Syndros is a Schedule II drug under the Controlled Substances Act, while Epidoloex, an oral solution of cannabidiol (CBD) containing no more than 0.1% THC, is a Schedule V medication. This determination was made in accordance with the Single Convention, which lists cannabis, cannabis resin and cannabis extracts and tinctures in List I. The cannabis plant contains more than 100 cannabinoids, including tetrahydrocannabinols (THC) and CBD. As such, material containing THC and CBD extracted from the cannabis plant is included in the list of cannabis extracts and tinctures for the purposes of the Single Convention, making it a Schedule I drug under the treaty. Under federal law, CBD that is derived from cannabis plants with more than 0.3% delta-9 THC is considered illegal.
This clarification could create a profound practical obstacle to the legal manufacture of most hemp-derived CBD products, as many processors and extractors in the industry know that hemp extract that is not in its final form almost invariably exceeds the delta-9 THC concentration of 0.3% at some point in the extraction process before that percentage returns to compliance with the law for the final product. The Drug Enforcement Administration (DEA) has reclassified Epidiolex, an oral solution of cannabidiol (CBD), from Schedule I to List V, the lowest category of substances listed. In addition to modifying the definitions of “tetrahydrocannabinols” and “marijuana extract” to exclude legal hemp, and eliminating CBD-based drugs approved by the FDA from scheduled control under the Controlled Substances Act (CSA), the DEA announced a new standard clarifying that all hemp derivatives or extracts that exceed 0.3% of THC delta-9 are still controlled substances of List I.This permission requirement applies to a drug containing CBD extracted from the cannabis plant because, as stated above, that product is a Schedule I drug under the Single Convention. In practice, this means that the reprogramming currently only applies to Epidiolex, since this is the only CBD formulation that has received FDA approval. With the issuance of this final order, certain drugs that have been approved by the Food and Drug Administration (FDA) and that contain cannabidiol (CBD) are now included in List V of the Controlled Substances Act (CSA). This combination of cannabis compounds is also key to understanding how the List I classification applies to CBD products. The final DEA rescheduling order is limited to FDA-approved drugs containing cannabis-derived CBD and no more than 0.1% tetrahydrocannabinol (THC).
Despite this, there is still a lot of confusion regarding the legal status of CBD, including its class schedule and whether or not it is a Schedule I medication. With this new standard, it is now clear that all hemp derivatives or extracts that exceed 0.3% of THC delta-9 are still controlled substances under List I. However, this creates greater uncertainty as to whether any hemp extract, even an unfinished product, containing more than 0.3% delta-9 THC is an illegal Schedule I controlled substance. A strong negative reaction can be expected from the hemp and CBD industries if this new standard is maintained. As such, it is important for those involved in these industries to stay up to date on any changes or developments regarding this issue.
