The US Department of Health and Human Services' (HHS) Office of Public Affairs at the Food and Drug Administration (FDA) wrote in a Sep. 30, 2011 email to

“It is important to know that the statements in the patent document [United States Patent #6,630,507  Oct 7, 2003] about the purported medical benefits [of cannabidiol] are based on in vitro data (antioxidant properties of this class of molecules, neuroreceptor binding studies, neuronal cell cultures, etc.), and in vivo rat studies. In order to make a determination that these compounds have a role in medical treatments, clinical data would be needed.

‘Does this patent indicate the US government’s position that cannabidiol has medical value?’ ‘no,’ (since that would be done through the NDA [New Drug Application] process and not the patent application process)…

DEA is responsible for administration of the Controlled Substances Act (CSA). DEA has determined that cannabidiol is a Schedule I substance because it is derived from marijuana… which is also listed in Schedule I. Marijuana is defined under the CSA to mean all parts of the plant, as well as every compound and derivative and preparation, etc. of the plant.

Thus far, an [NDA] for cannabidiol has not been submitted to the FDA that shows that cannabidiol can be used therapeutically. Thus, cannabidiol has no accepted medical use in medical treatment in the United States. Having ‘accepted medical use in the United States’ of a drug is a necessary finding for drugs that are not in Schedule I, but listed in a less restrictive, Schedules II through V. Thus, currently Schedule I is the only possible CSA schedule where cannabidiol could be listed.

This is not to say that cannabidiol cannot be studied for development or to support rescheduling. Delta-9-tetrahydrocannabinol (THC, dronabinol) was developed as an antiemetic and treatment for AIDS wasting and approved for marketing under the trade name Marinol. Marinol is listed in Schedule III. All research on cannabidiol would need to be conducted under a Schedule I license issued by the DEA.

An investigator wishing to remove cannabidiol from Schedule I would have to demonstrate that cannabidiol has NO abuse potential in order for it to be decontrolled. This would probably necessitate conducting studies to demonstrate that its pharmacology differs from other substances that have high abuse potential and that cannabidiol is not being abused by individuals…

Consideration of rescheduling or decontrol could be initiated by petitioning the DEA and providing all available and relevant data in the petition.”

[Editor’s Note: also emailed two additional questions below to HHS on Oct. 6, 2011. As of May 29, 2012, we have not yet received a response.

“1. Has HHS allowed other government agencies or private parties to use its patent?

2. Has HHS filed other patents regarding substances between drug code #7350 and drug code #7380? If so, could you please provide a list or direct us to where we could obtain such a list?”] Sep. 30, 2011