As anticipated, Delta-8 tetrahydrocannabinol (“Delta-8 THC”) has become the hottest, most flourishing cannabinoid currently found on the U.S. market. In the past few months, the sales of Delta-8 THC products have exploded, representing the fastest growing segment of hemp-derived products.
Federal Legal Framework
Although all hemp-derived cannabinoids, including hemp-derived Delta-8 THC, seem to fall squarely within the definition of hemp enacted under the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), uncertainties remain regarding the federal legality of cannabinoids like Delta-8 THC that are derivatives of other hemp-derived cannabinoids.
Because Delta-8 THC is not expressed in sufficient concentrations in most hemp strains to make its extraction financially viable, most Delta-8 THC on the market is derived from the chemical conversion of hemp-derived cannabidiol (“CBD”). This chemical conversion is at the root of the legal confusion.
Back in August 2020, the Drug Enforcement Administration (the “DEA”) released its Interim Final Rule (the “IFR”) in which the agency stated, in part, that “[a]ll synthetically derived tetrahydrocannabinols remain schedule I controlled substances.” (Emphasis added).
Given the DEA’s historical hostility toward cannabis and its broad interpretation of the term “synthetically derived THC” (more on that here), it seems highly plausible that the DEA would treat Delta-8 THC chemically derived from hemp-derived CBD as a “synthetically derived THC” substance, and thus, as an illegal schedule I controlled substance.
Consequently, until this lingering uncertainty is addressed by the DEA, through legislation or by the courts, anyone interested in venturing into this market should understand the potential risks associated with dealing this popular cannabinoid.
Delta-8 THC Products
Similarly to CBD-infused products intended for human consumption, Delta-8 THC products fall under the jurisdiction of the Food and Drug Administration (the “FDA”). This is because the 2018 Farm Bill expressly preserves the agency’s authority to regulate products containing cannabis or cannabis-derived compounds under the Food, Drug and Cosmetic Act (the “FDCA”) and Section 351 of the Public Health Service Act.
To our knowledge, Delta-8 THC, unlike CBD, has not been approved or investigated by the FDA as a new drug ingredient, 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 any substance that has been approved or investigated by the FDA as a new drug cannot also be sold and marketed as a food or dietary supplement– unless the substance was sold and marketed as such before investigation.
Assuming the Drug Exclusion Rule does not apply, the question of whether Delta-8 THC may be sold and marketed as a food or a dietary supplement depends on whether this cannabinoid is safe for human consumption. The safety of a substance added to conventional food products and dietary supplements is assessed by the FDA through pre-market approval processes, known as the “generally recognized as safe” (“GRAS”) and “new dietary ingredient” (“NDI”) notifications, respectively – you can learn more about the GRAS and NDI notification mechanisms here and here.
Therefore, even if Delta-8 THC falls under the federal definition of “hemp”, and thus, is treated as a legal substance, Delta-8 THC products intended for human consumption, specifically foods and dietary supplements, won’t be lawful under federal law until the substance receives pre-market approval from the FDA – just like CBD and other cannabinoid-infused products.
State Legal Frameworks
While many states have adopted the federal definition of “hemp,” which expressly includes cannabinoids and derivatives of hemp, and removes them from the definition of “marihuana” under the Controlled Substances Act, some states have yet to do so. Other states fail to differentiate THC derived from hemp and marijuana. And a handful of states expressly include Delta-8 THC on their list of controlled substances.
To complicate things, some of the states where Delta-8 THC and its derived products are expressly allowed have implemented their own set of regulations, including registration, labeling and testing requirements. This patchwork of state-by-state regulations forces manufacturers and distributors of Delta-8 THC products to limit their sales to states in which these products are allowed and expressly regulated. Businesses must follow a variety of (sometimes conflicting) regulations in each state where these products are sold.
Federal law issues aside, any company planning to manufacture, sell and market Delta-8 THC products should first gain a thorough understanding of the relevant state laws to ensure compliance with all applicable laws and regulations. This is the surest possible route to mitigate the risk of enforcement actions, based solely on the fact that a product contains Delta-8 THC.