[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1308.35]

[Page 96-97]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1308.35  Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols.

    (a) Any processed plant material or animal feed mixture containing 
any amount of tetrahydrocannabinols (THC) that is both:
    (1) Made from any portion of a plant of the genus Cannabis excluded 
from the definition of marijuana under the Act [i.e., the mature stalks 
of such plant, fiber produced from such stalks, oil or cake made from 
the seeds of such plant, any other compound, manufacture, salt, 
derivative, mixture, or preparation of such mature stalks (except the 
resin extracted therefrom), fiber, oil, or cake, or the sterilized seed 
of such plant which is incapable of germination] and
    (2) Not used, or intended for use, for human consumption, has been 
exempted by the Administrator from the application of the Act and this 
chapter.

[[Page 97]]

    (b) As used in this section, the following terms shall have the 
meanings specified:
    (1) The term processed plant material means cannabis plant material 
that has been subject to industrial processes, or mixed with other 
ingredients, such that it cannot readily be converted into any form that 
can be used for human consumption.
    (2) The term animal feed mixture means sterilized cannabis seeds 
mixed with other ingredients (not derived from the cannabis plant) in a 
formulation that is designed, marketed, and distributed for animal 
consumption (and not for human consumption).
    (3) The term used for human consumption means either:
    (i) Ingested orally or
    (ii) Applied by any means such that THC enters the human body.
    (4) The term intended for use for human consumption means any of the 
following:
    (i) Designed by the manufacturer for human consumption;
    (ii) Marketed for human consumption; or
    (iii) Distributed, exported, or imported, with the intent that it be 
used for human consumption.
    (c) In any proceeding arising under the Act or this chapter, the 
burden of going forward with the evidence that a material, compound, 
mixture, or preparation containing THC is exempt from control pursuant 
to this section shall be upon the person claiming such exemption, as set 
forth in section 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). In order to 
meet this burden with respect to a product or plant material that has 
not been expressly exempted from control by the Administrator pursuant 
to Sec. 1308.23, the person claiming the exemption must present rigorous 
scientific evidence, including well-documented scientific studies by 
experts trained and qualified to evaluate the effects of drugs on 
humans.

[66 FR 51544, Oct. 9, 2001]

                                Hearings