International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Request for Comments
International Drug Scheduling Convention on Psychotropic Substances Single Convention on Narcotic Drugs Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances Request for Comments OPEN
2017-08-18 2017-08-29 2017-08-29 2017-08-30 2017-08-30 2017-08-31 2017-08-31 2017-08-31 2017-08-31 2017-08-31
FDA-2017-N-4515-0436 FDA-2017-N-4515-1643 FDA-2017-N-4515-1651 FDA-2017-N-4515-1813 FDA-2017-N-4515-1821 FDA-2017-N-4515-1852 FDA-2017-N-4515-1871 FDA-2017-N-4515-1857 FDA-2017-N-4515-1862 FDA-2017-N-4515-1847
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https://api.regulations.gov/v4/comments/FDA-2017-N-4515-0436 https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1643 https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1651 https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1813 https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1821 https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1852 https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1871 https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1857 https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1862 https://api.regulations.gov/v4/comments/FDA-2017-N-4515-1847
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Cannabidiol most definitely has medical value and does not belong in schedule I in relation to the Controlled Substances Act.  This should be already known by the Department of Health and Human Services, but I will list it here anyway.  The Department of Health and Human Services has held a patent on the medical value of cannabinoids since 2003 (patent number 6630507) for their value as neuroprotectants.  I will attach the abstract of 6630507, but it states specifically that CBD is beneficial because it avoids toxicity.  CBD alone does help alieve a degree of inflammation and pain.  Cannabis in its entirety with its entourage effect involving all terpenes, all cannabinoids, and all other compounds working in synergy are what would be most beneficial to patients suffering with conditions that are not presently treatable with modern options in medicine.  The modern world is recognizing the benefits of the cannabis plants and its components.  As a patient, I can testify to the fact that both cannabidiol on its own, and the cannabis plant in its many forms has helped to relieve a great degree of my pain at times when I believed that I would no longer be able to survive, and when nothing else would work.  Allopathic medicine is not always the answer.   I am thankful to the FDA for awakening to the benefits of CBD and for acknowledging the scientific evidence that is being presented the world over.  CBD has also been shown to improve cognition in multiple studies of impairment.  Dr. Mechoulam is a researcher in Israel who hasbeen conducting US research on cannabis since 1964.  That is the year he began receiving $100,000 per year from the USNational Institutes of Health to begin researching the effects of cannabis and to determine medical benefits or effects.He received $100k per annum until 2010, and concluded long ago that there were medical benefits.  In an interview that appeared in Newsweek, Mechoulam stated, Having seen the clear medical benefits of cannabis over more than 50 years of research, he is baffled that theres still reluctance to embrace marijuana as medicine. We believe modern science is going ahead, right? he asks. Well, its not. When insulin was discovered in the 1920s, it became a drug in months. Cortisone was discovered in the late 1940s, and it was made into a drug a year or two later. Anandamide was discovered 23 years ago and has still never been administered to a human being. Im not sure thats progress.  Anandamide is a different cannabinoid other than CBD, but he has also researched CBD.  CBDforDiabetes Mechoulam has been testing CBD on mice bred to have a version of type1 diabetes that manifests around age 14 weeks. He and his co-workers treated these mice with CBD for their first 6-7 weeks of life, then tested them 6-7 weeks later and found that only 30% had developed diabetes (compared to 90-100% given placebo).  CBD did not just prevent onset but blocked development of diabetes. In a follow-up experiment the mice werent given a course of CBD until age 14 weeks, when they were developing diabetes. They were then tested at age 24 weeks, and again only 30% of the treated mice were found to have diabetes. In other words, CBD did not just prevent onset but blocked development of diabetes. Examination of the insulin-producing islets showed that only 8% were intact in the untreated diabetic mice, whereas 77% were intact in the mice treated with CBD.  I believe that here we have something very promising, Mechoulam said. We plan to have a clinical trial starting next week treating patients, and hopefully at the next meeting I will tell you that all of them are cured. LetshavesomemoreCBD Cardiologists working with mice at Hebrew University have found that CBD treatment at the time of a heart attack can reduce infarct size by about 66%. I am not going to list all of the wonderful things that CBD and THC do.  I will say that they act as balancing agents to oneanother.  MY FINAL SUMMARY IS TO DESCHEDULE CBD AND KEEP IT DESCHEDULED FROM THE CSA.  I BELIEVE THAT ALLCANNABINOIDS SHOULD REMAIN DESCHEDULED (THE NATURALLY OCCURING CANNABINOIDS).ALSO TRAMADOL, KETAMINE, AND PREGABLIN SHOULD NOT BE SCHEDULED SUBSTANCES.  SCHEDULING OF ANY OF THE SUBSTANCES I LISTED MAKE IT HARDER ON PATIENTS THAT ARE ALREADY SUFFERINGTO OBTAIN THE MEDICATIONS THEY MUCH NEED TO BE ABLE TO OBTAIN A BETTER QUALITY OF LIFE.PLEASE READ THE ATTACHMENTS AS SUPPORTING DOCUMENTATION.  PLEASE RELY ON SCIENTIFIC DATA.  PLEASELISTEN TO THE PEOPLE.  PLEASE RELY ON CURRENT DATA!!!  THANK YOU FOR THE OPPORTUNITY TO PROVIDEMY INPUT.   Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.david wettermandalassabre@aol.com1444 s old Bruceville RoadBruceville, Texas 76630 Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.Colleen Grahamcoll_rtz@hotmail.comHome, 130 w 4th aveSan Manuel, Arizona 85631 Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.Ive had six spinal surgeries I need a 7th from C2-C7 which has been done but needs reworked. I have ankylosing spondylitis, hep C and fibromyalgia. Ive almost died and the only reason Im breathing is from CBD oil. This government is destroying sick peoples ability to get help and you almost killed me. Have a conscience and start helping the Vets.. You are killing the men and women that would died for their country. This is a shame. Save our vets.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask  Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.Christopher Allamanchristopher.allaman@gmail.comG26 Forest HtsButler, Pennsylvania 16001 Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.I am reformed opioid addict - drugs prescribed by licensed VA doctors to treat crippling arthritis.  I would probably not be alive today, were it not for cannabis.  Yet Federal drug policy prohibits doctors from using a wonderfully effec Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.Jason McGrathjsnmcgrath1977@yahoo.com44 Foxwood Road Bear Creek , Pennsylvania 18702 Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.jacob haskinshaskins.jacob@gmail.com32592 N cherry Creek RDQueen Creek, Arizona 85142 Food and Drug Administration HHS,Please consider my public comments with regard to the potential inclusion of cannabidiol (CBD) in the World Health Organizations international drug scheduling code.I oppose the imposition of additional international restrictions limiting either its use or access. Cannabidiol lacks the sort of abuse potential and mood-altering activities to warrant such action by WHO. Seventeen US states explicitly recognize by state CBD as a therapeutic agent. Safety trials, such as those publicly available here: https://www.ncbi.nlm.nih.gov/pubmed/22716148 and here: https://www.ncbi.nlm.nih.gov/pubmed/22129319 here and here have determined the substance to be non-toxic and well-tolerated in human subjects. Even the head of the US National Institute on Drug Abuse, Dr. Nora Volkow, has publically acknowledged in an op-ed here: http://www.huffingtonpost.com/nora-volkow/cannabidiol_b_7834066.html that CBD is a safe drug with no addictive effects.Recent clinical trials have reported that CBD administration can safely and effectively mitigate epileptic seizure frequency, reduce blood pressure, improve the quality of life in patients with Parkinsons disease, mitigate anxiety, and potentially reduce certain drug cravings. However, the substance is unlikely to reach its full therapeutic potential if WHO imposes unnecessary and arbitrary restrictions upon its access or use. For these reasons, I ask the FDA to not recommend that WHO take any further action to either schedule or restrict CBD under international codes. Cannabidiol is not presently scheduled under existing UN treaties and it should remain that way.Arturo Valadezxtremeaj25@gmail.com613 CandlegloWindcrest, Texas 78239 CBD works , faster and longer for me then any pain pill , and no constipation , as I need it everyday , I rub it on my knuckles for instant relief from my arthritis at night , also on my shoulder that has had 2 rotator cuff surgerys a month apart, then in the morning I rub it on my back as I have a separated vertabre with a protruding disc for 30 yrs L5/S1 talk about great relief for a stiff sore morning back, but dont believe me TRY IT !!!! if it doesnt completely remove all the pain it takes away enough to make life more enjoyable ,and NO you dont get high from it , please try it youll find relief, I have also used on a stiff neck / great for that also.   