FDA Circular No. __________________
 
 
SUBJECT: 
​
General Guidelines for the Regulation of Vapor Products
 
I.
BACKGROUND/RATIONALE
 
Republic
Act
No.
(RA)
9711,
otherwise
known
as
The
Food
and
Drug
 
 
 
 
 
 
 
 
 
 
 
 
Administration
Act
of
2009,
declares
as
a
policy
that
the
State
shall
protect
and
promote
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the
right
to
health
of
the
Filipino
people
and
help
establish
and
maintain
an
effective
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
health
product
regulatory
system
based
on
the
country’s
health
needs
and
problems.
Thus,
 
 
 
 
 
 
 
 
 
 
 
 
 
the
State
must
enhance
and
strengthen
its
regulatory
capacity
over
all
health
products
and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
its industry.
 
Under
Sec.
144(C)
of
Act
No.
(RA)
11467
​
entitled
“An
Act
Amending
Sections
 
 
 
 
 
 
 
 
 
 
 
 
 
109,
141,
142,
143,
144,
147,
152,
263,
263-A,
265,
and
288-A,
and
Adding
a
New
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section
290-A
to
Republic
Act
No.
8424,
as
Amended,
Otherwise
Known
as
the
National
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Internal
Revenue
Code
of
1997,
and
For
Other
Purposes”
​
,
the
Food
and
Drug
 
 
 
 
 
 
 
 
 
 
 
 
 
Administration
(FDA)
is
mandated
to
periodically
determine
and
regulate,
consistent
 
 
 
 
 
 
 
 
 
 
with
evolving
medical
and
scientific
studies,
the
manufacture,
importation,
sale,
 
 
 
 
 
 
 
 
 
 
packaging,
advertising,
and
distribution
of
vapor
products,
including
banning
of
flavors,
 
 
 
 
 
 
 
 
 
 
 
and the sale to nonsmokers or persons below twenty-one (21) years old.
 
Likewise,
Executive
Order
No.
106
(EO
106)
entitled
​
“Prohibiting
the
 
 
 
 
 
 
 
 
 
 
Manufacture,
Distribution,
Marketing,
and
Sale
of
Unregistered
and/or
Adulterated
 
 
 
 
 
 
 
 
 
Electronic
Nicotine/Non-Nicotine
Delivery
Systems,
Heated
Tobacco
Products,
and
 
 
 
 
 
 
 
 
Other
Novel
Tobacco
Products,
Amending
Executive
Order
No.
26
(EO
26
s.
2017)
and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
for
Other
Purposes,
​
”
mandates
the
Philippine
FDA
to
(a)
develop
the
regulatory
 
 
 
 
 
 
 
 
 
 
 
 
framework
for
ENDS/ENNDS
and
HTPs
and
their
components
(b)
issuance
of
license
to
 
 
 
 
 
 
 
 
 
 
 
 
 
operate
(LTO)
to
establishments;
(c)
guidelines
in
the
importation
of
these
products,
and
 
 
 
 
 
 
 
 
 
 
 
 
 
(d) pertinent rules, regulations and standards thereto in the implementing guidelines.
 
Vapor
products,
including
Electronic
Nicotine
and
Non-Nicotine
Delivery
 
 
 
 
 
 
 
 
Systems
(ENDS/ENNDS),
and
HTPs
are
a
form
of
health
products
used
to
deliver
 
 
 
 
 
 
 
 
 
 
 
 
 
aerosolized
substances
to
the
lungs
by
mimicking
the
act
of
smoking.
Vapor
products
and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HTPs
are
not
likely
to
be
risk
free,
and
may
expose
users
to
chemicals
and
toxins
at
levels
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
that
have
the
potential
to
cause
health
effects.
Presented
by
the
industry
as
an
alternative
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to
conventional
tobacco
products,
these
products
still
contain
and
produce
harmful
and
 
 
 
 
 
 
 
 
 
 
 
 
potentially
harmful
substances.
There
is
currently
insufficient
evidence
to
demonstrate
 
 
 
 
 
 
 
 
 
 
that
vapor
products
or
HTPs
are
effective
in
assisting
people
to
quit
smoking
and
no
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
brand
of
these
products
have
been
approved
by
the
World
Health
Organization
(WHO)
or
 
 
 
 
 
 
 
 
 
 
 
 
 
 
any
National
Regulatory
Agency
(NRA)
for
this
purpose.
The
scientific
evidence
 
 
 
 
 
 
 
 
 
 
 
regarding
the
effectiveness
of
vapor
products
or
HTPs
as
a
smoking
cessation
aid
is
scant
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and
of
low
certainty,
making
it
difficult
to
draw
credible
inferences.
Furthermore,
current
 
 
 
 
 
 
 
 
 
 
 
 
 studies
are
not
yet
enough
to
conclude
that
the
long-term
use
of
vapor
products
and
HTPs
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
will
not
have
any
effect
on
human
health.
Concerns
have
been
raised
on
the
possibility
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
that
novel
tobacco
products
may
provide
a
gateway
to
nicotine
addiction
or
tobacco
 
 
 
 
 
 
 
 
 
 
 
 
 
product
use,
or
that
they
may
renormalize
smoking.
To
ensure
the
protection
of
public
 
 
 
 
 
 
 
 
 
 
 
 
 
 
health,
the
FDA
shall
establish
science-based
policies
and
regulations
that
limit
youth
 
 
 
 
 
 
 
 
 
 
 
 
access to vapor products and HTPs.
 
II.
OBJECTIVES
 
This
Memorandum
is
being
issued
to
provide
FDA’s
regulatory
framework
to
all
 
 
 
 
 
 
 
 
 
 
 
 
individuals,
enterprises
and
businesses
seeking
to
manufacture,
distribute,
import,
export,
 
 
 
 
 
 
 
 
 
 
sell, offer for sale, advertise, and/or use vapor products in the Philippines.
 
III.
SCOPE
 
 
This
issuance
shall
apply
to
all
entities
which
intend
to
manufacture,
distribute,
 
 
 
 
 
 
 
 
 
 
 
 
import,
export,
sell,
offer
for
sale,
and
advertise
vapor
products
not
classified
as
drug
 
 
 
 
 
 
 
 
 
 
 
 
 
 
products in the Philippines.
 
IV.
GUIDELINES
 
 
 
1.
Market Authorization of Vapor Products
 
 
1.1.
All
establishments
engaged
in
the
manufacture,
distribution,
importation,
exportation,
 
 
 
 
 
 
 
 
 
retail
and
sale,
including
online
sale,
of
vapor
products
shall
first
secure
a
License
to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Operate (LTO) through the current FDA e-portal system.
 
 
1.2.
No
establishment
shall
engage
in
activities
beyond
what
was
approved
by
the
FDA
in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
its issued LTO.
 
 
1.3.
FDA-licensed
manufacturers,
traders/importers,
and
distributors
shall
apply
for
an
 
 
 
 
 
 
 
 
 
FDA Electronic Registration Number (FERN) for their products.
 
 
1.4.
No
establishment
shall
engage
in
the
manufacture,
distribution,
importation,
 
 
 
 
 
 
 
 
 
exportation,
sale,
offering
for
sale,
and
advertising
of
vapor
products
without
first
 
 
 
 
 
 
 
 
 
 
 
 
securing the necessary authorizations from the FDA.
 
 
1.5.
Vapor
product
refills,
and
cartridges
with
or
without
nicotine,
bearing
product
claims,
 
 
 
 
 
 
 
 
 
 
 
 
such
as
but
not
limited
to
tobacco
cessation
claims,
reduced
risk/tobacco
harm
 
 
 
 
 
 
 
 
 
 
 
 
reduction
claims,
or
containing
nicotine
concentrations
above
65
mg/mL
(>65mg/mL)
 
 
 
 
 
 
 
 
 
 
shall
be
shall
comply
with
the
regulatory
requirements
and
standards
for
 
 
 
 
 
 
 
 
 
 
 
drug/pharmaceutical
products
under
the
Center
for
Drug
Regulation
and
Research
 
 
 
 
 
 
 
 
 
 
(CDRR).
 
 1.6.
Vapor
product
refills
and
cartridges
containing
nicotine
concentrations
above
20
 
 
 
 
 
 
 
 
 
 
mg/mL
but
not
more
than
65
mg/mL
(>20mg/mL-65mg/mL)
in
their
formulations,
 
 
 
 
 
 
 
 
 
 
 
and do not bear product claims, shall be applied for FERN Category 1 (FERN 1).
 
 
1.7.
Vapor
product
refills,
and
cartridges
with
nicotine
content
not
exceeding
20
mg/mL
 
 
 
 
 
 
 
 
 
 
 
 
and does not bear product claims, shall be applied for FERN Category 2 (FERN 2).
 
 
1.8.
Vapor
product
electronic
delivery
devices,
shall
be
issued
a
FERN
Category
3
(FERN
 
 
 
 
 
 
 
 
 
 
 
 
 
3)
authorization
upon
compliance
to
set
requirements
including
the
certificate
of
 
 
 
 
 
 
 
 
 
 
 
conformity issued by the Department of Trade and Industry (DTI).
 
 
1.9.
Vapor
product
refills
and
cartridges
categorized
under
FERN
1,
shall
be
subject
to
 
 
 
 
 
 
 
 
 
 
 
 
 
pre-application
documentary
evaluation
(PADE)
prior
to
submission
for
FERN
 
 
 
 
 
 
 
 
 
application.
 
 
1.10.
All
batches
of
vapor
product
refills
and
cartridges
shall
also
be
declared
with
the
FDA
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
through
the
batch
declaration
process
prior
to
importation,
distribution,
or
sale
in
the
 
 
 
 
 
 
 
 
 
 
 
 
 
Philippines.
 
 
 
1.11.
Only
vapor
products
that
have
complied
with
the
standards
set
by
the
FDA
shall
be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
issued a FERN Certificate.
 
 
1.12.
No
establishment
shall
operate
and
distribute/sell
vapor
products
in
the
Philippines
 
 
 
 
 
 
 
 
 
 
 
without the appropriate marketing authorizations from the FDA.
 
 
2.
Online Sale (Retail and Wholesale)
 
 
2.1.
Online
sellers
shall
apply
for
a
license
to
operate
based
on
their
intended
activity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(Manufacturer,
Trader,
Distributor,
or
Retailer)
with
the
addition
of
online
selling
 
 
 
 
 
 
 
 
 
 
 
activity in their LTO.
 
 
2.2.
Online
sellers
are
required
to
declare
a
physical
office
address
which
shall
be
subject
 
 
 
 
 
 
 
 
 
 
 
 
 
 
to FDA’s pre and post licensing inspection and monitoring.
 
 
2.3.
All
online
sellers
shall
require
customers
to
register
for
a
user
account
prior
to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
allowing access to the online store.
 
2.3.1.
For
retail
sellers,
proper
age
verification,
including
the
submission
of
a
 
 
 
 
 
 
 
 
 
 
 
government
issued
identification
card
or
certificate
reflecting
the
age
or
date
 
 
 
 
 
 
 
 
 
 
 
of birth of the person registering for a user account, shall be required.
 
2.3.1.1.
Individuals
below
the
age
of
twenty-one
(21)
years
are
not
eligible
to
 
 
 
 
 
 
 
 
 
 
 
 
have a user account.
 
2.3.2.
For
online
wholesalers,
the
submission
of
a
valid
FDA-issued
LTO
as
retailer
 
 
 
 
 
 
 
 
 
 
 
 
or
distributor/wholesaler
of
vapor
products,
shall
be
required
for
the
issuance
 
 
 
 
 
 
 
 
 
 
 
of a user account.
 2.3.3.
Sufficient
review
of
the
request
for
a
user
account
shall
be
conducted
by
the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
online
seller
prior
to
approval
of
the
request.
Automated
issuance
of
user
 
 
 
 
 
 
 
 
 
 
 
 
accounts shall not be allowed.
 
 
2.4.
Only
establishments
with
a
license
to
operate
as
retailers
can
conduct
online
retail
 
 
 
 
 
 
 
 
 
 
 
 
 
sales on their online platform.
 
 
2.5.
Online wholesalers shall only sell to verified FDA-licensed retailers and distributors.
 
2.5.1.
Products
must
only
be
delivered
at
the
official
address
of
the
retailer
or
 
 
 
 
 
 
 
 
 
 
 
 
 
distributor/wholesaler as reflected on its LTO.
 
 
2.6.
The
distribution,
shipping,
transport
and/or
delivery
of
vapor
products
shall
be
strictly
 
 
 
 
 
 
 
 
 
 
 
 
prohibited
in
places
where
the
sale
of
such
products
are
prohibited,
as
provided
under
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Executive Order No. 26 s. 2017 as amended by Executive Order No. 106 s. 2020.
 
2.7.
Under
no
circumstances
shall
an
online
wholesaler
or
retailer
be
allowed
to
transport
 
 
 
 
 
 
 
 
 
 
 
 
 
or deliver vapor products to persons below twenty-one (21) years of age.
 
2.7.1.
The
courier
shall
only
release
the
product
to
the
account
holder
after
proper
 
 
 
 
 
 
 
 
 
 
 
 
 
verification
of
the
recipient's
identity
and
age
by
means
of
any
valid
 
 
 
 
 
 
 
 
 
 
 
 
government-issued photographic identification containing the date of birth.
 
 
2.8.
All
forms
of
advertising
shall
be
restricted
within
the
web
address/site
and
shall
not
 
 
 
 
 
 
 
 
 
 
 
 
 
 
pop-up
in
other
online
platforms.
The
advertising
of
the
online
stores
may
be
allowed
 
 
 
 
 
 
 
 
 
 
 
 
 
 
provided
that
the
platforms
where
it
is
advertised
are
not
accessible
and
visible
to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
individuals below twenty-one (21) years of age.
 
 
2.9.
The
FDA
shall
have
the
authority
to
access
the
web
address/site
and
enter
the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
physical premise of the establishment to conduct routine or spot check inspections.
 
 
2.10.
All
establishments
engaged
in
electronic
commerce
must
ensure
compliance
with
the
 
 
 
 
 
 
 
 
 
 
 
requirements
for
product
quality
and
safety
and
consumer
data
protection
as
provided
 
 
 
 
 
 
 
 
 
 
 
 
under
the
DTI-DOH-DA
Joint
Administrative
Order
(AO)
No.
1,
otherwise
known
as
 
 
 
 
 
 
 
 
 
 
 
 
the
​
“Rules
and
Regulations
for
Consumer
Protection
in
a
Transaction
Covered
by
the
 
 
 
 
 
 
 
 
 
 
 
 
 
Consumer
Act
of
the
Philippines
(RA
7394)
through
Electronic
Means
under
the
 
 
 
 
 
 
 
 
 
 
 
 
E-commerce
Act
(RA
8792)”,
the
​
Data
Privacy
Act
of
2012
(RA
10173),
the
FDA
Act
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
of 2009 (RA 9711),
​
 
​
and other applicable laws.
 
 
3.
Product Standards
 
 
3.1.
All vapor product refills must be compliant with the set standards provided under
 
Annex A - 
​
“Vapor Product Refill and Cartridge Standards”
​
 prior to release for
 
distribution and/or sale in the Philippines.
 
 3.2.
The FDA shall set and issue pertinent standards on vapor product refills and
 
collaborate with the DTI for the issuance of standards on the electronic delivery
 
devices, guided by current available scientific evidence and international standards.
 
 
 
4.
Labelling and Packaging
 
 
4.1.
All
containers
and
packages
of
vapor
product
refills
and
cartridges
and
electronic
 
 
 
 
 
 
 
 
 
 
 
 
delivery
devices
shall
contain
appropriate
information
and
health
warnings
compliant
 
 
 
 
 
 
 
 
 
 
with
the
guidelines
provided
under
​
Annex
B
​
-
​
Labelling
Requirements
for
Vapor
 
 
 
 
 
 
 
 
 
 
 
 
Product
Refills
and
Cartridges,
and
​
Annex
C
-
​
“Labelling
Requirements
for
Vapor
 
 
 
 
 
 
 
 
 
 
 
 
Product Electronic Delivery Devices”
​
.
 
 
5.
Sale, Use, and Access Restrictions
 
 
5.1.
Retail
sale
of
pure
nicotine
and
nicotine
shots/concentrates
shall
be
strictly
prohibited.
 
 
 
 
 
 
 
 
 
 
 
 
Only
ready
to
use
mixtures
shall
be
sold
to
consumers.
Mixing
of
vape
solutions
at
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the point of sale shall be prohibited.
 
 
5.2.
Retail
sale
of
ingredients
for
the
purpose
of
modification
of
vapor
product
refills
shall
 
 
 
 
 
 
 
 
 
 
 
 
 
 
be prohibited. These products shall not be allowed to be sold in retail stores.
 
 
5.3.
No
manufacturer,
distributor,
importer,
exporter,
or
retailer
of
vapor
products
shall
 
 
 
 
 
 
 
 
 
 
 
sell to individuals under twenty-one (21) years of age.
 
 
5.4.
The
distribution,
sale,
offering
for
sale
and
use
of
vapor
products
shall
be
strictly
 
 
 
 
 
 
 
 
 
 
 
 
 
 
prohibited
in
places
provided
under
Executive
Order
No.
26
s.
2017
as
amended
by
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Executive Order No. 106 s. 2020.
 
 
5.5.
The
testing
and
use
of
vapor
products
shall
be
prohibited
inside
the
premises
of
retail
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
outlets
and
in
other
enclosed
public
places,
except
in
designated
smoking/vaping
 
 
 
 
 
 
 
 
 
 
 
areas (DSVAs).
 
 
 
5.6.
Vaping
lounges,
shall
follow
the
same
guidelines
and
requirements
for
DSVAs
as
 
 
 
 
 
 
 
 
 
 
 
 
provided under section 4 of EO 26 s. 2017 as amended by EO 106 s. 2020.
 
 
5.7.
Under
no
circumstances
shall
an
establishment
or
individual
be
allowed
to
publish
or
 
 
 
 
 
 
 
 
 
 
 
 
 
otherwise
communicate
tutorials
on
adulterating,
modifying,
manufacturing,
or
 
 
 
 
 
 
 
 
otherwise
tampering
of
vapor
products
through
any
print,
physical,
electronic,
or
 
 
 
 
 
 
 
 
 
 
 
online media.
 
 
5.8.
The
Food
and
Drug
Administration
shall
cooperate
with
the
National
 
 
 
 
 
 
 
 
 
 
Telecommunications
Commission,
the
Ads
Standards
Council,
and
other
concerned
 
 
 
 
 
 
 
 
 
government
enforcement
agencies
to
remove
any
materials
that
communicate
 
 
 
 
 
 
 
 
 
tutorials
on
adulterating,
modifying,
manufacturing,
or
otherwise
tampering
vapor
 
 
 
 
 
 
 
 
 
products from general circulation.
  
6.
Advertising, Promotion, and Sponsorship
 
 
6.1.
No
person,
establishment
or
organization,
shall
use
the
FDA
logo,
the
words
“Food
 
 
 
 
 
 
 
 
 
 
 
 
 
and
Drug
Administration”
or
“Philippine
FDA”,
the
initials
“FDA”,
or
any
imitation
 
 
 
 
 
 
 
 
 
 
 
 
of
such
words,
initials,
or
logo
in
print
and
other
forms
of
broadcast
media,
including
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the
internet,
in
connection
with
any
vapor
product
merchandise,
impersonation,
 
 
 
 
 
 
 
 
 
 
solicitation,
or
commercial
activity
in
a
manner
that
convey
that
such
use
is
approval,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
endorsement,
or
authorization
by
the
FDA
(e.g.
“FDA
approved”
or
“This
product
is
 
 
 
 
 
 
 
 
 
 
 
 
 
approved by the FDA”).
 
 
6.2.
Advertising
activities
shall
be
strictly
prohibited
except
in
FDA-licensed
retail
 
 
 
 
 
 
 
 
 
 
outlets/stores for vapor products.
 
 
6.3.
Marketing
materials
shall
not
bear
markings
or
characters
that
are
likely
to
promote
 
 
 
 
 
 
 
 
 
 
 
 
 
youth
use
such
as
the
use
of
cartoons,
anime,
manga,
animated
characters,
youth
 
 
 
 
 
 
 
 
 
 
 
 
 
influencers, personalities and the like.
 
 
6.4.
Only
print
media
on
fixed
locations,
within
the
premises
of
retail
establishments
shall
 
 
 
 
 
 
 
 
 
 
 
 
 
be
allowed.
Free
product
samples,
hand-outs,
flyers,
and
other
print
media
for
 
 
 
 
 
 
 
 
 
 
 
 
distribution to store patrons and passers-by, shall be strictly prohibited.
 
 
6.5.
Promotion
of
vaping
products
that
implies
health
benefits
may
be
derived
from
the
 
 
 
 
 
 
 
 
 
 
 
 
 
use of the product or from its emissions shall be prohibited.
 
 
 
6.6.
Modified risk descriptors (e.g., ‘‘light,’’ ‘‘low,’’ and ‘‘mild’’ descriptors) and
 
unsubstantiated claims (e.g. healthy, low harm, less harmful, helpful to quit smoking,
 
effective than other smoking cessation products, etc) are prohibited in the  sale and
 
distribution of products. These include misleading elements and notably any
 
suggestions that a particular vapor 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.).
 
 
6.7.
Placing,
posting,
or
displaying
vapor
products
and
its
marketing
materials
in
any
 
 
 
 
 
 
 
 
 
 
 
 
place
of
retail
outlets
that
is
open
and
visible
to
the
general
public,
especially
the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
youth,
such
as
but
not
limited
to
stalls,
kiosks,
booths,
or
stands
is
strictly
prohibited.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
For
such
retail
outlets,
only
the
use
of
a
signage
displaying
the
name
of
the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
establishment,
menu
cards
for
the
list
of
products
offered
(to
be
presented
to
verified
 
 
 
 
 
 
 
 
 
 
 
 
 
 
customers),
and
placement
of
a
single
simple
sign
with
white
background
and
black
 
 
 
 
 
 
 
 
 
 
 
 
 
font
and
not
exceeding
twelve
inches
by
eighteen
inches
(12”x18”)
in
size
stating
 
 
 
 
 
 
 
 
 
 
 
 
 
only the following: “Vapor products/HTPs Available Here” shall be allowed.
 
 
6.8.
Promotion
and
sponsorship,
including
corporate
social
responsibility
 
 
 
 
 
 
 
campaigns/activities by the vapor product industry shall be strictly prohibited.
 
 6.9.
Other
products
and
merchandises,
such
as
but
not
limited
to
clothing,
bags,
 
 
 
 
 
 
 
 
 
 
 
 
accessories,
toys,
food,
and
beverages,
especially
those
generally
intended
for
the
 
 
 
 
 
 
 
 
 
 
 
consumption
of
children
and
the
youth
shall
not
bear
names,
logos,
or
other
indicia
of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
vapor
product
brand(s)
nor
shall
it
be
presented
in
such
a
way
that
it
resembles
vapor
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
products.
 
 
6.10.
No
establishment
shall
engage
private
persons
to
promote
a
vaping
product
through
a
 
 
 
 
 
 
 
 
 
 
 
 
 
testimonial
or
an
endorsement,
displayed
or
communicated,
including
by
means
of
 
 
 
 
 
 
 
 
 
 
 
packaging or advertising materials.
 
 
7.
Enforcement
 
 
7.1.
The
FDA,
through
a
subsequent
Order,
shall
form
a
specialized
unit
under
the
Center
 
 
 
 
 
 
 
 
 
 
 
 
 
 
for
Cosmetics
Regulation
and
Research
(CCRR),
to
implement
and
co-develop
the
 
 
 
 
 
 
 
 
 
 
 
provisions of this policy.
 
 
 
7.2.
The
FDA
shall
conduct
post
market
surveillance
(PMS)
activities
for
verification
of
 
 
 
 
 
 
 
 
 
 
 
 
industry compliance and enforcement of FDA rules and regulations.
 
 
7.3.
The
DILG
through
the
LGUs,
PNP,
and
MMDA,
are
enjoined
to
adopt
and
 
 
 
 
 
 
 
 
 
 
 
 
 
implement
the
minimum
allowable
age
for
the
use
of
vapor
products.
​
The
sale
of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
vapor
products
shall
be
made
available
only
to
an
individual
who
demonstrates
that
 
 
 
 
 
 
 
 
 
 
 
 
 
he/she
is
more
than
21
years
of
age,
by
presenting
any
valid
government-issued
ID
 
 
 
 
 
 
 
 
 
 
 
 
 
 
that
either
includes
the
owner’s
birthdate
or
is
presented
in
conjunction
with
a
 
 
 
 
 
 
 
 
 
 
 
 
 
government-issued certificate supporting the claimed age of the customer.
 
 
7.4.
The
local
government
units
(LGU),
and
other
government
agencies
and
offices
 
 
 
 
 
 
 
 
 
 
 
involved
in
the
monitoring
and
regulation
of
the
use,
sale
and
distribution
of
vapor
 
 
 
 
 
 
 
 
 
 
 
 
 
 
products are enjoined to observe and implement the guidelines provided.
 
 
 
V.
EFFECTIVITY DATE AND TRANSITORY PERIOD
 
 
This
Circular
shall
take
effect
15
days
after
publication
in
a
newspaper
of
general
 
 
 
 
 
 
 
 
 
 
 
 
 
 
circulation and the Office of National Administrative Register of the UP Law Center.
 
 
Manufacturers,
importers,
distributors,
and
retailers
are
given
an
eighteen
(18)
month
 
 
 
 
 
 
 
 
 
 
 
grace
period,
from
the
effectivity
date
of
the
rules
and
regulations
implementing
RA
 
 
 
 
 
 
 
 
 
 
 
 
 
11467, to comply with the new regulations.
 
 
VI.
PENALTIES
 
 
Violation
to
any
provisions
of
this
Circular
shall
be
subject
to
the
penalties/sanctions
 
 
 
 
 
 
 
 
 
 
 
 
 
provided
under
Book
III,
Article
XI
of
the
Rules
and
Regulations
Implementing
 
 
 
 
 
 
 
 
 
 
 
 
Republic
Act
No.
9711,
The
Food
and
Drug
Administration
Act
of
2009,
Republic
 
 
 
 
 
 
 
 
 
 
 
 
 Act
No.
11346,
Republic
Act
No.
11467,
Executive
Order
No.
106
and
other
 
 
 
 
 
 
 
 
 
 
 
 
 
penalties provided by other applicable laws.
 
 
VII.
SEPARABILITY CLAUSE
 
 
If
any
provision
in
this
Circular,
or
application
of
such
provision
to
any
 
 
 
 
 
 
 
 
 
 
 
 
 
circumstances,
is
held
invalid,
the
remainder
of
the
provisions
in
this
Circular
shall
 
 
 
 
 
 
 
 
 
 
 
 
 
not be affected.
 
 
 
 
Keywords
 
Implementing
Guidelines,
Vapor
Products,
Electronic
Nicotine
Delivery
System,
Electronic
 
 
 
 
 
 
 
 
 
Non-Nicotine
Delivery
System,
ENDS/ENNDS,
Vape,
Electronic
Cigarettes,
E-Cigarettes,
 
 
 
 
 
 
 
 
E-Liquids, Vapor Products
 
Related Issuances, Laws, Directives
 
RA 9711, RA 11346, RA 11467, EO 106 s.2020