21 CFR 1308.35 - Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols.

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§ 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.
(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 § 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-08-28; vol. 79 # 167 - Thursday, August 28, 2014
    1. 79 FR 51243 - Schedules of Controlled Substances: Placement of Suvorexant into Schedule IV
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      DEPARTMENT OF JUSTICE, Drug Enforcement Administration
      Final rule.
      Effective Date: September 29, 2014.
      21 CFR Part 1308

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1308 after this date.

  • 2014-10-29; vol. 79 # 209 - Wednesday, October 29, 2014
    1. 79 FR 64349 - Schedules of Controlled Substances: Removal of Naloxegol From Control
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      DEPARTMENT OF JUSTICE, Drug Enforcement Admininstration
      Notice of proposed rulemaking.
      Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before November 28, 2014. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811)”, may file a request for hearing or waiver of participation pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45, 1316.47, 1316.48, or 1316.49, as applicable. Requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before November 28, 2014.
      21 CFR Part 1308