OPINION ON THE LEGALITY OF DELTA-8 TETRAHYDROCANNABINOL (THC)

Prepared for Dharma Isomers, LLC.  December 15, 2020

INTRODUCTION

 You have asked us to opine on the legal status of hemp-derived products that contain delta-8 THC.  Dharma Isomers, LLC (“you” or “Dharma”) is considering the distribution of products that contain delta-8 tetrahydrocannabinol (THC) converted from hemp-derived cannabidiol (CBD). You are interested in the legality of the delta-8 THC component of these products under federal law.

You have indicated that the CBD from which the delta-8 THC is converted derives from hemp that is lawfully produced as part of an agricultural pilot program established under the Agricultural Act of 2014 (“2014 Farm Bill”). You have attested that independent laboratory tests show that, prior to being converted into delta-8 THC, the hemp-derived CBD was extracted from hemp biomass that contained 0.3% delta-9 THC or less on a dry weight basis. Neither the starting hemp biomass material from which the delta-8 THC derives nor the delta-8 THC products in finished form contain more than 0.3% delta-9 THC on a dry weight basis, nor do they contain any controlled substances.

 BRIEF ANSWER

As outlined below, it is our informed opinion that delta-8 THC converted from hemp-derived CBD is legal as a matter of federal law. It is legal under federal law because the Agriculture Improvement Act of 2018 (“2018 Farm Bill”) defines hemp to include all hemp-derived cannabinoids, including CBD and THC, and removes THCs in hemp from scheduled control under the Controlled Substances Act (“CSA”).

Despite our opinion, we urge some caution. First, the legality of hemp-derived delta-8 THC is a novel issue that no federal hemp laws or regulations specifically address. Second, effective August 21, 2020, the U.S. Drug Enforcement Administration issued an Interim Final Rule (“DEA page 2 IFR”) purporting to treat all synthetically derived THCs as Schedule I controlled substances.^[1] While we think the DEA IFR is an overreach for various reasons, it necessitates caution nonetheless. There is risk that the DEA could categorize delta-8 THC as a synthetically derived THC that would be subject to the DEA IFR.

 Additionally, ingestible and topical products fall within the regulatory jurisdiction of the U.S. Food and Drug Administration (FDA) under the federal Food, Drug, and Cosmetic Act (“Food and Drug Act”). Although you have not asked us to consider the legality of delta-8 THC products under the Food and Drug Act, it is important to note that the FDA has stated that it is illegal to add CBD and THC to food and to market CBD and THC as a dietary supplement.^[2] Delta-8 THC products may be subject to enforcement by the FDA, particularly if they also contain CBD.

LEGAL ANALYSIS

1. FEDERAL LAW

2014 and 2018 Farm Bills  -    On December 20, 2018, President Trump signed the 2018 Farm Bill into law. In addition to establishing a permanent framework for the domestic production of hemp, the 2018 Farm Bill removes hemp and THCs in hemp from scheduled control under the CSA.^[3] In simple terms, neither hemp nor THCs in hemp are controlled substances under federal law.

The federal definition of hemp is broad. Hemp is defined 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, whether growing or not, with a delta-9 [THC] concentration of not more than 0.3 percent on a dry weight basis.”^[4] The definition clearly protects hemp-derived cannabinoids, including CBD and THC. The determination of whether a substance constitutes federally legal hemp is based on its delta-9 THC concentration on a dry weight basis and not on the form of the substance or the source of the hemp in the substance.

Under the federal legal regime created by the 2014 and 2018 Farm Bills, assessing the legality of hemp products is straightforward. So long as such products are lawfully produced under the 2014 or 2018 Farm Bill, contain 0.3% delta-9 THC or less on a dry weight basis, and do not contain a controlled substance, they are legal and explicitly protected in interstate commerce as a matter of federal law.  

Interstate activities involving hemp and hemp products are explicitly protected. Federal agencies, states, and Native American tribes are prohibited from enforcing against lawfully produced hemp and hemp products in interstate commerce. While these jurisdictions are free under the 2018 Farm Bill to regulate the production of hemp, their regulations may not extend beyond the growth of hemp. In practice, efforts to enforce against hemp or hemp products in interstate commerce would violate federal law. This was confirmed in the U.S. Department of Agriculture’s Interim Final Rule on the 2018 Farm Bill, which became effective October 31, 2019.^[5] 

There are other implications. Any attempt to impose criminal penalties on commerce involving legal hemp products could subject law enforcement to civil penalties. The Sixth Circuit Court of Appeals recently held that prosecutors who insisted on prosecuting against legal hempderived CBD products were not entitled to immunity that federal prosecutors and law enforcement officials generally enjoy.^[6] 

DEA IFR

The DEA IFR was published on August 21, 2020, and became effective the same day. In relevant part, the DEA IFR states that even after enactment of the 2018 Farm Bill, “[a]ll synthetically derived [THCs] remain schedule I controlled substances.” According to the DEA, “the concentration of [delta-9] THC is not a determining factor in whether the material is a controlled substance.”

The DEA IFR is causing consternation throughout the hemp industry because it upends the 2018 Farm Bill. What is somewhat reassuring, however, is that DEA spokesperson Sean Mitchell has indicated that the DEA is aware of the hemp industry’s policy concerns and “has higher enforcement priorities, such as opioids and methamphetamine.”^[7] Moreover, the DEA IFR is currently in the notice-and-comment stage of federal rulemaking. Nearly 2,500 comments have already been submitted, so it is possible the DEA IFR will be modified and improved before becoming a final rule. These comments, which are being submitted by stakeholders and industry groups like the U.S. Hemp Roundtable, the nation’s leading business advocacy organization for hemp, make clear that the DEA IFR is inconsistent with the 2018 Farm Bill and would work serious challenges on the hemp products industry.

There is also a chance that the DEA IFR will be invalidated in its entirety. It is currently the subject of at least two federal lawsuits, either of which could result in the DEA IFR being struck down. This Opinion does not consider the legality of synthetic THCs in the event the current version of the DEA IFR is left intact.

 FDA and the Food and Drug Act

As described above, even following enactment of the 2018 Farm Bill, the FDA retains jurisdiction over topical and ingestible products, including products that contain hemp cannabinoids. To date, the FDA has not approved CBD or THC as a food additive or dietary supplement ingredient and has taken the position that they are not generally recognized as safe for use in food and dietary supplement products. Consequently, it is likely that the FDA will consider delta-8 THC to be a new dietary ingredient (NDI) if it is to be used in dietary supplements. Manufacturers and distributors that wish to market dietary supplements that contain an NDI must notify the FDA and provide information that the NDI is safe to consume as recommended. The FDA might take a similar position in connection with premarket authorization reviews of deemed tobacco products that contain delta-8 THC. The FDA is not likely to agree that delta-8 THC is safe to consume. The FDA has stated in non-binding guidance that it is illegal under the Food and Drug Act to add CBD and THC to food and to market THC and CBD as a dietary supplement.^[8]  Caution is encouraged, as delta-8 THC products may be subject to enforcement by the FDA.

2. APPLICATION

In our opinion, delta-8 THC converted from hemp-derived CBD is legal as a matter of federal law. First, hemp-derived cannabinoids, such as CBD, are included in the 2018 Farm Bill’s definition of hemp, and lawfully produced hemp and hemp products are protected in interstate commerce. We think Congress clearly intended the 2018 Farm Bill to legalize all hemp-derived cannabinoids when present in products with 0.3% delta-9 THC or less on a dry weight basis.

Second, both hemp and hemp-derived THCs are removed from scheduled control under the CSA. Neither hemp nor THCs in hemp are federally controlled substances.

The DEA IFR does not change our opinion. The 2018 Farm Bill’s protections for hemp and hemp products are not limited to naturally occurring, hemp-derived cannabinoids. Even so, we are aware that there is evidence that delta-8 THC is naturally occurring in the hemp plant. As a result, there is a legitimate question whether the DEA IFR would even apply to delta-8 THC products. Moreover, we believe that the DEA IFR is an overreach and is subject to administrative and substantive attacks.

CONCLUSION

 In our opinion, delta-8 THC converted from hemp-derived CBD is legal as a matter of federal law. Due to the novelty of the issue, federal and/or state law enforcement and regulatory officials might disagree. For this reason, we urge caution.

The legal advice and opinions set forth herein are an expression of our professional judgment and not a guaranty of a result. The undersigned are only licensed to practice law in Kentucky and have not included attorneys licensed in any other state in the preparation of this Opinion. Rather, our analysis is based on our understanding of federal laws and regulations on hemp and our familiarity with other legal authorities. We have not considered the legality of delta-8 THC under any states’ laws or regulations and we caution that state laws vary and, in some cases, are prohibitive. It is important to understand that due to the confusing nature of current law enforcement agency policies and priorities, it is impossible to predict with absolute certainty how local, state, or federal law enforcement officials will treat hemp or hemp products, particularly products containing CBD.