moonymonkey
Active member
Wake up there trying to ruin the seed businesses discrimination by alternating dna breeding?..stop it nowww get ur seeds In order time wise...s.o.s..plan nowww..
:::::::USA Set to Reschedule Cannabis::::::: HHS Releases Recommendation Documents:::::::
- Thread starter pipeline
- Start date
dogzter
Drapetomaniac
You ok?
Got a sweet new blue glass pipe with good expansion and a new bronze zippo lighter with a cannabis leaf shape raised design. Times are changing. Time to be vocal, don't be afraid to speak up, but get your facts straight and prepare to answer the opposition.
Feds Release Marijuana Documents, Confirming Schedule III Recommendation Based On ‘Accepted Medical Use’
The U.S. government has released hundreds of pages of documents related to its ongoing review of marijuana’s status under federal law, officially confirming for the first time that health officials have recommended the Drug Enforcement Administration (DEA) place cannabis in Schedule III of the...
www.marijuanamoment.net
This is big news because it exposes the open fraud of the authorities demanding cannabis remain a Schedule 1 substance.
"Evidence shows that some individuals are taking marijuana in amounts sufficient to create a hazard to their health and to the safety of other individuals and the community. However,
7 evidence also exists showing that the vast majority of individuals who use marijuana are doing so in a manner that does not lead to dangerous outcomes to themselves or others."
7 evidence also exists showing that the vast majority of individuals who use marijuana are doing so in a manner that does not lead to dangerous outcomes to themselves or others."
moonymonkey
Active member
I'm fine do search it's there
dogzter
Drapetomaniac
I make my own beans same as always.
I bailed on buying and trading when autos and femming became things.
Zippo Manufacturing Company
Shop quality, authentic Zippo windproof pocket lighters in classic, pipe, or Slim®; add a new butane or rechargeable lighter insert too! Shop for a butane or rechargeable Candle Lighter, refillable or rechargeable Hand Warmer, sunglasses, reading glasses, and leather goods.
www.zippo.com
Your search for "cannabis " revealed the following:
There are numerous industries making products for the cannabis consumers. From Zippo to Boveda to Premier Promix media, fertilizer companies, restaurants, harvesting equipment. Cannabis is becoming more and more accepted. It said in the release,
"In this document, the term “marijuana” will be used to refer to Cannabis sativa L., to be responsive to language of the CSA definition of “marihuana” or “marijuana” and its listing as the Schedule I drug class that is subject of this evaluation. The present evaluation of marijuana discusses the scientific and medical information relative to each of the eight factors, presents
5 findings in the three required areas (abuse potential, CAMU, and safety or dependence liability) and makes a recommendation regarding the scheduling of marijuana. It is important to note that this evaluation is necessarily limited in scope and depth to those preclinical, clinical, and epidemiological data that are directly related to determining the abuse potential, physical dependence, and CAMU of marijuana in response to the eight factors described in the CSA. As such, this assessment is comprehensive, but is not exhaustive or encyclopedic. Extensive reviews of marijuana and cannabinoids are publicly available in papers published in the scientific and medical literature, as well as from federal entities such as NIDA and the Congressional Research Service, from professional medical associations, and from the National Academies of Science, Engineering and Medicine (NASEM). The current review is largely focused on modern scientific considerations on whether marijuana has a CAMU and on new epidemiological data related to abuse of marijuana in the years since the 2015 HHS 8FAs on marijuana. In the epidemiological analyses below regarding prevalence of marijuana abuse and associated harms, evaluations included comparators such as heroin (Schedule I), fentanyl (Schedule II), oxycodone (Schedule II), hydrocodone (Schedule II), cocaine (Schedule II), ketamine (Schedule III), benzodiazepines (Schedule IV), zolpidem (Schedule IV), tramadol (Schedule IV), and alcohol (FDA Office of Surveillance and Epidemiology, 2023). Each individual epidemiological database evaluated a specific group of drugs and not every comparator was evaluated under each database. It should be noted that although alcohol is well known to be abused, it was explicitly exempted from control under the CSA when it was enacted. Typically, substances that are not controlled under the CSA are not utilized as comparator drugs for scheduling placement considerations because they may not have been formally evaluated for abuse potential in standard preclinical and clinical abuse-related studies. However, alcohol is included in the analyses because of its extensive availability and use in the United States, which is also observed for nonmedical use of marijuana (also known as recreational use of marijuana). After assessing all available preclinical, clinical, and epidemiological data, FDA recommends that marijuana be rescheduled from Schedule I into Schedule III of the CSA. Schedule III drugs are classified as having a potential for abuse less than the drugs or other substances in schedules I and II, a currently accepted medical use in treatment in the United States, and moderate or low physical dependence or high psychological dependence that may result from their use. NIDA concurs with this recommendation."
"In this document, the term “marijuana” will be used to refer to Cannabis sativa L., to be responsive to language of the CSA definition of “marihuana” or “marijuana” and its listing as the Schedule I drug class that is subject of this evaluation. The present evaluation of marijuana discusses the scientific and medical information relative to each of the eight factors, presents
5 findings in the three required areas (abuse potential, CAMU, and safety or dependence liability) and makes a recommendation regarding the scheduling of marijuana. It is important to note that this evaluation is necessarily limited in scope and depth to those preclinical, clinical, and epidemiological data that are directly related to determining the abuse potential, physical dependence, and CAMU of marijuana in response to the eight factors described in the CSA. As such, this assessment is comprehensive, but is not exhaustive or encyclopedic. Extensive reviews of marijuana and cannabinoids are publicly available in papers published in the scientific and medical literature, as well as from federal entities such as NIDA and the Congressional Research Service, from professional medical associations, and from the National Academies of Science, Engineering and Medicine (NASEM). The current review is largely focused on modern scientific considerations on whether marijuana has a CAMU and on new epidemiological data related to abuse of marijuana in the years since the 2015 HHS 8FAs on marijuana. In the epidemiological analyses below regarding prevalence of marijuana abuse and associated harms, evaluations included comparators such as heroin (Schedule I), fentanyl (Schedule II), oxycodone (Schedule II), hydrocodone (Schedule II), cocaine (Schedule II), ketamine (Schedule III), benzodiazepines (Schedule IV), zolpidem (Schedule IV), tramadol (Schedule IV), and alcohol (FDA Office of Surveillance and Epidemiology, 2023). Each individual epidemiological database evaluated a specific group of drugs and not every comparator was evaluated under each database. It should be noted that although alcohol is well known to be abused, it was explicitly exempted from control under the CSA when it was enacted. Typically, substances that are not controlled under the CSA are not utilized as comparator drugs for scheduling placement considerations because they may not have been formally evaluated for abuse potential in standard preclinical and clinical abuse-related studies. However, alcohol is included in the analyses because of its extensive availability and use in the United States, which is also observed for nonmedical use of marijuana (also known as recreational use of marijuana). After assessing all available preclinical, clinical, and epidemiological data, FDA recommends that marijuana be rescheduled from Schedule I into Schedule III of the CSA. Schedule III drugs are classified as having a potential for abuse less than the drugs or other substances in schedules I and II, a currently accepted medical use in treatment in the United States, and moderate or low physical dependence or high psychological dependence that may result from their use. NIDA concurs with this recommendation."
Currently Accepted Medical Use of Marijuana To inform its scheduling recommendation, HHS has conducted an evaluation of whether marijuana has a CAMU for purposes of scheduling under the CSA, 21 U.S.C. § 812(b). Such an evaluation is one of the findings relevant to the placement of a substance in one of five drug control “schedules” set forth in 21 U.S.C. § 812(b). In evaluating CAMU when considering whether to recommend rescheduling of marijuana, HHS (acting through the FDA and NIDA) applied a two-part test (hereinafter, “CAMU test”) that takes into account the current widespread medical use of marijuana under the supervision of licensed HCPs under state-authorized programs. Under Part 1 of the CAMU test, OASH considered whether there is widespread current experience with medical use of marijuana in the United States by licensed HCPs operating in accordance with implemented state-authorized programs, where such medical use is recognized by entities that regulate the practice of medicine under these state jurisdictions.
Part 2 of the CAMU test evaluated whether there exists some credible scientific support for at least one of the medical conditions for which the Part 1 test is satisfied. FDA’s evaluation in Part 2 is not meant to be, nor is it, a determination of safety and efficacy under the Federal Food, Drug, and Cosmetic Act’s (FD&C Act’s) drug approval standard for new human or animal drugs. Rather, the two-part test is to determine whether a substance, in this case marijuana, has a CAMU for purposes of drug scheduling recommendations and placement in a drug schedule consistent with criteria set forth in 21 U.S.C. 812(b).
In the evaluation and assessment under Part 1 of the CAMU test, OASH found that more than 30,000 HCPs are authorized to recommend the use of marijuana for more than six million registered patients, constituting widespread clinical experience associated with various medical conditions recognized by a substantial number of jurisdictions across the United States. For several jurisdictions, these programs have been in place for several years, and include features that actively monitor medical use and product quality characteristics of marijuana dispensed. OASH, through the Assistant Secretary for Health, concluded that, taken together, the findings from Part 1 warranted an FDA assessment under Part 2 of the CAMU test to determine if there exists credible scientific support for the use of marijuana for at least one of the medical conditions identified by OASH under Part 1.
25 FDA conducted Part 2 of the CAMU test for seven indications, based in part on OASH’s findings under Part 1 of the CAMU test9 and in part on FDA’s own analysis of the landscape in which marijuana is currently used medically, including information from state-authorized programs on how and to what extent marijuana is being utilized for medical purposes. The seven indications are: anorexia,10 anxiety,11 epilepsy, inflammatory bowel disease (IBD), nausea and vomiting, pain, and post-traumatic stress disorder (PTSD). FDA’s evaluation under Part 2 of the CAMU test was based on systematic reviews of studies investigating the safety and effectiveness of marijuana, relevant professional societies’ position statements, data from state medical marijuana programs and United States national surveys, and the labeling of FDA-approved products relevant to the analysis. In evaluating whether there exists some credible scientific support under
Part 2 of the CAMU test for a particular use, factors considered in favor of a positive finding included whether: 1) favorable clinical studies of the medical use of marijuana, although not necessarily adequate and well-controlled clinical studies that would support approval of a NDA, have been published in peer-reviewed journals and/or 2) qualified expert organizations (e.g., academic groups, professional societies, or government agencies) have opined in favor of the medical use or provided guidance to HCPs on the medical use. Factors considered that weigh against a finding that Part 2 of the CAMU test is met included whether: 1) data or information indicate that medical use of the substance is associated with unacceptably high safety risks for the likely patient population, e.g., due to toxicity concerns; 2) clinical studies with negative efficacy findings for the medical use of marijuana have been published in peer reviewed journals; and/or 3) qualified expert organizations (e.g., academic or professional societies, government agencies) recommend against the medical use of marijuana (based on the available data at the time of their position statement). Our review of the available information identified mixed findings of effectiveness across indications, ranging from data showing inconclusive findings to considerable evidence in favor of effectiveness, depending on the source. The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain). For the pain indication, a systematic review of scientific and medical literature was conducted this year by the
University of Florida (UF) under contract with FDA. UF epidemiologists identified some data supporting effectiveness of marijuana, including some within their own meta-analysis; however, they ultimately concluded the results are inconclusive or mixed. FDA also conducted a separate review of published scientific reviews. Several of those reviews drew conclusions similar to UF. In contrast, numerous other systematic reviews concluded that there exists some level of evidence supporting the use of marijuana for painful conditions. Other reviews, such as the (National Academies of Sciences & Medicine, 2017), concluded there was “substantial evidence”12 supporting the use of cannabis products relevant to this review for pain. The Agency for Healthcare Research and Quality’s (AHRQ) living systematic review has concluded that there is some support for the use of marijuana-related products in the treatment of pain, but overall concluded these effects were small and the increased risk of dizziness, nausea, and sedation may limit the benefit. UF evaluated other therapeutic conditions mentioned above, i.e., anorexia, anxiety, epilepsy, inflammatory bowel disease (IBD), nausea, and PTSD, employing a similar systematic review of scientific and medical literature. UF found that there is low- to moderate-quality evidence13 supporting the use of marijuana as medical treatment for outcomes in anorexia, nausea and vomiting, and PTSD. However, FDA review of systematic reviews showed mixed results for these indications. In particular, FDA found that the potential for psychiatric adverse events associated with treating PTSD with marijuana may be more substantial than any limited benefit in observational studies.
Although UF did not conclude that there was evidence in support of the effectiveness of marijuana in IBD, both their review and other systematic reviews found some benefit with respect to subjective symptoms in this condition. With regard to epilepsy and anxiety, both UF’s review and FDA’s review of other systematic reviews did not find support for marijuana providing benefit in the treatment of these conditions. Where positive results on effectiveness outcome measures were found, the effects and the quality of evidence were generally in the low-to-moderate range. UF did not find high quality evidence supporting worsening of outcomes in any indication. None of the evidence from the systematic reviews included in our CAMU Part 2 analysis identified any safety concerns that would preclude the use of marijuana in the indications for which there exists some credible scientific support for its therapeutic benefit. The clinical safety data identified in the literature from controlled trials were generally consistent between sources but limited in the rigor of safety reporting. The vast majority of the observational studies evaluated in the context of medical use were excluded from the final synthesis of evidence due to concerns regarding their quality (only one observational study for the anxiety indication and one for the PTSD indication were included). Generally, data on safety from both clinical trials and observational studies were scarce. Literature shows marijuana has more AEs when compared to a placebo or active control group, however, typically in the mild to moderate severity range. Severe AEs were uncommon.27
FDA also reviewed results from state reporting data from 37 states with medical marijuana programs and surveys of patients using marijuana in Maryland and Minnesota, which had data available for review. Surveys of patients using marijuana in these two states found most patients did not report any side effects and those that did report side effects mostly described them as mild. Neither state’s databases included patients who chose to stop using marijuana, which may result in an overestimation of positive experiences. To date, real-world data sources available to FDA, in general, lack the necessary elements to identify the exposure (i.e., marijuana), to distinguish the reason for use (medical vs. recreational) and, if applicable, the condition that prompted its medical use, and/or to permit sound inferential analyses. Therefore, they were not included in this review.
Data from United States national surveys, in general, lacked details on patient characteristics and factors that prompted the use of marijuana for medical purposes, and data collection for these surveys was impacted by the coronavirus disease of 2019 (COVID-19) pandemic. Despite these limitations, these data suggested that medical use of marijuana increases as age increases. Only data from one survey provided information on the intended indication for use, suggesting that individuals often use marijuana to improve or manage conditions such as depression, anxiety, PTSD, pain, headaches or migraines, sleep disorders, nausea and vomiting, lack of appetite, and muscle spasms, but only approximately half of them reportedly had ever asked a healthcare professional for a recommendation to use medical marijuana. Additionally, although the safety data obtained from use in a medical context are considered to be the most relevant for the CAMU analysis, FDA evaluated the safety of marijuana in the nonmedical setting to inform the potential for more severe outcomes.
Specifically, FDA evaluated safety outcomes related to marijuana use in the setting of nonmedical use, use of uncertain intent, and unintentional exposure through a variety of epidemiological data sources and in relation to several comparator substances controlled under the CSA, including drugs in Schedule I: heroin (an illicit opioid drug); Schedule II: hydrocodone and oxycodone (approved opioid prescription drug products), cocaine and fentanyl (largely illicitly produced drugs in the nonmedical use setting, although there are approved prescription drugs); Schedule III: ketamine (an approved prescription drug); and Schedule IV: zolpidem, benzodiazepines, and tramadol (approved prescription drugs) (FDA Office of Surveillance and Epidemiology, 2023). The comparative data demonstrate that, even in the context of nonmedical use, marijuana has a less concerning overall safety profile relative to the comparators for a number of important outcomes (e.g., single substance use overdose death, hospitalizations). However, in young children, population-adjusted rates of ED visits and hospitalizations involving marijuana poisoning were higher than heroin, cocaine, and benzodiazepines for the periods studied. Of note, some of the comparator substances are approved for use in conditions similar to the indications for which marijuana was evaluated in the CAMU analysis (e.g., opioids for pain, benzodiazepines for anxiety-related conditions). FDA also considered position statements from professional organizations relevant to the indications discussed. The vast majority of professional organizations did not recommend the use of marijuana in their respective specialty; however, none specifically recommended against28
it, with the exception of the American Psychiatric Association (APA), which stated that marijuana is known to worsen certain psychiatric conditions. On balance, the available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain, anorexia related to a medical condition, and nausea and vomiting, with varying degrees of support and consistency of findings. Additionally, no safety concerns were identified in our review that would indicate that medical use of marijuana poses unacceptably high safety risks for the indications where there is some credible scientific evidence supporting its therapeutic use. Conclusions of CAMU Based on the totality of the available data, we conclude that there exists some credible scientific support for the medical use of marijuana in at least one of the indications for which there is widespread current experience in the United States, as identified by OASH under Part 1 of the CAMU test.
Seven indications were selected for evaluation under Part 2 of the CAMU test based on conclusions from Part 1 of the CAMU test as well as the FDA’s analysis of the landscape of medical use of marijuana. The indications evaluated anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, nausea and vomiting (e.g., chemotherapy-induced), pain, and post-traumatic stress disorder. The analysis and conclusions on the available data are not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication. However, the available data do provide some level of support for the way marijuana is being used in clinical practice. Thus, based on the widespread HCP experience and the extent of medical use evaluated by OASH under the Part 1 test, and an evaluation of available credible scientific support described herein for at least some therapeutic uses identified in the Part 1 test, we find that that, for purposes of the drug scheduling criteria in 21 U.S.C. 812(b), marijuana has a CAMU in the United States for: anorexia related to a medical condition; nausea and vomiting (e.g., chemotherapy-induced); and pain.
Part 2 of the CAMU test evaluated whether there exists some credible scientific support for at least one of the medical conditions for which the Part 1 test is satisfied. FDA’s evaluation in Part 2 is not meant to be, nor is it, a determination of safety and efficacy under the Federal Food, Drug, and Cosmetic Act’s (FD&C Act’s) drug approval standard for new human or animal drugs. Rather, the two-part test is to determine whether a substance, in this case marijuana, has a CAMU for purposes of drug scheduling recommendations and placement in a drug schedule consistent with criteria set forth in 21 U.S.C. 812(b).
In the evaluation and assessment under Part 1 of the CAMU test, OASH found that more than 30,000 HCPs are authorized to recommend the use of marijuana for more than six million registered patients, constituting widespread clinical experience associated with various medical conditions recognized by a substantial number of jurisdictions across the United States. For several jurisdictions, these programs have been in place for several years, and include features that actively monitor medical use and product quality characteristics of marijuana dispensed. OASH, through the Assistant Secretary for Health, concluded that, taken together, the findings from Part 1 warranted an FDA assessment under Part 2 of the CAMU test to determine if there exists credible scientific support for the use of marijuana for at least one of the medical conditions identified by OASH under Part 1.
25 FDA conducted Part 2 of the CAMU test for seven indications, based in part on OASH’s findings under Part 1 of the CAMU test9 and in part on FDA’s own analysis of the landscape in which marijuana is currently used medically, including information from state-authorized programs on how and to what extent marijuana is being utilized for medical purposes. The seven indications are: anorexia,10 anxiety,11 epilepsy, inflammatory bowel disease (IBD), nausea and vomiting, pain, and post-traumatic stress disorder (PTSD). FDA’s evaluation under Part 2 of the CAMU test was based on systematic reviews of studies investigating the safety and effectiveness of marijuana, relevant professional societies’ position statements, data from state medical marijuana programs and United States national surveys, and the labeling of FDA-approved products relevant to the analysis. In evaluating whether there exists some credible scientific support under
Part 2 of the CAMU test for a particular use, factors considered in favor of a positive finding included whether: 1) favorable clinical studies of the medical use of marijuana, although not necessarily adequate and well-controlled clinical studies that would support approval of a NDA, have been published in peer-reviewed journals and/or 2) qualified expert organizations (e.g., academic groups, professional societies, or government agencies) have opined in favor of the medical use or provided guidance to HCPs on the medical use. Factors considered that weigh against a finding that Part 2 of the CAMU test is met included whether: 1) data or information indicate that medical use of the substance is associated with unacceptably high safety risks for the likely patient population, e.g., due to toxicity concerns; 2) clinical studies with negative efficacy findings for the medical use of marijuana have been published in peer reviewed journals; and/or 3) qualified expert organizations (e.g., academic or professional societies, government agencies) recommend against the medical use of marijuana (based on the available data at the time of their position statement). Our review of the available information identified mixed findings of effectiveness across indications, ranging from data showing inconclusive findings to considerable evidence in favor of effectiveness, depending on the source. The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain). For the pain indication, a systematic review of scientific and medical literature was conducted this year by the
University of Florida (UF) under contract with FDA. UF epidemiologists identified some data supporting effectiveness of marijuana, including some within their own meta-analysis; however, they ultimately concluded the results are inconclusive or mixed. FDA also conducted a separate review of published scientific reviews. Several of those reviews drew conclusions similar to UF. In contrast, numerous other systematic reviews concluded that there exists some level of evidence supporting the use of marijuana for painful conditions. Other reviews, such as the (National Academies of Sciences & Medicine, 2017), concluded there was “substantial evidence”12 supporting the use of cannabis products relevant to this review for pain. The Agency for Healthcare Research and Quality’s (AHRQ) living systematic review has concluded that there is some support for the use of marijuana-related products in the treatment of pain, but overall concluded these effects were small and the increased risk of dizziness, nausea, and sedation may limit the benefit. UF evaluated other therapeutic conditions mentioned above, i.e., anorexia, anxiety, epilepsy, inflammatory bowel disease (IBD), nausea, and PTSD, employing a similar systematic review of scientific and medical literature. UF found that there is low- to moderate-quality evidence13 supporting the use of marijuana as medical treatment for outcomes in anorexia, nausea and vomiting, and PTSD. However, FDA review of systematic reviews showed mixed results for these indications. In particular, FDA found that the potential for psychiatric adverse events associated with treating PTSD with marijuana may be more substantial than any limited benefit in observational studies.
Although UF did not conclude that there was evidence in support of the effectiveness of marijuana in IBD, both their review and other systematic reviews found some benefit with respect to subjective symptoms in this condition. With regard to epilepsy and anxiety, both UF’s review and FDA’s review of other systematic reviews did not find support for marijuana providing benefit in the treatment of these conditions. Where positive results on effectiveness outcome measures were found, the effects and the quality of evidence were generally in the low-to-moderate range. UF did not find high quality evidence supporting worsening of outcomes in any indication. None of the evidence from the systematic reviews included in our CAMU Part 2 analysis identified any safety concerns that would preclude the use of marijuana in the indications for which there exists some credible scientific support for its therapeutic benefit. The clinical safety data identified in the literature from controlled trials were generally consistent between sources but limited in the rigor of safety reporting. The vast majority of the observational studies evaluated in the context of medical use were excluded from the final synthesis of evidence due to concerns regarding their quality (only one observational study for the anxiety indication and one for the PTSD indication were included). Generally, data on safety from both clinical trials and observational studies were scarce. Literature shows marijuana has more AEs when compared to a placebo or active control group, however, typically in the mild to moderate severity range. Severe AEs were uncommon.27
FDA also reviewed results from state reporting data from 37 states with medical marijuana programs and surveys of patients using marijuana in Maryland and Minnesota, which had data available for review. Surveys of patients using marijuana in these two states found most patients did not report any side effects and those that did report side effects mostly described them as mild. Neither state’s databases included patients who chose to stop using marijuana, which may result in an overestimation of positive experiences. To date, real-world data sources available to FDA, in general, lack the necessary elements to identify the exposure (i.e., marijuana), to distinguish the reason for use (medical vs. recreational) and, if applicable, the condition that prompted its medical use, and/or to permit sound inferential analyses. Therefore, they were not included in this review.
Data from United States national surveys, in general, lacked details on patient characteristics and factors that prompted the use of marijuana for medical purposes, and data collection for these surveys was impacted by the coronavirus disease of 2019 (COVID-19) pandemic. Despite these limitations, these data suggested that medical use of marijuana increases as age increases. Only data from one survey provided information on the intended indication for use, suggesting that individuals often use marijuana to improve or manage conditions such as depression, anxiety, PTSD, pain, headaches or migraines, sleep disorders, nausea and vomiting, lack of appetite, and muscle spasms, but only approximately half of them reportedly had ever asked a healthcare professional for a recommendation to use medical marijuana. Additionally, although the safety data obtained from use in a medical context are considered to be the most relevant for the CAMU analysis, FDA evaluated the safety of marijuana in the nonmedical setting to inform the potential for more severe outcomes.
Specifically, FDA evaluated safety outcomes related to marijuana use in the setting of nonmedical use, use of uncertain intent, and unintentional exposure through a variety of epidemiological data sources and in relation to several comparator substances controlled under the CSA, including drugs in Schedule I: heroin (an illicit opioid drug); Schedule II: hydrocodone and oxycodone (approved opioid prescription drug products), cocaine and fentanyl (largely illicitly produced drugs in the nonmedical use setting, although there are approved prescription drugs); Schedule III: ketamine (an approved prescription drug); and Schedule IV: zolpidem, benzodiazepines, and tramadol (approved prescription drugs) (FDA Office of Surveillance and Epidemiology, 2023). The comparative data demonstrate that, even in the context of nonmedical use, marijuana has a less concerning overall safety profile relative to the comparators for a number of important outcomes (e.g., single substance use overdose death, hospitalizations). However, in young children, population-adjusted rates of ED visits and hospitalizations involving marijuana poisoning were higher than heroin, cocaine, and benzodiazepines for the periods studied. Of note, some of the comparator substances are approved for use in conditions similar to the indications for which marijuana was evaluated in the CAMU analysis (e.g., opioids for pain, benzodiazepines for anxiety-related conditions). FDA also considered position statements from professional organizations relevant to the indications discussed. The vast majority of professional organizations did not recommend the use of marijuana in their respective specialty; however, none specifically recommended against28
it, with the exception of the American Psychiatric Association (APA), which stated that marijuana is known to worsen certain psychiatric conditions. On balance, the available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain, anorexia related to a medical condition, and nausea and vomiting, with varying degrees of support and consistency of findings. Additionally, no safety concerns were identified in our review that would indicate that medical use of marijuana poses unacceptably high safety risks for the indications where there is some credible scientific evidence supporting its therapeutic use. Conclusions of CAMU Based on the totality of the available data, we conclude that there exists some credible scientific support for the medical use of marijuana in at least one of the indications for which there is widespread current experience in the United States, as identified by OASH under Part 1 of the CAMU test.
Seven indications were selected for evaluation under Part 2 of the CAMU test based on conclusions from Part 1 of the CAMU test as well as the FDA’s analysis of the landscape of medical use of marijuana. The indications evaluated anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, nausea and vomiting (e.g., chemotherapy-induced), pain, and post-traumatic stress disorder. The analysis and conclusions on the available data are not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication. However, the available data do provide some level of support for the way marijuana is being used in clinical practice. Thus, based on the widespread HCP experience and the extent of medical use evaluated by OASH under the Part 1 test, and an evaluation of available credible scientific support described herein for at least some therapeutic uses identified in the Part 1 test, we find that that, for purposes of the drug scheduling criteria in 21 U.S.C. 812(b), marijuana has a CAMU in the United States for: anorexia related to a medical condition; nausea and vomiting (e.g., chemotherapy-induced); and pain.
I feel bad for paying taxes to this corrupt system. War is hell.
Check it out, the Health and Human Services, Food and Drug Administion sent a letter to the DEA, and it was just released in the unredacted form. Check out these condemning statements. The open fraud of criminalizing cainnabis is being exposed as they cannot maintain cannabis has NO accepted medical use any longer. DEA and other groups continue to demand Cannabis remain Schedule 1 substance considered dangerous and non-medical, until they can do further studies.
Check it out, the Health and Human Services, Food and Drug Administion sent a letter to the DEA, and it was just released in the unredacted form. Check out these condemning statements. The open fraud of criminalizing cainnabis is being exposed as they cannot maintain cannabis has NO accepted medical use any longer. DEA and other groups continue to demand Cannabis remain Schedule 1 substance considered dangerous and non-medical, until they can do further studies.
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Sweatloaf
Well-known member
Why the hell a single word needed to be redacted on the initial publishing of the document will never in my opinion have been justified, but apparently government scientists back the idea of reclassifying from Schedule I to Schedule III rather than declassifying like alcohol and tobacco are. Unfortunately I think, should this happen, that it sets the stage for Big Pharma to in effect, control cannabis and the federal government to continue to do so as well.
Sweatloaf
Well-known member
Any argument that cannabis has no accepted medical use is baseless and so obviously false that the majority of Americans (including those who don't use cannabis at all) in poll after poll don't believe it. How the DEA could continue to try to dupe people to believing this is baffling.
Yeah the move to schedule 3 still creates a conflict with state adult-use legalization laws.
They are aiming to make everyone a criminal over this. Looks like a real showdown, but the DEA said in their letter, they are taking into consideration several things. They named the recommendations of HHS as well as statutory and regulatory laws (such as adult-use legalization), health and substance use pattern research, among other things...
They are aiming to make everyone a criminal over this. Looks like a real showdown, but the DEA said in their letter, they are taking into consideration several things. They named the recommendations of HHS as well as statutory and regulatory laws (such as adult-use legalization), health and substance use pattern research, among other things...
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