Department of Justice Puts Cannabis Spotlight Back on the Plant and Patients

2. AMEND § 1308.11 BY REVISING THE RENUMBERED PARAGRAPH (D)(30) TO READ AS FOLLOWS:

(31) (30) Tetrahydrocannabinols 7370

(i) Meaning tetrahydrocannabinols, except as in paragraph (d)(31)(30)(ii) and (iii)  of this section, naturally contained in a plant of the genus Cannabis (cannabis plant), as well as synthetic equivalents of the substances contained in the cannabis plant, or in the resinous extractives extracts of such plant, and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity to those substances contained in the plant, such as the following: 1 cis or trans tetrahydrocannabinol, and their optical isomers 6 cis or trans tetrahydrocannabinol, and their optical isomers 3, 4 cis or trans tetrahydrocannabinol, and its optical isomers

 (Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.)

(ii) Tetrahydrocannabinols does not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.

(iii) Tetrahydrocannabinols does not include any substance that falls within the definition of marijuana set forth in 21 U.S.C. 802(16).

3. AMEND § 1308.13 BY ADDING NEW PARAGRAPHS (H), (I), AND (J) TO READ AS FOLLOWS:

1308.13 Schedule III.

(h) Marihuana Marijuana, as defined in 21 U.S.C. 802(16).

(i) Marihuana Marijuana Extract, meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, containing greater than 0.3 percent delta-9- tetrahydrocannabinol on a dry weight basis, other than the separated resin (whether crude or purified) obtained from the plant.

(j) Naturally Derived Delta-9-Tetrahydrocannabinols.

Meaning those delta-9-tetrahydrocannabinols, except as in paragraphs (j)(ii) and (j)(iii) of this section, that are naturally contained in a plant of the genus Cannabis (cannabis plant).

Naturally derived delta-9-tetrahydrocannabinols do not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.

Naturally derived delta-9-tetrahydrocannabinols do not include any delta-9- tetrahydrocannabinols contained in substances excluded from the definition of marijuana as set forth in 21 U.S.C. 802(16)(B) (ii)

Current Statute Citations:

7 U.S.C. §1639o. Definitions (1) Hemp- The term “hemp” means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.

21 U.S.C. 802 (16)(A) Subject to subparagraph (B), the terms “marihuana” and “marijuana” mean 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.

(B) The terms “marihuana” and “marijuana” do not include-

(i) hemp, as defined in section 1639o of title 7; or

(ii) 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 there from), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

B. UNREGULATED SCHEDULE III PRODUCTS ARE STILL ILLEGAL

Quote from DOJ rationale.

“If marijuana is transferred into schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA’s definition of “marijuana” would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act (“FDCA”).”

C. DEA TEEING UP FOR AN ADMINISTRATIVE HEARING

FROM DOJ RATIONALE FOR PROPOSED RULE

“DEA anticipates that updated epidemiological survey data since 2022 may be appropriate for consideration”

“DEA anticipates that additional data on other marijuana constituents, routes of administration of marijuana, and the impact on ∆9-THC potency may be appropriate for consideration.”

“DEA anticipates that additional information arising from this rulemaking will further inform the findings that must be made to reschedule marijuana, including with respect to this factor. DEA also notes that, according to the World Health Organization, cannabis is globally the most commonly used psychoactive substance under international control.”

“DEA anticipates that additional psychic or physiological dependence liability may be appropriate for consideration.”

“DEA believes that additional data on marijuana’s pattern of abuse may be appropriate for consideration in assessing this factor.”

“DEA anticipates that additional data on diversion from State programs and DEA-registered manufacturers may aid in a determination of whether diversion is taking place. “

“DEA anticipates that additional data on seizures of marijuana by law enforcement, cannabis-related ED visits, as well as updated epidemiological survey data since 2022, may be appropriate for consideration.”

“DEA anticipates that additional data on other marijuana constituents, routes of administration of marijuana, and the impact on ∆9-THC potency may be appropriate for consideration.”

“DEA believes that additional data on marijuana’s pharmacological effects may be appropriate for consideration in assessing this factor.”

“DEA believes that additional information arising from this rulemaking will further inform the findings regarding the appropriate schedule for marijuana. DEA has maintained an active review of the scientific literature addressing marijuana with a focus on how it relates to the scientific and medical evaluation and informs any updates to the eight-factor analysis. In addition to HHS’s scientific and medical determinations, which are binding until the issuance of this NPRM and which must be accorded significant deference throughout the rulemaking, DEA believes that factual evidence (including scientific data) and expert opinions, including additional data regarding different forms, formulations, and delivery methods for marijuana, as well as evidence regarding the effects of marijuana at various dosages or concentrations, may be relevant.”

“DEA also believes that additional information regarding the scope, duration, and significance of marijuana abuse may be appropriate for consideration in assessing this factor.”

D. WHAT’S NEXT

• DOJ Posts Proposed Rule
• 60 Days of Public Comment
• DEA Responds to all public comments.
• DEA will decide to move forward with an administrative hearing. Findings are not binding.
• DOJ will make Final Rule
• Stakeholders will have 60 days to ask for judicial rule (lawsuits). Rescheduling could be put on hold until cases are decided.