On Sept. 27, the Drug Enforcement Administration for the first time rescheduled a cannabis-derived product: Epidiolex, a treatment for epileptic seizures. The DEA placed Epidiolex in Schedule V of the 1970 Controlled Substances Act, the classification for drugs with accepted medical applications and a low potential for abuse.<\/p>\n
But much to the consternation of cannabis advocates, CBD, the cannabinoid that is the active ingredient in\u00a0Epidiolex<\/a>, was not itself rescheduled. CBD remains in Schedule I<\/a>, the highly restrictive classification for drugs that supposedly have a high potential for abuse and no legitimate medical applications.<\/p>\n But according to a letter that FDA sent to the DEA that has just recently been made public, the FDA also believes that CBD should be removed from the list of scheduled drugs. The\u00a0Marijuana Moment<\/a>\u00a0website reports that in a May letter to the DEA, the FDA had actually questioned whether CBD should be considered a controlled substance at all. The letter reveals something of the bureaucratic back-and-forth between the two agencies concerning CBD and its status under both the Controlled Substances Act and the U.N. Single Convention treaty, which sets international standards for the classification of controlled substances.<\/p>\n According to the FDA letter, studies have demonstrated that \u201cCBD and its salts\u2026 do not have a significant potential for abuse and could be removed\u201d from the Controlled Substances Act.<\/p>\n The FDA found that CBD has \u201cnegligible potential for abuse,\u201d has a \u201ccurrently accepted medical use in treatment,\u201d and that any possible abuse \u201cmay lead to limited physical dependence\u201d similar to other Schedule V drugs. \u201cUpon consideration\u201d of these and other factors, the FDA asserted that CBD \u201ccould be removed from control\u201d under the CSA.<\/p>\n \u201cWe reach this conclusion because we find that CBD does not meet the criteria for placement in any of Schedules II, III, IV, or V under the CSA,\u201d the letter stated.<\/p>\n<\/blockquote>\n However, the letter also made note that the previous month, the DEA had \u201casserted that the United States would not be able to keep obligations under the 1961 Single Convention on Narcotic Drugs if CBD were decontrolled under the CSA.\u201d<\/p>\n In response to this concern, the FDA amended its recommendation, advising the DEA to place CBD in Schedule V, the least restrictive category under the CSA. But the FDA included a caveat, still holding out hope for CBD\u2019s eventual descheduling: \u201cIf treaty obligations do not require control of CBD, or if the international controls on CBD change in the future, this recommendation will need to be promptly revisited.\u201d\u00a0<\/strong><\/p>\n The path to this seemingly contradictory policy began with the Food & Drug Administration\u2019s June 25 approval of Epidiolex, produced by the British multinational\u00a0GW Pharmaceuticals<\/a>. This approval came despite CBD\u2019s Schedule I status. With the DEA obliged by the FDA decision to reconsider that status, cannabis advocates hoped that CBD or marijuana would be rescheduled, or even descheduled \u2014 that is, removed from the schedule system entirely. These hopes were dashed by the DEA\u2019s decision to just reschedule\u00a0Epidiolex.<\/p>\n The DEA\u2019s own statement upon its September decision was somewhat equivocal.<\/p>\n \u201cDEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,\u201d the agency\u2019s acting administrator Uttam Dhillon said in a\u00a0press release<\/a>. \u201cDEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective.\u201d<\/p>\n The pharmaceutical industry was immediately enthused, with companies hoping their own cannabis-derived products could be next.<\/p>\n Nevada-based\u00a0GB Sciences<\/a> \u2014 now\u00a0working<\/a>\u00a0with\u00a0Catalent<\/a>\u00a0of New Jersey to develop a cannabinoid-based treatment for Parkinson\u2019s disease \u2014 said in a\u00a0press release<\/a>\u00a0that the company \u201chas gained momentum in its innovative drug discovery program with the Drug Enforcement Administration\u2019s decision\u2026 There is now both a regulatory precedent for market approval on a plant-based cannabinoid-containing drug and a path to its commercialization\u2026 The odds of successful commercialization of cannabis-based therapeutics have now been greatly increased, not only in the U.S., but given the stature of the U.S. FDA, across the globe.\u201d<\/p>\n Dr. Andrea Small-Howard, chief science officer of GB Sciences, added, \u201cI am very hopeful about the rescheduling of FDA-approved CBD to Schedule V\u2026 \u00a0This may be the best time in history to be developing cannabis-based medicines!\u201d<\/p>\n But her statement was somewhat misleading, as the DEA actually hasn\u2019t rescheduled CBD \u2014 only opened the door for rescheduling patented pharmaceutical products that contain the cannabinoid and less than 0.1 percent THC, and gain FDA approval.<\/p>\n Cannabis advocates meanwhile lament not only that CBD itself remains in Schedule I, but that neither the FDA nor DEA has considered any change in the Schedule I status of the psychoactive cannabinoid\u00a0THC.<\/p>\n \u201cWe anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. These are welcome alternatives,\u201d said Paul Armentano, deputy director of the National Organization for the Reform of Marijuana Laws (NORML<\/a>), speaking to\u00a0The Fix<\/a>, a website dedicated to issues of addiction and recovery. \u201cBut these products should not be regulated in such a manner that patients no longer have ready access to herbal cannabis \u2014 a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 31 states.\u201d<\/p>\n TELL US<\/strong>, do you think the DEA should take CBD off the Controlled Substances List?<\/p>\n The post Report: The DEA Ignored the FDA\u2019s Call to Deschedule CBD<\/a> appeared first on Cannabis Now<\/a>.<\/p>\n
On Sept. 27, the Drug Enforcement Administration for the first time rescheduled a cannabis-derived product: Epidiolex, a treatment for epileptic seizures. The DEA placed Epidiolex in Schedule V of the 1970 Controlled Substances Act, the classification for drugs with accepted medical applications and a low potential for abuse. But muchContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":190,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[5615,50,689,848,3156,1170,3157,81,6083],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/29716"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/190"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=29716"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/29716\/revisions"}],"predecessor-version":[{"id":29717,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/29716\/revisions\/29717"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=29716"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=29716"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=29716"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
Inter-Bureaucratic Bickering Brought to Light<\/h4>\n
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\nRead More: Report: The DEA Ignored the FDA\u2019s Call to Deschedule CBD<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"