The DEA recently released an interim final rule on the enforcement of the 2018 Agricultural Improvement Act for hemp (aka the Farm Bill). But the rule has left a lot of hemp companies frustrated and worried. Specifically, the DEA aims to criminalize such cannabinoids in what seems to be a blatant breach of the letter and spirit of the Farm Bill.
Many in the industry are especially concerned about the potential effect of the rule on delta-8 tetrahydrocannabinol (THC), which has been rapidly increasing recently due to its vast and therapeutic benefits, including stimulation of the appetite, decreased nausea and relief of anxiety and pain.
What does the DEA Rule say about this?
Throughout the publication, the DEA consistently points out that the intent of the Rule is simply to codify what has already been modified by the 2018 Farm Bill: “This interim final rule merely complies with the DEA Regulations with the statutory amendments to the CSA that have already taken effect and does not add additional requirements to the Regulations.”
According to the Law, there are only four conforming amendments:
The definition of “Tetrahydrocannabinols” on Schedule I of the official “Schedule of Controlled Substances” (21 CFR 1308) is modified to carve out “any material, compound, mixture, or preparation that falls within the definition of hemp” (as defined in the 2018 Farm Bill). What does this mean?
- Regardless of what any product label may say (i.e., “hemp” or otherwise), if a product has more than 0.3% Delta-9 THC, it is a controlled substance.
- Regardless of being hemp-derived, if the derivative, extract or product has more than 0.3% Delta-9 THC, it is a controlled substance.
- None of these changes, alters or affects the FDA’s jurisdiction over products containing cannabis and cannabis-derived compounds.
- Naturally occurring THCs in cannabis are not controlled substances so long as they are at or under the 0.3% Delta-9 THC threshold. Any of those that are above the 0.3% Delta-9 THC threshold are controlled substances.
- Synthetically derived THCs are all controlled substances, regardless of THC content.
- Essentially removes Epidiolex (and any generics the FDA may subsequently approve) from control in schedule V (21 CFR 1308).
- Also removes the requirement for import and export permits for Epidiolex (and any future generics).
- The definition of “Marihuana Extract” on Schedule I is modified to be limited to extracts “containing greater than 0.3 percent delta-9-tetrahydrocannabinol on a dry weight basis.” What does this mean?
- Regardless of whether the extract comes from hemp or marijuana, if it exceeds the 0.3% threshold, it is illegal.
- It is important to point out that this definition, even before the Rule, includes the following exception: “other than the separated resin (whether crude or purified) obtained from the plant.”
The Rule reiterates these changes were already mandated under the 2018 Farm Bill: “DEA’s regulatory authority over any plant with less than 0.3% THC content on a dry weight basis, and any of the plant’s derivatives under the 0.3% THC content limit, is removed as a result.”
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