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
Notice CDER 2018-186 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 OPEN
2018-04-25 2018-04-25 2018-04-25 2018-04-25 2018-04-25 2018-04-25 2018-04-25 2018-04-25 2018-04-18
FDA-2018-N-1072-6217 FDA-2018-N-1072-6215 FDA-2018-N-1072-6398 FDA-2018-N-1072-6632 FDA-2018-N-1072-6859 FDA-2018-N-1072-6865 FDA-2018-N-1072-6922 FDA-2018-N-1072-6890 FDA-2018-N-1072-4762
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6217 https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6215 https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6398 https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6632 https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6859 https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6865 https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6922 https://api.regulations.gov/v4/comments/FDA-2018-N-1072-6890 https://api.regulations.gov/v4/comments/FDA-2018-N-1072-4762
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Abuse potential is a retained drug ability that makes an individual dependent on the drug. The ability depends on drug administration, as well as the speed at which the drug enters an individuals bloodstream and nervous system to enhance production of a high sensation. Drugs that enter the body system fast are easily addicted compared to those with a slower rate. Most drugs are harmful to health, because of abuse, and have a potential of bringing dependency, for instance, cannabis. Cannabis contains multiple cannabinoids and psychoactive chemicals THC. Cannabinoids have activities at cannabinoid 1, and 2 (CB1 and CB2) and CB1 are most abused due to its effects on memory processing, inflammation, and pain. Researchers have conducted on the effects of abuse potential of cannabis with an aim of getting information on its harmful and legitimate use, national controls status and the potential effect of international control of the drug.Actual abuse occurs when individuals consume drugs in harmful amounts or methods. Actual abuse results in psychological, social and physical harm. Cannabis, being the commonly abused drug has led to a review concerning it by the World Health Organization (WHO).Cannabis can be categorized into the cannabis resin and plant, cannabis tinctures, extracts, and delta -9-tetrahydrocannabinol. Actual abuse of cannabis mainly occurs when it is used in excess for medical purpose and due to the emergence of pharmaceutical preparations that are related to cannabis, and useful in therapies.Cannabis, also known as marijuana, is extracted from a hemp plant, known as cannabis sativa that is also used for medical purposes. It can be taken in the form of a capsule, pill, mouth spray, and smoke, or maybe baked and then eaten. It is used to relieve and control symptoms such as nausea, pain, insomnia, tremors, and numbness caused by damaged nerves. In the administration of cannabis, considerations must be put on the amount, because it varies in strength and quality. There are however restrictions on marijuana administration, that is: certain individuals are not allowed to consume it, for instance, pregnant or breastfeeding mothers and mental health patients. The most used illegal drug in the United States is cannabis and synthetic THC, also known as dronabinol, which is an approved drug ingredient that is derived from marijuana and is used to make MARINOL capsules (generic), as well as SYNDROS oral solution. MARINOL and SYNDROS are useful in anorexia treatment, which is related to a loss of weight of acquired immunodeficiency syndrome (AIDS) patients, as well as vomiting and nausea by cancer chemotherapy patients who are faced with difficulties during treatment.Trafficking drugs is an illegal trade comprising cultivation, manufacture, distribution, and sale of products that are prohibited by laws on drugs. Despite the medical use of cannabis, FDA does not approve products from or containing marijuana. FDA refers to schedule I under the CSA, which controls marijuana and its substances, hence, they consider trafficking illegal. MARINOL and SYNDROS, which are authorized for various medical purposes, are also controlled, but in different schedules that are MARINOL, control is in schedule III, while SYNDROS is in schedule II under the CSA.The 1961 convention that contains schedule II puts together cannabis resin, cannabis, extracts, and cannabis tinctures, while schedule of 4 of the same years convention contains the cannabis resin and cannabis plant. There is, however, change in 1971s convention whereby the schedule I and II contains synthetic and natural cannabinoids. The impact gained from scheduling changes is an increase in the medical use of cannabis and its components, for instance, in therapeutic use. The impacts obtained from scheduling can be considered a preliminary analysis, and they are not useful in determining whether to change the control status of a substance. Abuse potential is a retained drug ability that makes an individual dependent on the drug. The ability depends on drug administration, as well as the speed at which the drug enters an individuals bloodstream and nervous system to enhance production of a high sensation. Drugs that enter the body system fast are easily addicted compared to those with a slower rate. Most drugs are harmful to health, because of abuse, and have a potential of bringing dependency, for instance, cannabis. Cannabis contains multiple cannabinoids and psychoactive chemicals THC. Cannabinoids have activities at cannabinoid 1, and 2 (CB1 and CB2) and CB1 are most abused due to its effects on memory processing, inflammation, and pain. Researchers have conducted on the effects of abuse potential of cannabis with an aim of getting information on its harmful and legitimate use, national controls status and the potential effect of international control of the drug.Actual abuse occurs when individuals consume drugs in harmful amounts or methods. Actual abuse results in psychological, social and physical harm. Cannabis, being the commonly abused drug has led to a review concerning it by the World Health Organization (WHO).Cannabis can be categorized into the cannabis resin and plant, cannabis tinctures, extracts, and delta -9-tetrahydrocannabinol. Actual abuse of cannabis mainly occurs when it is used in excess for medical purpose and due to the emergence of pharmaceutical preparations that are related to cannabis, and useful in therapies.Cannabis, also known as marijuana, is extracted from a hemp plant, known as cannabis sativa that is also used for medical purposes. It can be taken in the form of a capsule, pill, mouth spray, and smoke, or maybe baked and then eaten. It is used to relieve and control symptoms such as nausea, pain, insomnia, tremors, and numbness caused by damaged nerves. In the administration of cannabis, considerations must be put on the amount, because it varies in strength and quality. There are however restrictions on marijuana administration, that is: certain individuals are not allowed to consume it, for instance, pregnant or breastfeeding mothers and mental health patients. The most used illegal drug in the United States is cannabis and synthetic THC, also known as dronabinol, which is an approved drug ingredient that is derived from marijuana and is used to make MARINOL capsules (generic), as well as SYNDROS oral solution. MARINOL and SYNDROS are useful in anorexia treatment, which is related to a loss of weight of acquired immunodeficiency syndrome (AIDS) patients, as well as vomiting and nausea by cancer chemotherapy patients who are faced with difficulties during treatment.Trafficking drugs is an illegal trade comprising cultivation, manufacture, distribution, and sale of products that are prohibited by laws on drugs. Despite the medical use of cannabis, FDA does not approve products from or containing marijuana. FDA refers to schedule I under the CSA, which controls marijuana and its substances, hence, they consider trafficking illegal. MARINOL and SYNDROS, which are authorized for various medical purposes, are also controlled, but in different schedules that are MARINOL, control is in schedule III, while SYNDROS is in schedule II under the CSA.The 1961 convention that contains schedule II puts together cannabis resin, cannabis, extracts, and cannabis tinctures, while schedule of 4 of the same years convention contains the cannabis resin and cannabis plant. There is, however, change in 1971s convention whereby the schedule I and II contains synthetic and natural cannabinoids. The impact gained from scheduling changes is an increase in the medical use of cannabis and its components, for instance, in therapeutic use. The impacts obtained from scheduling can be considered a preliminary analysis, and they are not useful in determining whether to change the control status of a substance. CANNABIS KILLS CANCERREF:   http://freecannabiscancerbook.com. Cannabis for Treatment of Cancer by Justin Kander and Dennis Hill.Cannabis Kills Cancer by multiple mechanisms including Apoptosis and Reactive Oxidative State. This is described in the eBook available online Cannabis for Treatment of Cancer by Justin Kander, Cannabis Researcher, and Dennis Hill, Biochemist formerly of MD Anderson Cancer Center in Houston Texas.  The Anderson Cancer Center in Houston is the number one rated cancer center in the United States. Dennis Hill started his own hash oil extract treatment after being diagnosed with aggressive Prostate Cancer.  He started his treatment as an alternative to conventional chemotherapy, radiation, and surgery.  Dennis started his treatment on July 8, 2010, and was still alive in good health as of October 2017.  Dennis Hill has Videos on YouTube where he discusses the mechanisms of cannabis extracts killing cancer.  Its worth noting that CBD, another Cannabis extract is known to be active against cancer as well.  The hash oil treatment as popularized by Rick Simpson and is known as Phoenix Tears or Rick Simpson Hash Oil.I know of a Liver Cancer patient diagnosed July 14, 2014, with an advanced stage primary liver cancer with a tumor size of 4 x 5 inches.  The tumor marker AFP was 133651.  Traditional treatment at the City of Hope Cancer in Duarte California reduced the size of the tumor, and the AFP was in the 20,000 to 25,000 level by January 2015. Patients last Chemo treatment was in April of 2015.  The last Oxycodone prescription was in mid-year 2015.  Tumor marker AFP continued to improve gradually declining to 44.5 on September 28 October 2015. Patients hair grew back, gained weight and condition continued to improve.  Patients condition continues to be in good health as of 4/21/2018. There is no advanced stage cancer present.  All of patients friends remark on how good conditions appear to be.  The patient is treated by Aunt Zeldas dispensary located in Bodega Bay California. Patient treatment is by THC and CBD Hash Oils.Aunt Zeldas dispensary is featured in documentary to be released shortly about Pediatric Cancer Treatment by CBD and THC Hash Oils.    Patients in the state of Utah are trying to be heard with a ballot initiative for medical cannabis for the 2018 ballot.  My personal story is I have facial nerve pain,  fibromyalgia, degenerative disk disease, facet disease, stenosis foraminal meaning the narrowing of the neurological chamber around my spine, and bone spurs.  I visited my dying auntin the legal cannabis state of Washington where she gave me what was left of her cannabis oil to see if it would help. Just a drop the size of a grain of rice of full cannabis oil was all it took and I wouldnt have to take muscle relaxants, sleep pills, antI-nflammatories, anxiety medication, pain pills and if I was there long enough I could of probably of gone off the seizure medication as well. Most have heard about how well it effects the part of the brain in controlling seizures.Seizure medication is what they give me to numb down my central nervous system that misfires. The problem is you cannot numb down one nerve you numb them all down so my vision has become impaired, my hearing has decreased, I have problems with memory and coming up with words. I have neuralgia, where I cannot feel in extremities, so for a moment consider all those pills and their debilitating side effects from each one of them. The thought of taking what our own government, in their patent on cannabis, called a neurolprotectant as opposed to something that causes neurological decline is a no brainer. People, like myself, just want to have a better quality of life without all the pills.So it definitely made a believer and an activist out of me. Once you open the doors to all the information that is out there and hear peoples stories you just cannot go back. I will continue to to use the voice my aunt no longer has of how well this works and how it would have helped her so much more if she would have had it available sooner because she lived here in Utah and only moved in her last 3 months of life.I enclosed a lot of good investigative information with reliable links for your review.Knowledge is power, it should not be illegal to take care of ourselves and our illnesses we defiantly should not have to leave our familys and our homes to have a better quality of life.Thanks for your time and attention in this matter.  Hemp is the most renewable and versatile crop that God has given us!! Its a fuel, a medicine, a textile and we are Fools for falling into the ploy of Big business and Big Pharma!! It Is Not, Has Not nor Ever Will be a gateway drug. If you need an industry to ban for the good of the people/public safety, it should be alcohol!!    Several individuals have used the same words to describe their feelings to keep the regulations on marijuana and the cannabinoids, and they have used the words supporter of scientific research as a reason to do so.  When one looks at the research, however, these individuals have no concept of the scientific research on marijuana and the cannabinoids.  Here are some SCIENTIFIC REALITIES to consider  1. Scientists from the National Institutes of Health (NIH) have written a 61-page review (Pharmacol Rev. 2006, 58 (3): 389-462; article in attachments) entitled THE ENDOCANNABINOID SYSTEM AS AN EMERGING TARGET OF PHARMACOTHERAPY with 67 pages of references.  A few quotes from the abstract are shown below:a. In the past decade, the endocannabinoid system has been implicated in a growing number of physiological functions, both in the central and peripheral nervous systems and in peripheral organs.b. More importantly, modulating the activity of the endocannabinoid system turned out to hold therapeutic promise in a wide range of disparate diseases and pathological conditions, ranging from mood and anxiety disorders, movement disorders such as Parkinsons and Huntingtons disease, neuropathic pain, multiple sclerosis and spinal cord injury, to cancer, atherosclerosis, myocardial infarction, stroke, hypertension, glaucoma, obesity/metabolic syndrome, and osteoporosis, to name just a few.c. The growing number of preclinical studies and clinical trials with compounds that modulate the endocannabinoid system will probably result in novel therapeutic approaches in a number of diseases for which current treatments do not fully address the patients need.  2. Patent US 6,630,507 B1 issued 10/7/2003 to the assignee THE UNITED STATES OF AMERICA AS REPRESENTED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES.  The patent is entitled CANNABINOIDS AS ANTIOXIDANTS AND NEUROPROTECTANTS.  The summary of the patent states:a. Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism.  This new-found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. b. The Cannabinoids are found to have 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 Alzheimers disease, Parkinsons disease and HIV dementia.  3. InMed Pharmaceuticals have demonstrated positive results with cannabinoids treating glaucoma. (inmedpharma.com).  4. GW Pharmaceuticals has a pending FDA application with CBDa. An advisory panel to the U.S. Food and Drug Administration on Thursday unanimously voted in favor of approving the first cannabis-derived medicine in the country, a childhood epilepsy treatment developed by GW Pharma. (ReutersAnother comment by those individuals using the same worded anti-marijuana statement was:     Todays high-potency dispensary marijuana has a high potential for abuse, a high incidence of actual abuse, has not been proven to be safe or effective for the treatment of any medical condition, and is heavily trafficked in illicit markets.The people that make this comment offer no references to a high incidence of actual abuse to support their cause and clearly are unaware, or ignoring, all the data that shows THC and CBD to have medicinal benefits. One can also list folks, who have previously been against marijuana, move to have it legalized once they had seen the positive effects that THC and CBD can have.   1. Government officials, such as the previous Speaker of the House, John Boehner and former governor of MA, William Weld, have realized that marijuana and the cannabinoids have medicinal value to people.    2. RAMP, Republicans Against Marijuana Prohibition, was started by a mother who personally experienced the positive benefits of cannabinoids for her son.  3. On a personal note, I have experienced the pain-relieving properties of CBD for my arthritic hand.In summary, I strongly support a decision to deregulate cannabis, THC and CBD and the other cannabinoids in the cannabis and hemp plants so that the true potential of these chemicals can be fully realized.  It seems unconscionable to keep these therapeutic agents out of the hands of people in need. Comments on International Cannabis SchedulingTo 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 bodys 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? Marijuanas placement in the CSAs 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. Americas 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, no. 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, Mary Jane BordenTreasurer, Ohio Rights Group  To whom it may apply,I hope this rescheduling takes place soon, and allows patients to access a medicine that they need. I work in the Cannabis industry as a graphic designer for one of the top producing edibles and concentrates manufacturers in the country. We offer edibles, wellness products and concentrate products for recreational use, and also for medical patients. However, what were most proud to offer is high THC:CBD oil for patients with seizure disorders.One of our patients, Super Nova, perhaps the sweetest 5 year old you will meet, is also tasked with rare neurological disorder-Schizencephaly. She was having 100 seizures a day until she started treatment with our oil. The severity of her condition led to stalled physical and mental development. She is currently 6 months seizure free. At five years old, she just sat up on her own power. At five years old - she just told her mother she loved her for the first time.This is powerful medicine, but it is also extremely helpful for those of us with muscle pain, back spasms, PTSD, anxiety and numerous other issues. However, the recreational side of it should not be ignored - Its a much safer substance than alcohol or cigarettes, which are currently both available to the public. I have dealt with alcoholics my whole life, and have had my life upended because of them. Ive never had a person high on marijuana kick in my front door, wreck my car or threaten me. I have had an alcoholic do all of those things to me, though.Please free this plant. 