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As expected, Delta-8-Tetrahydrocannabinol (“Delta-8 THC”) is the hottest and most blooming cannabinoid currently on the US market. In the last few months, sales of Delta-8-THC products have exploded, representing the fastest growing segment of hemp products.
Despite its growing popularity, the legality of Delta-8 THC, including that of Delta-8 THC products, remains murky. This blog post provides a comprehensive overview of this problem.
Federal legal framework
While all hemp-derived cannabinoids, including hemp-derived Delta-8 THC, appear to fall exactly under the definition of hemp set out in the 2018 Farm Bill, uncertainties remain about federal legality of cannabinoids such as Delta-8 THC, which are derivatives of other cannabinoids derived from hemp.
Because delta-8-THC is not expressed in sufficient concentrations in most strains of hemp to make its extraction financially viable, most delta-8-THC on the market is derived from the chemical conversion of hemp-derived cannabidiol (“CBD”) won. This chemical conversion is the root of the legal confusion.
As early as August 2020, the Drug Enforcement Administration (the “DEA”) published its preliminary final rule (the “IFR”) in which the agency partially stated that “[a]All synthetically derived tetrahydrocannabinols remain controlled substances according to Plan I. “(Emphasis added).
Given the DEA’s historical hostility towards cannabis and its broad interpretation of the term “synthetically derived THC” (more on this here) it seems highly plausible that the DEA Delta-8-THC, which is chemically derived from CBD extracted from hemp, is considered would synthetically “treat THC derived” substance, and thus, as an illegal schedule, I controlled the substance.
Consequently, anyone interested in getting into this market should understand the potential risks associated with handling this popular cannabinoid until this ongoing uncertainty is addressed by the DEA, legislation, or the courts.
Delta-8 THC products
Similar to CBD-infused products intended for human consumption, Delta-8-THC products come under the jurisdiction of the Food and Drug Administration (the “FDA”). This is because the 2018 Farm Bill expressly empowers the agency to regulate products containing cannabis or cannabis-derived compounds under the Food, Drug and Cosmetic Act (“FDCA”) and Section 351 of the Public Health Service Act preserved.
To the best of our knowledge, unlike CBD, Delta-8 THC has not been approved or studied as a new drug ingredient by the FDA, which means the drug exclusion rule should not apply to this cannabinoid. Readers of this blog will recall that the Drug Exclusion Rule provides that substances that have been approved or investigated by the FDA as new drugs cannot also be sold and marketed as foods or dietary supplements – unless the substance has been approved sold as such and marketed prior to investigation.
Assuming that the drug exclusion rule does not apply, the question of whether Delta-8 THC can be sold and marketed as a food or dietary supplement depends on whether this cannabinoid is safe for human consumption. The safety of a substance added to conventional foods and dietary supplements is assessed by the FDA through pre-market approval processes known as “Generally Recognized Safe” (“GRAS”) and “New Ingredient” (“NDI”). Notifications – You can learn more about the GRAS and NDI notification mechanisms here and here.
Even if Delta-8 THC falls under the federal definition of “hemp” and is therefore treated as a legal substance, Delta-8 THC products are intended for human consumption, especially foods and dietary supplements, therefore not lawful federal law until the substance was FDA approved before it was placed on the market – just like CBD and other cannabinoid infused products.
State legal framework
As with CBD and CBD products, the legality of Delta-8 THC and Delta-8 THC products varies from state to state.
While many states have adopted the federal definition of “hemp” which specifically includes cannabinoids and derivatives of hemp and removed them from the definition of “marijuana” under the Controlled Substances Act, some states have not yet done so. Other states do not differentiate THC from hemp and marijuana. And a handful of states specifically include Delta-8 THC on their controlled substance lists.
To complicate matters, some states that specifically allow Delta-8 THC and its derived products have introduced their own regulations, including registration, labeling, and testing requirements. This patchwork of government regulations is forcing manufacturers and distributors of Delta 8 THC products to limit their sales to states where those products are approved and specifically regulated. Businesses must follow a number of (sometimes conflicting) regulations in each state in which these products are sold.
Federal law issues aside, any company that plans to manufacture, sell, and market Delta-8 THC products should first gain a thorough understanding of applicable state laws to ensure compliance with all applicable laws and regulations. This is the safest way to reduce the risk of enforcement action based solely on the fact that a product contains Delta-8 THC.
Is Delta-8 THC a Controlled Substance? Yes. No, maybe.
The content of this article is intended to provide general guidance on the subject. A professional should be obtained about your particular circumstances.