ANNEX A
 
Heated Tobacco Product Refill/Cartridge and Device Standards
 
GUIDELINES
 
1.
All
Heated
Tobacco
Product
(HTP)
Refills
or
Cartridges
shall
comply
with
the
the
 
 
 
 
 
 
 
 
 
 
 
 
 
following regulations:
 
a.
Only
naturally
occurring
nicotine,
present
in
the
tobacco
leaves
used
for
the
 
 
 
 
 
 
 
 
 
 
 
 
production
of
HTP
refills
or
cartridges
shall
be
allowed
in
the
product.
Addition
 
 
 
 
 
 
 
 
 
 
 
 
 
of synthetic or natural nicotine shall be strictly prohibited.
 
b.
All
HTP
refills
or
cartridges
that
will
be
offered
for
sale
shall
submit
the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
following information;
 
i.
Brand name
 
 
ii.
Characteristics
of
tobacco
leaves
used
(e.g.
Virginia,
Burley,
Oriental,
etc
 
 
 
 
 
 
 
 
 
 
and the percentage of each type of tobacco leaf used in the product)
 
iii.
Physical
dimensions,
technical
specifications,
and
material
composition
of
 
 
 
 
 
 
 
 
the loose tobacco leaves or cartridges, as applicable.
 
iv.
Full
disclosure
of
ingredients,
including
tobacco
leaf
strains,
substances,
 
 
 
 
 
 
 
 
 
compounds,
and
additives
that
are
added
by
the
manufacturer
to
the
 
 
 
 
 
 
 
 
 
 
 
tobacco,
paper,
filter,
or
other
part
of
each
tobacco
product
by
brand
and
 
 
 
 
 
 
 
 
 
 
 
 
 
by quantity in each brand and sub-brand
 
v.
Product
weight
of
tobacco,
tobacco
type
in
grams
(g)
of
each
ingredient
 
 
 
 
 
 
 
 
 
 
 
 
and component of the ingredient per unit or per g of the tobacco product
 
vi.
Full
disclosure
of
harmful
and
potentially
harmful
ingredients
including
 
 
 
 
 
 
 
 
 
aerosol/emission constituents, when used with the intended HTP device.
 
c.
Any
change
in
the
formulated
product
should
require
a
distinct
application
and
 
 
 
 
 
 
 
 
 
 
 
 
corresponding
approval
from
the
FDA
prior
to
manufacture
or
importation
of
the
 
 
 
 
 
 
 
 
 
 
 
 
product.
 
 
d.
Nicotine content per unit refill or cartridge of HTPs shall not exceed 1 mg.
 
e.
No
pharmacologically
active
molecule,
except
for
naturally
occurring
nicotine,
 
 
 
 
 
 
 
 
 
shall
be
used
as
an
ingredient
in
the
formulation/manufacture
of
HTP
refills
and
 
 
 
 
 
 
 
 
 
 
 
 
 
cartridges.
These
include
all
medicinal,
stimulant,
psychoactive
components,
 
 
 
 
 
 
 
 
anabolic
and
narcotic
substances
especially
those
listed
under
RA
9165
or
the
 
 
 
 
 
 
 
 
 
 
 
 Comprehensive
Dangerous
Drugs
Act
of
2002
and
its
related
implementing
rules
 
 
 
 
 
 
 
 
 
 
 
and regulations and issuances.
 
f.
Likewise,
herbal
medicine
and
therapy,
nutraceuticals,
cosmeceuticals,
 
 
 
 
 
 
 
aromatherapy
ingredients,
and
vitamins
and
minerals
as
food
supplements
shall
 
 
 
 
 
 
 
 
 
 
not
be
used
as
ingredients
in
the
formulation/manufacture
of
HTP
refills
and
 
 
 
 
 
 
 
 
 
 
 
 
cartridges.
 
g.
No
oil
or
fat,
of
mineral
origin
including
essential
or
aromatic
oils
shall
be
used
as
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
an ingredient in the manufacture of HTP refills and cartridges.
 
h.
Irritants and sensitizers shall not be allowed for use in HTP refills and cartridges.
 
i.
Preservatives
and
antiseptics
shall
not
be
used
as
ingredients
in
the
manufacture
 
 
 
 
 
 
 
 
 
 
 
 
of HTP refills and cartridges.
 
j.
Cartridges shall not use colorants other than plain white.
 
k.
No pesticide or pesticide residues shall be present in the final product.
 
l.
Prohibited Ingredients
 
i.
Additives that have flavoring properties or that enhance flavor, including;
 
1.
Additives
identified
as
flavoring
agents
by
the
Joint
FAO/WHO
 
 
 
 
 
 
 
 
 
Expert
Committee
on
Food
Additives
in
the
Committee’s
 
 
 
 
 
 
 
 
evaluation,
as
published
from
time
to
time
in
the
WHO
Technical
 
 
 
 
 
 
 
 
 
 
 
Report Series.
 
2.
Additives
identified
as
flavoring
substances
by
the
Flavor
and
 
 
 
 
 
 
 
 
 
Extract
Manufacturers
Association
(FEMA)
Expert
panel
in
its
 
 
 
 
 
 
 
 
lists
of
GRAS
(Generally
Regarded
as
Safe)
flavoring
substances
 
 
 
 
 
 
 
 
 
referred
to
as
“GRAS
3”
to
“GRAS
24”
and
subsequent
GRAS
 
 
 
 
 
 
 
 
 
 
 
lists, as published from time to time, if any.
 
2.
All HTP Devices shall comply with the the following regulations:
 
a.
Each
iteration
of
heated
tobacco
product
devices
that
will
be
offered
for
sale
shall
 
 
 
 
 
 
 
 
 
 
 
 
 
 
submit the following information;
 
i.
Brand name
 
 
ii.
Full disclosure of technical specifications and product design
 
iii.
Raw material sources for each component of the products
 
iv.
Full
disclosure
of
operating
mechanisms
of
the
product,
including
the
 
 
 
 
 
 
 
 
 
 
range
of
expected
nicotine
flux
in
the
target
consumer,
based
on
(1)
 
 
 
 
 
 
 
 
 
 
 
 
typical
operating
ranges
for
heating
plate
temperatures
(2)
fast
(33-mL/s)
 
 
 
 
 
 
 
 
 
 
and
slow
(17-mL/s)
puffing
velocities
and
(3)
2s,
4s,
and
8s
puff
 
 
 
 
 
 
 
 
 
 
 
 
durations, when used with each of the intended HTP cartridges.
 v.
Full
disclosure
of
harmful
and
potentially
harmful
ingredients
including
 
 
 
 
 
 
 
 
 
aerosol/emission
constituents
including
quantity,
construction,
 
 
 
 
 
components
and
physical
properties
of
the
tobacco
product,
when
used
 
 
 
 
 
 
 
 
 
 
with the intended HTP cartridges.
 
b.
Any
change
in
the
product
should
require
and
approval
from
the
FDA
prior
to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
manufacture of the product.
 
 
c.
All
changes
in
the
product
design,
technical
specifications
of
the
device
should
 
 
 
 
 
 
 
 
 
 
 
 
require
a
distinct
application
and
approval
from
the
FDA
prior
to
manufacture
or
 
 
 
 
 
 
 
 
 
 
 
 
 
importation of the product.
 
 
 
3.
The
FDA
reserves
the
right
to
update
the
policies
on
HTP
refill,
or
cartridge,
and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
device
product
standards
consistent
with
the
evidence
on
the
health
impacts
of
locally
 
 
 
 
 
 
 
 
 
 
 
 
 
available
HTPs,
such
as,
but
not
limited
to,
those
pertaining
permissible
exposure
limits
and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
product contents and ingredients.
 
 
 
A.
Table _____ Prohibited Additives in Heated Tobacco Products
 
 
 
CHEMICAL
 
CHEMICAL ABSTRACT SERVICE
 
NO (CAS No)
 
Benzoic acid and its salts
 
65-85-0
 
Butylated hydroxytoluene
 
Carboxy methyl cellulose
 
128-37-0
 
9000-11-7
 
Citric acid and its salts
 
77-92-9
 
Ethanol
 
64-17-5
 
Ethoxylated sorbitan monolaureate
 
9005-64-5
 
Fumaric acid
 
110-17-8
 
Glycerol
 
56-81-5
 Guar gum
 
9000-30-0
 
Menthol
 
89-78-1
 
L
​
-menthol
 
2216-51-5
 
L
​
-menthone
 
14073-97-3
 
N-propyl acetate
 
109-60-4
 
Paraffin wax
 
8002-74-2
 
Propylene glycol
 
57-55-6
 
Rosin glycerol ester
 
8050-31-5
 
Sodium acetate anhydrous
 
127-09-3
 
sodium alginate
 
9005-38-3
 
Sorbic acid and its salts
 
110-44-1
 
Triacetin
 
102-76-1
 
Tributyl acetyl citrate
 
77-90-7)
 
 
 B. Table _____Other Prohibited Ingredients
 
 
No
 
Name of Ingredient
 
1
 
Vitamins
 
2
 
Minerals
 3
 
Amino acids
 
4
 
Omega 3 and omega 6 fatty acids
 
5
 
Probiotics
 
6
 
Caffeine
 
7
 
Guarana
 
8
 
Taurine
 
9
 
Glucuronic Acid and related substances
 
10
 
Bitter almond oil and related substances
 
11
 
Bitter Lettuce and related substances
 
12
 
Agaric acid and related substances
 
13
 
Black Juniper oil and related substances
 
14
 
Areca palm and related substances
 
15
 
Fern and related substances
 
16
 
Ergot of rye and related substances
 
17
 
Damiana and related substances
 
18
 
Opium and related substances
 
19
 
Jute and related substances
 
20
 
Birch tree oil and related substances
 
21
 
Camphor tree and related substances
 22
 
Camphor oil and related substances
 
23
 
Quassia tree and related substances
 
24
 
Cat nip and related substances
 
25
 
Sweet woodruff and related substances
 
26
 
Coumarin and related substances
 
27
 
Lobelia and related substances
 
28
 
 
Panama bark and related substances
 
29
 
Peyote cactus
 
30
 
Safrole
 
31
 
Sassafras tree, oil, bark and leaves
 
32
 
Herb of grace
 
33
 
Tancy and related substances
 
34
 
Stropharia and related substances
 
35
 
Melilot and related substances
 
36
 
Tonka bean and related substances
 
37
 
Thujone and related substances
 
38
 
Wild vanilla and related substances
 
39
 
Wild basil and related substances
 
40
 
Wild Jasmine and related substances
  
C. Table ____ Prohibited Substance for Filter Paper
 
 
Coloring
agents,
excluding
those
used
to
whiten
paper
or
filter
or
to
imitate
a
cork
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
pattern on tipping paper
 
a.
Coloring
agents
excluding
those
used
to
whiten
plug
wrap
paper,
to
render
 
 
 
 
 
 
 
 
 
 
 
 
tipping paper brown or bronze to imitate a cork pattern on tipping paper
 
 
D.
Table ____   Restricted Ingredients
 
 
No
 
Ingredient
 
Limitations
 
1
 
Vanilla
 
 
Vanilla
added
to
tobacco
must
not
be
no
more
 
 
 
 
 
 
 
 
 
than
0.05%
of
the
total
tobacco
weight
of
the
 
 
 
 
 
 
 
 
 
refill
 
2
 
Ethyl Vanilla
 
Ethyl
vanilla
added
to
tobacco
must
not
be
more
 
 
 
 
 
 
 
 
 
than
0.05%
of
the
total
tobacco
weight
of
the
 
 
 
 
 
 
 
 
 
refill
 
4.
Criteria for Harmful or Potentially Harmful Chemical (HPHC)
 
•
Constituents
identified
as
known,
probable,
or
possible
carcinogens
by
the
 
 
 
 
 
 
 
 
 
 
International
Agency
for
Research
on
Cancer
(IARC)
including
IARC
Group
1
 
 
 
 
 
 
 
 
 
 
 
(carcinogenic
to
humans),
IARC
Group
2
(probably
carcinogenic
to
humans),
and
 
 
 
 
 
 
 
 
 
 
 
IARC Group 2B (possibly carcinogenic to humans);
 
 
•
Constituents
identified
as
known,
likely,
probably,
or
possible
human
carcinogens
by
 
 
 
 
 
 
 
 
 
 
 
the
U.S.
Environmental
Protection
Agency
(EPA)
or
the
European
Union
Chemicals
 
 
 
 
 
 
 
 
 
 
 
Agency (ECHA);
 
 
•
Constituents
identified
as
human
carcinogens
or
reasonably
anticipated
to
be
human
 
 
 
 
 
 
 
 
 
 
 
carcinogens by the National Toxicology Program (NTP);
 
 
•
Constituents identified as potential occupational carcinogens by the National Institute
 
for Occupational Safety and Health (NIOSH):
 
 •
Constituents identified by EPA or the Agency for Toxic Substances and Disease
 
Registry (ATSDR) as having adverse respiratory or cardiac effects;
 
 
•
Constituents having, based upon a review of the peer-reviewed literature, evidence of
 
at least two of the following measures of abuse liability (addiction):  
 
•
Central nervous system activity;
 
 
•
Animal drug discrimination;
 
 
•
Conditioned place preference;
 
 
•
Animal self-administration;
 
 
•
Human self-administration;
 
 
•
Drug liking;
 
 
•
Signs of withdrawal; and
 
•
Constituents banned in other health products