ANNEX B
 
 
Labeling Requirements for Heated Tobacco Product (HTP) Refills and Cartridges
 
 
 
GUIDELINES
 
 
1.
Packaging Materials for Refills and Cartridge
 
1.1
The
packaging
material
for
HTP
refills
and
cartridges
shall
not
release
toxic
 
 
 
 
 
 
 
 
 
 
 
 
 
substances
and
mixtures
into
the
product,
by
migration,
leaching
or
dissolution,
which
 
 
 
 
 
 
 
 
 
 
 
 
are liable to constitute a human health hazard
 
 
2.
The
minimum
mandatory
information
required
to
appear
in
the
primary
packaging
of
 
 
 
 
 
 
 
 
 
 
 
 
HTP refills and cartridges are as follows:
 
2.1
Brand name
 
2.2
Name of Product Variant
 
2.3
Nicotine
concentration
per
unit
refill,
expressed
in
mg
nicotine/cartridge.
 
 
 
 
 
 
 
 
 
Furthermore,
the
FDA
will
require
a
nicotine
warning
statement
to
read
 
 
 
 
 
 
 
 
 
 
 
‘‘WARNING:
This
product
contains
nicotine.
Nicotine
is
an
addictive
 
 
 
 
 
 
 
 
 
chemical”.
 
2.4
Net volume or weight, as applicable.
 
2.5
The
term
“Heated
Tobacco
Product
Refill”
as
applicable,
to
describe
the
 
 
 
 
 
 
 
 
 
 
 
product.
 
2.6
The exact statements “Do not swallow” and “Keep out of the reach of children.”
 
2.7
Graphic
Health
Warnings,
as
prescribed
by
the
Department
of
Health
for
 
 
 
 
 
 
 
 
 
 
 
conventional tobacco products.
 
2.8
Batch/Lot number
 
2.9
Expiry date
 
2.10
FERN
 
2.11
If
possible,
the
following
information
should
also
be
printed
on
the
primary
 
 
 
 
 
 
 
 
 
 
 
 
packaging.
However,
in
cases
where
the
required
information
does
not
fit
in
the
 
 
 
 
 
 
 
 
 
 
 
 
 
primary
package,
a
secondary
packaging
shall
be
provided
to
reflect
the
 
 
 
 
 
 
 
 
 
 
 
following information in addition to the information already provided above:
 
2.11.1
Marketing Authorization Holder Information
 
2.11.2
Company Name
 
2.11.3
Company Address
 
2.11.4
Company Contact Details
 
2.11.5
LTO Number
 
2.11.6
Country of Origin
 
2.11.7
List
of
ingredients
contained
in
the
product,
in
descending
order
of
 
 
 
 
 
 
 
 
 
 
 
concentration, with potential allergens emphasized in bold characters.
 
2.11.8
Instructions
for
the
handling,
refill,
use,
and
storage
of
the
HTP
 
 
 
 
 
 
 
 
 
 
 
refills/cartridge, as appropriate.
 
 2.11.9
Usage
cases
to
be
avoided
(in
the
context
of
current
medications,
 
 
 
 
 
 
 
 
 
 
 
health
conditions,
and
interactions
with
other
drugs
and
other
 
 
 
 
 
 
 
 
 
substances),
warnings
for
specific
groups
and
possible
adverse
effects,
 
 
 
 
 
 
 
 
 
addictiveness and toxicity
 
2.11.10
Instructions for the disposal of the HTP containers
 
2.11.11
Directions in case of ingestion or skin contact
 
2.11.12
Undesirable adverse health effects
 
2.11.13
Warning statements:
 
2.11.13.1
 Do not swallow
 
 
2.11.13.2
Keep out of the reach of children
 
2.11.13.3
Avoid prolonged contact with the skin
 
2.11.13.4
Nicotine is an addictive substance
 
2.11.13.5
Not
suitable
for
pregnant
women,
nursing
 
 
 
 
 
 
mothers,
children,
persons
with
respiratory
or
 
 
 
 
 
 
cardiovascular diseases
 
2.11.13.6
Call
the
poison
center
or
the
hospital
near
you
 
 
 
 
 
 
 
 
 
in
case
of
accidents,
injury,
or
illness
arising
from
the
 
 
 
 
 
 
 
 
 
 
use of this product.
 
2.11.14
The
updated
contact
information
of
the
Philippine
General
Hospital,
 
 
 
 
 
 
 
 
 
National Management and Control Center, as of the time of manufacture
 
2.11.15
The
exact
statement:
“For
complaints
or
reports
on
product
quality
and
 
 
 
 
 
 
 
 
 
 
 
safety,
please
contact
the
Food
and
Drug
Administration
by
email:
 
 
 
 
 
 
 
 
 
 
ntru@fda.gov.ph
​
.”
 
 
3.
All information on the product label must only be written in either English or
 
Filipino.
 
 
 
4.
The labels of HTPs applying for FERN shall not contain any health, therapeutic,
 
nutritional, or functional claims such as, but not limited to, tobacco harm reduction or
 
tobacco cessation aid claims.
 
 
5.
The labels of HTPs applying for FERN shall not contain any misleading phrases. The
 
following is a non-exhaustive list of misleading words or phrases that shall not be
 
allowed for these products:
 
5.1    Light; Lites; Ultra Lite
 
5.2
   Supreme
 
5.3
   Safer
 
5.4
   No.1
 
5.5
   Leading
 5.6
Most
 
5.7
Finest
 
5.8
Clean
 
6.
Modified
risk
descriptors
(e.g.,
‘‘light,’’
‘‘low,’’
and
‘‘mild’’
descriptors)
and
 
 
 
 
 
 
 
 
 
 
unsubstantiated
claims
(e.g.
healthy,
low
harm,
less
harmful,
helpful
to
quit
smoking,
 
 
 
 
 
 
 
 
 
 
 
 
etc)
are
not
allowed
in
the
sale
and
distribution
of
products
applying
for
FERN.
This
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
includes
misleading
elements
and
notably
any
suggestions
that
a
particular
tobacco
 
 
 
 
 
 
 
 
 
 
 
product
is
less
harmful
than
other
similar
products
(eg.
claims
that
HTPs
cut
the
risk
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
of
tobacco-related
diseases
and
are
less
risky
than
continuing
to
smoke
cigarettes,
 
 
 
 
 
 
 
 
 
 
 
 
etc.)
 
 
 
7.
No
claims
of
FDA
endorsement
shall
be
allowed
on
the
packaging,
such
as
placement
 
 
 
 
 
 
 
 
 
 
 
 
 
 
of
the
FDA
logo
or
the
inscription
of
the
words
“Food
and
Drug
Administration,”
or
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
“Philippine
FDA,”
the
initials
“FDA,”
or
any
imitation
of
such
words,
initials,
or
 
 
 
 
 
 
 
 
 
 
 
 
 
logo.
 
 
8.
Within eighteen (18) months from the effectivity of Republic Act No. 11346, all HTP
 
refills and cartridges shall comply with the templates and specifications of Graphic
 
Health Warnings as issued by the Department of Health pursuant to Republic Act No.
 
11346 and Republic Act No. 10643, otherwise known as “The Graphic Health
 
Warning Law”, and its subsequent issuances.