December 2, 1993
Dear Mr. Olsen:
This replies to your July 21, 1993, letter concerning synthetic dronabinol (delta-9-THC).
In respect to the naturally extracted and synthetically manufactured dronabinol, the Drug Enforcement Agency has promulgated the enclosed regulation. Please note that tetrahydrocannabinol is a Schedule I substance, but dronabinol, synthetic, in sesame oil and in a soft gelatin capsule, is a U.S. Food and Drug Administration approved drug product and is a Schedule II substance. Both marijuana and tetrahydrocannabinol are Schedule I substances.
With respect to your other questions on marijuana, the original chemical researcher was Dr. Roger Adams of the University of Illinois chemistry department. The pharmacology of the compounds was investigated by Dr. Seigried Lowe of the University of Utah. A review of marijuana is given on page 549-553 of Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th Edition, Pergamon Press, 1990.
Consumer Safety Officer
CDER Executive Secretariat Staff (HFD-8)
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane