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DEA Comment Period Open

The U.S. Drug Enforcement Administration (DEA) opened a 60-day comment period on its proposed Interim Final Rule on hemp (IFR). How often does DEA ask your opinion? This is one, so don’t blow it; tell them what you think about marijuana prohibition and Schedule 1.

This IFR is a minor technical housekeeping clarification of what DEA has been doing since December 2018 anyway, and is effective immediately. Clarifies hemp is legal even if it contains 0.3% delta-9 THC by dry weight, plant and products (which creates legal exposure for extractors and processors of Crude, which can be greater than 0.3% THC before dilution). Clarifies synthetic THC is Schedule 1, nothing new there. Clarifies that CBD is not a Schedule 1 controlled substance. Removes import and export restrictions on CBD even if from marijuana if <0.1% THC. DEA clarifies the THC standard is delta-9, not Total THC. Deschedules Epidiolex by GW Pharmaceuticals. Clarifies you can’t talk your way out of being over 0.3% with your silver tongue (labeling, ads, etc). Even if “from hemp,” if it is over 0.3% THC then it is Schedule 1 marijuana.

It is silent on delta-8 THC, except indirectly when referring to “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.” I don’t share the opinion that delta-8 THC is synthetic and thus Schedule 1. Delta-8 is considered by scientists to be naturally-occurring in processing. That it is produced by conversion of THCa or delta-9 is little different than the normal decarboxylation of THCa to THC, or CBDa to CBD, or isomerization of CBD to Δ9 or Δ8 THC or CBN. In any event, the opening round is no time to concede.

This IFR can only be enforced by DEA on non-hemp and DEA Licensees. But no doubt other LEOs might use it. While DEA can do anything they want but only to their Licensees, they can’t write new law. The rest of us are RICO felons to them.

CBD Crude (called Work-In-Process Hemp Extract (WIPHE) by Attorney Rod Kight) that is over 0.3% delta-9 THC before dilution was always a gray area as it was over 0.3% THC but it was a naturally and unavoidable consequence of processing of compliant <0.3% THC hemp. That was found by the Ninth Circuit Court of Appeals to be legal in 2004, no maximum THC. That decision also permanently enjoined DEA from enforcing the Controlled Substances Act (CSA) on THC found in compliant hemp. This IFR clarification creates a conflict with the Ninth Circuit decision. One workaround is to get a DEA 225 License (despite being a requirement violating the Fifth Amendment).

From that case in the Ninth:
IV. CONCLUSION
The DEA’s Final Rules purport to regulate foodstuffs containing “natural and synthetic THC.” And so they can: in keeping with the definitions of drugs controlled under Schedule I of the CSA, the Final Rules can regulate foodstuffs containing natural THC if it is contained within marijuana, and can regulate synthetic THC of any kind. But they cannot regulate naturally-occurring THC not contained within or derived from marijuana-i.e., non-psychoactive hemp products-because non-psychoactive hemp is not included in Schedule I. The DEA has no authority to regulate drugs that are not scheduled, and it has not followed procedures required to schedule a substance.

For the hemp supply chain, the biggest potential disruption is the chains’ belief, right or wrong, that “CBD is illegal” because of the publicity. That happened in 2001 when HIA accomplished the very thing they accused DEA of attempting, namely killing the hemp food market. They almost killed off Canadian hemp with it.

This tempest in a teapot and confusion over the IFR could be a good thing if it reduces the number of Cannabinoid Cowboys seeing delta-8 like they did CBD: $€£¥. That would leave more market for the lion-hearted and might increase overall quality.


Executive Summary

The Agriculture Improvement Act of 2018, Public Law 115-334 (the AIA), was signed into law on December 20, 2018. It provided a new statutory definition of “hemp” and amended the definition of marihuana under 21 U.S.C. 802(16) and the listing of tetrahydrocannabinols under 21 U.S.C. 812(c). The AIA thereby amends the regulatory controls over marihuana, tetrahydrocannabinols, and other marihuana-related constituents in the Controlled Substances Act (CSA).

This rulemaking makes four conforming changes to DEA’s existing regulations:

It modifies 21 CFR 1308.11(d)(31) by adding language stating that the definition of “Tetrahydrocannabinols” does not include “any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639 o.”

It removes from control in schedule V under 21 CFR 1308.15(f) a “drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1% (w/w) residual tetrahydrocannabinols.”

It also removes the import and export controls described in 21 CFR 1312.30(b) over those same substances.

It modifies 21 CFR 1308.11(d)(58) by stating that the definition of “Marihuana Extract” is limited to extracts “containing greater than 0.3 percent delta-9-tetrahydrocannabinol on a dry weight basis.”

This interim final rule merely conforms DEA’s regulations to the statutory amendments to the CSA that have already taken effect, and it does not add additional requirements to the regulations. Accordingly, there are no additional costs resulting from these regulatory changes. However, as discussed below, the changes reflected in this interim final rule are expected to result in annual cost savings for affected entities.

[…]

Taken together, these two changes made by the AIA limit the definition of marihuana to only include cannabis or cannabis-derived material that contain more than 0.3% delta-9-tetrahydrocannabinol (also known as Δ9-THC) on a dry weight basis. […] Pursuant to the AIA, unless specifically controlled elsewhere under the CSA, any material previously controlled under Controlled Substance Code Number 7360 [only for DEA Licensees, THC extracts] (marihuana) or under Controlled Substance Code Number 7350 [only for DEA Licensees, extracts such as CBD] (marihuana extract), that contains 0.3% or less of Δ9-THC on a dry weight basis—i.e., “hemp” as that term defined under the AIA—is not controlled. Conversely, any such material that contains greater than 0.3% of Δ9-THC on a dry weight basis remains controlled in schedule I.

In order to meet the AIA’s definition of hemp, and thus qualify for the exception in the definition of marihuana, a cannabis-derived product must itself contain 0.3% or less Δ9-THC on a dry weight basis. It is not enough that a product is labeled or advertised as “hemp.” The U.S. Food and Drug Administration (FDA) has recently found that many cannabis-derived products do not contain the levels of cannabinoids that they claim to contain on their labels. Cannabis-derived products that exceed the 0.3% Δ9-THC limit do not meet the statutory definition of “hemp” and are schedule I controlled substances, regardless of claims made to the contrary in the labeling or advertising of the products.

[…]

Finally, nothing in the AIA or in these implementing regulations affects or alters the requirements of the Food, Drug, & Cosmetic Act (FD&C Act). See 7 U.S.C. 1639r(c). Hemp products that fall within the jurisdiction of the FD&C Act must comply with its requirements [foods, beverages, cosmetics]. FDA has recently issued a statement regarding the agency’s regulation of products containing cannabis and cannabis-derived compounds, and DEA refers interested parties to that statement, which can be found at https://www.fda.gov/newsevents/Newsroom/PressAnnouncements/ucm628988.htm.

[…]


People give DEA way more power than it deserves. It can’t write new law, so every Grand Pronouncement is just for its Licensees. But having a comment period is golden, it allows the People to be heard. Just like when the USDA opened their comment period on rule changes a year ago, and FDA opened one on Cannabis which is still open, this is our chance to get our opinion and concerns on the record.

Every Activist, Farmer, Processor, Distributor, Retailer, Fan, Customer, Patient, Patriot, or other interested party should comment, just on Principle. This is our chance; 100,000 comments changed organic policy at USDA in 2010.

Always always always comment when the government allows it, and especially get others empowered to influence the outcome this way. It’s the ONLY easy way to build a base of supporters and influence policy, short of buying a Senator. It’s a gift from God, use it.

Although DEA says it can ignore comments, I suggest nevertheless making them by October 20. Final Rule is effective starting August 21, 2020. Electronic comments must be submitted, and written comments must be postmarked, on or before October 20, 2020 at 11:59 p.m. Eastern Time.

The Hemp Industries Association lost HIA 3 in 2018 because it failed to comment on CBD being assigned Controlled Substance Code Number 7350 in the proscribed period in 2016, back when it was comment period. HIA hadn’t yet figured out CBD was its future thus were silent. It also failed to make a comment to FDA’s list of pre-DSHEA ingredients in 2017. It lost HIA 3 solely because it never commented. It appears you need to comment to have standing before the court to complain about a policy previously open to public comment.

Click here to make comments to DEA on Cannabis, CBD, Cannabinoids, Marijuana, Hemp, or Schedule 1 for what DEA once called “safest therapeutically active substance known to man” but FDA says has “no medical value.”

Here are suggestions for comments:

Since 47 states have found medical value from marijuana, deschedule from its current Schedule 1 (“no medical value”). Deschedule completely at the state and federal levels, decriminalize. Leave to the states to regulate as each sees fit. End the last Nixon Dirty Trick.

Allow the release current nonviolent marijuana prisoners, commute, pardon and/or expunge past records. Restore their voting rights.

Encourage an end to Mandatory Minimum sentences which take sentencing discretion away from Judges.

Cut DEA’s budget by at least by 1/3, reflecting changes in state marijuana laws and thus its Mission. Address the growing and deadly opioid crisis or the trafficking of children instead.

Allow patients to choose, possess, grow, and make their choice of medicine without fear of arrest.

End the arrests of adults for marijuana in “legal marijuana” states.

There are over 43,427 studies on the U.S. National Institutes of Health’s PubMed on Cannabis and Cannbinoids, going back to 1840. That’s 43,427 reasons to deschedule starting long before DEA or FDA even existed.

Safe, popular, efficacious Cannabis products professionally-prepared by many of today’s mainstream drug companies and sold over-the-counter by pharmacists pre-date FDA by almost a century, and should be allowed today.

Legalizing medical marijuana enjoys over 90% support, and legalizing adult-use marijuana enjoys 70% support. Please follow the will of The People.

Respect the Ninth Circuit Court of Appeals permanent injunction against DEA enforcing the Controlled Substances Act against chemicals found in compliant hemp. We both know 0.31% THC hemp is not marijuana and should be treated as such by DEA or the USDA.

DEA must not interfere with USDA’s administration of compliant hemp, including requiring analytical laboratories be registered with DEA.

Exempt from the Controlled Substances Act all products originally derived from compliant hemp.

Stalk and fiber has always been exempt from the Controlled Substances Act, so do not subject stalk, fiber and fiber products to maximum THC limits.

Allow FDA to declare Cannabinoids and resin GRAS, a food ingredient existing before 1994.

Encourage hemp as a non-tobacco tobacco replacement for improved public health.

The definition of Hemp should raised to 1% maximum delta-9 THC, from 0.3% today.

Allow THC testing methods other than post-decarboxylation.

Allow drug felons who have paid their debt to society to participate in the USDA hemp program for rehabilitation.

Hemp extract works in process” should be exempt from THC limits.

DEA has no jurisdiction in wholly intRAstate operations. Even Justice Clarence Thomas agrees: “In the early days of the Republic, it would have been unthinkable that Congress could prohibit the local cultivation, possession, and consumption of marijuana.

Schedule 1 is a very severe penalty for what DEA’s own Administrative Law Judge called “the safest therapeutic substance known to man.” Please deschedule completely.


This Rule document was issued by the Drug Enforcement Administration (DEA).

Action
Interim final rule with request for comments.

Summary
The purpose of this interim final rule is to codify in the Drug Enforcement Administration (DEA) regulations the statutory amendments to the Controlled Substances Act (CSA) made by the Agriculture Improvement Act of 2018 (AIA), regarding the scope of regulatory controls over marihuana, tetrahydrocannabinols, and other marihuana-related constituents. This interim final rule merely conforms DEA’s regulations to the statutory amendments to the CSA that have already taken effect, and it does not add additional requirements to the regulations.

Dates
Effective August 21, 2020. Electronic comments must be submitted, and written comments must be postmarked, on or before October 20, 2020. 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.

Addresses
To ensure proper handling of comments, please reference “RIN 1117-AB53/Docket No. DEA-500” on all correspondence, including any attachments.

Electronic comments: The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on http://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted, and there is no need to resubmit the same comment.

Paper comments: Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to:

Drug Enforcement Administration
Attn: DEA Federal Register Representative/DPW
Diversion Control Division
8701 Morrissette Drive, Springfield, VA 22152

For Further Information Contact
Scott A. Brinks

Diversion Control Division
Drug Enforcement Administration
8701 Morrissette Drive, Springfield, Virginia 22152
Telephone: (202) 598-2596.

Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document and the complete Economic Impact Analysis, to this interim final rule are available in their entirety under the tab “Supporting Documents” of the public docket of this action at http://www.regulations.gov under FDMS Docket ID: DEA-500 (RIN 1117-AB53/Docket Number DEA-500) for easy reference.

One thought on “DEA Comment Period Open”

  1. This is highly unfair to people that have arthritis back, shoulder and knee pain. I know people who suffered from seizures and they haven’t had them since they started receiving CBD/THC. It increases the appetite for cancer patients and also helps them rest.

    Several states have legalized the use of Marijuana/Hemp. Why are we dragging our feet and coming up with every excuse possible to not do so? Recreational and Medicinal

    Please reconsider.

Comments are closed.

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