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Comments on International Cannabis Scheduling

April 24, 2018

The following letter was posted and uploaded to regulations.gov in response to a call for comments by the U.S. Food and Drug Administration in conjunction with the World Health Organization regarding the scheduling of cannabis and its various forms.

 To Whom It May Concern,

 

The Ohio Rights Group (ORG) is responding to request by the U.S. Food and Drug Administration for comments concerning the International Drug Scheduling for five substances: Cannabis plant and cannabis resin, extracts and tinctures of cannabis, THC, CBD, and stereoisomers of THC. The ORG is 501(c)(4) non-partisan, organization that advocates for the rights of Ohioans to make medical, therapeutic and industrial use of the Cannabis plant and supports the growing number of individuals, organizations and industries facilitating those uses. Our comments are:

 

The plant. Cannabis is complex. The plant is comprised of 450 chemicals, including 78 largely un-researched, but arguably therapeutic cannabinoids, in addition to delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The FDA tends to view medicinal value through the limited lens of a single chemical entity, failing so far to approve any product derived from a botanical. Well, it should. Cannabinoids work synergistically together to create an “entourage effect” in which the whole is greater than the sum of its parts.

 

The endocannabinoid system. Both THC and CBD were newborn discoveries when the 1971 Convention on Psychotropic Substances was codified. Then, neither scientists nor politicians understood the human body’s close relationship with the cannabis plant. During the 1990s, researchers uncovered internal “cannabinoid receptors” and cannabinoids such as Anandamide. They called this configuration the “endocannabinoid system,” essentially cannabis within. What is its purpose? The stability, harmony and homeostasis of the body. This is why cannabinoids, whether internal or external, modulate motor coordination, memory processing, pain, and inflammation, and have anxiolytic effects. What happens in the absence of cannabinoids? An endocannabinoid deficiency syndrome develops.

 

Research. The HHS is charged with undertaking a scientific and medical evaluation of the five substances. Dare we say, finally? Marijuana’s placement in the CSA’s most restrictive Schedule I obstructed cannabis research in the United States for almost 50 years. Most of the major advancements have, by necessity, occurred elsewhere. Science has only scratched the surface of the treasure trove that embodies the medicinal benefits of cannabis and cannabinoids. In 2004, a search of “cannabinoid” in Pubmed.gov from the National Library of Medicine produced 5,900 citations; in 2010, that number was 12,000.  Now, that same search finds 23,365 results. Cannabinoid medicine is clearly a science whose time has come.

 

Public policy. The CSA uses three criteria to determine classification under Schedule I: high potential for abuse, no currently accepted medical value in the U.S. and lack of accepted safety under medical supervision. When drafted, cannabis’ placement in the CSA was deemed provisional by HHS pending a review, which was completed with the 1972 Shafer Commission report. Not surprisingly, the Nixon administration ignored the report because it favored decriminalization. That sinister move had devastating consequences. Over the following 45 years, arrest and incarceration rates in the U.S. exploded. More than 20 million Americans have been arrested for some type of marijuana violation, particularly people of color who comprise almost 60% of those incarcerated for drug offenses. America’s prison population now tops 2.1 million, the largest in the world, and spending to prosecute the drug war exceeds $50 billion. Clearly, HHS considerations go far beyond scientific and medical evaluations.

 

But strictly concerning Schedule 1.

  • High potential for abuse, no. An estimated 35 million Americans use cannabis monthly. Considering the endocannabinoid system and its deficiency syndrome, perhaps otherwise law abiding citizens are augmenting their systems and mediating a deficiency, instead of abusing CB1 receptors. The lexicon of the FDA, HHS and WHO must change.

  • No accepted medical value, incorrect. Because of federal intransience, 45 states have legalized medical marijuana, whether whole plant or CBD only. Each of these laws is predicated on medical expertise.

  • Lack of safety, untrue. In 1988, DEA Administrative Law Judge, Francis Young ruled, “Marijuana in its natural form is one of the safest therapeutically active substances known to man. By any measure of rational analysis marijuana can be safely used within the supervised routine of medical care.” Enough said.

The FDA, HHS and WHO have a critical and unique opportunity to make right a 45-year old wrong. To end the revolving door of mass arrest and incarceration. To unleash a new wave of honest research to uncover the truth about this medicinal plant. And most importantly, to ease human suffering, which may in turn heal the planet.

 

Respectfully submitted,

 

Ohio Rights Group

 

Note: These comments will appear as an article in the May 2018 edition of the Columbus Free Press.

 

Docket No. 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.”

 

 

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