By Benjie Cooper
YouTube: Lucid’s Vlog
In response to a report that was being compiled by a drug dependance committee of the World Health Organization (WHO) in 2017, the Food and Drug Administration (FDA) reached out to the public for input on the “abuse potential, actual abuse, medical usefulness, trafficking and impact of scheduling changes on availability for medical use of 17 substances.”
Among the substances on the list were the controversial and often-banned synthetic marijuana components 5F-ADB, 5F-PB-22, AB-CHMINACA, AB-PINACA, and UR-144. Also included was the natural cannabinoid, cannabidiol (CBD).
Having signed on to the 1971 Convention on Psychotropic Substances, the United States is obligated to report any information to the secretary general of the United Nations regarding substances that are believed to necessitate the implementation or alteration of international controls.
After prompting by WHO, the FDA requested public input on the substances that were under review and submitted the resulting information.
Data from the United States and other countries were compiled into a series of separate pre-review reports for each substance which were then distributed to members of a committee that met November 6-10 in Geneva, Switzerland.
When the WHO completed their deliberations, they found that there was, “no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD.”
“CBD has been demonstrated as an effective treatment of epilepsy in several clinical trials, with one pure CBD product (Epidiolex®) currently in Phase III trials,” wrote the authors of the report. “There is also preliminary evidence that CBD may be a useful treatment for a number of other medical conditions.”
Authors noted that some countries have adjusted their laws to allow citizens to use CBD medicinally and that it was usually well tolerated and possessed a “good safety profile” in animal discrimination models and human interactions. They stated that any reported adverse reactions to CBD might be a result of how the cannabinoid interacts with another medication that a patient might be taking.
In light of the information presented by the Expert Committee on Drug Dependence (ECDD) report, WHO ended up deciding that CBD should not be considered a controlled substance on the international stage.
In an article posted on December 13, 2017, WHO wrote that due to increased interest in medical cannabis from Member States, they had been able to compile more comprehensive research regarding the medicinal use of marijuana and possible side-effects.
“Current evidence also shows that cannabidiol is not likely to be abused or create dependence as for other cannabinoids (such as Tetra Hydro Cannabinol (THC), for instance),” the article states. “The ECDD therefore concluded that current information does not justify the scheduling of cannabidiol and postponed a fuller review of cannabidiol preparations to May 2018 when the committee will undertake a comprehensive review of cannabis and cannabis-related substances.”
Ahead of WHO’s upcoming, more-comprehensive review of international cannabis classification, the FDA is once again requesting the American public’s input on medical marijuana.
Associate Commissioner for Policy, Leslie Kux penned a notice on April 4; “The FDA is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of five drug substances.”
“These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs,” writes Kux. “WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs.”
Those wishing to contribute experiences and relevant information can do so by filling out the online form or by sending paper submissions to the FDA Dockets Management Staff (HFA-305) at:
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Comments made online will be publicly visible, but submissions sent through the hand delivery will be kept confidential.
For those submitting their confidential comments by mail, the FDA requests that two copies be sent. The first copy should include a heading or cover that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION,” and the second one should have any sensitive information redacted/blacked out.
Submissions must include the docket number: FDA-2018-N-1072 for “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol (THC); Stereoisomers of THC; Cannabidiol; Request for Comments.”
For further information, contact James R. Hunter or controlled substance staff at the Center for Drug Evaluation and Research:
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 51, Rm. 5150
Silver Spring, MD 20993-0002
Electronic submissions must be received by the FDA by midnight Eastern Time on April 23. Hand-delivered comments will be considered if they are postmarked before the 23rd. Late entries via either route will be rejected.
The 40th Expert Committee on Drug Dependence (ECDD) will convene June 4-7 in Geneva where they will review the compiled cannabis data from the U.S. and others to assess the potential dependency, abuse, and potential therapeutic applications for cannabis and cannabis-derived products.
The Department of Health and Human Services (HHS) does not plan to make any recommendations regarding international controls until WHO has reviewed all of the information and decided whether or not to change restrictions on cannabis.