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Is this legal

Regarding the legal status of harvested hemp and hemp products containing tetrahydrocannabinolic acid (THCa) in concentrations that exceed 0.3% by dry weight but with delta-9 tetrahydrocannabinol (delta- 9 THC) concentrations that do not exceed 0.3% by dry weight. The specific question addressed is: “Are harvested hemp flowers, buds, crystals, and other cannabis parts and products that contain THCa concentrations in excess of 0.3% by dry weight controlled substances under federal law when their delta-9 THC concentrations do not exceed 0.3% by dry weight?” As discussed in this letter, the answer to this question is “No”. With respect to harvested cannabis material and products made from hemp, the sole factor that distinguishes between lawful hemp and unlawful marijuana is the concentration of delta-9 THC.

The analysis and conclusions contained in this letter are based on the Agricultural Act of 2014 (2014 Farm Act)1, the Agricultural Improvement Act of 2018 (Farm Bill)2, the federal Controlled Substances Act (CSA)3, the Drug Enforcement Administration’s (DEA) Interim Final Rule (IFR)4, the DEA’s letter to the Alabama Board of Pharmacy (Letter)5, a DEA letter regarding cannabis seeds and other cannabis materials 6 , a letter from the DEA to an undisclosed recipient regarding the control status of several compounds7, and an opinion by the Ninth Circuit Court of Appeals8. This letter does not address any requirements under the federal Food, Drug & Cosmetic Act and associated regulations by the Food and Drug Administration (FDA). This letter is solely for Premium Cultivars. All third parties are specifically advised that this letter is not intended to be legal advice for any party other than Premium Cultivars and should not be construed or relied upon as such. It is accurate as of the date above

PART 1- DISCUSSION OF THE ISSUE: THE CONCENTRATION OF DELTA-9, NOT THCA, IS THE SOLE FACTOR IN DETERMINING A CANNABIS PRODUCT’S CONTROLLED STATUS

There are dozens of forms of the tetrahydrocannabinol (THC) molecule. Some of these forms are called isomers. An isomer is one of two or more compounds that contain the same number of atoms of the same elements but differ in structural arrangement and properties.9 There are at least thirty THC isomers10, of which delta-9 THC is the most well-known. Additionally, delta- 8 THC (D8-THC) and delta-10 THC (D10-THC) have recently gained more attention in the media and marketplace. As discussed below, the only THC isomer that is used to determine whether harvested hemp and hemp products are lawful under federal law is delta-9 THC. The quantity and concentration of other THC isomers, and other cannabinoids and forms of THC, including THCa, are totally irrelevant with respect to the legal status of harvested hemp and hemp products.11

PART 2- HEMP IS NOT A CONTROLLED SUBSTANCE

Hemp initially became exempt from the CSA, and thus removed from the list of controlled substances, by virtue of the 2014 Farm Act when produced pursuant to a state’s industrial hemp pilot program. The current Farm Bill, enacted at the end of 2018, removed both “hemp” and “THC in hemp” from the CSA.12 Hemp is lawful throughout the United States (US). The Farm Bill defines “hemp” expansively. The definition includes the hemp plant 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 THC concentration of not more than 0.3 percent on a dry weight basis.”13 (emphasis added) The sole distinction between lawful cannabis (hemp) and unlawful cannabis (marijuana) is the concentrations of delta-9 THC in the harvested material. Harvested cannabis with delta-9 THC concentrations that do not exceed 0.3% is legal hemp. On the other hand, harvested cannabis with delta-9 THC concentrations that exceed 0.3% is illegal marijuana. The concentrations of the other cannabinoids in harvested cannabis, including THCa, are irrelevant with respect to its legal status.14 If the delta-9 THC concentration in harvested hemp or a hemp product does not exceed 0.3% by dry weight, then it is not a controlled substance under federal law.

IT IS LAWFUL TO TRANSPORT HEMP AND HEMP-DERIVED PRODUCTS IN INTERSTATE COMMERCE

The interstate transfer of hemp is authorized by 7 USC § 1621 subsection 10114(b), which states in relevant part: “No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with subtitle G of the Agricultural Marketing Act of 1946 (AMA) (as added by section 10113) through the State or the territory of the Indian Tribe, as applicable.”15 Although state laws vary with respect to hemp and hemp products, it is absolutely clear that states and Indian tribes may not prohibit the transport of them through their borders.

HEMP AND HEMP PRODCUTS ARE LAWFUL ACCORDING TO THE DEA

I. The Interim Final Rule
The DEA has expressly stated that hemp and hemp products are not controlled substances. On August 21, 2020, the DEA published its Interim Final Rule (IFR) in the federal register16. In its IFR, the DEA stated:

“In order to meet the definition of “hemp”, and thus qualify for the exemption from [S]chedule I, the derivative must not exceed the 0.3% delta-9 THC limit. The definition of “marihuana” continues to state that “all parts of the plant Cannabis sativa L.” and “every compound manufacture, salt, derivative, mixture, or preparation of such plant,” are [S]chedule I controlled substances unless they meet the definition of “hemp” (by falling below the 0.3% delta-9 THC limit on a dry weight basis)…” (Emphasis added).17 The DEA’s IFR continues by stating that the listing for “tetrahydrocannabinols” (ie, “THC”) under 21 U.S.C. 812(c) “does not include tetrahydrocannabinols in hemp.” The DEA’s IFR confirms that hemp products, which by definition must contain no more than 0.3% delta-9 THC on a dry weight basis, are not controlled substances in the US.

II. DEA Public Statements In addition to the IFR, the DEA has indicated in four public statements that cannabinoids and other cannabis materials are not controlled substances when their delta-9 THC concentrations do not exceed 0.3% on a dry weight basis.

1. DEA’s First Public Statement- Town Hall Meeting

The DEA’s first public statement is in the form of a video webinar called a “Town Hall with USDA and DEA” conducted by the Florida Department of Agriculture and Consumer Services (FLDACS) on June 24, 2021. In the Town Hall webinar, the DEA representative stated the following: “[W]hat I want to say, and I’ll be very, very deliberate and clear. At this time, I repeat again, at this time, per the Farm Bill, the only thing that is a controlled substance is delta-9 THC greater than 0.3% on a dry-weight basis.” (emphasis added)18 2.

2. DEA’s Second Public Statement- Letter to the Alabama Board of Pharmacy

The DEA publicly addressed the legal status of the various forms of THC in hemp again in the form of a response letter to the Alabama Board of Pharmacy (ABOP) dated September 15, 2021. In this letter, Terrence L. Boos, Ph.D., Chief of the DEA’s Drug and Chemical Evaluation Section of the Diversion Control Division, responds to the ABOP’s request for the controlled status of delta-8 THC. After differentiating between the legal status of marijuana and hemp, both of which are botanically “cannabis sativa l”, the DEA states:

“[C]annabinoids extracted from the cannabis plant that have a delta-9 THC concentration of not more than 0.3 percent on a dry weight basis meet the definition of “hemp” and thus are not controlled under the CSA.”

Additionally, the DEA states the following in a footnote
“The Agricultural Improvement Act of 2018 (AIA), Pub. L. 115-334, § 12619, amended the CSA to remove “tetrahydrocannabinols in hemp” from control. See 21 U.S.C. § 812, Schedule I(c)(17). As noted, however, “hemp” is defined to “mean 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.” 7 U.S.C. 1639o. Thus, only tetrahydrocannabinol in or derived from the cannabis plant—not synthetic tetrahydrocannabinol—is subject to being excluded from control as a “tetrahydrocannabinol[] in hemp.” (emphasis added)19

3. DEA’s Third Public Statement- Response Letter Regarding Seeds and Cannabis Materials

In response to an inquiry regarding the DEA’s interpretation of its implementing regulations regarding cannabis the DEA stated in a letter dated January 6, 2022: “[M]aterial that is derived or extracted from the cannabis plant such as tissue culture and any other genetic material that has a delta-9-tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis meets the definition of “hemp” and thus is not controlled under the CSA.” (emphasis added)20

4. DEA’s Fourth Public Statement- Response Letter Regarding the Control Status of Several Compounds

On June 9, 2023, the DEA issued a letter to a currently undisclosed recipient in response to a request for the control status of several compounds, including delta-9 THCA.21 In that letter, the DEA states: “[C]annabinoids that are extracted from the cannabis plant and that have a delta-9 THC concentration of not more than 0.3% on a dry weight basis meet the definition of ‘hemp’.” The DEA also addresses the control status of delta-9 THCA, stating:

“In regards to delta-9-THCA, Congress has directed that, when determining whether a substance constitutes hemp, delta-9 THC concentration is to be tested “using post- decarboxylation or other similarly reliable methods.”.  The “decarboxylation” process converts delta-9 THCA to delta-9 THC. Thus, for the purposes of enforcing the hemp definition, the delta-9 THC level must account for any delta-9-THCA in a substance…. Accordingly, cannabis derived delta-9 THCA does not meet the definition of hemp under the CSA because upon conversion for identification purposes as required by Congress, it is equivalent to delta-9 THC.”22

In this portion of the letter, the DEA is clearly referring to hemp that has not been harvested. This is because, while federal law requires the use of a post-decarboxylation test prior to harvesting hemp, neither a post-decarboxylation test, nor any test, applies to post-production hemp for the purposes of determining its control status. The two statutes cited by the DEA in its letter are the only two places in the Agriculture Improvement Act of 2018, commonly known as the “2018 Farm Bill”, that the term “post decarboxylation” appears. They both apply solely to hemp production. In the first statutory provision, 7 USC § 1639p(a)(2)(A)(ii), Congress sets forth the criteria that states and Indian tribes must comply with in order to “have primary regulatory authority over the production of hemp” within their jurisdictions. The second statutory provision, 7 USC § 1639q(a)(2)(B), is similar in that it sets forth the criteria that the USDA shall use to “monitor and regulate [hemp] production” in states that do not have an approved hemp plan and thus do not have primary authority over hemp production within their jurisdictions. The key word in the above provisions is “production”. In the context of hemp, “production” is a legal term of art. Under 7 CFR § 990.1, to “produce” means: “To grow hemp plants for market, or for cultivation for market, in the United States.” Additionally, 7 CFR § 718.2 defines a “producer” as “an owner, operator, landlord, tenant, or sharecropper, who shares in the risk of producing a crop and who is entitled to share in the crop available for marketing from the farm, or would have shared had the crop been produced. A producer includes a grower of hybrid seed.” To produce hemp means to grow it. Since the post-decarboxylation test clearly applies to producers, the DEA is correct with respect to hemp that has not been harvested when it states that “for the purposes of enforcing the hemp definition, the delta-9 THC level must account for any delta-9-THCA.” However, once the pre-harvested hemp has accounted for delta-9 THCA and passed the required post- decarboxylation test, it may be harvested and no further tests are required. Further, as discussed above, the DEA has confirmed that, “the only thing that is a controlled substance is delta-9 THC greater than 0.3% on a dry-weight basis.”23 24

The DEA’s public statements all clearly indicate that harvested hemp and hemp products containing less than 0.3% delta-9 THC on a dry weight basis are lawful.

NINTH CIRCUIT COURT OF APPEALS CONFIRMS THAT HEMP PRODUCTS ARE NOT CONTROLLED SUBSTANCES

The federal Court of Appeals for the Ninth Circuit issued an opinion regarding hemp products, specifically products containing delta-8 THC, in the context of a trademark dispute. In its opinion, the Ninth Circuit noted that “the only statutory metric for distinguishing controlled marijuana from legal hemp is the delta-9 THC concentration level.” (emphasis added)25 Premium Cultivars’ products with no more than 0.3% delta-9 THC on a dry-weight basis are not controlled substances under US federal law. They conform to the Farm Bill, the CSA, and the IFR. They also comply with the legal metric set forth by the Ninth Circuit Court of Appeals.

CONCLUSION

Harvested cannabis material, including products made from it, containing delta-9 THC concentrations that do not exceed 0.3% by dry weight are lawful hemp under federal law, regardless of the concentrations of THCa or any other cannabinoid.

SOURCES

1. https://www.govinfo.gov/content/pkg/BILLS-113hr2642enr/pdf/BILLS-113hr2642enr.pdf
2. https://www.congress.gov/115/bills/hr2/BILLS-115hr2enr.pdf
3. 21 U.S. Code § 801 et seq.
4. https://www.deadiversion.usdoj.gov/fed_regs/rules/2020/fr0821.htm
5. https://docs.google.com/viewerng/viewer?url=https://cannabusiness.law/wp-content/uploads/DEA- letter-re-D8-to-Alabama.pdf&hl
6. https://s3.documentcloud.org/documents/21580238/21-7692-shane-pennington-cannabis-seeds-tissue- genetic-material-11-18-21-signed-1.pdf
7. file:///Users/rodkight/Downloads/DEA-THCA-and-HHC-letter.pdf
8. AK Futures LLC v. Boyd St. Distro, LLC, 35 F.4th 682 (9th Cir. 2022)
9. https://www.merriam-webster.com/dictionary/isomer
10. See, eg, this website: https://cannabislifenetwork.com/amount-of-isomers-in-thc/. See also, this website: https://cannabusiness.law/thc-analogs-a-family-divided/
11. Note that, while the concentration of THCa is not relevant in determining the legal status of harvested hemp or hemp products, it is relevant in determining the legal status of hemp that has not been harvested. This is because USDA regulations require hemp to be tested for delta-9 THC using a “post- decarboxylation method” before it can be harvested. Because THCa converts to delta-9 THC when decarboxylated the THCa concentration of a pre-harvest hemp sample matters. However, and as discussed in this letter, this only applies to hemp that has not been harvested. It does not apply to harvested hemp and products made from it. Further reading on this issue, including testing standards, can be found at the following websites: https://cannabusiness.law/total-thc-and-harvested-hemp/, https://cannabusiness.law/thca-and-the-dea-rod-breaks-down-the-latest-news/
12. 21 U.S.C. § 802(16)(B): “The term “marihuana” does not include— (i) hemp, as defined in section 1639o of title 7.”
13. 7 U.S.C. § 1639o(1)
14. https://cannabusiness.law/thca-and-the-dea-rod-breaks-down-the-latest-news/
15. https://uscode.house.gov/statviewer.htm?volume=132&page=4914#
16. “Implementation of the Agriculture Improvement Act of 2018”, Federal Register Volume 85, Number 163 (Friday, August 21, 2020).
17. https://www.govinfo.gov/content/pkg/FR-2020-08-21/html/2020-17356.htm
18. The pertinent portions of the webinar can be viewed at this website: https://cannabusiness.law/is-d8- from-hemp-a-controlled-substance-dea-says-no/
19 Ibid.
20. https://s3.documentcloud.org/documents/21580238/217692shanepenningtoncannabisseeds
tissuegeneticmaterial111821signed1.pdf
21. file:///Users/rodkight/Downloads/DEATHCAandHHCletter.pdf
22. Ibid.
23. See footnote 18, above.
24. The following website discusses this issue: https://cannabusiness.law/thca-and-the-dea-rod-breaks-
down-the-latest-news/

THCA FLOWER

What is THCa hemp flower? “THCa hemp flower” is the name for cannabis buds with delta-9 THC levels that do not exceed 0.3% by dry weight, but which have high levels of THCa.

What is THCa? “THCa” is the abbreviation for “tetrahydrocannabinolic acid”, a cannabinoid produced in abundance by the cannabis plant. THCa does not produce intoxication; however, under certain conditions, including heat, exposure to light, and time, it can convert to delta-9 THC, which does have an intoxicating effect. The conversion from THCa to delta-9 THC is known as “decarboxylation” and occurs when THCa flower is smoked or vaped.

Will smoking or vaping THCa hemp flower make users feel “high”? Although everyone is different, it is possible that a user will feel intoxicated or “high” after smoking THCa hemp flower. We recommend informing your customers of the possibility of feeling “high” or intoxicated when using this product. We also recommend that you not sell THCa hemp flower to minors.

Will using THCa hemp flower cause users to fail a drug test? Yes. THCa hemp flower contains cannabinoids, including THC, which may cause a user to fail a drug test. Therefore, individuals should not use THCa hemp flower if they are subject to drug testing.

Is THCa hemp flower lawful under federal law? Yes. Under federal law, harvested THCa hemp flower is lawful. This is because the federal 2018 Farm Bill distinguishes between lawful harvested hemp and unlawful marijuana based on the levels of delta-9 THC, not THCa.1 Harvested cannabis, including its flowers and buds, with no more than 0.3% delta-9 THC by dry weight is lawful hemp, regardless of the amount of THCa or any other cannabinoid, such as CBD, that it contains. Additionally, the federal Controlled Substances Act, which regulates drugs, removes hemp from the definition of marijuana. In other words, hemp is not an illegal controlled substance under federal law.2

What does the DEA say about THCa hemp flower? THCa hemp flower meets the DEA’s definition of lawful hemp. According to the DEA, “material that is derived or extracted from the cannabis plant such as tissue culture and any other genetic material that has a delta-9 tetrahydrocannabinol concentration of no more than 0.3 percent on a dry weight basis meets the legal definition of “hemp” and is thus not controlled under the CSA.”3

Have any federal courts ruled on THCa hemp flower? No. However, the federal Ninth Circuit Court of Appeals has stated the following regarding another type of hemp product, which supports the legal status of THCa hemp flower: “the only statutory metric for distinguishing controlled marijuana from legal hemp is the delta-9 THC concentration level.”4

Is THCa hemp flower lawful in all states? No. State laws differ regarding whether or not harvested hemp and hemp flower can be sold or possessed and if a license or permit is required in order to handle it. Additionally, some states calculate the concentrations of both delta-9 THC and THCa, rather than just delta-9 THC, to determine if a harvested cannabis bud is lawful hemp or unlawful marijuana. This calculation, in which both THCa and delta-9 THC are used to determine the legal status of a harvested hemp flower, is referred to as “total THC”. It is the calculation used in all states for pre-harvested hemp. The total THC calculation is also used in some states, but not all states, for harvested hemp and/or hemp products. You should not possess or sell THCa hemp flower if it is illegal in your state. You should consult with a lawyer if you are unsure of the legal status of THCa hemp flower in your state.

Can THCa hemp flower be shipped across state lines? Yes, the interstate transfer of hemp, which includes THCa hemp flower, is authorized by federal law. 7 USC § 1621 subsection 10114(b), states in relevant part: “No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with subtitle G of the Agricultural Marketing Act of 1946 (AMA) (as added by section 10113) through the State or the territory of the Indian Tribe, as applicable.”5 Although state laws vary with respect to hemp and hemp products, it is absolutely clear that states and Indian tribes may not prohibit the transport of them through their borders.

Is it lawful to smoke THCa hemp flower in public or to have a package of it open in a car? Because state laws vary regarding THCa hemp flower, and also due to the current confusion about its legal status, we do not recommend smoking it in public or having an open package of it in vehicles. Additionally, we recommend that it be sold to consumers only in pre-packaged, sealed bags or containers with labels clearly stating that it is lawful hemp.

How can you be sure that the THCa hemp flower you are purchasing meets the legal requirement for hemp? We recommend reviewing a lab report, called a Certificate of Analysis (COA), in conjunction with your attorney. A COA shows the levels of cannabinoids, including delta-9 THC, in a hemp product. Premium Cultivars always provides a current COA for its hemp products showing that they are compliant under federal law at the time they leave the facility. Importantly, if your state uses a total THC calculation6 to determine whether post-harvest cannabis flower is lawful, then THCa hemp flower is probably not legal in your state and we recommend that you consult a lawyer before receiving, possessing, or selling it.

How should you store THCa hemp flower? All of Premium Cultivars hemp flower is tested to ensure legal compliance. In other words, Premium Cultivars only possesses and distributes lawful hemp. However, it is important to understand that THCa hemp flower will change form and become illegal marijuana if the THCa in it decarboxylates and raises the concentration of delta-9 THC to above 0.3%. In addition to the natural process of decarboxylation over time, THCa will also convert to delta-9 THC when it is exposed to heat and light. We strongly recommend storing THCa hemp flower in a cool, dark, dry location in order to limit the amount of THCa that is unintentionally converted to delta-9 THC through the process of decarboxylation.

Does Premium Cultivars have a legal opinion letter about THCa hemp flower? Yes. Premium Cultivars has a legal opinion letter regarding the legal status of THCa hemp flower.

Please be advised that this informational document and the opinion letter were created solely for Premium Cultivars and that they are not intended to be, nor should they be relied upon as, legal advice to any other person or company.

SOURCES

1. See 7 U.S.C. § 1639o(1) (2018 Farm Bill): “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.”
2. See 21 U.S.C. § 802(16)(B) (Controlled Substances Act): “The term “marihuana” does not include— (i) hemp, as defined in section 1639o of title 7.”
3. You can read the DEA’s letter here: https://s3.documentcloud.org/documents/21580238/21-7692- shane-pennington-cannabis-seeds- tissue-genetic-material-11-18-21-signed-1.pdf
4. AK Futures LLC v. Boyd St. Distro, LLC, 35 F.4th 682 (9th Cir. 2022)
5. 7 USC § 1621 subsection 10114(b) can be read here: https://uscode.house.gov/statviewer.htm?volume=132&page=4914#
6. A total THC calculation adds the delta-9 THC amount to 87.7% of the THCa amount to see if the total THC does not exceed 0.3%. Fortunately, most COAs show the total THC amount in addition to delta-9 THC so that you do not need to do the calculation yourself.

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