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CBD

  • by Paul Armentano, NORML Deputy Director April 17, 2019

    Marijuana CBD OilRepublican Gov. Brian Kemp signed legislation into law today to facilitate regulations governing the licensed production and distribution of oils and other products containing limited amounts of plant-derived THC.

    House Bill 324 (aka Georgia’s Hope Act) establishes a regulatory commission to oversee the eventual “production, manufacturing, and dispensing” of products possessing specified quantities of plant-derived THC to qualified patients. The law allows for the licensing of up to six cultivation operations, and seeks collaboration with the University of Georgia in the manufacturing of THC-infused extracts and oils.

    Under a 2015 state law, qualified patients are exempt from criminal prosecution for the possession of oil extracts containing not more than 5 percent THC and an amount of CBD equal to or greater than the amount of THC. However, the law failed to provide any mechanism for patients to obtain low-THC products from a state-regulated producer or provider.

    Approximately 9,500 patients are currently registered with the state to possess medical cannabis products.

    For additional information on pending state legislation, visit NORML’s ‘Take Action’ Center here.

  • by NORML June 25, 2018

    Regulators at the US Food and Drug Administration today granted market approval for Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD), for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

    The FDA’s decision was not unexpected, as the proprietary extract formulation — developed by the British biotechnology firm GW Pharmaceuticals — had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. Epidiolex had previously received Fast Track Designation and Orphan Drug Status from the FDA. It is the fourth marijuana-based medicine to receive US FDA approval — joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids.

    Commenting on the agency’s decision, NORML Deputy Director Paul Armentano said: “The FDA’s approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis. However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford.” According to the New York Times, analysts expect Epidiolex to cost $2,500 to $5,000 a month.

    He added: “We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis — a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states.”

    Federal agencies have 90 days to determine the scheduling of Epidiolex. The new drug is anticipated to become available to patients later this fall. In clinical trials, patients administered Epidiolex, on average, obtained a 40 percent reduction in seizure frequency.

    Lennox-Gaustaut syndrome is estimated to account for between one and four percent of all cases of childhood epilepsy. Dravet syndrome is estimated to effect about 1 in 40,000 people.

    Despite today’s approval, the FDA acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” FDA Commissioner Scott Gottlieb further added: “This is the approval of one specific CBD medication for a specific use. … [T]his is not an approval of marijuana or all of its components.”

  • by Paul Armentano, NORML Deputy Director May 2, 2018

    A three judge panel for the Ninth Circuit Court of Appeals has denied a petition filed by the Hemp Industries Association challenging the DEA’s authority to establish a new administrative drug code specifically for marijuana extracts. The DEA first announced the proposed rule change in 2011, but did not enact the new policy until January 13, 2017.

    In a decision filed on April 30, the Court rejected petitioners’ arguments – opining the DEA’s classification of marijuana extracts does not conflict with the provisions of either the Agricultural Act of 2014 (aka the ‘Farm Bill) or the Consolidated Appropriations Act, which limits the Justice Department from spending federal dollars to intervene in state-sanctioned activities involving marijuana or industrial hemp. The Court also dismissed petitioners’ argument that the rule substantively amended the federal Controlled Substances Act. Justices opined that such extract products, including those containing primarily CBD, were already classified under federal law as schedule I controlled substances.

    The DEA has long contended that it possesses broad regulatory authority over “all parts of the plant Cannabis sativa L.,” including “the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.” The agency includes among this definition products containing cannabidiol or any other non-THC cannabinoids derived from the marijuana plant. It further states, “[T]he Agricultural Act of 2014 does not permit entities [who are not registered with the DEA] … to produce non-FDA-approved drug products made from cannabis.”

    Over a dozen states have enacted legislation in recent years exempting certain persons who possess extracts high in cannabinoid from criminal prosecution. Legislation to approve the retail sale of CBD extracts to adults in Kansas is awaiting gubernatorial action. Indiana lawmakers approved a similar law in April. Several pieces of legislation seeking to exclude CBD from the federal definition of marijuana are pending in Congress. In 2015, Nora Volkow, the Director of the US National Institute on Drug Abuse, publicly acknowledged that CBD is “a safe drug with no addictive effects.”

    Petitioners say that they intend to appeal the ruling.

    The case is Hemp Industries Association et al., v. US Drug Enforcement Administration et al., (No. 17-70162).

  • by Paul Armentano, NORML Deputy Director December 19, 2017

    mj_researchThe daily administration of CBD (cannabidiol) as an adjunctive therapy mitigates psychotic symptoms in patients with schizophrenia, according to clinical trial data published online ahead of print in The American Journal of Psychiatry.

    British researchers assessed the adjunctive use of CBD compared to placebo over a six-week period in a randomized trial of 88 schizophrenic patients. Participants ingested 1000mg of plant-derived CBD per day.

    Subjects in the CBD treatment group “had lower levels of positive psychotic symptoms and were more likely to have been rated as improved and as not severely unwell by the treating clinician” at the conclusion of the trial. CBD administration was also associated with “improvements in cognitive performance and in the level of overall functioning,” although these changes did not reach statistical significance.

    “These findings suggest that CBD has beneficial effects in patients with schizophrenia,” authors concluded. “As CBD’s effects do not appear to depend on dopamine receptor antagonism, this agent may represent a new class of treatment for the disorder.”

    Results of the prior clinical trial published in the journal Translational Psychiatry determined that CBD is superior to amisulpride, a potent anti-psychotic agent, in mitigating psychotic symptoms in schizophrenic patients.

    An abstract of the study, “Cannabidiol (CBD) as an adjunctive therapy in schizophrenia: A multicenter randomized controlled trial,” appears online here.

  • by Paul Armentano, NORML Deputy Director December 13, 2017

    oil_bottlesThe use of the naturally occurring cannabinoid CBD (cannabidiol) possesses no likely abuse potential and therefore should not be subject to international drug scheduling restrictions, according to recommendations finalized today by the World Health Organization’s Expert Committee on Drug Dependence.

    Concludes WHO: “Recent evidence from animal and human studies shows that its use could have some therapeutic value for seizures due to epilepsy and related conditions. Current evidence also shows that cannabidiol is not likely to be abused or create dependence as for other cannabinoids (such as Tetra Hydro Cannabinol (THC), for instance). The ECDD therefore concluded that current information does not justify scheduling of cannabidiol and postponed a fuller review of cannabidiol preparations to May 2018, when the committee will undertake a comprehensive review of cannabis and cannabis related substances.”

    A preliminary report issued by WHO in November affirmed, “[T]here is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD.”

    In September, NORML submitted written testimony to the US Food and Drug Administration in opposition to the imposition of new international restrictions regarding CBD access. The FDA is one of a number of agencies that advised the World Health Organization in their review.

    Despite the international health agency’s acknowledgment that CBD is therapeutic, safe, and well-tolerated, it remains classified under US law as a schedule I controlled substance.

    “The domestic classification and criminalization of cannabidiol as a schedule I controlled substance is out of step with both available science and common sense,” NORML Political Director Justin Strekal said. “It is yet another example of the US government placing ideology over evidence when it comes to issues related to the cannabis plant.”

    Text of the WHO recommendations are online here.

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