International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Cannabis and cannabis resin; Dronabinol (delta-9-tetrahydrocannabinol); Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol); Extracts and tinctures of cannabis; Cannabidiol preparations; Pharmaceutical preparations produced eit
2019-113 CDER International Drug Scheduling Convention on Psychotropic Substances Single Convention on Narcotic Drugs World Health Organization Scheduling Recommendations Cannabis and cannabis resin Dronabinol (delta-9-tetrahydrocannabinol) Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol) Extracts and tinctures of cannabis Cannabidiol preparations Pharmaceutical preparations produced either by chemical synthesis or as preparation of cannabis Request for Comments OPEN
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FDA-2019-N-0767-1767 FDA-2019-N-0767-1763 FDA-2019-N-0767-1772 FDA-2019-N-0767-1789 FDA-2019-N-0767-1838 FDA-2019-N-0767-1834 FDA-2019-N-0767-1801 FDA-2019-N-0767-1837 FDA-2019-N-0767-1790 FDA-2019-N-0767-1771
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I strongly recommend rescheduling cannabis from a class 1 to schedule 3 or 4, the least restrictive. Imposing more restrictions on manufacturing and distribution will only strengthen the Black Market More restrictions will only result in more incarcerations and cause the continued use and demand of even more psychotropic substances such as it is the case today.The benefits, facts, science, and statistics can all be found on your computer. Any restrictions of cannabis has always resulted in terrible consequences for the people. As 9-THC is liable to similar abuse as cannabis and has similar ill-effects, it meets the criteria for inclusion in Schedule I of the 1961 Single Convention on Narcotic Drugs.Currently, approved medicines with 9-THC as the only active compound use synthetically produced 9-THC, e.g., Marinol, Syndros, although it is possible in the future that medicines with equivalent amounts of 9-THC could be prepared from cannabis. There is no difference in the therapeutic effects or adverse effects of synthetic 9-THC compared to 9-THC from the cannabis plant.If there is no difference between synthetic and plant-derived 9-THC, as acknowledged by WHO, then they should be scheduled the same.  Schedule I drugs have no therapeutic usefulness.  That cannot possibly true if There is no difference in the therapeutic effects or adverse effects of synthetic 9-THC compared to 9-THC from the cannabis plant.  Medical marijuana (containing 9-THC) is approved in many states in the US for some of the same uses as synthetic dronabinol like decreased appetite and nausea for cancer and HIV patients.  There is therapeutic benefit for all of the cannabinoids in the cannabis plant and it should not be scheduled any lower than Schedule III. March 13, 2019Dear Food and Drug Administration,As Chairman of the Health Committee of the House of Representatives of Tennessee, and a practicing physician, I am contacting you in support of rescheduling, or descheduling, the cannabis plant and all its chemicals.Though cannabis and its derivatives are considered to be Schedule 1 chemicals, recently, the surgeon general has recommended removing cannabis from this status, claiming this status hinders scientists ability to conduct research on the plants effects and potential benefits. Likewise, after an extensive analyzation of completed cannabis studies, the World Health Organization (WHO) also recommended removing cannabis from its current restrictive status. I would concur with these sentiments.Studies have shown that the chemicals in cannabis have medicinal properties and, if used properly, they have low risk of morbidity and mortality. Currently, thirty-three states have passed legislation permitting the use of cannabis for medicinal purposes, leaving most of the country at odds with the federal governments longstanding prohibition. Despite this prohibition, the recently signed federal spending bill prevents the Department of Justice from spending money against states who have enacted a medical cannabis program.As a Chairman, physician, parent, and patient advocate, I am urging the FDA to reschedule or deschedule cannabis and its chemicals for the research and medical benefits of Tennesseans, and all Americans.Regards:Rep. Bryan Terry, M.D. I am a Professor of Neurology and researcher on cannabis.  Researchers need better access to good quality cannabis products in the US.  My patients, most have Parkinson disease, are experimenting and some hallucinate and others have better sleep.  the various components of cannabis may have great benefit and risk - we need to be able to do the research, especially since our fragile patients have access to it!  presently there is little choice of products and little available.  we need more than the U of Miss as a source of cannabis for research.   Please make my medicine legal. At least drop the schedule 1 to a 3 or 4.  We dont see over dosing like a schedule 1 drug.  It has multiple health benefits.  I suffer from crippling anxiety and delta- 9 tetrahydrocannabinol is the only thing that works for me.  In the past I was addicted to my pills I was given for anxiety and I had to up the dosage often (under a Dr. care).  Insomnia is practically cured with delta-9THC.  I also suffer from an eating disorder and the only way I am able to eat a full meal is with delta-9THC.  I am an Autistic person and have three Autistic children I know could benefit, yet without govt approval we will suffer in silence, waiting.  Thank you for your time,  Anna I submit the following video evidence in favor of ending all forms of cannabis prohibition:Endocannabinoid Systemhttps://youtu.be/M8S2nfotTR8Understanding the Endocannabinoid Systemhttps://youtu.be/3sEwoJv_NRcDr. William Courtney and the dietary benefits of raw cannabishttps://youtu.be/eRLVyGfGcZs The Scientists : The story of Raphael Mechoulam and the Endocannabinoid Systemhttps://youtu.be/oQDJi6Jb8d4Medical cannabis and its Impact on Human Health https://youtu.be/2u5TpN_vGTE Cancer Killed by Cannabis -https://youtu.be/iksA-DD3990 Leafhttps://youtu.be/7xPmR8j4plw Prof. Raphael Mechoulam - Medical Cannabis- Complete Doctors Interviewhttps://youtu.be/sD1ZF0dE5nw Canna Tech 2016 welcome and keynotehttps://youtu.be/AeFn13R6ujsCannabis and cannabinoids - dr. Jeffrey Hergenrather, MDhttps://youtu.be/M8ieS2ICHME Dr. Mercola and Dr Getty on Medical Marijuana Full Interviewhttps://youtu.be/qerjjVVFVaQ CNN Documentary Weed 4 with Sanjay Guptahttps://youtu.be/R90JW1fTw8U  We urge strongly that all cannabis products are declassified. THC should not be considered a harmful substance and instead regulated, as it has been, to enable a thriving industry that also helps individuals with a myriad of physical, emotional and mental issues that are well treated by cannabis. In addition, cannabis is a safe option for recreation and is less harmful than alcohol and tobacco, both of which have been part of the fabric of society for as long as most of us can recall. The regulated, recreational and medicinal cannabis industries for products that contain THC have also created countless jobs, created small businesses, and brought economic opportunity to towns larger and small. Studies have also shown that states with a regulated cannabis market have seen opioid deaths decrease, another major reason to encourage this plant to be made more accessible. In terms of CBD, this is a harmless substance as well which should be declassified. Limiting CBD use in tinctures, capsules, edibles and topicals at a level only achievable by pharmaceutical organizations would be a great loss to those who use it as a health aid in their lives, many of whom have been able to remove harmful substances from their daily routine, and who have found better lives with the use of the product. Keeping it accessible, affordable and in varying forms to suit the consumer is key. This is an industry as well that has created jobs, businesses and opportunities in every part of the country and the world. Attention to quality, testing, avoidance of the use of pesticides or herbicides, or other harmful ingredients, should be considered as a requirement for labeling CBD products so that consumers can choose for themselves the brands and companies that are creating products that are good for them at the level that they desire, much like the natural health and wellness sector vs. the lower grade food and product sectors. Consumers should have the options to choose for the themselves. In addition, banking laws need to be amended so that businesses in this sector, whether wholesale, retail, consulting, or peripheral, can work in the industry without financial repercussions like being robbed, having business accounts shut down, or not being able to secure loans or mortgages, like every other hard working person is able to do. Thank you for reviewing these comments.  Former Minnesota Gov. Jesse Ventura tweeted, I truly feel sorry for South Dakota. @govkristinoem denied the state a great opportunity. #Hemp is a food-source for plant based protein, its jobs for farmers, its FEDERALLY LEGAL. She clearly did ZERO research before vetoing this bill. Cannabis is a sacred, healing plant that has been used by peoples all over the world for millennia. It is a generally safe drug, and no one has EVER died from a cannabis overdose. Other drugs cannot claim this. I have heard of many people, including children, who have found relief from seizures with cannabis, where they have not had success with pharmaceuticals. These folks experience none of the side effects that pharmaceuticals give them, and now rely on cannabis to live their lives again. I feel it would be a crime to not allow these people easy access to something that is so helpful, and that has given them their lives back. For myself, being a strong, healthy person, I find that when I have puffs of cannabis before I go to sleep, I sleep much better, have better dreams and wake in the morning refreshed. I know others have this experience as well. This is just one of the many benefits of this plant.Cannabis is a natural plant that is easily grown. It may be a threat to the pharmaceutical giants because of this and because of its healing and calming effects on the human body, and that is exactly why it needs to be decriminalized and rescheduled. It is not addictive, despite what some say, and generally has no harmful side effects. It certainly does not deserve to be in the same category as cocaine or heroin. Seriously. This is so very wrong. Like I said before, no one has ever died of a cannabis overdose. Check the research on this.Please, please, please use your common sense and your sense of right and wrong and do the right thing here for cannabis. Thank you for doing the right thing for those who need this plant. To Whom This May Concern:Hi, I would like to provide my support for the national decriminalization and rescheduling of marijuana and CBD derivatives. I am a practicing, board certified, and licensed Psychiatric Mental Health Nurse Practitioner in the state of TN. I have seen in practice and clinical rotations I had as a student many different individuals that use marijuana to help with anxiety, insomnia, pain relief, and mood regulation. Marijuana should not be classified as an illegal substance any longer. It has positive results in all realms of healthcare and I have seen this personally with my own patients I care for each and everyday. I support this as a way to provide better care to the people I see and their families. Some of these patients have replaced a highly addictive and highly abused class of medications- benzodiazepines- used in the realm of psych for anxiety and insomnia with marijuana use. Marijuana is a much safer alternative to benzodiazepines, it is cleaner, does not show to interfere with any other prescription drugs that they may be required to take, and does not come with a listing of side effects that can occur as is true for numerous prescription drugs that are written everyday. Another reason I support marijuana rescheduling and decriminalization, is due to the elimination of the concern of apnea- defined as the cessation of breathing- when marijuana is used in place of benzodiazepines. Apnea can occur with benzodiazepine use, as well as, muscle relaxers and pain medications. This adverse reaction is potentiated with the use of several of these classes of medications when they are prescribed together or in combination with one another. As a prescriber, seeing patients and families suffer from addiction, addiction recovery, and legal concerns, combined with mental health disorders, it is very hard to then have to turn to the use of medications- one stated above benzodiazepines- to help with symptoms of their disorders as there are not many choices of prescription drugs used to treat anxiety and insomnia adequately. Anxiety and insomnia are both disorders that many people suffer from and usually receive minimal coverage treatment at best for these disorders. Marijuana has been proven to treat these conditions among many others with great efficacy and ignoring these facts would be negligent and erroneous of our national leaders.  Thanks for your time and attention! 