The rule also establishes that the FDA-approved medications that include CBD, such as the epilepsy treatment Epidiolex, are to be removed from Schedule V of the Controlled Substances Act.
The U.S. Drug Enforcement Administration on Thursday submitted a proposed rule clarifying how it will implement the 2018 Farm Bill’s legalization of hemp, saying any hemp derivative will still be considered a controlled substance if it exceeds the legal limit of psychoactive THC.
It establishes for DEA purposes that any cannabis extract or product that exceeds the threshold of 0.3% delta-9-THC — the psychoactive compound in cannabis — is still considered a controlled substance, regardless of how it is marketed.
In addition, the U.S. Food and Drug Administration (FDA) has recently found that many cannabis-derived products do not contain the levels of CBD that they claim to contain on their labels. The agency also clarified that THC, which is synthetically derived, is still a controlled substance regardless of the concentration, since the Farm Bill only amended the definition of THC that is extracted from the cannabis crop.