Tell The FDA We Must
DESCHEDULE, DECLASSIFY, DECRIMINALIZE!

Register Your Comment About Cannabis With The FDA Before It’s Too Late!

DEADLINE FOR PUBLIC COMMENTS: Monday, April 23th, 2018
Right now, we have the opportunity to make our voices heard regarding the DESCHEDULING of Cannabis to the U.S. Food & Drug Administration, the World Health Organization, and the United Nations.

Please find below instructions and suggested comments to submit through the official government comment docket link:
https://www.regulations.gov/document?D=FDA-2018-N-1072-0001

What’s Going On?
The Food and Drug Administration (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: Cannabis plant, Cannabis resin, Extracts and tinctures of cannabis; delta-9-tetrahydrocannabinol (THC; stereoisomers of THC; and cannabidiol (CBD).

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 by the Secretary of Health and Human Services (Secretary of HHS) to the Secretary-General of the United Nations (the U.N. Secretary-General). WHO will use this information to consider whether to recommend that further international restrictions be placed on cannabis, or to remove restrictions. This notice requesting comments is required by the Controlled Substances Act (the CSA) and the 1971 Convention on Psychotropic Substances (Psychotropic Convention).

The World Health Organization (WHO) is holding the 40th Expert Committee on Drug Dependence (ECDD) will meet in Geneva June 4-8, 2018. The 40th ECDD will convene in a special session to review cannabis and cannabis-related substances on their potential to cause dependence, abuse and harm to health, and potential therapeutic applications.

How Will This Help?
Like bureaucratic processes, it will not happen immediately, but change will come if WE make OUR voices heard on this matter. We must let them know we know the truth about cannabis as a safer alternative to other scheduled substances, alcohol, and tobacco—and that prohibition is a failed policy.

Making public comments is one way to use our First Amendment right to assert this knowledge!

When Is The Deadline For Comments?
You must submit either electronic or written comments by Monday, April 23, 2018.

Where To Submit Your Comments?
Click this link to go the FDA Comment Page:
https://www.regulations.gov/document?D=FDA_FRDOC_0001-8331

INSTRUCTIONS FOR PUBLIC COMMENTS:

Enter Your Comment In Section 1
We recommend that you speak to why cannabis should not be subject to international restrictions based on the benefits of wellness and public health. You can cut & paste the text below (delete the citation link!) as your public comment, but it is suggested that you add 1 or 2 additional sentences to personalize your public comment.

IMPORTANT: WITH REGARD TO COMMENTS REGARDING CBD SPECIFICALLY, PLEASE FOCUS ON THE FACT THAT THERE IS NO POTENTIAL FOR ABUSE OF CBD OR PSYCHOACTIVE EFFECTS.

IMPORTANT: Please Read Everything Below Before Submitting Comment!!

Suggestions For Comments or Content:

Suggested Comment #1:
Cannabis plant, Cannabis resin, Extracts and tinctures of cannabis; delta-9-tetrahydrocannabinol (THC; stereoisomers of THC; and cannabidiol (CBD). The U.S. Department of Health and Human Services has held Patent 6630507 since 2003 that states cannabinoids (found in cannabis) are useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia. FDA and WHO must recommend to deschedule, declassify, and decriminalize cannabis to restore human rights and increase access to patients.
(Citation)

Suggested Comment #2:
Cannabis plant, Cannabis resin, Extracts and tinctures of cannabis; delta-9-tetrahydrocannabinol (THC; stereoisomers of THC; and cannabidiol (CBD). Building upon earlier research, a peer-reviewed study recently published in the Journal of Health Economics funded by the National Institute on Drug Abuse found that states that have a marijuana law with a legal, operational dispensary provision show a statistically significant decline in opioid overdose death rates of about 25%. According to another recent study published by the Minnesota Department of Health, out of the patients known to be 6 taking opiate painkillers upon their enrollment into the state medical cannabis program, 63% were able to reduce or eliminate opioid usage after six months. FDA and WHO must recommend to deschedule, declassify, and decriminalize cannabis to restore human rights and increase access to patients.
(Citation1, Citation2, Citation3)

Suggested Comment #3:
Cannabis plant, Cannabis resin, Extracts and tinctures of cannabis; delta-9-tetrahydrocannabinol (THC; stereoisomers of THC; and cannabidiol (CBD). The criminalization of cannabis is a bigger public health threat than the plant and its properties. The prohibition of cannabis removed our ability to further understand its benefits, and by scheduling it alongside substances that can cause death created a false equivalency when it is safer to use as an alternative to treat pain than opiates and opiate derivatives. Cannabis has been consumed in one form or another throughout human history in cultures around the world. The U.S. Drug Enforcement Administration (DEA) knows there has never been a single fatal overdose from cannabis use as published in their “Drugs of Abuse” report. FDA and WHO must recommend to deschedule, declassify, and decriminalize cannabis to restore human rights and increase access to patients.
(Citation)

Suggested Comment #4:
Cannabis plant, Cannabis resin, Extracts and tinctures of cannabis; delta-9-tetrahydrocannabinol (THC; stereoisomers of THC; and cannabidiol (CBD). The War on Drugs is an abject failure costing more than $1 trillion and countless lives, keeping people from access to safer treatments that could save lives while incarcerating people for non-violent offenses while ruining families and communities all over the world. This has lead to public health crises: an overburdened justice system, a strained health care system, lost productivity, environmental destruction, destabilization of various countries, and the use of resources that could have been put towards treatment, education, and restoring our communities—instead of tearing them apart. The systemic trauma from law enforcement using the possession and use of cannabis as means to violate human rights has led to discrimination throughout our legal systems, exacerbating these public health crises. FDA and WHO must recommend to deschedule, declassify, and decriminalize cannabis to restore human rights and increase access to patients.
(Citation1, Citation2, Citation3)

Suggested Comment #5 in favor of Cannabidiol (CBD) specifically:
CBD should not be restricted because there is no abuse liability and diversion potential. CBD should not be restricted because CBD is not addictive, nor does it have the potential for abuse or used for psychoactive purposes. CBD should not be restricted because CBD does not have the potential for abuse or addictive properties. Cannabidiol has a plethora of beneficial health effects and has no relevant side effects, even when it is administered at high doses. A comprehensive review on the safety and side effects of CBD shows that even very high doses of CBD are safe and well tolerated without significant side effects. In a total of 132 reviewed publications, CBD did not induce catalepsy; it did not affect factors such as heart rate, blood pressure, body temperature, gastrointestinal transit, nor did it alter psychomotor and cognitive functions. FDA and WHO must recommend that no international restrictions be placed on CBD.
(Citation: Bergamaschi, M. M., Queiroz, R. H. C., Zuardi, A. W. & Crippa, J. A. S. (2011): Safety and side effects of cannabidiol, a Cannabis sativa constituent. Current drug safety, 6(4), 237-249. Information on toxicological effects: IVN-MUS LD50: 50 mg/kg; IVN-DOG LD50: >254 mg/kg; IVN-MKY LD50: 212 mg/kg; ORL-MKY TDL: 27 gm/kg; ORL-MUS TDL: 750 mg/kg.)

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