Answer 1 of Question, my husband uses CBD oil for sleep. No THC, but no CBD oil is legal in Japan, however THC is not. Most CBD oils. Japan's market for CBD products is growing almost % The products were shipped from its U.S. subsidiary, which operates farms in. Phivida manufactured CBD products are hemp derived, making them federally legal in the US and Japan. The legal distinction is when CBD is.
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However, the proceedings of the Diet discussion on the medical use of Cannabis only involved the above conversations, and the draft of CCA was subsequently passed by the Welfare Committee of the HoC on June 25, , and by the HoC itself on June 28, On July 10, , the CCA was promulgated and enforced. Three commodities concerning Cannabis -based medicines were listed in the Japanese Pharmacopoeia, namely Cannabis indica, Extractum Cannabis indica 1st edition, , and Tinctura Cannabis indicae 4th edition, ; however, these items were deleted in the review process of the sixth edition Then, why was the separation of law necessary to protect the farmers?
Table 2 shows the relationship of the control of cultivation and medical use of narcotics with the CCA 11 and the NCA. On the other hand, the NCA allows medical use of narcotics with a license, but not cultivation.
Cultivation of Cannabis has numerous purposes such as for food, fiber, and medicine, whereas other narcotic plants are grown mainly as sources of drugs. If CCA had allowed not only cultivation but also medical use, its enforcement would have been difficult in terms of controlling the medical use because it was laborious to distinguish which Cannabis farms for which uses especially in the confused period just after the end of the war.
Therefore, in our opinion, the Japanese Government has stifled the medical use of Cannabis to continue allowing its cultivation by hemp farmers and, thereby, has protected the industry.
Indeed, the current version of the CCA only regulates the handling of Cannabis leaves and spikes, which contain psychoactive substances, while the seeds and stem, which are the resource of food and fiber, were excluded from the control. When the laws were enacted in , Cannabis seeds were also subject to the CCA, but were excluded from the control by the third revision of March 17, This amendment was also intended to simplify the control and facilitate the ease of cultivation.
As mentioned previously, although the CCA prohibits the medical use of Cannabis and its extracted products in article 4, it does not regulate the mature stalks, seeds, and related products. It only regulates the leaves and spikes of Cannabis. Indeed, a clinical trial of dronabinol was planned according to the research report of the Ministry of Health, Labour and Welfare MHLW -funded project, 24 but was not initiated.
In , cannabinoids and the endocannabinoid system had not yet been discovered, and the therapeutic properties of Cannabis were not well investigated or provided with a scientific basis.
However, the scientific discovery process of the cannabinoids has been accelerated, which includes investigation of efficacy and safety profiles in clinical trials and this has initiated global approval of phytocannabinoid-based medicines. Therefore, there is no current plausible reason for the regulatory prohibition of investigations of phytocannabinoid-based medicines in Japan.
The evidence of the existence of an endocannabinoid system implies that phytocannabinoids are potentially useful substances for medical applications. The argument that the clinical investigation of synthetic cannabinoids, which is permitted under the current regulation, is sufficient for pharmacological assessments in drug development may be proffered.
However, synthetic cannabinoid medicines usually consist of a single agent, while phytocannabinoid-based medicines and medicinal Cannabis contain various types of cannabinoids as well as terpenoids that might induce the entourage effects to complementary therapeutic activities.
Ultimately, reforming the regulations would be an ethical response to patients who have been appealing for the access to treatment of their diseases with possible phytocannabinoid-based medicines. The regulations need to be positively revised to meet the medical requirements and rights of the patients. It is noteworthy that in , a patient advocacy group commenced appeals for the revision of the CCA in Japan. However, as a prerequisite for the revision, stakeholders need to cooperate with legal professionals to establish a new comprehensive regulatory system to strictly guide the appropriate use of cannabinoid-based medicines, including medical Cannabis.
It is important to prevent the risk of any abuses or evasions of law by learning lessons from the precedents of other countries and developing rigid schemes to control cannabinoid-based medicine, especially medical Cannabis. Legislating a compassionate use program might be one of the choices to improve the current situation without revising article 4 of the CCA.
Moreover, the authors are not in a position to deregulate the recreational use of Cannabis. The demonstration of the existence of the endocannabinoid system in the human body implies that cannabinoids are essential substances and they can be positively applied as therapies for various symptoms and diseases.
There are over basic research studies on cannabinoids that have been supported by the Grants-in-Aid for Scientific Research from the MEXT, and more than 10 of the investigated topics are intended to innovate the drug development or clinical application of Cannabinoids. These regulatory prohibitions have contributed to creating the valley of death, which may be difficult to overcome without revising article 4 of the CCA or creating new regulations such as a compassionate use program.
Phytocannabinoids have been neglected as potentially beneficial therapeutic agents in clinical research for almost 70 years in Japan. Fortunately, Japan recently stepped up efforts to institutionalize changes to foster the Japanese medical research environment. AMED aims to promote integrated research and development in the field of medicine from basic research to clinical trials by consolidating budgets for research expenses, which were previously allocated to several ministries such as the MEXT and MHLW for basic and clinical research, respectively.
Thus, the nation now has a conducive environment and the opportunity to positively revise the regulation on cannabinoids. The government, academia, industries, and medical and legal professionals need to come together cooperatively and address these issues with all seriousness and a view to resolving them. Currently, clinical research on phytocannabinoids is prohibited in Japan based on regulations that were instituted during the postwar period of World War II, which have contributed to the valley of death in cannabinoid translational research.
These prohibitive regulations have been an undesired obstacle to the phytopharmacological development of Cannabis for almost 70 years. Scientific discoveries in cannabinoid research have accelerated our understanding of the potential benefits of these agents.
Consequently, there have been positive reforms of the regulations governing Cannabis globally, and Japanese regulatory bodies are now faced with the window of opportunity to revise article 4 of the CCA.
The first author would like to thank Mr. Cite this article as: National Center for Biotechnology Information , U. Journal List Cannabis Cannabinoid Res v. Published online Jan 1. Find articles by Tempei Miyaji. Find articles by Michiyuki Nagasawa. Find articles by Takuhiro Yamaguchi.
Find articles by Kiichiro Tsutani. Author information Copyright and License information Disclaimer. Associated Data Supplementary Materials Supplemental data. Open in a separate window. Number of articles related to cannabis or cannabinoids on Pubmed. The same applies hereinafter in this item. Methods We conducted a thorough literature review of nationally archived official documents from the end of World War II in to when the CCA was established.
Debate of the Japanese Diet Committee After receiving these memoranda, the Welfare Committee of the Diet held a preparatory meeting to discuss enacting the law of narcotic control. Problem associated with article 4 of the CCA As mentioned previously, although the CCA prohibits the medical use of Cannabis and its extracted products in article 4, it does not regulate the mature stalks, seeds, and related products.
Article 4 of the CCA awaits appropriate revision The demonstration of the existence of the endocannabinoid system in the human body implies that cannabinoids are essential substances and they can be positively applied as therapies for various symptoms and diseases.
Conclusion Currently, clinical research on phytocannabinoids is prohibited in Japan based on regulations that were instituted during the postwar period of World War II, which have contributed to the valley of death in cannabinoid translational research. Supplementary Material Supplemental data: Click here to view.
Author Disclosure Statement No competing financial interests exist. Biochem Biophys Res Commun.
Cannabis in Japan
However, CBD is non-psychoactive and is therefore legal in many Of all countries, the CBD situation within the United States is by far the. But contrary to what these articles suggest, CBD products are not "legal in all 50 US states." If that were the case, why would Ndiaye be charged. New player in Japan's CBD market as Phivida secures regulatory approval and its Vida+ line of clinical CBD hemp oil products in the country.