DEA Enforcement Directive Regarding the Presence of Cannabinoids in Products (Research Opinion)

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Information was relayed to me regarding a DEA statement about CBD

 

(paraphrasing and embellishing for your entertainment).

– Check this article out on the internet.  The DEA said it was OK. They are not going to bust people or enforce the law for CBD or that stuff. We won…You can do it. Spread the word.

 

So I asked…what did I win, what can I do and do you actually believe things you read on the internet? The conversation ended there.

 

BTW – Regarding all this medical marijuana and anything related to it… After a personal experience with the “laws” that can be twisted into a required narrative… my catch phrase is…“You can…But you can’t”.

 

 

So it goes…

 

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

(May 22, 2018)

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.

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I call BS…

 

So…Is anyone seeing it the way I am?  I am sure you law hawks are…right?!!  I keep reading it over and I see the same ball of confusion that’s always regurgitated by law makers that allows one to step into the trap and when the trap is triggered, they compound their advantage by throwing more charges upon you just to increase their odds of winning.  With almost unlimited funds and time,  prosecutors have the upper hand and winning is everything no matter the cost…except for the accused, their family and the rest of life’s burdens. 

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Whoah there self…bring it back to the subject of this article.

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OK here is what I am talking about and I will break it down highlighting the important parts.  I have limited time because I have to get back to work…after all…I am just the copy boy.

Note: (From here on OPINIONS, observations and definitions to words or stuff you should focus on will be in red text. There will also be underlined items to pay attention to.)

The news goes…

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 (v. for a court to order that someone either do a specific act, cease a course of conduct or be prohibited from committing a certain act. )  DEA from enforcing certain regulations (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 (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 (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  (adj 1 : directed toward or effecting a disposition (as of a case) [an endless variety of …pretrial motions “Robert Shaw-Meadow”] 2 : relating to a disposition of property [ words in a will] 3 : providing a final resolution (as of an issue) : having control over an outcome [ of the question]  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 (falls within the CSA definition of marijuana).

 

OK…BEFORE WE LOOK AT AN UPDATED CODE…LET US CHECK THE DEFINITION OF MARIJUANA IN THE CONTROLLED SUBSTANCE ACT….Keep in mind that it is a Schedule 1 drug.

 

Title 21 United States Code (USC) Controlled Substances Act

 802. Definitions

(15) The term “manufacture” means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice. The term “manufacturer” means a person who manufactures a drug or other substance.

(16) The term “marihuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.

Such term does not include 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.

What? Read it slowly again and be ready to come back to it to read again. Is it or isn’t it?

 

Keep this in mind from above…(The DEA thus does not enforce that provision as to such products under  21 C.F.R. § 1308.35)

 

PART 1308 — SCHEDULES OF CONTROLLED SUBSTANCES

EXEMPT 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 (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.

 

The way I interpret it is…If you are not human the DEA will not enforce it or really if it is not made for human consumption as defined above. So Hemp Oil / CBD / Soap / Lotion / Hemp Beer / Soda /etc… Are they legal or an illegal Schedule 1 possession

 

But wait…you say there is no THC in those products…the burden is on you to scientifically prove it and of course…

 

The DEA States –  \1\ Although it might be theoretically possible to produce a CBD extract that contains absolutely no amounts of other cannabinoids, the DEA is not aware of any industrially-utilized methods that have achieved this result.

 

OK Define Cannabinoids (the new way)

 

(58) Marihuana Extract–7350

“Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.”

Still a Schedule 1 drug…………..

§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):

 

Which brings us to the new drug code for Marijuana Extract .

 

The United Nations Conventions on international drug control treats extracts from the cannabis plant somewhat differently than marihuana or tetrahydrocannabinols. The creation of a new drug code in the DEA regulations for marihuana extracts will allow for more appropriate accounting of such materials consistent with treaty provisions.

 

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-342] RIN 1117-AB33

Establishment of a New Drug Code for Marihuana Extract

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

SUMMARY: The Drug Enforcement Administration is creating a new Administration Controlled Substances Code Number for “Marihuana Extract.” This code number will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana. This, in turn, will aid in complying with relevant treaty provisions.

Under international drug control treaties administered by the United Nations, some differences exist between the regulatory controls pertaining to marihuana extract versus those for marihuana and tetrahydrocannabinols. The DEA has previously established separate code numbers for marihuana and for tetrahydrocannabinols, but not for marihuana extract. To better track these materials and comply with treaty provisions, DEA is creating a separate code number for marihuana extract with the following definition: “Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.” Extracts of marihuana will continue to be treated as Schedule I controlled substances.

DATES: Effective: January 13, 2017.

 

Read on – Specifically the comments

 

SUPPLEMENTARY INFORMATION:

Background

As provided in 21 CFR 1308.03, each controlled substance or basic class thereof is assigned a four digit Administration Controlled Substance Code Number (“Code number” or “drug code”) that is used to track quantities of the controlled substance imported and exported to and from the United States. Additionally, the DEA uses these code numbers in establishing aggregate production quotas for basic classes of controlled substances listed in Schedules I and II as required by 21 U.S.C. 826.

Consistent with the Controlled Substances Act (CSA), the schedules contained in DEA regulations include marihuana (drug code 7360) in Schedule I. 21 CFR 1308.11(d)(23). This listing includes (unless specifically excepted or unless listed in another schedule) any material, compound, mixture, or preparation, which contains any quantity of the substance, or which contains any of its salts, isomers, and salts of isomers that are possible within the specific chemical designation. Because the definition of marihuana in 21 U.S.C. 802(16) includes both derivatives and preparations of marihuana, the DEA until now has used drug code 7360 for extracts of marihuana.

This final rule finalizes a July 5, 2011, Notice of Proposed Rulemaking (76 FR 39039) in which the DEA proposed that a new drug code 7350 be used for extracts of marihuana.

Why a New Code Number Is Needed

The United Nations Conventions on international drug control treats extracts from the cannabis plant somewhat differently than marihuana or tetrahydrocannabinols. The creation of a new drug code in the DEA regulations for marihuana extracts will allow for more appropriate accounting of such materials consistent with treaty provisions.

The Single Convention on Narcotic Drugs, 1961 (“Single Convention”) and the 1971 Convention on Psychotropic Substances (“Psychotropic Convention”) provide for the international control of marihuana constituents. Many of the CSA’s provisions were drafted to comply with these Conventions. The CSA includes schemes of drug scheduling and procedures for adding, removing, and transferring drugs among the schedules that are similar, in some ways, to those in the Single Convention. With respect to those drugs that are subject to control under the Single Convention, the CSA mandates that DEA control such drugs in a manner that will ensure the United States meets its obligations under the Single Convention. 21 U.S.C. 811(d)(1).

Somewhat similar to the CSA, the Single Convention lists substances in four schedules. However, under the Single Convention, the drugs that are subject to the most stringent controls are in Schedule IV. Another difference between the CSA and the Single Convention is that, under the latter, a drug can be listed in more than one schedule. Cannabis and cannabis resin are listed in both Schedule IV and Schedule I of the Single Convention. Schedule I controls under the Single Convention include: Requirements for import and export authorization, licensing of manufacturers/distributors, recordkeeping requirements, a requirement for prescriptions for medical use, annual estimate of needs, quotas, annual statistical reporting, and a requirement that use be limited to medical and scientific purposes. Schedule II of the Single Convention is similar in controls to Schedule I with a few exceptions, and Schedule III is less restrictive. All substances listed in Schedule IV are also listed in Schedule I under the Single Convention in order to encompass the requirements mentioned above. In addition, as indicated, the Single Convention imposes certain heightened measures of control with respect to Schedule IV drugs. The placing of a drug into both Schedule I and Schedule IV, therefore imposes the most stringent controls under the Single Convention. Although cannabis and cannabis resin are listed in Schedules I and IV of the Single Convention, cannabis extracts are listed only in Schedule I.

 

Read these…

 

Comments

In response to the July 5, 2011, Notice of Proposed Rulemaking (76 FR 39039), the DEA received six submissions from five commenters. Three of the comments raised issues relating to the medical use or legality of marihuana/cannabis; these comments were not germane to the issues addressed by this rulemaking. A fourth comment was merely a clarification of a comment previously submitted.

One comment requested clarification of whether the new drug code will be applicable to cannabidiol (CBD), if it is not combined with cannabinols.

DEA response:  For practical purposes, all extracts that contain CBD will also contain at least small amounts of other cannabinoids. \1\ However, if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code 7350. In view of this comment, the regulatory text accompanying new drug code 7350 has been modified slightly to make clear that it includes cannabis extracts that contain only one cannabinoid.

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\1\ Although it might be theoretically possible to produce a CBD extract that contains absolutely no amounts of other cannabinoids, the DEA is not aware of any industrially-utilized methods that have achieved this result.

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Another comment from a pharmaceutical firm currently involved in cannabinoid research and product development praised DEA’s efforts to establish a new drug code for marihuana extracts as a means to more accurately reflect the activities of scientific research and provide more consistent adherence to the requirements of the Single Convention. However, the comment expressed concerns that the proposed definition for the new drug code (i.e. “meaning extracts that have been derived from any plant of the genus Cannabis and which contain cannabinols and cannabidiols”) is too narrow. The comment suggested that the broader term “cannabinoids” be substituted for “cannabinols and cannabidiols.” The comment pointed out that other constituents of the marihuana plant may have therapeutic potential. The comment further clarified that the broader term “cannabinoid” includes both cannabinol-type compounds and cannabidiol-type compounds, as well as cannabichromene-type compounds, cannabigerol-type compounds, and other categories of compounds.

DEA response: DEA agrees with the commenter that the term “cannabinoid” would provide for a broader definition of marihuana extract; however, use of the term “cannabinoid” necessitates that the DEA clarify that the new marihuana extract category (drug code 7350) is not intended to include “cannabis resin” as defined in the U.N. Single Convention.

As discussed in the NPRM, a new drug code is necessary in order to better account for these materials in accordance with treaty obligations. The Single Convention placed “cannabis” and “cannabis resin” under both Schedule I and IV of the Convention, the most stringent level of control under the Convention. While “cannabis resin” is extracted from “cannabis,” the Single Convention specifically controls “extracts” separately. Extracts of cannabis are controlled only under Schedule I of the Convention, which is a lower level of control than “cannabis resin.”

Accordingly, it is the DEA’s intent to define the term “marihuana extract” so as to exclude material referenced as “cannabis resin” under the Single Convention on Narcotics. “Cannabis resin” (regulated under the CSA as a resin of marihuana) contains a variety of “cannabinoids” and will continue to be regulated as marihuana under drug code 7360. The new drug code for marihuana extracts under 21 CFR 1308.11(d)(58) will exclude the resin. Cannabis resin and marihuana resin remain captured under the drug code for marihuana (drug code 7360), thus differentiating this material from marihuana extracts (new drug code 7350). This will maintain compliance with the Single Convention.

 

Final Action

After careful consideration of all comments, the DEA is hereby amending 21 CFR 1308.11(d) to include a new subparagraph (58) which creates a new code number in Schedule I as follows:

“(58) Marihuana Extract–7350

“Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.”

The creation of this new drug code in the DEA regulations for marihuana extracts allows for more appropriate accounting of such materials consistent with treaty provisions. Such marihuana extracts remain in Schedule I. Entities registered to handle marihuana (under drug code 7360) that also handle marihuana extracts, will need to apply to modify their registrations to add the new drug code 7350 to their existing DEA registrations and procure quotas specifically for drug code 7350 each year.

 

 

Bottom Line as I see it regarding CBD /Hemp…

If it was not made for human use as defined by the law the DEA will not enforce it.

Anyone say different – let me know.

 

Signed,

The Copy Boy