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US Federal Gov't wants input on cannabis reclassification

Discussion in 'Legalization and Activism' started by HighMountainSkier, Apr 6, 2018.

  1. This just came out today. Final draft should be released on Monday April 9, 2018.

    Federal Register :: Public Inspection: International Drug Scheduling; Convention on Psychotropic Substances: Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; Cannabidiol
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  2. Can't wait to read that shit it's been a long time coming. Get away from Reefer Madness. At the very least it's on it alcohol tip. All them fake ass lies and rumors over the freaking last 80 years can't wait to read it I hope there's truth in it not a bunch of fake ass lies. Maybe I should say fake news LOL

    Sent from my LGMS631 using Tapatalk
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    Food and Drug Administration
    [Docket No. FDA-2018-N-1072]
    International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9- Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; Cannabidiol; Request for Comments

    AGENCY: Food and Drug Administration, HHS.
    ACTION: Notice; request for comments.
    SUMMARY: 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. 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. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).
    DATES: Submit either electronic or written comments by April 23, 2018.

    I. Background
    The United States is a party to the 1971 Convention on Psychotropic Substances

    (Psychotropic Convention). Article 2 of the Psychotropic Convention provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it shall so notify the Secretary-General of the United Nations (the U.N. Secretary-General) and provide the U.N. Secretary-General with information in support of its opinion.

    Paragraph (d)(2)(A) of the CSA (21 U.S.C. 811) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Psychotropic Convention that it has information that may justify adding a drug or other substances to one of the schedules of the Psychotropic Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of the scientific and medical evaluations of the drug or substance.

    II. WHO Notification
    The Secretary of HHS received the following notice from WHO:

    The World Health Organization (WHO) presents its compliments to Member States and Associate Members and has the pleasure of informing that the 40th Expert Committee on Drug Dependence (ECDD) will meet in Geneva from 4 to 8 June 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. WHO will make recommendations to the UN Secretary-General on the need for and level of international control of these substances. Recommendations made from the 39th meeting can be found on the ECDD website (https://www.who.int/mason/entity/medicines/news/2017/letter-DG- 39thECDDrecommendations.pdf?ua=1).

    At its 126th session in January 2010, the Executive Board approved thepublication “Guidance on the WHO review of psychoactive substances for international control” (EB126/2010/REC1, Annex 6) which requires theSecretariat to request relevant information from Ministers of Health in Member States to prepare a report for submission to the ECDD. For this purpose, a questionnaire was designed to gather information on the legitimate use, harmful use, status of national control and potential impact of international control for each substance under evaluation. Member States are invited to collaborate, as in

    the past, in this process by providing pertinent information as requested in the questionnaire and concerning substances under review.

    It would be appreciated if a person from the Ministry of Health could be designated as the focal point responsible for coordinating answers to the questionnaires. A list of focal points designated by Member States for the 39th ECDD in November 2017 is attached. It is requested that if a focal point’scontact details including email address are to be added or amended, that Member States inform the Secretariat by 26 February 2018. Any additions or amendments to focal point designations should be emailed to ecddsecretariat@who.int.


    III. Substances Under WHO Review
    WHO will convene in a special session to review the following substances: cannabis plant and resin; extracts and tinctures of cannabis; delta-9-tetrahydrocannabinol (THC; stereoisomers of THC; and cannabidiol (CBD).

    The Committee from the 37th ECDD requested that Secretariat begin collecting data towards a pre-review of cannabis, cannabis resin, extracts, and tinctures of cannabis at a future meeting. Subsequent to this request, WHO commissioned two updates on the scientific literature for cannabis and cannabis resin, which were prepared and presented to the 38th ECDD. That Committee noted that the current Schedule I under the 1961 Convention groups together cannabis and cannabis resin, extracts, and tinctures of cannabis, that cannabis plant and cannabis resin are also in Schedule IV of the 1961 Convention, that there are natural and synthetic cannabinoids in Schedule I and Schedule II of the 1971 Convention, and that cannabis had never been subject to pre-review or critical review by the ECDD. The Committee also noted an increase in the use of cannabis and its components for medical purposes and the emergence of new cannabis-related pharmaceutical preparations for therapeutic use. From this review, the 38th ECDD Committee recommended that preparations be made to conduct pre-reviews at a future meeting dedicated to the following substances: cannabis plant and cannabis resin, extracts and tinctures of cannabis, THC, CBD, and stereoisomers of THC. An excerpt from the report of the 38th ECDD stated that the purpose of the pre-review was to determine whether current information justifies an Expert Committee critical review. They noted that the categories of information for evaluating substances in pre-reviews are identical to those used in critical reviews and that the pre-review is a preliminary analysis, and findings should not determine whether the control status of a substance should be changed.

    Cannabis, also known as marijuana, refers to the dried leaves, flowers, stems, and seeds from the Cannabis sativa or Cannabis indica plant. It is a complex plant substance containing multiple cannabinoids and other compounds, including the psychoactive chemical THC and other structurally similar compounds. Cannabinoids are defined as having activity at cannabinoid 1 and 2 (CB1 and CB2 respectively) receptors. Agonists of CB1 receptors are widely abused and are known to modulate motor coordination, memory processing, pain, and inflammation, and have anxiolytic effects. Marijuana is the most commonly used illicit drug in the United States.

    The principal cannabinoids in the cannabis plant include THC, CBD, and cannabinol. FDA has not approved any product containing or derived from botanical marijuana for any indication. These substances are controlled in Schedule I under the CSA. Synthetic THC (dronabinol) is the active ingredient in two approved drug products in the United States, MARINOL capsules (and generics) and SYNDROS oral solution. MARINOL is controlled in Schedule III, while SYNDROS is controlled in Schedule II under the CSA. Both MARINOL and SYNDROS are approved to treat anorexia associated with weight loss in patients with acquired immunodeficiency syndrome (AIDS), and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional treatment.

    CBD is another cannabinoid identified in cannabis. CBD has been tested in experimental animal and laboratory models of several neurological disorders, including those of seizure and epilepsy. In the United States, CBD-containing products are in human clinical testing in several therapeutic areas, but no such products have marketing approval by FDA for any medical purposes in the United States. CBD is controlled as a Schedule I substance under the CSA.

    CBD is not specifically listed in the schedules of the 1961, 1971, or 1988 International Drug Control conventions.

    At the 39th (2017) meeting of the ECDD, the committee pre-reviewed CBD and recommended that extracts or preparations containing almost exclusively CBD be subject to critical review at the 40th ECDD meeting.

    IV. Opportunity to Submit Domestic Information
    As required by paragraph (d)(2)(A) of the CSA, FDA, on behalf of HHS, invites interested persons to submit comments regarding the five drug substances. Any comments received will be considered by HHS when it prepares a scientific and medical evaluation of these drug substances, responsive to the WHO Questionnaire request for these drug substances. HHS will forward such evaluation of these drug substances to WHO, for WHO’s consideration in deciding whether to recommend international control/decontrol of any of these drug substances. Such control could limit, among other things, the manufacture and distribution (import/export) of these drug substances and could impose certain recordkeeping requirements on them.

    Although FDA is, through this notice, requesting comments from interested persons, which will be considered by HHS when it prepares an evaluation of these drug substances, HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in mid-2018. Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting public comments, as required by paragraph (d)(2)(B) of the CSA.
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  4. Any opinions on what is going to be the outcome of this?
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  5. It says he is just lobbying for medical at the end of the article. What a bummer. Crazy how you can be caught being a crooked politician and still have grounds to operate.
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  6. I can only imagine some of the feed back their getting. Probably pathetic bunch of suits laughing all day at post from dumb asses.
    Hopefully someone intelligent is covering our asses.
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  7. I'm not even reading it it sort of sounds interesting but I'm not from the USA. It's a shame here in the UK they couldn't do more about cannabis other than it being a class b drug or whatever it is these days bit still something you can be arrested for.

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  8. I honestly believe someone somewhere is stopping the legalization or even just the reclassification of cannabis merely for personal gain. Which is down right despicable.

    We aren't just talking about a means for fuels, foods, medicines, and economic expansion. We are talking about a plant that grows naturally on this earth, a plant that can heal the planet if used correctly, and a plant that can change the outcome of how we as humans, well and really the rest of life on this planet foresees the future to come.

    If used respectively as well as intelligently, we can reverse some of the side effects we've created in the past. We can bring back health to ourselves and help the ecosystems flourish with food supplies. Increasing the fertility of the soils, reducing the industrial waste that pollutes our rivers, streams, lakes, ponds, and air. Bringing with it vigor to our fish species, animals, reptiles, insects, forests, fields, etc. The list goes on, and with that new found rejuvenation of the earth, comes the resurgence of ourselves.

    Not to mention the economy will soon begin to flourish and with it, its people. Here's a small example. Farmers can benifit as well as the companies that produce equipment because with the increase of farm labor, comes a need for tools. Many jobs will be established.

    If you think of all the starvation and then you see a plant that can and does grow almost anywhere, one with seeds that provide all the live giving fatty acids needed and produces complete proteins and essential oil on an ideal ratio for human consumption, you surely can see the impact it can make on the lives of those who need it the most. Now that's hemp I am speaking of in most cases but in all actuality "marijuana" as the drug form as it issometimes referred to as is important in many facets as well, and technically from the same plant.

    You guys can see the many points we all make here though right? 100% without a doubt, the decriminalization or better yet, legalization of the cannabis plant is almost indisputably the only way to go. It is an act of war carried out not just on you and I but on our Mother Earth. From some folks who are trying to safeguard their own profitable assets. In a race against time to countiue their established control.

    We must fight back. Something has got to give. Don't give up and certainly don't let them continue to misinform us. Open your eyes and see the truth. Even though I know it's hard when they are red and droopy. :GettingStoned:

    J Evergreen
  9. I totally agree man. There’s to much to gain by keeping ppl sick both mentally and physically. And the pharmaceutical company is world wide.
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  10. Goldman Sachs is already questioning whether it's financially smart to fund researchers who can actually cure diseases. We live in very sad times.

    "The potential to deliver 'one shot cures' is one of the most attractive aspects of gene therapy, genetically-engineered cell therapy and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies," analyst Salveen Richter wrote in the note to clients Tuesday. "While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow."

    To go back to the OP subject, just like the new census that asks if 'you are a legal citizen' that the current resident of the white house is putting out, they may not receive proper feedback because people are afraid to admit to committing a federal crime.
  11. #12 Jeffro7, Apr 23, 2018
    Last edited: Jun 1, 2018

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