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CBD

  • by Paul Armentano, NORML Deputy Director July 18, 2019

    Members of the US Senate Committee on Agriculture, Nutrition, and Forestry will hear expert testimony next week regarding the production of industrial hemp and hemp-derived products.

    The Senate hearing, titled “Hemp Production and the 2018 Farm Bill,” is scheduled to take place on Thursday, July 25, at 9:30am est.

    Representatives from the United States Department of Agriculture, the US Food & Drug Administration, and the National Hemp Association are among those who will testify at next week’s hearing.

    In December, Congress enacted legislation removing industrial hemp (defined as cannabis containing less than 0.3 percent THC) and products containing cannabinoids derived from hemp from the federal Controlled Substances Act. Under the law, states that wish to license commercial hemp cultivation must submit their plan to the USDA. Last month, the agency filed a notice in the Federal Register indicating its intention to finalize regulations governing the licensed production of industrial hemp by late August.

    Separately, the US FDA is discussing options regarding the regulation of hemp-derived CBD products, which it currently states may not legally be marketed as either nutritional supplements or food additives. In May, NORML provided written testimony to the FDA calling on the agency to clarify confusion among both consumers and regulators with regard to the legality of certain CBD products. NORML further recommended that the FDA move expeditiously to provide regulatory guidelines governing the products’ manufacturing, standardization, and quality.

  • by NORML May 21, 2019

    The administration of oral CBD reduces cue-induced cravings and anxiety in subjects with a history of heroin use, according to clinical data published in The American Journal of Psychiatry.

    Investigators at The Mount Sinai Health System in New York City assessed the effect of CBD versus placebo in 42 drug-abstinent participants with a history of heroin use. In contrast to placebo, CBD dosing of either 400mg or 800mg “significantly reduced both the craving and anxiety induced by drug cues … in the acute term. CBD also showed significant protracted effects on these measures seven days after the final short-term exposure.”

    Researchers concluded, “CBD’s potential to reduce cue-induced craving and anxiety provides a strong basis for further investigation of this phytocannabinoid as a treatment option for opioid use disorder.”

    In observational models, patients with legal access to cannabis typically reduce or eliminate their use of opioids. In clinical models, CBD administration has been shown to reduce cravings for tobacco. CBD dosing has also been associated with reduced cravings for methamphetamine in preclinical models.

    Commenting on the study’s findings, NORML Deputy Director Paul Armentano said, “These conclusions add to the growing body of evidence that cannabis and its constituents represent an exit away from the use or abuse of other controlled substances rather than a supposed ‘gateway.'”

    The abstract of the study, “Cannabidiol for the reduction of cue-induced craving and anxiety in drug-abstinent individuals with heroin use disorder: A double-blind randomized placebo controlled trial,” appears online here. Additional information is available in NORML’s fact-sheet, “Relationship between marijuana and opioids.”

  • by NORML May 15, 2019

    Marijuana CBD OilNORML has submitted written comments to the US Food and Drug Administration ahead of the agency’s scheduled hearing on the regulation CBD-infused products. The agency will be taking in person public testimony on Friday, May 31, with regard to the “manufacturing, product quality, marketing, labeling, and sale” of CBD-infused retail products.

    In its written testimony, NORML encourages the FDA to act expeditiously to clarify confusion among both consumers and regulators with regard to the legality of specific CBD products. It further recommends that the FDA provide regulatory guidelines governing product manufacturing, standardization, and quality.

    Currently, commercially marketed CBD-infused products are not subject to explicit federal regulations. As a result, third-party lab testing has frequently revealed inconsistencies between the percentage of CBD advertised and the amount actually contained in the product. In many cases — such as those reported here, here, here, here, and here — actual quantities of CBD in the product is far lower than advertised. In other cases, testing has revealed the presence of THC, which may put consumers in jeopardy for legal ramifications – such as arrest or the loss of employment (due to a drug test failure). Some commercial products have also been identified to contain unwanted and potentially dangerous adulterants – such as 5F-ADB (aka ‘Spice’) or DXM – as well as heavy metals and solvents.

    NORML’s testimony concluded: “For years, producers of these products have navigated in a grey area of the law — manufacturing products of variable and sometimes questionable quality and safety. Now it is time for the FDA to craft benchmark safety and quality standards for hemp-derived CBD products in order to increase consumer satisfaction and confidence as this nascent industry transitions and matures into a legal marketplace.”

    The FDA is accepting written comments from the public through July 2, 2019.

    In December, Congress enacted legislation removing industrial hemp (defined as cannabis containing less than 0.3 percent THC) and products containing cannabinoids derived from hemp from the federal Controlled Substances Act. The following day, the FDA stated: “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.” The agency further opined, “[I]t’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”

    In March, outgoing FDA Commissioner Scott Gottlieb suggested that it may take “years” for the agency to establish rules and regulations governing the marketing of hemp-derived cannabinoid products.

  • by Paul Armentano, NORML Deputy Director April 29, 2019

    House and Senate lawmakers have approved legislation, House File 732, to expand the state’s medical cannabis access program. The measure now awaits action from Republican Gov. Kim Reynolds.

    Under existing law, licensed dispensaries may only dispense plant-derived extracts possessing CBD and no more than three percent THC. House Fill 732 eliminates the THC cap. It also permits physician assistants and/or advanced registered nurses to make medical cannabis recommendations, and expands the pool of patients eligible for cannabis therapy to include those with “severe or chronic” pain.

    The new measure imposes restrictions regarding the total amount of THC a patient may possess in a 90-day period (25 grams). However, this limit may be waived at the advice of a health practitioner.

    About 1,000 Iowans are currently authorized to access low-THC cannabis oils.

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

  • 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.

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