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

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.