Will the FDA’s Ban on E-Cigarettes Affect CBD Vaping Devices?

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fda vape ecig nicotine cannabis

On
January
2,
the
Food
and
Drug
Administration
(“FDA”)
issued
non-binding

guidance
 (“Guidance”)
in
which
the
agency
explains
how
it
intends
to
prioritize
enforcement
actions
to
tackle
the
growing
increase
in
youth
use
of
electronic
nicotine
delivery
systems
(“ENDS”)–more
commonly
and
broadly
referred
to
as
“e-cigarettes”–as
well
as
to
address
vaping-associated
lung
injuries.
According
to
a

press
release

by
the
U.S.
Department
of
Health
and
Human
Services,
the
FDA
intends
to
ban
flavored
cartridge-based
ENDS
that
appeal
to
children,
including
fruit
and
mint
flavors,
beginning
30
days
from
the
publication
of
the
notice
of
availability
of
this
guidance
in
the
Federal
Register.

Specifically,
the
agency
intends
to
prioritize
enforcement
against:

  • Any
    flavored,
    cartridge-based
    ENDS
    product
    (other
    than
    a
    tobacco-
    or
    menthol-flavored
    ENDS
    product);
  • All
    other
    ENDS
    products
    for
    which
    the
    manufacturer
    has
    failed
    to
    take
    (or
    is
    failing
    to
    take)
    adequate
    measures
    to
    prevent
    minors’
    access;
    and
  • Any
    ENDS
    product
    that
    is
    targeted
    to
    minors
    or
    whose
    marketing
    is
    likely
    to
    promote
    use
    of
    ENDS
    by
    minors.

Since
the
enactment
of
the

2018
Farm
Bill
,
a
wide
range
of
hemp-derived
CBD
(“Hemp
CBD”)
products
have
sparked
the
interest
of
American
consumers,
including
CBD
vaping
devices.
Despite
the
growing
popularity
of

CBD
smokable
products
,
the
FDA
has
yet
to
issue
regulations
for
these
products.
Consequently,
the
sale
of
Hemp-CBD-infused
smokable
products
is
in

a
legal
gray
area
,
not
explicitly
allowed
nor
prohibited
under
federal
law.

The
lack
of
FDA
regulation
surrounding
this
issue
likely
stems
from
the
fact
that
many
of
these
products
are
free
of
tobacco
and/or
nicotine.

As
we
previously

discussed
,
federal
law
gives
the
agency
the
authority
to
regulate
the
sale,
manufacture,
and
marketing
of
tobacco
products
under
the
2009
Family
Smoking
Prevention
and
Tobacco
Control
Act
(“TCA”).
In
2016,
the
FDA
finalized
a
rule
that
extended
its
regulatory
authority
to
all
products
meeting
the
TCA’s
statutory
definition
of
a
tobacco
product,
including
e-cigarettes.

The
FDA
now
oversees
all
products
“made
or
derived
from
tobacco
that
[are] intended
for
human
consumption
.
.
.
.”
The
definition
also
includes
components,
parts,
and
accessories
of
tobacco
products
and
excludes
products
that
are
classified
as
drugs
or
devices
under
the
Food,
Drug,
and
Cosmetic
Act
(“FDCA”),
even
if
those
products
are
made
or
derived
from
tobacco.

The
FDA
has

consistently

declined
to
interpret
“tobacco
products”
so
broadly
as
to
include
products
free
of
nicotine
or
tobacco.
Under
this
reasoning,
it
seems
to
follow
that
most
Hemp-CBD
smokable
products,
which
are
free
of
nicotine
and
tobacco,
would
not
be
considered
“tobacco
products.”

The
newly
published
Guidance
seems
consistent
with
this
rationale.

The
Guidance
expressly
provides
that
it
“does
not
address
products
that
are
not
tobacco
products”
and
that
only
“[l]iquids
that
do
not
contain
nicotine
or
other
material
or
derived
from
tobacco,
but
that
are

intended
or
reasonably
expected
to
be
used
with
or
for
the
human
consumption
of
a
tobacco
product
,
may
be
components
or
parts
and,
therefore,
subject
to
FDA’s
tobacco
control
authorities.”
(Emphasis
added).

So,
while
most
Hemp-CBD-infused
vaping
devices
don’t
fall
under
the
FDA’s
jurisdiction,
and
thus,
won’t
be
affected
by
this
upcoming
enforcement
effort,
industry
players
should
keep
in
mind
that:

  1. Any
    flavored
    CBD
    vaping
    product
    that
    does
    contain

    nicotine

    is
    subject
    to
    this
    federal
    ban;
  2. Any
    CBD
    vaping
    product
    that
    contains

    nicotine

    and
    for
    which
    the
    manufacturer

    fails
    to
    take
    adequate
    measures
    to
    limit
    minors’
    access

    is
    subject
    to
    FDA
    enforcement
    actions;
  3. Any
    CBD
    vaping
    product
    that
    is
    targeted
    at
    minors
    or
    whose
    marketing
    is

    likely
    to
    promote
    the
    ENDS
    use
    by
    minors

    falls
    under
    the
    FDA
    ban;
    and
  4. The
    manufacture,
    sale
    and
    marketing
    of
    non-flavored,
    nicotine
    or
    tobacco-free
    CBD
    vaping
    products,
    as
    well
    as
    other

    smokable
    hemp
    products
    ,
    may
    nonetheless
    be
    banned
    under
    certain
    state
    laws.
    Accordingly,
    manufacturers,
    distributors
    and
    retailers
    of
    these
    products
    should
    refrain
    from
    selling
    their
    products
    in
    these
    jurisdictions
    to
    mitigate
    the
    risk
    of
    local
    enforcement
    actions.

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