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House
File
612
-
Introduced
HOUSE
FILE
612
BY
GOLDING
and
BARKER
A
BILL
FOR
An
Act
relating
to
the
regulation
of
kratom,
and
making
1
penalties
applicable.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
TLSB
2242YH
(9)
91
ss/ko
H.F.
612
Section
1.
NEW
SECTION
.
124F.1
Definitions.
1
As
used
in
this
chapter:
2
1.
“Attractive
to
children”
means
a
kratom
product
that
3
is
manufactured
in
the
shape
of
cartoons
or
animals
or
is
4
manufactured
or
packaged
in
a
form
that
bears
any
reasonable
5
resemblance
to
an
existing
candy
product
that
is
familiar
to
6
the
public
as
a
widely
distributed,
branded
food
product,
such
7
that
a
product
could
be
mistaken
for
the
branded
product,
8
especially
by
children.
9
2.
“Department”
means
the
department
of
health
and
human
10
services.
11
3.
“Independent
testing
laboratory”
means
a
laboratory
that
12
is
accredited
to
standard
ISO/IEC
17025
by
an
international
13
organization
for
standards-approved
accrediting
body.
14
4.
“Kratom”
means
the
plant
Mitragyna
speciosa
or
any
part
15
of
the
plant,
including
all
alkaloids
present
in
the
plant.
16
5.
“Kratom
extract”
means
a
substance
or
compound
obtained
17
by
extraction
of
the
Mitragyna
speciosa
leaf,
intended
for
18
ingestion,
containing
more
than
trace
amounts
of
Mitragyna
19
speciosa
and
containing
other
alkaloids
of
the
kratom
plant,
20
but
does
not
contain
any
controlled
substances
or
levels
of
21
residual
solvents
higher
than
is
allowed
in
the
United
States
22
pharmacopeia
467.
23
6.
“Kratom
food
service
establishment”
means
a
person
24
who
sells
kratom
as
a
beverage
prepared
on
site,
or
sells
25
prepackaged
kratom
beverages
or
finished
kratom
products,
at
a
26
food
establishment
as
defined
in
section
137F.1.
27
7.
“Kratom
processor”
means
a
person
who
manufactures,
28
distributes,
maintains,
or
sells
a
kratom
product
or
a
person
29
who
advertises,
represents,
or
claims
to
sell,
prepare,
or
30
maintain
a
kratom
product.
31
8.
“Kratom
product”
means
a
finished
article
containing
32
any
part
of
a
leaf
of
the
plant
Mitragyna
speciosa
in
fresh,
33
dehydrated,
or
dried
form,
or
a
kratom
extract.
34
9.
“Registrant”
means
a
person
or
kratom
processor
that
35
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sells,
prepares,
manufactures,
distributes,
or
maintains
kratom
1
products,
or
advertises,
represents,
or
holds
itself
out
as
2
selling,
preparing,
or
maintaining
kratom
products.
3
10.
“Retailer”
means
a
person
that
sells,
distributes,
4
advertises,
represents,
or
holds
itself
out
as
selling
kratom
5
products.
6
11.
“Synthesized
material”
means
an
alkaloid
or
alkaloid
7
derivative
that
has
been
created
by
chemical
synthesis
or
8
biosynthetic
means,
including
fermentation,
recombinant
9
techniques,
yeast-derived
techniques,
and
enzymatic
techniques,
10
rather
than
traditional
food
preparation
techniques,
such
11
as
heating
or
extracting,
that
synthetically
alters
the
12
composition
of
any
kratom
alkaloid
or
constituent.
13
Sec.
2.
NEW
SECTION
.
124F.2
Kratom
product
——
registration.
14
1.
A
person
responsible
for
placing
a
kratom
product
into
15
commerce
in
the
state
shall
register
annually
to
offer
the
16
kratom
product
for
sale
or
distribution.
The
application
for
17
registration
shall
include
all
of
the
following:
18
a.
A
certification
from
a
qualified
independent
auditor
19
that
the
applicant
meets
or
exceeds
guidelines
published
by
20
the
federal
food
and
drug
administration
for
current
good
21
manufacturing
practices
for
any
facility
that
manufactures,
22
processes,
packs,
or
holds
a
kratom
product.
23
b.
A
current
federal
food
and
drug
administration
food
24
facility
registration
certificate
for
any
kratom
processor
25
facility
that
manufactures,
processes,
packs,
or
holds
a
kratom
26
product.
27
c.
A
statement
that
the
applicant
has
a
reasonable
basis
28
that
the
product
is
safe
for
consumption
under
the
conditions
29
of
use
set
forth
on
the
label
and
that
the
applicant
assumes
30
responsibility
and
liability
for
any
kratom
product
offered
for
31
sale
by
the
applicant.
32
d.
A
certificate
of
analysis
from
an
independent
testing
33
laboratory
showing
compliance
with
the
requirements
of
this
34
chapter
for
residual
solvents,
7-hydroxymitragynine
content,
35
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and
heavy
metal
contaminants.
1
e.
An
application
fee
as
determined
by
the
board
by
rule.
2
2.
An
application
for
registration
may
include
multiple
3
kratom
products
if
the
kratom
products
contain
the
same
4
ingredients
sold
in
the
same
form
but
in
a
different
container,
5
package,
or
volume.
6
3.
The
department
shall
create
and
maintain
on
the
7
department’s
internet
site
a
database
of
all
kratom
products
8
that
are
registered
for
sale
in
this
state.
9
Sec.
3.
NEW
SECTION
.
124F.3
Kratom
product
——
limitations.
10
1.
A
registrant
shall
not
prepare,
distribute,
sell,
11
or
expose
for
sale
a
kratom
product
containing
a
level
12
of
7-hydroxymitragynine
in
the
alkaloid
fraction
that
is
13
greater
than
two
percent
of
the
alkaloid
composition
of
14
the
kratom
product.
A
product
that
contains
a
level
of
15
7-hydroxymitragynine
greater
than
two
percent
shall
not
be
16
marketed
as,
labeled
as,
or
contain
any
reference
on
the
17
product’s
packaging,
that
it
is
a
kratom
product
or
state
that
18
the
product
is
derived
from
the
alkaloid
mitragynine.
19
2.
A
kratom
processor,
registrant,
or
retailer
shall
not
20
offer
for
sale
a
kratom
product
that
contains
any
of
the
21
following:
22
a.
A
poisonous
or
otherwise
deleterious
non-kratom
23
ingredient,
including
a
controlled
substance.
24
b.
A
dangerous
psychoactive
compound,
including
synthetic
25
cannabinoids,
synthetic
cathinones,
or
any
other
compound
that
26
significantly
alters
the
safety
profile
of
the
kratom
product.
27
3.
A
kratom
processor,
registrant,
or
retailer
shall
not
28
offer
for
sale
any
of
the
following:
29
a.
A
kratom
product
that
is
combustible,
intended
to
be
used
30
for
vaporization,
or
injectable.
31
b.
A
kratom
product
that
is
attractive
to
children.
32
c.
A
product
containing
kratom
that
is
not
a
kratom
product.
33
Sec.
4.
NEW
SECTION
.
124F.4
Kratom
product
——
labeling.
34
A
kratom
product
produced,
manufactured,
distributed,
35
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612
offered,
sold,
or
offered
for
sale
shall
include
a
label
1
that
clearly
and
conspicuously
provides
all
of
the
following
2
information
on
each
retail
package:
3
1.
A
statement
against
the
use
by
individuals
who
are
4
under
twenty-one
years
of
age,
who
are
pregnant,
or
who
are
5
breastfeeding.
6
2.
A
recommendation
to
consult
a
health
care
professional
7
prior
to
use.
8
3.
A
statement
that
kratom
may
be
habit
forming.
9
4.
The
following
statement:
“These
statements
have
not
been
10
evaluated
by
the
United
States
food
and
drug
administration.
11
This
product
is
not
intended
to
diagnose,
treat,
cure,
or
12
prevent
any
disease.”
13
5.
The
name
and
address
for
the
place
of
business
of
the
14
registrant.
15
6.
Directions
for
use
that
include
all
of
the
following:
16
a.
A
recommended
amount
of
the
kratom
product
per
serving.
17
(1)
For
kratom
products
sold
as
capsules,
gummies,
or
18
prepackaged
single-serving
units,
the
recommended
amount
shall
19
be
clearly
described
on
the
label.
20
(2)
For
kratom
products
sold
as
beverages,
liquids,
or
21
loose
powders,
a
clear
instruction
or
a
mark
on
the
package
or
22
container
that
clearly
informs
the
consumer
of
the
recommended
23
serving
size.
24
b.
The
number
of
servings
that
can
be
safely
consumed
in
a
25
twenty-four-hour
period.
26
c.
A
listing
of
the
servings
per
container.
27
d.
A
listing
of
kratom
alkaloids
and
other
ingredients
in
28
the
product,
including
a
quantitative
not-to-exceed
declaration
29
of
the
amount
per
serving
of
each
of
the
following:
30
(1)
Mitragynine.
31
(2)
7-hydroxymitragynine.
32
e.
A
kratom
food
service
establishment
that
sells
kratom
as
33
a
beverage
prepared
on
site
shall
provide
an
equivalent
label
34
in
card
form,
or
prominently
display
the
required
language
in
a
35
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612
location
next
to
the
point-of-sale
device
to
the
customer,
at
1
the
time
the
beverage
is
purchased
by
the
consumer.
2
f.
A
kratom
product
that
contains
psychoactive
compounds
3
otherwise
permitted
by
law
must
be
clearly
labeled
with
a
full
4
disclosure
of
all
active
ingredients,
the
exact
concentration
5
of
each
compound,
and
adequate
warning
statements
about
the
6
potential
interactions
and
risks
associated
with
the
combined
7
use
of
these
substances.
8
Sec.
5.
NEW
SECTION
.
124F.5
Enforcement.
9
1.
A
person
shall
not
sell
or
distribute
a
kratom
product
10
that
is
not
currently
registered
for
sale
in
this
state.
11
The
department
shall
seize
and
destroy
an
unregistered
12
kratom
product
and
the
costs
shall
be
assessed
to
the
person
13
responsible
for
the
availability
of
the
kratom
product
in
this
14
state.
A
kratom
processor
that
sells
or
distributes
a
kratom
15
product
that
is
not
currently
registered
for
sale
in
this
state
16
is
subject
to
the
following
penalties:
17
a.
For
the
first
sale
or
distribution
of
an
unregistered
18
kratom
product,
ten
thousand
dollars,
to
be
collected
by
the
19
department
and
deposited
in
the
general
fund
of
the
state.
20
b.
For
the
second
sale
or
distribution
of
an
unregistered
21
kratom
product
for
which
a
fine
was
imposed
pursuant
to
22
paragraph
“a”
,
fifteen
thousand
dollars,
to
be
collected
by
the
23
department
and
deposited
in
the
general
fund
of
the
state.
24
c.
Upon
the
third
sale
or
distribution
of
an
unregistered
25
kratom
product
for
which
a
fine
was
imposed
pursuant
to
26
paragraph
“a”
,
the
kratom
processor
shall
be
prohibited
from
27
selling
or
distributing
any
kratom
product
in
this
state
28
for
a
period
of
two
years
following
the
third
sale
of
the
29
unregistered
kratom
product.
30
2.
A
person
shall
not
knowingly
or
willfully
sell
or
31
distribute
a
kratom
product
to
a
person
under
twenty-one
years
32
of
age.
A
person
who
violates
this
subsection
shall
be
subject
33
to
the
following:
34
a.
For
a
first
offense,
a
simple
misdemeanor.
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b.
For
a
second
or
subsequent
offense
within
one
year
of
the
1
date
of
the
first
offense,
a
serious
misdemeanor.
2
3.
A
person
shall
not
knowingly
or
willfully
manufacture,
3
deliver,
hold,
offer
for
sale,
distribute,
or
sell
a
kratom
4
product
that
contains
any
controlled
substance.
A
person
who
5
violates
this
subsection
is
guilty
of
a
class
“D”
felony.
6
4.
A
person
shall
not
knowingly
or
willfully
manufacture,
7
deliver,
hold,
offer
for
sale,
distribute,
or
sell
a
kratom
8
product
that
contains
synthetic
mitragynine,
synthetic
9
7-hydroxymitragynine,
or
any
other
synthetically
derived
10
compound
of
the
plant
Mitragyna
speciosa.
A
person
who
11
violates
this
subsection
is
guilty
of
a
serious
misdemeanor.
12
5.
a.
If
the
department
has
reason
to
believe
that
13
a
registered
kratom
product
in
this
state
violates
the
14
requirements
for
registration
under
this
chapter,
the
15
department
shall
require
the
registrant
to
produce
a
current
16
certificate
of
analysis
from
an
independent
testing
laboratory
17
showing
compliance
with
the
requirements
for
registration
18
under
this
chapter.
If
the
registrant
does
not
produce
19
a
current
certificate
of
analysis
showing
compliance
with
20
the
requirements
for
registration
under
this
chapter
within
21
a
reasonable
time
period,
the
department
shall
revoke
the
22
registration
for
the
kratom
product
and
immediately
order
the
23
stoppage
of
all
sales
of
the
kratom
product.
24
b.
If
the
department
has
reason
to
believe
that
the
25
independent
testing
laboratory
used
by
a
registrant
has
not
26
provided
accurate
results,
the
department
shall
submit
the
27
kratom
product
for
testing
to
an
independent
testing
laboratory
28
of
the
department’s
choice
and
the
costs
of
the
test
shall
be
29
assessed
to
the
registrant.
If
the
registrant
fails
to
tender
30
payment
within
thirty
calendar
days
of
receipt
of
a
request
for
31
payment
from
the
department,
the
department
shall
revoke
the
32
registration
for
the
kratom
product
and
immediately
order
the
33
stoppage
of
all
sales
of
the
kratom
product.
34
6.
A
registrant
does
not
violate
this
section
by
35
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manufacturing,
delivering,
holding,
offering
for
sale,
1
distributing,
or
selling
a
kratom
product
that
contains
2
psychoactive
compounds
that
has
been
reviewed
and
approved
3
by
the
department
for
safe
consumption
under
clearly
defined
4
conditions
of
use.
5
7.
A
retailer
does
not
violate
this
section
if
the
6
retailer
shows
by
a
preponderance
of
the
evidence
that
the
7
retailer
relied
in
good
faith
upon
the
representations
of
a
8
manufacturer,
packer,
or
kratom
processor
regarding
a
product
9
represented
to
be
a
kratom
product.
10
Sec.
6.
NEW
SECTION
.
124F.6
Rules.
11
The
department
shall
adopt
rules
pursuant
to
chapter
17A
for
12
the
administration
of
this
chapter.
The
rules
shall
include
13
all
of
the
following:
14
1.
The
process
for
the
registration
of
a
kratom
product
by
a
15
kratom
processor
or
retailer.
16
2.
The
requirements
for
the
enforcement
of
the
prohibition
17
of
the
sale
of
a
kratom
product
to
a
person
under
twenty-one
18
years
of
age.
19
3.
Testing
requirements
for
independent
testing
20
laboratories
that
issue
certificates
of
analysis
for
kratom
21
products.
22
4.
Other
rules
as
necessary
for
the
implementation
of
this
23
chapter.
24
Sec.
7.
NEW
SECTION
.
124F.7
Legislative
intent.
25
It
is
the
intent
of
the
general
assembly
that
this
chapter
be
26
liberally
construed
to
ensure
the
safety
of
kratom
products
and
27
prevent
the
distribution
of
kratom
products
to
minors.
28
EXPLANATION
29
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
30
the
explanation’s
substance
by
the
members
of
the
general
assembly.
31
This
bill
relates
to
the
regulation
of
kratom.
The
bill
32
requires
a
person
responsible
for
placing
a
kratom
product,
33
defined
in
the
bill,
into
commerce
in
the
state
to
annually
34
register
that
product
for
sale
with
the
department
of
health
35
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7/
10
H.F.
612
and
human
services
(department).
The
bill
requires
an
1
application
for
registration
to
include
a
certification
2
that
the
product
is
manufactured,
processed,
and
held
in
a
3
facility
that
complies
with
federal
laws
for
good
manufacturing
4
practices,
a
current
federal
food
and
drug
administration
5
food
facility
registration
certificate,
a
statement
that
the
6
applicant
has
a
reasonable
basis
to
believe
that
the
kratom
7
product
is
safe,
a
certificate
from
an
independent
testing
8
laboratory
showing
compliance
with
the
requirements
of
the
9
bill,
and
an
application
fee.
The
bill
allows
an
application
10
for
registration
to
include
multiple
kratom
products
if
the
11
kratom
products
contain
the
same
ingredients
sold
in
the
same
12
form
but
in
a
different
container,
package,
or
volume.
The
13
bill
requires
the
department
to
create
and
maintain
a
database
14
of
all
kratom
products
that
are
registered
for
sale
in
this
15
state.
16
The
bill
prohibits
a
kratom
product
from
containing
17
certain
adulterants.
The
bill
prohibits
a
kratom
processor,
18
registrant,
or
retailer
from
selling
a
kratom
product
that
is
19
combustible,
vaporizable,
attractive
to
children,
as
defined
in
20
the
bill,
or
a
product
containing
kratom
that
is
not
a
kratom
21
product.
22
The
bill
requires
a
kratom
product
produced,
manufactured,
23
distributed,
offered,
sold,
or
offered
for
sale
in
this
state
24
to
include
a
label
that
advises
against
use
by
individuals
25
who
are
under
21
years
of
age,
who
are
pregnant,
or
who
are
26
breastfeeding,
recommends
consultation
with
a
health
care
27
professional,
states
that
kratom
may
be
habit
forming,
states
28
that
the
efficacy
of
the
product
has
not
been
evaluated
by
the
29
United
States
food
and
drug
administration,
includes
the
name
30
and
address
for
the
place
of
business
of
the
registrant,
and
31
includes
directions
for
use.
32
The
bill
prohibits
a
person
from
selling
or
distributing
a
33
kratom
product
that
is
not
currently
registered
for
sale
in
34
this
state.
The
bill
requires
the
department
to
seize
and
35
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10
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612
destroy
an
unregistered
kratom
product
and
to
assess
the
costs
1
to
the
person
responsible
for
the
availability
of
the
kratom
2
product
in
this
state.
The
bill
requires
the
department
to
3
impose
a
fee
for
the
first
and
second
sale
or
distribution
of
a
4
particular
unregistered
kratom
product
and
to
prohibit
a
person
5
from
selling
or
distributing
kratom
products
for
two
years
6
following
the
third
sale
or
distribution
of
an
unregistered
7
kratom
product.
The
bill
prohibits
a
person
from
knowingly
or
8
willfully
selling
or
distributing
a
kratom
product
to
a
person
9
under
21
years
of
age.
A
person
who
violates
this
provision
of
10
the
bill
for
the
first
time
is
guilty
of
a
simple
misdemeanor.
11
A
simple
misdemeanor
is
punishable
by
confinement
for
no
more
12
than
30
days
and
a
fine
of
at
least
$105
but
not
more
than
13
$855.
A
person
who
violates
this
provision
of
the
bill
a
14
second
or
subsequent
time
within
one
year
of
the
first
offense
15
is
guilty
of
a
serious
misdemeanor.
A
serious
misdemeanor
is
16
punishable
by
confinement
for
no
more
than
one
year
and
a
fine
17
of
at
least
$430
but
not
more
than
$2,560.
The
bill
prohibits
18
a
person
from
knowingly
or
willfully
manufacturing,
delivering,
19
holding,
offering
for
sale,
distributing,
or
selling
a
kratom
20
product
that
contains
a
controlled
substance.
A
person
who
21
violates
this
provision
of
the
bill
is
guilty
of
a
class
“D”
22
felony.
A
class
“D”
felony
is
punishable
by
confinement
for
23
no
more
than
five
years
and
a
fine
of
at
least
$1,025
but
not
24
more
than
$10,245.
The
bill
prohibits
a
person
from
knowingly
25
or
willfully
manufacturing,
delivering,
holding,
offering
26
for
sale,
distributing,
or
selling
a
kratom
product
that
27
contains
synthetically
derived
compounds
of
the
plant
Mitragyna
28
speciosa.
A
person
who
violates
this
provision
of
the
bill
is
29
guilty
of
a
serious
misdemeanor.
30
If
the
department
has
reason
to
believe
that
a
registered
31
kratom
product
violates
the
requirements
for
registration,
32
the
bill
requires
the
department
to
require
the
registrant
to
33
produce
a
current
certificate
of
analysis
from
an
independent
34
testing
laboratory
showing
compliance
with
the
requirements
for
35
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10
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612
registration
under
the
bill.
If
the
registrant
does
not
timely
1
produce
a
certificate
showing
compliance,
the
bill
requires
the
2
department
to
revoke
the
registration
of
the
kratom
product
3
and
immediately
order
the
stoppage
of
all
sales
of
the
kratom
4
product.
If
the
department
has
reason
to
believe
that
the
5
independent
testing
laboratory
used
by
a
registrant
has
not
6
provided
accurate
results,
the
bill
requires
the
department
to
7
submit
the
kratom
product
for
testing
to
an
independent
testing
8
laboratory
of
the
department’s
choice,
with
costs
assessed
to
9
the
registrant.
If
the
registrant
fails
to
tender
payment
10
within
30
calendar
days
of
receipt
of
a
request
for
payment
11
from
the
department,
the
bill
requires
the
department
to
revoke
12
the
registration
of
the
kratom
product
and
immediately
order
13
the
stoppage
of
all
sales
of
the
kratom
product.
The
bill
14
exempts
a
retailer
from
punishment
for
a
violation
of
the
bill
15
if
the
retailer
shows
by
a
preponderance
of
the
evidence
that
16
the
retailer
relied
in
good
faith
upon
the
representations
of
a
17
manufacturer,
packer,
or
kratom
processor
regarding
a
product
18
represented
to
be
a
kratom
product.
19
The
bill
requires
the
department
to
adopt
rules
for
the
20
implementation
of
the
bill,
including
for
the
process
of
21
registration
of
a
kratom
product,
the
requirements
for
22
enforcing
the
prohibition
on
sale
of
kratom
products
to
23
persons
under
21
years
of
age,
the
testing
requirements
for
24
independent
testing
laboratories,
and
other
rules
as
necessary
25
for
implementation
of
the
bill.
26
The
bill
includes
legislative
intent
language.
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