AHPA submitted comments this week in response to a request from the US Food and Drug Administration. FDA sought input from stakeholders on the abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of five cannabis derived drug substances, including CBD. The input gathered by FDA will be considered in preparing the US response at the World Health Organization's (WHO's) 40th Expert Committee on Drug Dependence (ECDD) which will take place in Geneva, Switzerland on June 4-8.
AHPA’s president Michael McGuffin, who authored the comments, supported the conclusions put forth in the ECDD pre review of the issue which was filed last November. McGuffin wrote that that review found that, “CBD is not currently a scheduled substance in its own right (only as a component of cannabis extracts). ECDD also found that no case reports of abuse or dependence relating to the use of CBD were identified, and that current information does not justify a change in this scheduling status nor does it justify scheduling of the substance.”
Fuzzy status in US
The regulatory status of CBD, or cannabidiol, in the United States is fuzzy at the moment. The plant from which the molecule was first derived (it has also been synthesized), Cannabis sativa, is a schedule 1 controlled substance on the list maintained by the Drug Enforcement Administration. According to DEA and the federal Department of Justice, unless and until that changes, the plant and its parts are illegal in interstate commerce.
Federal authorities have however taken a hands-off approach toward enforcement in the many states where voters have approved cannabis products either for medicinal or full recreational use.
Complicating the issue is FDA’s determination that CBD is not a legal dietary ingredient. This is because the ingredient has been first investigated as a drug by English company GW Pharmaceuticals. While some industry sources dispute that determination, FDA says to date no individual or company has come forward with evidence that CBD was on the market prior to GW commencing its investigations. Without that, the ruling stands, has been the agency’s position.
Splitting CBD out would clarify issue
Separating CBD from cannabis (which contains THC, or tetrahydrocannabinol, the narcotic fraction) when determining its status would at least clarify the issue to some extent. It won’t necessarily change FDA’s position on the molecule, but might at least set aside the DEA concerns.
McGuffin also took pains in the comments to include CBD derived from cannabis—as opposed to the synthesized variety—in his recommendation.
McGuffin recommended that, “That extracts or preparations containing almost exclusively CBD be subject to critical review at that upcoming meeting. AHPA is aware of no information that suggests that extracts or preparations of Cannabis containing almost exclusively CBD are any more subject to abuse or dependence than CBD itself and therefore recommends and requests that the United States support a position to acknowledge that such extracts and preparations should not be scheduled under any international drug control convention to which the United States is a party.”