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Rod Kight

THCO is a Schedule 1 Controlled Substance Says DEA

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I have been concerned about the proliferation of THC acetate ester (THCO) for a while. It has always been my view that THCO is a controlled substance under federal law. Although it can be made from cannabinoids from hemp, THCO is not naturally expressed by the hemp plant. It is a laboratory creation that does not occur in nature, at least not from the hemp plant.

I have had many consultations in which people equate THCO with delta-8 THC (D8) based on the fact that most of the D8 on the market is made chemically from another cannabinoid. During these conversations, people say that D8 is a “derivative” of hemp and it is considered lawful “hemp” under the 2018 Farm Bill. By extension, they state that since THCO is also a hemp derivative it meets the definition of hemp, too. I always inform them that they are wrong. D8 and THCO are different in a very important way, namely that D8 is naturally produced by the hemp plant; THCO is not. 

To be clear, as I have consistently argued, and which both the DEA and the 9th Circuit Court of Appeals have confirmed, D8 falls within the definition of “hemp” because it is a “derivative” as set forth in the 2018 Farm Bill. For this reason, many people assume that THCO also meets the definition of a hemp derivative since it is typically created from a starter cannabinoid. This is not correct. D8 is distinguishable from THCO because the hemp plant naturally produces D8; however, it does not produce THCO. From this perspective, and unlike D8, THCO is properly seen as synthetic THC, not “hemp”. For this reason, I have consistently advised clients not to create or distribute THCO. On a personal level, and based on a research letter published earlier this year in the Journal of Medical Toxicology, I routinely advise personal friends not to consume THCO due to the potentially serious medical consequences of vaping it.

Due to my concerns, I asked the Drug Enforcement Administration (DEA) for its opinion on THCO. In its response letter, below, it states:

Delta-9-THCO and delta-8-THCO do not occur naturally in the cannabis plant and can only be obtained synthetically, and therefore do not fall under the definition of hemp…. Thus, delta-9-THCO and delta-8-THCO meet the definition of “tetrahydrocannabinols,” and they (and products containing delta-9-THCO and delta-8-THCO) are controlled in schedule I by 21 U.S.C. § 812(c) Schedule I, and 21 CFR § 1308.11(d).

Although I do not always agree with the DEA’s view on cannabis matters, I agree with this opinion and, frankly, am not surprised. This is what I have been saying for a while. 

 

Go to Rod’s Site to read correspondence

https://cannabusiness.law/thco-is-a-schedule-1-controlled-substance-says-dea/

 



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Rod Kight

IS FLORIDA IS ABOUT TO KILL OFF ITS HEMP INDUSTRY?

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As legislative sessions across the country continue this spring, we have started to notice an emerging trend among elected officials. Many state senators and congresspersons are being bombarded with requests to clarify, curb, or cancel the rapidly emerging market of mood-altering products containing hemp-derived cannabinoids. We wrote about Virginia’s attempt to regulate these products last week. Short of a veto by the Governor, the future of VA’s hemp industry looks dire.

This post focuses on Florida. We will continue write about states where the hemp industry is under threat from state legislatures and regulators.

YES, FLORIDA IS ABOUT TO KILL OFF ITS HEMP INDUSTRY. HERE’S HOW:

The Sunshine State is attempting to address the popularity of products containing mood-altering hemp-derived cannabinoids. Two bills, House Bill 1475 and Senate Bill 1676 (collectively, the “Bills”), were filed in Florida’s General Assembly on March 3, 2023. These bills (which are identical) address, inter alia, hemp extract and certain regulations surrounding hemp extract.

At present, the Bills provide new and/or revised definitions (underlined below) for Florida’s hemp-derived products marketplace. Specifically, the Bills define “hemp” as:

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 thereof, whether growing or not, that has a total delta 9-tetrahydrocannabinol concentration that does not exceed 0.3 percent on a dry-weight basis, with the exception of hemp extract, which may not exceed 0.3 percent total delta-9 tetrahydrocannabinol on a wet-weight basis. The term does not include synthetically derived cannabinoids.”

Additionally, “hemp extract” is further defined as:

a substance or compound intended for ingestion, containing more than trace amounts of a cannabinoid, or for inhalation which is derived from or contains hemp and which does not contain controlled substances. The term includes snuff, chewing gum, and smokeless products derived from or containing hemp, but does not include cannabinoids that are synthetically derived or seeds or seed-derived ingredients generally recognized as safe by the United States Food and Drug Administration.”

“Synthetically derived cannabinoids” are defined to mean: “any cannabinoid created by reacting a cannabis- or noncannabis derived extract with solvent or acid to increase the concentration of a present cannabinoid or to create a new cannabinoid not originally found in the extract.

Finally, “total tetrahydrocannabinol” is defined as: “the sum of all tetrahydrocannabinol isomers, with a concentration of more tetrahydrocannabinol-A multiplied by 0.877, in milligrams per gram multiplied by the labeled weight of the product.”

Clearly the new definitions of “hemp” and “hemp extract” are aimed at prohibiting the distribution of products that contain mood-altering hemp-derived cannabinoids. As many readers of this blog will know, there has been a growing trend among hemp-derived product manufacturers to introduce “compliant Delta-9 gummies” that, while containing less than 0.3% Delta-9 THC on a dry-weight basis, contain a sufficient quantity of Delta-9 THC to have mood-altering effects on the consumers of those products. By amending the definitions of “hemp” and “hemp extract” and including new definitions regarding “synthetically derived cannabinoids” and “total tetrahydrocannabinol” the Florida legislature is seeking to restrict the ability of manufacturers to introduce many hemp-derived products into the stream of commerce.

Additional efforts to regulate these products in the marketplace can be seen in other changes the legislature is making to Florida’s hemp regulations, particularly regarding the distribution and retail sale of hemp extract. For instance, the Bills stipulate that:

Hemp extract may only be distributed and sold in the state if the product:

… The batch was processed in a facility that holds a current and valid permit issued by a human health or food safety regulatory entity with authority over the facility, and that facility meets the human health or food safety sanitization requirements of the regulatory entity. Such compliance must be documented by a report from the regulatory entity confirming the facility meets such requirements.”

The Bills mandate that “hemp extract may only be sold to a business in this state if that business is properly permitted as required by this section.” Additionally, the Bills expand on other limitations that were previously in place, such as insisting that certain products be sold only to persons over the age of twenty-one as well as including serving or container size requirements. For reference, the Bills state:

Products that are intended for human ingestion or inhalation and contain hemp extract may not:

  1. Be sold in this state to a person who is under 21 years of age; or
  2. Exceed 0.5 milligrams total tetrahydrocannabinol per dose or 2 milligrams total tetrahydrocannabinol per container.”

Finally, the Bills provide additional restrictions on the sale and distribution of “hemp extract” by stating:

The Department shall adopt rules for:

  1. Packaging and labeling requirements that ensure that hemp extract intended for human ingestion or inhalation is not attractive to children.
  1. Advertising regulations that ensure hemp extract intended for human ingestion or inhalation is not marketed or advertised in a manner that specifically targets or is attractive to children.
  1. The department shall adopt rules pursuant to § 120.54 and § 120.536 to establish tetrahydrocannabinol isomers to include in calculating total tetrahydrocannabinol, which must include, at a minimum, delta-8 tetrahydrocannabinol, delta-9 tetrahydrocannabinol, delta-10 tetrahydrocannabinol, exo tetrahydrocannabinol, and hexahydrocannabinol.”

The Bills are set to take effect on July 1, 2023. These Bills are an existential threat to Florida’s hemp-derived products industry, particularly for manufacturers and retailers of products that will no longer be permitted should these Bills become law. While industry participants should prepare themselves accordingly for the effective date of these regulations, a more pertinent approach to these newfound prohibitions would be to reach out to Florida legislators in order to express your dissatisfaction with these proposed regulations. Click here to find who your Florida legislators are so you can contact them today.

Notably, the Florida chapter of the Healthy Alternatives Association is soliciting assistance donations to defeat these bills. 

Kight Law can provide information on how to push back against these bills, and also to help you navigate the ever-changing regulatory landscape surrounding cannabis products. Click here to schedule a consultation today.

March 9, 2023

ATTORNEY PHILIP SNOW IS EXPERIENCED IN ADVISING BUSINESSES ABOUT HEMP, DELTA-8 THC, AND CBD. 

This article was written by attorney Philip Snow. Kight Law represents hemp businesses in the US and throughout the world. To schedule a consultation please click here and mention this article.

 

Source: https://cannabusiness.law/is-florida-is-about-to-kill-off-its-hemp-industry/



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Rod Kight

Is Virginia Really for (hemp) Lovers?

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Virginia House Bill 2294 (Bill) recently passed through both the House and Senate of the Virginia General Assembly. This Bill, which can be read in its entirety here, has the potential to severely alter the landscape surrounding hemp-derived products in the Commonwealth of Virginia.

Unfortunately, and as mentioned above, the Bill has already passed through both Chambers of Virginia’s General Assembly and is headed Governor Youngkin’s desk for signature. It is expected the Governor will sign the Bill in an effort to chill the fervor of the hemp-derived products industry in Virginia, an industry which has enjoyed immense success while Virginia wrestles with its ability to make good on its promises for an adult-use marijuana marketplace by 2024. This blog is intended to provide information about the Bill, as well as what manufacturers and retailers of these products need to address or be aware of moving forward.

As a threshold matter, the Bill mandates that every industrial hemp extract product offered for retail sale contain no more than 0.3 percent total tetrahydrocannabinol (THC), and that products containing industrial hemp extract contain no more than 2 milligrams of total THC per package.

For reference, the Bill defines “tetrahydrocannabinol” as: “any naturally occurring or synthetic tetrahydrocannabinol, 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 and any preparation, mixture, or substance containing, or mixed or infused with, any detectable amount of tetrahydrocannabinol. For the purposes of this definition, “isomer” means the optical, position, and geometric isomers.”

Also, the Bill classifies “total tetrahydrocannabinol” as: “the sum, after the application of any necessary conversion factor, of the percentage by weight of tetrahydrocannabinol and the percentage by weight of the tetrahydrocannabinolic acid.”

The Bill defines “industrial hemp extract” as: “an extract (i) of industrial hemp, (ii) that is intended for human consumption, and (iii) except as otherwise provided in subsection M of § 54.1-3442.6, when offered for sale, that (a) contains a total tetrahydrocannabinol concentration that is no greater than 0.3 percent and (b) contains no more than two milligrams of total tetrahydrocannabinol per package. “Industrial hemp extract” is not a hemp seed-derived ingredient that is approved by the U.S. Food and Drug Administration or is the subject of a generally recognized as safe notice for which the U.S. Food and Drug Administration had no questions.”

In addition to providing these clarifying definitions, the Bill states that any person who “manufactures, sells, or offers for sale an industrial hemp extract or food containing an industrial hemp extract shall be subject to requirements of the Bill and regulations adopted pursuant to the Bill.”

Alarmingly, the Bill states:

Any person who (i) manufactures, sells, or offers for sale an industrial hemp extract or food containing an industrial hemp extract without first obtaining a permit to do so from the Commissioner pursuant to § 3.2-5100, unless exempt from a permit pursuant to subdivision C 6 of § 3.2-5130; (ii) continues to manufacture, sell, or offer for sale an industrial hemp extract or food containing an industrial hemp extract after revocation or suspension of such permit; (iii) fails to disclose on a form prescribed by the Commissioner that he intends to manufacture, sell, or offer for sale a substance intended to be consumed orally that contains an industrial hemp-derived cannabinoid; (iv) manufactures, sells, offers for sale a food that (a) has a total tetrahydrocannabinol concentration that is greater than 0.3 percent or (b) contains more than two milligrams of total tetrahydrocannabinol per package; (v) manufactures, offers for sale, or sells in violation of this chapter or a regulation adopted pursuant to this chapter a substance intended to be consumed orally that is advertised or labeled as containing an industrial hemp-derived cannabinoid; or (vi) otherwise violates any provision of this chapter or a regulation adopted pursuant to this chapter, in addition to any other penalties provided, is subject to a civil penalty not to exceed $10,000 for each day a violation occurs.”

To be clear, violations of this new Bill carry with them a $10,000 per day fine for each day the violations occur. In addition to these steep monetary penalties, the Bill also states that in addition to any other penalties, any violation of the Bill also carries with it a Class I misdemeanor and that each day in which a violation occurs shall constitute a separate offense.

The Bill also imposes strict labeling and packaging requirements for products containing industrial hemp extract. These products must be contained in “child-resistant packaging”. Each industrial hemp extract or food containing industrial hemp extract must be packaged and equipped with labels that satisfy all Bill criteria. In addition to font-size requirements and a mandate to include each ingredient in the product, these product labels must also state that the industrial hemp extract or the food containing the industrial hemp extract contains tetrahydrocannabinol. Finally, the Bill mandates that these products cannot be sold to persons younger than 21 years of age.

Moreover, industrial hemp extract or foods containing an industrial hemp extract, when offered for sale, must be accompanied by a certificate of analysis, produced by an independent laboratory that is registered with the U.S. Drug Enforcement Administration and is accredited pursuant to the standard ISO/IEC 17025 of the International Organization for Standardization by a third-party accrediting body; that states the total tetrahydrocannabinol concentration of the substance or the total tetrahydrocannabinol concentration of the batch from which the substance originates.

In addition to other requirements that mandate identifying batches for traceability, the Bill specifically prohibits the inclusion of claims “indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease, which shall render the product a drug, as that term is defined in 21 U.S.C. § 321(g)(1). An industrial hemp extract or food containing an industrial hemp extract with a label that contains a claim indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease shall be considered misbranded.”

The Bill places limitations on the ability to sell hemp-derived products intended for smoking to persons over the age of 21. Along with these limitations, penalties for violations of these provisions have increased from $50 to $500. Keep in mind these restrictions apply equally to sales online and in brick-and-mortar locations. Online sales must be done using a commercially available database that verifies the age of the purchaser, as well as a delivery service that ensures the person signing for the package is over the age of 21.

While a great deal of the Bill’s new regulations are aimed at increasing safety and transparency of the hemp-derived products industry, others seem to be specifically targeted at regulating an industry out of existence. Instead of establishing a regulatory framework surrounding adult-use marijuana, lawmakers instead focused their efforts on bullying hemp-derived product manufacturers and retailers.

Regardless of legislative intent or ultimate outcome, industry participants need to be aware of the Bill’s impact on their business. Finally, industry participants who are residents of the Commonwealth, or who know residents of the Commonwealth, should speak up by voting this year as all seats in Virginia’s General Assembly are up for election in 2023.

For more information on Virginia’s new hemp-derived product regulations, or for questions regarding cannabis laws across the country, please contact Kight Law today.

February 27, 2023

ATTORNEY PHILIP SNOW IS EXPERIENCED IN ADVISING BUSINESSES ABOUT HEMP, DELTA-8 THC, AND CBD. 

This article was written by attorney Philip Snow. Kight Law represents hemp businesses in the US and throughout the world. To schedule a consultation please click here and mention this article.



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Rod Kight

DEFAMATION, MISINFORMATION, AND SHOOTING THE MESSENGER- A THCO STORY

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February 21 2023

On February 13, I posted an article about the DEA’s response to my inquiry regarding the legal status of THCO. As my readers are aware, the DEA stated that THCO is a schedule 1 controlled substance. The DEA’s position, which was spread via my article, created what several people have called a “shitstorm”. For several days afterwards, I was contacted by both cannabis and non-cannabis mainstream media. My phone rang constantly, and my email inbox filled up with questions and requests for comments about THCO from people all over the US and also from several continents. Frankly, I was surprised at the public response to the DEA’s position and my article.

Then three things happened.

First, many people and numerous media organizations misread (or did not read) my article and pronounced in bold and inaccurate headlines that the DEA said delta-8 THC is illegal. (The DEA’s position is actually the opposite, as I discuss in an article you can read by clicking here.) Several clients who manufacture and distribute delta-8 THC products told me that their phones were ringing constantly with distressed customers asking about what they should do now that “delta-8 THC is illegal”. Once misinformation is spread, it is difficult to undo the damage. I attempted to clarify things in an article I posted on February 18. In a continued effort to staunch the flow of misinformation, I want to be very clear:

The DEA letter to me was solely about THCO, specifically delta-8 THCO and delta-9 THCO. It did not in any way address delta-8 THC or any other compound. The legal status of delta-8 THC was not impacted in any way by the DEA’s letter, except to the extent that its lawful status as “hemp” was reinforced, an issue that I discussed in the article referenced above.

Second, I began hearing that people were angry with me, even though I was only the messenger. To be clear, I anticipated the DEA’s position and do not dispute it. As the author of the “derivatives” argument that provided the legal foundation for delta-8 THC, I found myself in the surreal position of having people use my argument against me in an attempt to justify why the DEA and I are both wrong. I discussed this in detail with Cannintelligence.com. I said that I would be “laughed out of court” if I argued to a Judge that a synthetic compound that the hemp plant does not produce, and in fact can only be produced in a lab, meets the legal definition of “hemp” under the 2018 Farm Bill. (“Mr. Kight, so you’re trying to convince me that this synthetic, lab-produced compound is “hemp” when the hemp plant does not even produce it? Are you kidding me?”)

Regardless of one’s personal views on THCO, the fact is that it is indefensible as “hemp”, derivative or not. My primary goal is to support the hemp industry, and this simply is not possible when legal arguments, including the very ones I created, are stretched to their breaking point in an attempt to justify the legal status of a synthetic compound that is plainly not “hemp”. I do not want my clients to spend decades in jail for selling a controlled substance, nor do I want the entire hemp industry as we know it to be placed on the Congressional chopping block because some people end up harmed, or even dying, due to their inhalation of a product that is sold as “hemp”.

Third, the anger at me for publishing the DEA’s position and for having the audacity to agree with it, morphed into something sinister: flagrant defamation. Yesterday, a good client forwarded me an email by a sales representative for a hemp company I do not represent. This woman, whose name I am intentionally not publishing to protect her privacy, sent out 65 emails to the company’s customers, most of whom are retail outlets throughout the US, making some ridiculous and wholly untruthful allegations about me. Her email, followed by her apology and retraction, is below. Those retail outlets then proceeded to forward the libelous email to their contacts in the hemp industry. (I should note that the President of the company called and informed me that this email did not represent the position of the company.) Based on this wildfire of defamation, I am now in the position of having to post a blog article to deny the allegations. So, here it goes:

  • My article about THCO was not “a misleading ulterior motive piece.” My purpose for contacting the DEA about THCO was twofold. First, I had a concern about the rising popularity of THCO and was worried that hemp industry participants who sold it would end up in jail. I wanted to know the DEA’s position from the “horse’s mouth”, so to speak. Second, a client wanted to ship THCO to Europe. Rather than learn the DEA’s position after seizing my client’s shipment before it left the US, or while he was behind bars, I decided it was best to know the DEA’s position before he took any action. I’m glad I did.

 

  • I am not “a marijuana Lobbyist who has scammed people within the hemp industry to think THCA is legal so [my] marijuana growers can make money on a dying marijuana market.” I am not a lobbyist. I am not a marijuana lobbyist. I have not scammed anyone, and certainly not people in the hemp industry. I have no motives whatsoever in advising clients that THCa hemp flower is lawful under federal law except to advise them that it is lawful and also to help expand their businesses and the hemp industry in general. In fact, I routinely speak out publicly against Big Corporate Marijuana and its negative effects on the cannabis and hemp industry.

 

  • I am not “being sued by many people for misleading them on THCA so [I’m] trying to spin and deflect.” I am not being sued by anyone, nor have I misled anyone about THCa hemp flower, nor am I trying to spin or deflect anything. My article about the DEA’s position on THCO was simply another news/legal analysis article of the type that I have been writing for the past eight years.

 

As I write this, my office manager (who is also my wife) is literally fielding a call from an angry person who called out of the blue and who is screaming at her about THCO and that I am “working with the government”. So, I guess I should also address that, too. I do not work for the government. In fact, I have sued the government (specifically, the DEA) in several lawsuits and usually disagree publicly with the DEA.

I am a cannabis advocate. I changed my career after personally experiencing the enormous medical and health benefits that cannabis provides when I had cancer. I represent hundreds of hemp businesses and spend a lot of time, both paid and pro bono, working to promote and expand the hemp industry. It is thus frustrating, maddening, and demoralizing to be defamed and made subject to angry and misinformed calls, emails, and disinformation campaigns in response to my publication of a letter from the DEA regarding an important issue for the hemp industry that I diligently work to protect.

Thank you for taking the time to read this article, which I regret having to post in the first place. I continue to work hard for the cannabis industry, and in particular, the hemp industry. Please feel free to contact me directly if you have any questions or need assistance.

Below is the libelous email and the apology/retraction. I hope that if you receive similar emails and/or hear similar things being said about me, you will refute them and even reach out to let me know. This type of thing wastes time and impedes my ability to focus on working for clients and the industry at large.

 

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