FDA Circular No. __________________
 
 
SUBJECT: 
​
General Guidelines for the Regulation of Heated Tobacco 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
its
regulatory
capacity
and
strengthen
its
capacity
for
the
 
 
 
 
 
 
 
 
 
 
 
 
 
regulation of health products and its industry.
 
Under
Sec.
144(B)
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
heated
tobacco
products
(HTPs),
including
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)
issue
license
to
 
 
 
 
 
 
 
 
 
 
 
 
operate
(LTO)
to
establishments;
(c)
formulate
guidelines
in
the
importation
of
these
 
 
 
 
 
 
 
 
 
 
 
 
products,
and
(d)
develop
pertinent
rules,
regulations
and
standards
thereto
in
the
 
 
 
 
 
 
 
 
 
 
 
 
implementing guidelines.
 
HTPs
deliver
aerosolized
substances
to
the
lungs
by
mimicking
the
act
of
 
 
 
 
 
 
 
 
 
 
 
 
smoking.
HTPs
expose
users
to
chemicals
and
toxins
at
levels
that
have
health
effects.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Presented
by
industry
as
an
alternative
to
combustible
tobacco
products,
these
products
 
 
 
 
 
 
 
 
 
 
 
 
still
contain
and
produce
harmful
and
potentially
harmful
substances.
There
is
currently
 
 
 
 
 
 
 
 
 
 
 
 
insufficient
evidence
to
demonstrate
that
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.
 
 
 
 
 
 
 
 
 
 
 Independent
scientific
evidence
regarding
the
effectiveness
of
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
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 HTPs.
 
 
II.
OBJECTIVES
 
This
Circular
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
heated
tobacco
products
(HTPs)
in
the
 
 
 
 
 
 
 
 
 
 
 
 
 
Philippines.
 
 
III.
SCOPE
 
 
This
issuance
shall
apply
to
all
individuals,
enterprises
and
businesses
which
 
 
 
 
 
 
 
 
 
 
 
intend
to
manufacture,
distribute,
import,
export,
sell,
offer
for
sale,
and
advertise
HTPs
 
 
 
 
 
 
 
 
 
 
 
 
 
not classified as drug products in the Philippines.
 
IV.
GUIDELINES
 
 
 
1.
Market Authorization of  HTPs
 
 
1.1.
All
establishments
engaged
in
the
manufacture,
distribution,
importation,
exportation,
 
 
 
 
 
 
 
 
 
retail
sale,
including
online
sale,
of
HTPs
shall
first
secure
a
License
to
Operate
(LTO)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
from the Center for Cosmetics Regulation and Research (CCRR).
 
 
1.2.
No
establishment
shall
engage
in
activities
beyond
what
was
approved
by
the
FDA
in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
its issued LTO.
 
 
1.3.
Only FDA-licensed manufacturers, traders/importers, and distributors can 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
HTPs
without
first
securing
the
 
 
 
 
 
 
 
 
 
 
 
 
 
necessary authorizations from the FDA.
 
 
1.5.
Heated
tobacco
products
shall
be
registered
per
refill/cartridge-device
combination
 
 
 
 
 
 
 
 
 
(e.g.
refill/cartridge
variant
1
+
device
model
1)
and
shall
be
filed
under
a
single
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
application,
with
the
issuance
of
a
FERN
after
compliance
to
the
set
standards
and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
requirements.
 
 
 
1.6.
HTPs
not
bearing,
and
not
marketed
with
health
claims
(such
as
but
not
limited
to:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
tobacco
harm
reduction,
tobacco
cessation
aid
claims)
shall
be
required
to
undergo
 
 
 
 
 
 
 
 
 
 
 
 
pre-application
documentary
evaluation
(PADE)
at
least
3
months
prior
to
applying
for
 
 
 
 
 
 
 
 
 
 
 
 
a FERN.
 
 
1.7.
All
batches
of
HTP
refills
and
cartridges
shall
also
be
declared
with
the
FDA
through
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the
batch
declaration
process
prior
to
importation,
distribution,
or
sale
in
the
 
 
 
 
 
 
 
 
 
 
 
 
Philippines.
 
 
 
1.8.
HTPs
bearing,
or
are
marketed
with
therapeutic
or
health
claims
(such
as
but
not
 
 
 
 
 
 
 
 
 
 
 
 
 
 
limited
to:
tobacco
harm
reduction,
tobacco
cessation
aid
claims)
shall
comply
with
 
 
 
 
 
 
 
 
 
 
 
 
the
regulatory
requirements
and
standards
for
drug/pharmaceutical
products
under
the
 
 
 
 
 
 
 
 
 
 
Center for Drug Regulation and Research (CDRR).
 
 
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
HTPs,
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
HTPs
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 HTPs 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
without
 
 
 
 
 
 
 
 
 
 
 
 
 
 
delay
and
at
reasonable
hours
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 HTPs must be compliant with the set standards provided under 
​
Annex A - “Heated
 
Tobacco Product Refill/Cartridge and Device Standards”
​
 prior to release for
 
distribution and/or sale in the Philippines.
  
3.2.
The FDA shall set and issue pertinent standards on HTP refills/cartridges 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
HTP
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
Heated
Tobacco
 
 
 
 
 
 
 
 
 
 
 
Product
Refills
and
Cartridges”
​
,
​
Annex
C
-
“Labelling
Requirements
for
Heated
 
 
 
 
 
 
 
 
 
 
 
Tobacco Product Electronic Delivery Devices
​
”
​
.
 
 
5.
Sale, Use, and Access Restrictions
 
 
5.1.
Retail
of
ingredients
for
the
purpose
of
modification
of
HTP
refills
and
cartridges,
 
 
 
 
 
 
 
 
 
 
 
 
 
such
as
but
not
limited
to
flavorings,
nicotine
shots,
and
other
additives,
shall
be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
prohibited. These products shall not be allowed to be sold in retail stores.
 
 
5.2.
No
manufacturer,
retailer,
distributor,
importer,
exporter,
or
retailer
of
HTPs
shall
sell
 
 
 
 
 
 
 
 
 
 
 
 
to individuals under twenty-one (21) years of age.
 
 
 
5.3.
The
distribution,
sale,
offering
for
sale
and
use
of
HTPs
shall
be
strictly
prohibited
in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
places
provided
by
Executive
Order
No.
26
s.
2017
as
amended
by
Executive
Order
 
 
 
 
 
 
 
 
 
 
 
 
 
 
No. 106 s. 2020.
 
 
5.4.
The
testing
and
use
of
HTPs
shall
be
prohibited
inside
the
premises
of
retail
outlets
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and
in
other
enclosed
public
places,
except
in
designated
smoking
and
vaping
areas
 
 
 
 
 
 
 
 
 
 
 
 
 
(DSVAs).
 
 
 
5.5.
Smoking
and
vaping
lounges
and
similar
establishments
shall
follow
the
same
 
 
 
 
 
 
 
 
 
 
 
guidelines
and
requirements
provided
under
this
circular
and
section
4
of
EO
26
s.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2017 as amended by EO 106 s. 2020.
 
 
5.6.
Under
no
circumstances
shall
an
establishment
or
individual
be
allowed
to
publish
or
 
 
 
 
 
 
 
 
 
 
 
 
 
otherwise
communicate
tutorials
on
adulterating,
modifying,
manufacturing,
or
 
 
 
 
 
 
 
 
otherwise tampering of HTPs through any print, physical, electronic, or online media.
 
 
 5.7.
The
FDA
shall
collaborate
with
the
National
Telecommunications
Commission,
the
 
 
 
 
 
 
 
 
 
 
Ads
Standards
Council,
and
other
concerned
enforcement
agencies
to
remove
any
 
 
 
 
 
 
 
 
 
 
 
materials
that
communicate
tutorials
on
adulterating,
modifying,
manufacturing,
or
 
 
 
 
 
 
 
 
 
otherwise tampering HTPs 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
HTPs
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 of HTPs.
 
 
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
FDA-authorized
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.
 
 
 
 
 
 
 
 
 
 
 
 
 
For
HTP
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: “HTPs Available Here" shall be allowed.
 
 
6.5.
Promotion
of
HTPs
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 HTP 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.).
  
6.7.
Placing,
posting,
or
displaying
HTPs,
and
its
advertising
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.
 
 
 
6.8.
Promotion
and
sponsorship,
including
corporate
social
responsibility
 
 
 
 
 
 
 
campaigns/activities by the HTP 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
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HTP brands nor shall it be presented in such a way that it resembles HTPs.
 
 
6.10.
No
establishment,
organization,
or
juridical
person
shall
engage
an
individual
to
 
 
 
 
 
 
 
 
 
 
 
promote
HTPs
through
a
testimonial
or
an
endorsement,
however
displayed
or
 
 
 
 
 
 
 
 
 
 
 
communicated, including by means of packaging or advertising materials
​
.
 
 
 
 
7.
Enforcement
 
 
7.1.
The
FDA
shall
conduct
post
market
surveillance
(PMS)
activities
for
verification
of
 
 
 
 
 
 
 
 
 
 
 
 
industry compliance and enforcement of FDA rules and regulations.
 
 
7.2.
The
FDA
shall
collaborate
with
the
Department
of
Interior
and
Local
Government
 
 
 
 
 
 
 
 
 
 
 
 
through
the
local
government
units
(LGUs),
Philippine
National
Police,
and
 
 
 
 
 
 
 
 
 
 
Metropolitan
Manila
Development
Authority,
in
the
enforcement
of
the
minimum
 
 
 
 
 
 
 
 
 
 
allowable
age
for
the
use
of
HTPs.
​
Sale
of
HTPs,
shall
be
made
only
to
an
individual
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
who
demonstrates
that
he/she
is
more
than
21
years
of
age,
through
(a)
any
valid
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
government
ID;
(b)
a
valid
passport
issued
by
the
Department
of
Foreign
Affairs
or
 
 
 
 
 
 
 
 
 
 
 
 
 
 
any
other
country;
or
(c)
an
identification
card
issued
by
the
FDA
for
the
use
of
such
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
products.
 
 
7.3.
The
LGUs
and
other
government
agencies
and
offices
involved
in
the
monitoring
and
 
 
 
 
 
 
 
 
 
 
 
 
 
regulation
of
the
use,
sale
and
distribution
of
HTPs
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, Heated Tobacco Products, HTP, Heat-Not-Burn
 
Related Issuances, Laws, Directives
 
RA 9711, RA 11346, RA 11467, EO 106 s.2020
 
 
 
 