AGO 2017-7
Official Opinion 2017-7
Indiana Attorney General Opinion
State of Indiana Office of the Attorney General
November 21, 2017
RE:
Cannabidiol & HEA 1148
EXECUTIVE
SUMMARY
The
Office of the Indiana Attorney General provides this opinion
and information for the public regarding whether it is lawful
to sell, use or possess products containing a chemical
compound commonly known as cannabidiol.
"CBD"
is the scientific abbreviation for a chemical compound known
as "Cannabidiol"
("cann-uh-bid-DYE-all"). Cannabidiol is one of the
more prevalent chemical compounds in the Cannabis (or
Marijuana) plant. The chemical compounds that bind together
in an array that constitute cannabidiol are defined as
"2-(6-isopropenyl-3-methyl-2-cyclohexen-l~yl)-5~pentyl-1,3-benzenediol."1
As a
matter of legal interpretation, products or substances
marketed for human consumption or ingestion, and containing
cannabidiol, remain unlawful in Indiana, and under federal
law.2
The
state and federal laws that place cannabidiol in the category
of a Schedule I controlled substance do not hinge on the
degree or prevalence of the pharmacological effects of a
substance on a person, for those effects vary from person to
person, substance to substance, and component to component.
Simply put, cannabidiol is a Schedule I controlled substance
because marijuana (Cannabis saliva) is a Schedule I
controlled substance. Although it is a relatively new
phenomenon, after thoroughly tracking the language of the
Indiana law defining "marijuana," it is evident
that cannabidiol is now and historically has been derived
from "a part of the plant genus
Cannabis."3 Scientific literature confirms that
cannabidiol simply cannot be distilled in sufficient amounts
from any of the inert parts of the plant (such as the
"mature stalks of the plant" or the
"sterilized seeds of the plant"), Ind. Code
35-48-l-19(b), which are specifically excluded from
the basic description of what constitutes
"marijuana" according to both state and federal
authorities alike.4 Thus, experts and federal authorities
are in agreement that mature stalks, sterilized seeds, and
other exempt components of the Cannabis plant are
insufficient for the manufacture of
cannabidiol.5 With that being the case, it is also
clear that the parts of the plant being used to manufacture
cannabidiol will necessarily include the floral bracts,
resin, and leaves of the Cannabis plant.6
This
same analysis has been applied by federal authorities
operating under the federal Controlled Substances Act,
pursuant to guidance put out by the United States Drug
Enforcement Administration ("DEA"), and known as
"the Extract Rule."7 Read together, these
definitions under Indiana law clearly establish that a
"substance containing cannabidiol," being extracted
from the resinous (non-inert, non-exempt) parts of the plant
genus Cannabis, is "marijuana" and is a Schedule I
controlled substance.
Cannabidiol
is likely to contain some amount of other cannabinoids
(i.e., another basic molecular building-block of
Cannabis) such as "Tetrahydrocannabinol,"
which is better known as "THC."8 THC is known to
science and the courts as the key cannabinoid found in
marijuana. THC is also the key compound known to produce the
euphoric, passive, intoxicated or hallucinogenic state sought
after by many who consume marijuana.
Under
Indiana law, a "substance containing cannabidiol"
is defined to contain a certain amount of cannabidiol (at
least 5% by weight) and an amount of THC (not more than 0.3%
by weight).9 Under Indiana law, THC, including that
found in the "resinous extractives of Cannabis," is
itself a Schedule I controlled substance.[10]
Accordingly, any substance containing cannabidiol is
prohibited in Indiana as it falls under the definition of
"marijuana" and contains THC, both of which result
in it being a Schedule I controlled substance.
In
2017, House Enrolled Act 1148 established a limited and
focused exception for possession and use of substances
containing cannabidiol by patients and caregivers battling a
diagnosis of juvenile or adult treatment-resistant
epilepsy.11 According to this legislation,
despite the threshold consideration that substances
containing cannabidiol retain their prohibition as Schedule I
controlled substances, a limited affirmative defense is
available. Under this legislatively-created defense, the law
makes clear that the burden of proof is on the defendant to
show that he qualifies, if he can show that he was properly
registered under Indiana's newly created Indiana State
Department of Health Cannabidiol Registry ("the
Registry").
The
existence of the Registry reaffirms that absent this
narrowly-focused affirmative defense, substances containing
cannabidiol are Schedule I controlled substances, and if
identified or so labeled in plain view of a law enforcement
officer, are subject to seizure. Individuals possessing or
using such substances are subject to prosecution under both
state and federal law, barring proof being shown that they
qualified for the Registry defense, which under HEA 1148 is
limited to those who are battling treatment-resistant
epilepsy or their caregivers. Despite the existence of this
affirmative defense under HEA 1148, which addresses a kind of
medical use and possession by registered, qualified
individuals, the Indiana legislature has not yet addressed
the distribution or sale of this product. At present, then,
no one in Indiana is authorized to commercially distribute or
sell CBD or substances containing CBD.
One
additional exception allows for limited possession and even
cultivation of marijuana under certain narrowly-prescribed
circumstances, and that is Indiana's exclusion of
"industrial hemp" from its definition of marijuana.
On March 26, 2014, Indiana's Industrial Hemp Law
("IHL") was signed by the Governor, and became
effective. The IHL classifies industrial hemp as an
agricultural product and authorizes the Indiana State Seed
Commissioner to pursue the necessary federal permits allowing
for the production of, possession of, scientific study of,
and limited commerce of industrial hemp. The IHL attempts to
make available to Indiana producers the opportunities to
cultivate and study industrial hemp afforded by the federal
2014 Farm Bill.12The federal 2014 Farm Bill created an
exception to the federal CSA for the limited growth,
cultivation and marketing research experimentation with
industrial hemp by an institution of higher education or a
State department of agriculture if such activities are
conducted within federal legal boundaries.
On
August 12, 2016, the United States Department of Agriculture
("USDA"), in consultation with the DEA and the
United States Food and Drug Administration ("FDA")
published a Statement of Principles on Industrial
Hemp ("Statement of Principles") in the
Federal Register to inform the public about how Federal law
applies to activities associated with industrial hemp. The
Statement of Principles reiterates that Section 7606 did not
remove industrial hemp from the controlled substances list.
In a
statement to the public,13 the DEA further advised that it
considers Section 7606 to authorize institutions of higher
education and state departments of agriculture to grow and
cultivate industrial hemp as defined under the 2014 Farm
Bill; however, it does not permit such entities, or anyone
else, to produce approved drug products subject to FDA
approval for human consumption that are made from Cannabis.
This is a direct example of a joint affirmation of federal
policy, promulgated by three separate federal agencies,
affirming that no industrial hemp pilot program, state or
federal, is intended to encompass products for immediate
human consumption as food, food supplement, or a drug.
Upon
careful study and deliberation, it is the opinion of the
Indiana Attorney General that the purchase, possession, use
and sale of cannabidiol, and substances, food products or
edible oils containing cannabidiol are unlawful under both
Indiana and federal law. HEA 1148, as it was intended by the
Indiana General Assembly, established a limited affirmative
defense for the express purpose of treating those with
treatment resistant epilepsy.
BACKGROUND
On
April 26, 2017, the Honorable Governor Eric J. Holcomb signed
HEA 114814 (codified at Ind. Code §
16-42-28.6 et seq) into law, which permits the legal
use of a substance containing cannabidiol for the treatment
of epilepsy under limited conditions.15 Under the new
law, the Indiana State Department of Health
("ISDH") is authorized to develop and implement a
cannabidiol...