DEA Internal Directive Regarding the Presence of Cannabinoids

DEA Internal Directive Regarding the Presence of Cannabinoids in Products and Materials Made from the Cannabis Plant

(May 22, 2018)

In 2004, the U.S. Court of Appeals for the Ninth Circuit enjoined DEA from enforcing certain regulations with respect to tetrahydrocannabinols (THC). See Hemp Industries Ass’n v. DEA, 357 F.3d 1012 (9th Cir. 2004). The government did not seek Supreme Court review of that decision. In response to various inquiries, DEA hereby issues to DEA personnel the following internal directive on how to carry out their duties in light of the Ninth Circuit’s decision.

The Ninth Circuit enjoined enforcement of what is now 21 C.F.R. § 1308.11(d)(31) (drug code 7370) with respect to products that are excluded from the definition of marijuana in the Controlled Substances Act (CSA). DEA thus does not enforce that provision as to such products.

Consistent with the Ninth Circuit’s decision, DEA does not enforce 21 C.F.R. § 1308.35.

Products and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA. Such products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations. The mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana.

The Controlled Substances Import and Export Act incorporates the schedules of the CSA. See generally 21 U.S.C. §§ 951-971. Accordingly, any product that the U.S. Customs and Border Protection determines to be made from the cannabis plant but which falls outside the CSA definition of marijuana may be imported into the United States without restriction under the Controlled Substances Import and Export Act. The same considerations apply to exports of such products from the United States, provided further that it is lawful to import such products under the laws of the country of destination.

This directive does not address or alter DEA’s previous statements regarding the drug code for marijuana extract and regarding resin. See Establishment of a New Drug Code for Marihuana Extract, 81 Fed. Reg. 90194 (Dec. 14, 2016); Clarification of the New Drug Code (7350) for Marijuana Extract. As DEA has previously explained, the drug code for marijuana extract extends no further than the CSA does, and it thus does not apply to materials outside the CSA definition of marijuana.

PART 1308 — SCHEDULES OF CONTROLLED SUBSTANCES

SCHEDULES

§1308.11 Schedule I.

(a) Schedule I shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.

(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation (for purposes of paragraph (b)(34) only, the term isomer includes the optical and geometric isomers):

(c) Opium derivatives. Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(d) Hallucinogenic substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation (for purposes of this paragraph only, the term “isomer” includes the optical, position and geometric isomers):

(e) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(f) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:

(g) Cannabimimetic agents. Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(h) Temporary listing of substances subject to emergency scheduling. Any material, compound, mixture or preparation which contains any quantity of the following substances:

(i) Fentanyl-related substance means any substance not otherwise listed under another Administration Controlled Substance Code Number, and for which no exemption or approval is in effect under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], that is structurally related to fentanyl by one or more of the following modifications:

(A) Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;

(B) Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;

(C) Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;

(D) Replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or

(E) Replacement of the N-propionyl group by another acyl group.

(ii) This definition includes, but is not limited to, the following substances:

(A)-(B) [Reserved]

[39 FR 22141, June 20, 1974]

Editorial Note: For Federal Register citations affecting §1308.11, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

Effective Date Notes: At 82 FR 20544, May 3, 2017, §1308.11 was amended by adding (h)(16), effective May 3, 2017, until May 3, 2019. At 82 FR 47974, Oct. 16, 2017, §1308.11 was amended by redesignating (h)(16) as paragraph (h)(13).

2. At 82 FR 32457, July 14, 2017, §1308.11 was amended by adding (h)(17), effective July 14, 2017, until July 15, 2019. At 82 FR 47974, Oct. 16, 2017, §1308.11 was amended by redesignating (h)(17) as paragraph (h)(14).
3. At 82 FR 49508, Oct. 26, 2017, §1308.11 was amended by adding reserved paragraphs (h)(15) through (h)(18) and (h)(19), (20) and (21), effective Oct. 26, 2017,, through Oct. 28, 2019.
4. At 82 FR 51558, Nov. 3, 2017, §1308.11 was amended by adding paragraph (h)(18), effective Nov. 3, 2017, through Nov. 4, 2019.
5. At 83 FR 472, Jan. 4, 2018, §1308.11 was amended by adding paragraph (h)(22), effective Jan. 4, 2018. through Jan. 4, 2020.
6. At 83 FR 4584, Feb. 1, 2018, §1308.11 was amended by adding paragraphs (h)(23) through (h)(29), effective Feb. 1, 2018 through Feb. 1, 2020.
7. At 83 FR 5191, Feb. 6, 2018, §1308.11 was amended by adding paragraph (h)(3), effective Feb. 6, 2018, through Feb. 6, 2020.
8. At 83 FR 10368, Mar. 9, 2018, §1308.11 was amended by revising paragraphs (h)(23) and (h)(29), effective Mar. 9, 2018, through Feb. 1, 2020.

PART 1308 — SCHEDULES OF CONTROLLED SUBSTANCES

EXEMPT CANNABIS PLANT MATERIAL, AND PRODUCTS MADE THEREFROM, THAT CONTAIN TETRAHYDROCANNABINOLS

• 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 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]