Requests that the FDA issue a Final Order adding to Title 21, Section 310, Subpart E, of the Code of Federal Regulations (C.F.R.) a provision in the form of a negative monograph that adds marijuana and THC to the current list contained therein and described in an FDA document
titled, "Guidance for Industry: Marketed Unapproved Drugs - Compliance Policy Guide; CLOSED
Citizen Petition CDER Drug Watch International,  Inc. adds marijuana and THC to the current list contained Guidance for Industry Marketed Unapproved Drugs Compliance Policy Guide published on September 19, 2011 therein and described in an FDA document Title 21, Section 310, Subpart E Code of Federal Regulations CLOSED
2018-11-13 2018-05-29 2018-04-17 2018-04-17 2018-02-13 2018-11-01 2018-11-01 2017-12-27 2018-11-01 2018-11-01
FDA-2017-P-6692-0081 FDA-2017-P-6692-0041 FDA-2017-P-6692-0027 FDA-2017-P-6692-0020 FDA-2017-P-6692-0012 FDA-2017-P-6692-0076 FDA-2017-P-6692-0079 FDA-2017-P-6692-0008 FDA-2017-P-6692-0054 FDA-2017-P-6692-0063
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https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0081 https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0041 https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0027 https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0020 https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0012 https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0076 https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0079 https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0008 https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0054 https://api.regulations.gov/v4/comments/FDA-2017-P-6692-0063
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Dear decision makers,I am a 53 year old woman, and I believe that the prohibition of cannabis has been against the best interest of the United States. I would like to see cannabis RESCHEDULED so that we can do the research necessary to finally discover the medical benefits of this wonder plant, see criminal justice reform, which has disproportionally affected African Americans, and allow ADULTS to decide for themselves if they want to use it in a responsible way. Thank you for your consideration,Jennifer KeatsLexington, Kentucky  Mr. Colemans citizens petitions ultimate goal is the safety of the American people. The petition requests the Food and Drug Administration (FDA) to explicitly order a negative monograph which places marijuana and THC on the current list of unapproved drugs. This is particularly significant because it is the responsibility of the FDA to protect its citizens. Numerous states have bought into the manufacturers advertisements and endorsements that marijuana is the miracle drug for all diseases. Sadly, many individuals with cancer and seizures, for instance, have abandoned appropriate drug therapies in exchange for medical marijuana because they believe it will cure them. As Mr. Coleman stated, there is insufficient research and evidence on the efficacy of medical marijuana. In addition, some studies have shown success, however, long-term research on the side effects of these drugs have not been conducted. While rounding with physicians in the emergency department,  we observed three cases where patients presented with uncontrollable abdominal pain, vomiting, and diarrhea. After assessing the patients cases, we observed an interesting commonality between all three; these patients had recently begun self-medicating with marijuana. The attending physician informed me that unusual patient cases were showing up in Americas ERs after these patients began self-medicating with the drug. Patients are very susceptible to the false advertisement, especially when it states there is a cure for a condition they have been suffering from on a daily basis. Unfortunately, we have a zero tolerance for pain mentality within our social circles. Since patients desire immediate relief, they will try to alleviate their plan regardless of associated health risks. This further exacerbates the need to seek quick relief. This is where the FDA comes into play. With medical marijuana being advertised heavily and with an increase in the number of states legalizing its use, the FDA must place heavy regulations on this drug to protect the US citizens. Colorado is a prime example of what can result from marijuana legalization before adequate regulations and research have taken place. It was noted that medical marijuana licenses increased substantially from 4,819 to 116,287 licenses within the span of six years.1 Such drastic increases meant that the increased availability of marijuana and its exposure result in the exacerbation of chronic health conditions.1 Colorados EDs were presented with increased visits for marijuana intoxication; 1 to 2 patients presented with cases of marijuana intoxication and 10 to 15 for marijuana-related illnesses.1 With the increase of marijuana legalizations, there is evidence of harmful public health effects on children.2  Caretakers do not perceive marijuana as a dangerous substance and improperly store marijuana. Therefore, they expose the child to the drug by leaving marijuana containing products within the childs reach.2 Emergency Departments in Colorado concluded the most affected population appears to be children ages 0 to 5, specifically after ingesting edible THC products.1 Similarly, The University of Colorado burn center reported a rise in the number of marijuana-related burns, some of which involve over 70 percent of patients body surface area.1  Burns occur during the extraction process from the plants. Since the blind legalizing of marijuana, Colorado has faced a surplus of adverse health outcomes. Nevertheless, it is important to note that proper conversions of marijuana have yet to be established. Appropriate conversion formulations become exceptionally significant when individuals are utilizing both marijuana and opioids. According to recent studies, it was demonstrated that there is only about a 17 percent accuracy rate in 75 different marijuana-based product labels.3 This is quite alarming considering that more legalizations are happening. Unless accurate conversion data is established, states must steer away from marijuana legalizations to protect overall public safety.ReferencesBecker, W. and Tetrault, J. (2016). Medical Marijuana in Patients Prescribed Opioids. Mayo Clinic Proceedings, 91(7), pp.830-832.Monte, A., Zane, R. and Heard, K. (2015). The Implications of Marijuana Legalization in Colorado. JAMA, [online] 313(3), p.241. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/ [Accessed 15 May 2018].Wang, G., Heard, K. and Roosevelt, G. (2017). The Unintended Consequences of Marijuana Legalization. The Journal of Pediatrics, [online] 190, pp.12-13. Available at: https://www.jpeds.com/article/S0022-3476(17)31081-8/fulltext [Accessed 16 May 2018]. Medical Marjiuana.Please make medicinal marijuana available to specific diseases like epilepsy, autism, cancer, etc.  It promises such hope for many of these families having to give their children dangerous pharmaceuticals. As a nurse and a social worker who has worked in healthcare for 30 years, I must tell you that marijuana is not our problem. I have never assisted one person in getting treatment for marijuana addiction, never assisted anyone as a nurse or a social worker who was very ill or highly intoxicated from marijuana. All of the people I have helped have had addiction to alcohol, heroin, meth and/or crack as well as prescription pills. Marijuana has actually helped people with depression and PTSD, it has helped people function in the world who would otherwise need prescription medication that almost always includes some type of side effect.  It needs to be fully legalized for people to sell it, grow it and use it. I am not saying that there wont be people who do take it to another level but those same people are going to drink alcohol or use other drugs.  This ridiculous prohibition needs to stop. I feel it wont however, since the FDA and/or our pharmaceutical companies will not make the millions of dollars that they do from prescription drugs.  Presumably, a negative monograph as described herein, would not apply to products containing marijuana, THC, or any other constituent part of the marijuana plant, sold as food, cosmetics, or beverages - unless unsupported medical claims also are made for their use.Well thanks for that Mr. John Coleman. But let me tell you the FDA is trying to shut down all cannabis foods and dietary constituents (which are not making medical claims) against the will of the American People.   The the hypothetical harm feared by drug war proponents has not materialized under the limited trials in medical and subsequently recreational states.  As conventional science has very slowly embraced the opportunity to study this once wholly forbidden plant, we are discovering the broad potential tied to the natural receptor system, built into the human body triggered by these natural compounds.  Common sense shows the madness has not met with the hype. As my hippie father told me back in the 1980s, the only truly common sense approach would be to legalize and regulate/tax cannabis like tobacco or alcohol. In the states where this method is being tested, the public benefits are clearly apparent.  Abundant public funds are being applied to deficiencies resulting from the recession... Can we honestly evaluate cannabis impact on the economic recovery and burgeoning prosperity of our country? From the local level I can vouch for its reality.  Time to replicate the success in every locality willing to accept the benefits. The hypocrisy of cigarettes and alcohol being legal, without any medicinal uses (both resulting in addiction, permanent damage to the body, and death). while marijuana is considered a controlled substance and a gateway drug to opiod addiction is insane. Marijuana has many medicinal effects, including; pain control, help with appetite  nausea, anxiety and sleep disturbances. Refusing the medicinal use of marijuana equates to patients needing to take multiple medications that can cause horrible side effects and permanent damage to the body, and death. How many deaths have been reported due to marijuana use? *NONE*.  How many overdoses have been reported due to marijuana? *NONE*. WHY is it illegal? Because Big Pharma, lumber and cotton lobbyists will lose profits. If you truly cared about the health and well-being of people, cigarettes and alcohol would be illegal and marijuana would be allowed to help with the symptoms of injuries and illnesses. It would actually help to reduce the opiod epidemic.By denying medicinal marijuana and allowing other damaging  addictive substances shows that you really dont care about the health and well-being of people, only how much $ you can profit from special interest groups. Shame on you  Dr. Coleman is completely correct in re his opposition to Big Pharma and the FDA should place more restraints on their trafficking in dangerous drugs, drugs that are making their way to School age. Please restrain those drug traffickers. I implore you to please whole heartedly reconsider this reclassification of this drug. Please think about your kids and your family members. This is not a cure all. Please understand that we know that. But please understand that we are looking for a solution. We are looking to help our country in more ways than one. We are trying for our mental health. We are wanting the chance to be better.  We think that this cannabis plant could help our children live normal lives when prescription drugs made them lifeless and somber. Its helping people heal. People who fought to save us. Please reschedule the cannabis plant. According to the DEA, schedule I drugs are substances or chemicals that are defined as drugs with no currently accepted medical use and a high potential for abuse. Currently, cannabis is listed as schedule I. It is known that no amount of cannabis has ever caused overdose in any individual. It is also relatively well known that CBD can have several therapeutic properties when used for certain ailments. While the debate about recreational marijuana legalization is still very much an open topic, the rescheduling of cannabis will allow for further study of the drug and its influences on human health and behavior. Cannabis is currently scheduled higher than the often fatal and addictive drug fentanyl. If cannabis is rescheduled, it will allow researchers to gather data in order for the public and the nation to make an informed decision about medical and recreational cannabis in the future. I firmly support the rescheduling of cannabis in order to perform necessary health research. 