ANNEX B
 
 
 
Packaging and Labeling Requirements for Vapor Product Refills and Cartridges
 
 
 
GUIDELINES
 
 
 
1.
 
​
Packaging Materials for Refills and Cartridges
 
 
 
1.1.
The
packaging
material
for
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.
 
 
 
1.2.
For
vapor
product
refills
and
cartridges,
in
order
to
minimize
the
risks
of
 
 
 
 
 
 
 
 
 
 
 
 
 
migration,
leaching,
dissolution
and
owing
to
the
potential
toxicity
of
their
 
 
 
 
 
 
 
 
 
 
 
monomers
and
additives,
these
materials
are
prohibited
in
the
manufacture
 
 
 
 
 
 
 
 
 
 
of refill containers:
 
 
1.2.1.
polyvinyl chloride (PVC) (CAS No. 9002-86-2)
 
1.2.2.
polystyrene (PS) (CAS No. 9003-53-6)
 
1.2.3.
polycarbonate (PC) (CAS No. 25037-45-0)
 
1.2.4.
acrylonitrile-butadiene-styrene (ABS) (CAS No. 9003-56-9)
 
1.2.5.
styrene-acrylonitrile (SAN) (CAS No. 9003-54-7)
 
1.2.6.
polyoxymethylene (POM) (CAS No. 9002-81-7)
 
 
 
2.
Child-Resistant/Tamper-Proof Vapor Product Refill Solution Containers
 
 
2.1.
Refills
of
vapor
product
solutions
in
re-closable
containers
shall
at
least
 
 
 
 
 
 
 
 
 
 
 
comply
with
ISO
8317:2015
standards.
Single-use
vapor
products
shall
 
 
 
 
 
 
 
 
 
employ
child-resistance
mechanisms
to
prevent
dermal,
gastrointestinal,
or
 
 
 
 
 
 
 
 
inhalational toxicity among children.
 
 
2.2.
The
sole
use
of
non-resealable
containers
for
vapor
product
refill
solutions
 
 
 
 
 
 
 
 
 
 
 
shall not be allowed.
 
 
 
3.
Product Labels
 
 
3.1.
The
labels
of
vapor
products
shall
not
contain
any
health,
therapeutic,
 
 
 
 
 
 
 
 
 
 
 
nutritional,
or
functional
claims
unless
approved
by
the
FDA
during
 
 
 
 
 
 
 
 
 
 
registration.
 
 
3.2.
Misleading
phrases
shall
not
be
allowed
in
vapor
products.
The
following
 
 
 
 
 
 
 
 
 
 
 
is
a
non-exhaustive
list
of
misleading
words
or
phrases
that
shall
not
be
 
 
 
 
 
 
 
 
 
 
 
 
 
allowed:
 
 3.2.1.
Light; Lites; Ultra Lite
 
3.2.2.
Supreme
 
3.2.3.
Safer
 
3.2.4.
No.1
 
3.2.5.
Leading
 
3.2.6.
Most
 
3.2.7.
Finest
 
3.2.8.
Clean
 
 
 
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.
​
This
includes
misleading
elements
and
notably
any
suggestions
 
 
 
 
 
 
 
 
 
that
a
particular
product
is
less
harmful
than
other
similar
products
(eg
 
 
 
 
 
 
 
 
 
 
 
 
claims
that
vapor
products
cut
the
risk
of
tobacco-related
diseases
and
are
 
 
 
 
 
 
 
 
 
 
 
 
less risky than continuing to smoke cigarettes, etc)
 
 
 
 
3.3.
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.
 
 
 
3.4.
All
information
on
the
product
label
must
only
be
written
in
either
English
 
 
 
 
 
 
 
 
 
 
 
 
 
or Filipino.
 
 
3.5.
For
vapor
product
refills
and
cartridges
with
nicotine
concentrations
not
 
 
 
 
 
 
 
 
 
 
exceeding
65mg/mL
and
does
not
bear
health/therapeutic
claims,
the
 
 
 
 
 
 
 
 
 
following
information
should
be
available
and
printed
legibly
on
the
 
 
 
 
 
 
 
 
 
 
primary packaging of vapor product refills and cartridges.
 
 
 
3.5.1.
Brand name
 
3.5.2.
Name of Product Variant
 
3.5.3.
Nicotine
concentration
per
unit
refill,
expressed
in
mg
nicotine/mL
 
 
 
 
 
 
 
 
 
of
solution
or
mg,
or
the
words
“nicotine-free,”
as
applicable.
 
 
 
 
 
 
 
 
 
 
Furthermore
the
FDA
will
require
a
nicotine
warning
statement
to
 
 
 
 
 
 
 
 
 
 
read
​
‘‘WARNING:
This
product
contains
nicotine.
Nicotine
is
 
 
 
 
 
 
 
 
an addictive chemical”.
 
3.5.4.
Net volume or weight, as applicable
 
3.5.5.
The term “Vapor Product Refill” to describe the product.
 
3.5.6.
The
exact
statements
“Do
not
swallow”
and
“Keep
out
of
the
reach
 
 
 
 
 
 
 
 
 
 
 
 
of children.”
 
3.5.7.
Graphic Health Warning
 
3.5.8.
Batch/Lot number
 
3.5.9.
Expiry date
 
3.5.10.
FDA Electronic Registration Number [FERN].
 3.5.11.
Prohibited
on
packs
–
offers
and
discounts,
product
safety
or
health
 
 
 
 
 
 
 
 
 
 
 
claims
 
 
3.6.
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:
 
 
 
3.6.1.
Marketing Authorization Holder Information
 
 
3.6.1.1.
Company Name
 
3.6.1.2.
Company Address
 
3.6.1.3.
Company Contact Details
 
3.6.1.4.
LTO Number
 
 
3.6.2.
Country of Origin
 
 
3.6.3.
List
of
ingredients
contained
in
the
product,
in
descending
order
of
 
 
 
 
 
 
 
 
 
 
 
concentration,
with
potential
allergens
emphasized
in
bold
 
 
 
 
 
 
 
characters.
 
 
3.6.4.
Instructions
on
the
handling,
refill,
use,
and
storage
of
the
vapor
 
 
 
 
 
 
 
 
 
 
 
product solutions, when appropriate
 
 
3.6.5.
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
 
 
3.6.6.
Instructions
for
the
disposal
of
the
vapor
product
solutions
and
 
 
 
 
 
 
 
 
 
 
containers
 
3.6.7.
Directions in case of ingestion or skin contact
 
 
3.6.8.
GHS Pictogram, Signal Word, and Hazard Statement
 
 
3.6.9.
Undesirable adverse health effects
 
 
3.6.10.
Warning statements:
 
 
 
3.6.10.1.
Do not swallow
 
3.6.10.2.
Keep out of the reach of children
 
3.6.10.3.
Avoid prolonged contact with the skin
 
3.6.10.4.
Nicotine is an addictive substance
 3.6.10.5.
Not
suitable
for
pregnant
women,
nursing
mothers,
 
 
 
 
 
 
 
children,
persons
with
respiratory
or
cardiovascular
 
 
 
 
 
 
diseases
 
3.6.10.6.
Call
the
poison
center
or
the
hospital
near
you
in
case
of
 
 
 
 
 
 
 
 
 
 
 
 
accidents,
injury,
or
illness
arising
from
the
use
of
this
 
 
 
 
 
 
 
 
 
 
product.
 
 
 
3.6.11.
The
updated
contact
information
of
the
Philippine
General
 
 
 
 
 
 
 
 
Hospital,
National
Poison
Management
and
Control
Center,
as
of
 
 
 
 
 
 
 
 
 
the time of manufacture
 
 
3.6.12.
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
​
.”
 
 
4.
Graphic Health Warnings
 
 
 
 
4.1.
All vapor products shall bear graphic health warnings on its packaging.
 
 
4.2.
Within
18
months
from
the
effectivity
of
Republic
Act
No.
11346,
all
 
 
 
 
 
 
 
 
 
 
 
 
vapor
products
must
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.