FDA Evaluates the Reclassification of Cannabis as Schedule I Substance

The Food and Drug Administration (FDA) is currently evaluating the drug classification of cannabis, an action that could result in downgrading marijuana’s status as a Schedule I substance.

“FDA conducts for [Health and Human Services] a scientific and medical analysis of the drug under consideration,” FDA Press Officer Jeff Ventura said. “HHS then recommends to DEA that the drug be placed in a given schedule. The DEA considers HHS’s analysis, conducts its own assessment, including such issues as diversion, and makes a final scheduling proposal in the form of a proposed rule.”

As a Schedule I substance, cannabis is currently regarded as having “no accepted medical use” and is considered to have a “high potential for abuse.”

The ultimate power to reclassify a drug rests with the attorney general as the head of the DEA. According to the Controlled Substances Act, the attorney general must consider eight factors in reclassifying a drug. These factors include scientific evidence of its pharmacological effect, its history and current pattern of abuse and what, if any, risk there is to public health.

Attorney General Eric Holder stated last month that he would be “glad to work with Congress if there is a desire to look at and reexamine how the drug is scheduled.”

Major corporations, such as Prairie Plant Systems and CEN Biotech, actively support the reclassification of cannabis. Marijuana activism organizations, such as the Drug Policy Alliance have also recommended de-scheduling or the complete removal of marijuana from the Controlled Substances Act.

The Controlled Substances Act does not set a deadline for the evaluation to take place, but merely states the action must occur “within a reasonable time.”

In testimony before the House Committee on Oversight and Government Reform last Friday, FDA Deputy Director Doug Throckmorton said the DEA requested the FDA conduct a review of marijuana’s classification in 2001 and 2006. Both reviews resulted in the recommendation that cannabis remain a Schedule I substance. The Huffington Post reports this recent DEA review request was made as a result of two public citizens’ petitions.

The FDA has only approved two drugs derived from botanical sources, Throckmorton said. These drugs are Marinol and Cesamet. Marinol includes a synthetic THC while Cesemet contains the synthetic cannabinoid, nabilone. Both have been approved for use in illnesses that involve nausea or vomiting.

In addition, the FDA is currently conducting trials on Epidiolex, a drug made by GW Pharmaceuticals that contains cannabidiol (CBD).