The Drug Enforcement Administration (DEA) provided
the following explantion of the similarities and differences
between Marinol, Dronabinol, and Delta-9-Tetrahydrocannabinol
(THC) in 1999 and 2002 in correspondence related to the 1995
cannabis rescheduling petition.
In a letter to petitioners on June 28, 1999
the DEA provided the following clarification:
A prefatory note is warranted to clarify the
distinction between "Marinol" and "dronabinol."
Although these terms are sometimes mistakenly used interchangeably,
they have distinct meanings. Dronabinol is the United States
Adopted Name for the substance (-)-[Delta-9]-(trans)-tetrahydrocannabinol
which is thought to be the primary psychoactive ingredient
in marijuana. See 21 C.F.R. § 1308.12(f)(1).
Marinol is the brand name of a product approved by the Food
and Drug Administrtion (FDA) that contains synthetically
manufactured dronabinol in sesame oil and encapsulated in
a soft geletin capsule. Id. Dronabinol is the active
ingredient in Marinol. Dronabinol, in its pure form, is
a schedule I controlled substance since it is one of the
tetrahydrocannabinols and it has no currently accepted medical
use in treatment in the United States. See 21 U.S.C.
§ 812(b)(1); 21 C.F.R. §1308.11(d)(27). Marinol,
in contrast, has an accepted medical use and is a schedule
II substance [editors note: Marinol has since been rescheduled
to schedule III]. See 21 C.F.R. 1308.12(f)(1); 51 Fed. Reg.
17,476 (1986) (DEA final rule transferring Marinol from
schedule I to schedule II following FDA approval of the
drug for marketing). It was approved for marketing by the
FDA in 1985 for the treatment of nausea and vomiting asociated
with cancer chemotherapy. Id. In 1992, FDA expanded Marinol's
approved indications to include treatment of anorexia associated
with weight loss in patients with AIDS. (1)
In additional correspondance on September 26,
2002 the DEA repeated this clarification and noted Marinol's
recent rescheduling as a schedule III drug::
In a leter dated June 28, 1999, the Administrtor
of DEA clarified . . . the point that "dronabinol"
os the United States Adopted Name for the substance (-)-Δ-9-(trans)-tetrahydrocannabinol
(also designated (-)-[Delta-9]-(trans)-THC),
which is generally accepted as the primary psychoactive
ingredient in marijuana. See 21 C.F.R. § 1308.12(f)(1).
Marinol is the brand name of a specific pharmaceutical product
approved ghe the Food and Drug Administration (FDA) that
contains synthetically manufactured dronabinol in sesame
oil and encapsulated in a soft gelatin capsule. Id.
Dronabinol is tha active ingredient in Marinol. The specific
product formulation along, Marinol (dronabinol in sesame
oil and encapsulated in a soft geletin capsule), remains
in schedule III. See 64 FR, 35928, 21 C.F.R. § 1308.13
(g)(1). Dronabinol, in its pure form, is a Schedule I controlled
substance since it is one of the tetrahydrocannabinols and
it has no currently accepted medical use in the United States.
See 21 U.S.C. § 812(b)(1); 21 C.F.R. §1308.11(d)(27).
In plain English, the DEA explains that for
regulatory purposes THC has been renamed dronabinol, and that
it only has an accepted medical use when it is mixed with
sesame oil and placed in a capsule. This semantic exercise
allows the DEA to deny that THC has an accepted medical use
in the United States. THC, according to DEA, is the same chemical
as dronabinol, which has an accepted medical use when it is
placed in a gelatin capsule and referred to as Marinol. Despite
the fact that THC, dronabinol, and Marinol all refer to the
same active ingredient, DEA insists that the name of THC be
changed twice-over before it can be referred to as a drug
with accepted medical use. While this is precisely correct
in legal and regulatory contexts, DEA's semantic exercise
begs reference Shakespeare's famous observation: "That
which we call a rose, By any other name would smell as sweet."
(1) (21) Donnie Marshall, Deputy Administor
DEA, Letter to Simore Monesebian, July 28, 1999.
(2) John B. Brown, Deputy Administrator DEALetter to Jon Gettman,
September 26, 2002.
(3) William Shakespeare, "Romeo and Juliet", Act
2 scene 2.