisions of RA 11054 or the “Bangsamoro Organic Act” and subsequent rules and
policies issued by the Bangsamoro government.

IV. DEFINITION OF TERMS

The following terminologies are operationally defined consistent with the definitions
provided for by the following laws and policies: RA No. 10643 or “The Graphic Health
Warnings Law,” RA No. 9711 or the “Food and Drug Administration Act of 2009,” RA
Nos. 11346 and 11467; DOF-DOH-DBM-BIR-PhilHealth Joint Memorandum Circular
No. 003-2020; EO No. 106 series 2020; DOH AO No. 2020-0055 “Regulation on Vapor
Products and Heated Tobacco Products (HTPs) under the Food and Drug Administration
(FDA).”

A. Container - refers to any object used for or capable of holding one or more vapor
products or HTPs packaging or wrapping. |

Graphic Health Warnings (GHW) - refer to the photographic image printed on the
product package, which accurately depicts the hazards of use of or exposure to a
product, and is accompanied by a textual warning related to the picture.

Heated Tobacco Products (HTPs) - refer to tobacco products that may be

consumed through heating tobacco, either electrically or through other means
sufficiently to release an aerosol that can be inhaled without burning or any
combustion of the tobacco. HIPs include liquid solutions and gels that are part of
the product and are heated to generate an aerosol.

Insert - refers to any communication inside an individual package and/or carton

purchased at either wholesale or retail by consumers, such as a leaflet or brochure.

Misleading Descriptors - refers to any element or feature, whether or not part of

the brand name, which includes but is not limited to any number or descriptor, or
other sign, mark, or term such as but limited to “low tar,” “ultra lite,” “clean,”
“fine,” “leading,” “supreme,” “mild,” “extra,” “ultra,” and similar terms in any
language that directly or indirectly creates the false impression or claims or
misleads a consumer to believe that the particular product is healthier, safer, or less
harmful than others; or that it can be used as tobacco cessation aids or other terms in
any language, that are likely to mislead consumers or suggests that the product has
lifestyle or health benefits.

fo
. Novel Tobacco Products - refer to all substances, devices, and innovations entirely
or partly made of tobacco plant as raw material, already existing or to be developed
in the future that are intended for use as substitutes for cigarettes, conventional
tobacco products, vapor products, or HTPs.

. Onsert - refers to any communication affixed to the outside of an individual

package and/or carton purchased at either wholesale or retail by consumers, such as
a brochure beneath the outer cellophane wrapping or glued to the outside of the
package.

. Other similar products - refers to novel and/or emerging nicotine, vapor, and
tobacco product which may differ in some aspects or design but which either have
the same functionality, or expose users to similar health hazards or whose
components are similarly addictive and toxic or which share the same delivery
mechanisms as that of vapor and HTPs. Other similar products shall adopt the
corresponding GHW for vapor products or HTPs, whichever they are most similar
to.

Packaging -refers to bottles, packs, boxes, cartons, or containers of any kind used
on vapor products or HTPs being offered for sale to consumers.

Primary Packaging - refers to any material, including printed material, employed

on the packaging of the product, excluding any outer packaging used for transport
or shipment, that is in direct contact with the vapor product or HTP device,
cartridges, and/or refills:
1. In the case of devices, mods, pods, and/or cartridges: the packs, boxes, cartons,
containers or packaging of any kind; and
2. In the case of vape or HTP juice and/or refills: the juice or refill bottles.

. Principal Display Surface - refers to “Principal Display Area or Principal Display

Panel” that is predominantly displayed or visible under normal or customary
conditions where the GHW:s are visibly shown:
1. In the case of a package and carton that has at least two (2) equal sides or
surfaces, other than the top and bottom, that may be displayed or visible under
normal or customary conditions of sale or use: the areas of each of the two (2)
largest surfaces.
2. In the case of a spherical, cylindrical or conical container: the two (2) largest
surfaces that are predominantly displayed.
3. In the case of a package and carton that does not have a particular side or
surface that is predominantly displayed or visible under normal or customary
conditions of sale or use or those that are not described under subsections 1 and
2: fifty percent (50%) of the three (3) dominant sides or the total surface thereof,
whichever is bigger, which will ensure that the GHW are visibly shown.
4. In the case of vape or HTP juice bottles or cylindrical packages with caps:
a. the areas below the cap, provided that the cap is not used for advertising or
promotion purposes including but not limited to the use of brand colors or
the provision of brand information; or
b. the areas from the tip of the cap to the bottom of the bottle, provided that
the cap is used for advertising or promotion purposes.

J
 Secondary Packaging - refers to any material, including printed material, employed
on the packaging of the product, excluding any outer packaging used for transport
or shipment, that is not in direct contact with the vapor product or HTP device,
cartridges, and/or refills (e.g. product inserts, tags, etc.):
1. In the case of devices, mods, pods, and/or cartridges: any additional packaging,
if any; and
2. In the case of vape or HTP juice and/or refills: the packs, boxes, cartons,
containers or packaging of any kind.

. Side Panel - refers to the surface of the package that has the largest surface
available next to the principal display surface where GHWs shall appear. This is in
addition to any fiscal markings as may be required by FDA, BIR, other government
agencies.

. Vapor Products - refer to electronic nicotine and non-nicotine delivery systems

(ENDS/ENNDS), which are a combination of (i) a liquid solution or gel, that
transforms into an aerosol without combustion through the employment of a
mechanical or electronic heating element, battery or circuit that can be used to heat
such solution or gel and includes but not limited to (ii) a cartridge, (iii) a tank, and
(iv) the device without the cartridge or tank. It is commonly known as nicotine
salt/salt nicotine, and conventional ‘freebase’ or classic nicotine, and other similar
products.

GENERAL GUIDELINES

A. The DOH shall issue a maximum of twelve (12) templates of GHWs for vapor
products and for HTPs and other similar products upon the approval of this Order
and shall issue new templates every two (2) years thereafter to be used by all
manufacturers, importers, and distributors of said products that are introduced in the
Philippine market.

. The twelve (12) templates of GHWs shall be printed simultaneously and shall be
rotated periodically for each brand family and for each variant, so that every two (2)
years, the variations of the warnings shall appear in the market with approximately
equal frequency and equal display of health warnings and messages on retail
packages.

The GHWs, in addition to other product information required by FDA pursuant to

RA No. 9711 such as but not limited to warnings, product contents, direction for
use, disposal, maintenance, first aid instructions, and information for traceability,
shall be placed on the packaging, whether primary or secondary, including insert or
onsert.

. The GHWs on vapor products, HIPs, and other similar products packages shall be
printed in accordance with the product guide in the Annex I of this Order, without
prejudice to subsequent or additional warnings, such as those in accordance with the
Globally Harmonized System of Classification and Labelling Chemicals, or updates
to policies that may be issued by the DOH or FDA in accordance with relevant laws
such as RA No. 9711.

»
 E. The composite images of the GHWs shall be contained in a digital storage device
and/or an electronic repository which shall be maintained by the DOH.

F. All vapor products, HTPs and other similar product packages not compliant shall be
subject to removal and/or confiscation by appropriate authorities and shall not be
allowed to be sold or distributed in the Philippine market.

VIL SPECIFIC GUIDELINES

A. Size
1. The GHWs shall be printed on fifty percent (50%) of the principal display
surfaces of any vapor products, HTPs, and other similar product packages,
whether primary or secondary.
2. It shall occupy fifty percent (50%) of the front and fifty percent (50%) of the
back panel.

B. Position. The GHWs shall be located at the lower portions of the panels or principal
display areas.

C. Visibility
1. No part of the warning shall be obliterated, obscured, folded, severed or become
unreadable when a wrapper or sleeve on the package is removed.
2. Nothing shall be printed or applied on a location where it is likely to obscure or
cover in part or in whole the GHWs.

D. Color and Printing Quality

1. The GHWs shall be printed in four colors /-cmyk-/ screen 133 lines per inch
based on a source file of 300 dpi.
2. The printing of the GHWs shall be done using current available technology for
purposes of providing vivid and realistic pictures. The primary consideration in
determining the printing quality shall be the overall effect on the vapor products,
HTPs, and other similar products packaging.
3. The printing shall be clear and legible throughout the lifecycle of the product,
under normal or customary conditions of transportation, storage, sale and use.
4. The GHWSs shall be as clear, vivid and vibrant as the rest of the packaging. Any
ink used in the printing of the GHWs shall be of such a quality that will not
fade, bleed, or modify the appearance of the warning over time.
5. The printing shall not include any features designed to modify the warnings,
including, but not limited to heat activated inks, inks or embellishments
designed to appear gradually over time, or inks that appear fluorescent in certain
light.
6. The printing of the GHWs shall be done without the use of any border, frame,
cropping, distortion or any other design that will effectively lessen the size of
the warning, reduce its clarity and vividness, or modify the appearance.
7. The GHWs shall be printed or inscribed on the package in a color which
contrasts conspicuously with the background of the package or its labels, as
provided by these guidelines and templates.
8. The GHWs shall be reproduced in the same quality, color and proportion as
provided by the DOH in the templates or in the digital form, whichever is
clearer and more vivid, without modification.
 E. Language. The text warning accompanying the photographic image shall be printed
in Filipino on the front panel and English on the back panel. In the case of other
containers where there is only one (1) external surface area, the accompanying text
shall be printed alternately in English or Filipino.

F. Side Panel. Vapor products, HTPs, and other similar products packages found in the
market, shall bear, on one (1) side panel, additional health warnings, hotlines and/or
websites on cessation, which shall be prominently displayed without the use of any
border, frame or any other design that will effectively lessen the size of the textual
warning, in accordance with the templates provided. Such information shall occupy
thirty percent (30%) of the display surface of one side panel.

G. Misleading Descriptors
1. Vapor products, HTPs, and other similar product packages shall not bear any
number or descriptor, or other sign, mark, or term such as but limited to “low
tar,” “ultra lite,” “clean,” “fine,” “leading,” “supreme,” “mild,” “extra,” “ultra,”
and similar terms in any language that claims or misleads a consumer to believe
that the vapor products, HTPs, and other similar products or variant is healthier,
safer, less harmful or approved for use as a smoking cessation device, unless
otherwise approved for such use by the FDA.
2. The DOH shall not approve any proposal, proof or other submission of GHWs
that is affixed to vapor products, HTPs, and other similar products packages that
bear any such number or descriptor.

VII. ROLES AND RESPONSIBILITIES

A. The Health Promotion Bureau (HPB) shall:

1. Develop the GHW templates on vapor products, HTPs, and other similar
products; and oversee its dissemination, implementation, monitoring and
evaluation;
2. Develop health promotion and communication plans on health effects of vapor
products, HTPs and other similar products, including capacity building and
health education in schools, workplaces, and communities;
3. Maintain a digital storage device and/or an electronic repository of the GHWs
on vapor products, HTPs and other similar products; and
4. Coordinate and provide technical assistance to public health advocates,
professional and civil societies, and various relevant stakeholders in relation to
GHW on vapor products, HTPs and other similar products.
|

B. The Food and Drug Administration (FDA) shall oversee the regulation and ensure
application of GHW as well as other health warnings or information on the
ingredients or contents of the vapor products, HTPs and other similar products.

C. The Epidemiology Bureau (EB) shall include in the conduct of Global Tobacco
Surveillance System relevant information on vapor products, HTPs and other
similar products such as but not limited to: prevalence of use, access by minors,
placement of GHW, and advertisement and promotions.

D. The Bureau of International Health Cooperation (BIHC) shall collaborate with

International Organizations such as but not limited to World Health Organization

ya
 and Member States, to further strengthen the capacity in the implementation of this
Order.

E. The DOH Hospitals and other health facilities shall promote cessation of the use
of vapor products, HTPs and other similar products in all levels of care.
F. The DOH Centers for Health Development and the Ministry of Health-BARMM
shall:
1. Orient concerned stakeholders on the policy and advocate for its adoption and
implementation; and
2. Provide technical assistance to Local Government Units and other partners on
health effects of vapor use, HTPs, and other similar products.

G. The Local Government Units, including Provincial and District Hospitals, are
enjoined to promote the cessation of use of vapor products, HTPs and other similar
products in all levels of care.

VIIL TRANSITORY PERIOD

All manufacturers, importers, distributors and sellers of vapor products, heated tobacco
products, and other similar products shall comply with the guidelines set out in this
Order in a timeline consistent with Rule III, Section 3 of the DOF-DOH-DBM-BIR-
PHIC Joint Memorandum Circular No. 003-2020 or the “Implementing Rules and
Regulations of Heated Tobacco Products and Vapor Products as Prescribed by RA Nos.
11346 and 11467.”

In this regard, all manufacturers and importers of vapor products, heated tobacco
products, and other similar products shall comply with the requirements of this Order
and shall apply the first (1st) set of GHW templates for vapor products, heated tobacco
products, and other similar products in full effect by May 11, 2022.

All distributors and sellers of vapor products, heated tobacco products, and other similar
products shall be provided with additional sixty (60) days or until July 11, 2022 to fully
comply with the same.

Thereafter, no person or legal entity shall sell or commercially distribute or display any
vapor product, heated tobacco product, and other similar product without ensuring that
the packages meet the standards under this Order. Manufacturers, importers, distributors
and sellers shall ensure the removal from all displays of non-compliant products.

PENALTY CLAUSE
Violations and non-compliance of this Order shall be subject to existing penalties and
sanctions in RA No. 10643 or the “The Graphic Health Warnings Law” and relevant
laws as applicable.

SEPARABILITY CLAUSE
If any provision of this Order is declared invalid, unenforceable or unconstitutional, the
validity or enforceability of the remaining provisions shall not be affected, and this
Order shall be interpreted as if it did not contain the particular invalid, unenforceable, or
unconstitutional provision.

Vd 7
XI. EFFECTIVITY
This Order shall take effect immediately after publication in the Official Gazette or a
newspaper of general circulation and submission to the Office of the National
Administrative Registry (ONAR) at the UP Law Center.

FRANCISCO QUE III, MD, MSc

Secrétary of Health
 ANNEX I. Product Guide

A. Summary of packaging requirement by product component

Product Components

Packaging Devices/Mods/Pods/Cartridges Juice/Refill Bottles

Packs, boxes, cartons, containers

Juice/Refill bottle
or packaging of any kind
)
Primary
with GHW
with GHW

Packs, boxes, cartons, containers

Adifigonal (Lang)
os Gpo
packaging y
Secondary or packaging of any kind
with GHW

B. Summary of GHW application for round or disc-type packaging, wide box packaging,
and standard box packaging:

GHW Size ® 50% of the principal display surface both front and back

GHW Position ® Lower portion of the principal display surface

GHW Visibility eo GHW shall not be obscured or covered

GHW Color and ® Four colors of 300

/-cmyk-/ screen 133 lines per inch source file
Printing Quality dpi
eo GHW shall be clear, legible, vivid and vibrant.
© GHW shall not fade, bleed, or modify the appearance of the
warning over time.
® No features designed to modify the warnings overtime
® No border, frame, cropping, distortion or any other design that will
lessen the size of the GHW.

GHW Language e Filipino on the front panel; English on the back panel

Side Panel ® Additional health warnings, hotlines, and/or websites on cessation

® Occupying 30% of the display surface of one side panel

Misleading o Shall not bear any misleading descriptors or claims

Descriptors

ro
 SP
Round or Disc-Type Packaging

TTT"
Principal Display
moomoo
\

1
Surface i

i
|
i
|

! | |

! |
|

1
§

Principal Display

=
\

surface
9
i

I
N

ga Se
5$ : panel for addi
A

S——
'

82 '
3

eo
|
|
)
) | i

]
)
)

30% of the — —
-
circumference

©
Wide Box Packaging

od
i

Principal Display
Surface4
i
4

'
a
Ni
<

{ 3 50% of the
b
i Principal Display
i

i
: surface
|
‘

Eee
|
|

Standard Box Packaging

\
£
z
a,
Eo
ior
2d
on

li |

'

253
' |

1
3
3:
| i

i
slo
}

' |

}
| i

| |

1
£ |

a
i
1
1

:£ E
2
Tf 1 -———-—F pS]

‘ |

ol i

z!
=
‘

il |

i
|
height heig !

H
:

! |

!
the
the |
|
i
of
| of |

50% |

0)
C. GHW application for vape and HTP juice or refill bottles

i. For bottles with caps that are NOT used for advertising or promotion purposes, including
but not limited to the use of brand colors or the provision of brand information;
Prescribed color include: plain black, white, brown

GHW Size ® 50% of the principal display

surface of the full circumference
of the bottle with measurement
x of the height starting from below
the cap
>

GHW Position e Lower portion of the principal

display surface

GHW ® GHW shall not be obscured or

Principal Display Principat Diapioy Visibility covered
surface Surtace

GHW Color ® Four colors /-cmyk-/ screen 133

lines per inch source file of 300
=
and Printing

1
(

x=
height

= height Quality
°
dpi
GHW shall be clear, legible,

o
the the

:
of of vivid and vibrant.
GHW shall not fade, bleed, or
50% 50%

i
eo

ne
:

modify the appearance of the

over time.
- =

warning
=

e——
sien we - ® No features designed to modify
front feet
the warnings overtime

tl chumtoence -
No border, frame, cropping,
distortion or any other design
that will lessen the size of the
|
GHW.
—

in Filipino
—

height
GHW e Either or English
Language
GHW ott

the

50%of
Misleading © Shall not bear any misleading
Descriptors descriptors or claims
~~~
ii. For bottles with caps colored other than with plain black, white, or brown, and are used
Jor advertising or promotion purposes, including but not limited to the use of brand
colors or the provision of brand information

GHW Size e 50% of the principal display

surface of the full circumference
of the bottle with measurement

of the height starting from the

tip
of the cap
GHW Lower portion the of principal
Position display surface
Pilot Oper Frc Daplsy

—
|

— GHW © GHW shall not be obscured or

Visibility covered

GHW Color e Four colors /-cmyk-/ screen 133

= i = } and Printing lines per inch source file of 300

oa
T
oO
:
:
i
§
Quality
°
dpi
GHW shall be clear, legible,
vivid and vibrant.
e GHW shall not fade, bleed, or
modify the appearance of the

ree
—e
Pom
rors
pm
So
e
‘warning over time.
No features designed to modify

the warnings overtime

e No border, frame, cropping,
" :
distortion or any other design
! that will lessen the size of the
) GHW.

i GHW e Either in Filipino or English

Language
GHW $
£

: Misleading e Shall not bear any misleading

!
Descriptors descriptors or claims

12