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  • by Paul Armentano, NORML Deputy Director August 2, 2019

    Marijuana Indoor GrowingA federal court has ordered the Drug Enforcement Administration to respond to a lawsuit charging the agency with failing to move forward with a 2016 policy to expand the total number of federally licensed marijuana cultivators.

    In August 2016, Drug Enforcement Administration officials adopted a policy “to increase the number of entities registered under the Controlled Substances Act (CSA) to grow marijuana to supply legitimate researchers in the United States.” To date, however, the agency has neither affirmed or denied any of the 26 applicants that have sought the DEA’s permission for a federal cultivation license.

    (Read NORML’s new op-ed, “Three years ago the DEA said they would remove roadblocks to cannabis research — they still haven’t, here.)

    In June, one of those applicants – the Scottsdale Research Institute – filed a petition in the US Court of Appeals for the District of Columbia for a writ of mandamus to order the DEA to comply with its 2016 policy, arguing that the agency has engaged in unreasonable delays. On July 29, the Appellate Court ordered the DEA to provide a written response to the filing within 30 days.

    “While most states recognize that cannabis has medical value, the DEA says otherwise, pointing to the absence of clinical research. But at the same time, government regulations and bureaucracy prevent researchers like SRI from ever doing the clinical research the DEA has overtly demanded,” SRI Principal Investigator Dr. Sue Sisley said. “[This filing is] asking the court for an order compelling the DEA to process our application. We hope that this … encourages the DEA not only to process our application, but to process the applications of others, so that we can all continue to do important research into the safety and efficacy of cannabis for treatment resistant illnesses.”

    Since 1968, the agency has only licensed the University of Mississippi to engage in the growing of cannabis for FDA-approved clinical research. Scientists familiar with the product have consistently said that it is of inferior quality and fails to accurately reflect the types of marijuana varieties commercially available in legal states.

    Additional information regarding the SRI petition is available online here.

  • 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 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 15, 2019

    Marijuana FieldMarijuana grown by the University of Mississippi for clinical research purposes is genetically divergent from strains of cannabis commercially available in retail markets, according to an analysis prepared by researchers at the University of Northern Colorado. Since 1968, the University of Mississippi farm, which is governed by the US National Institute on Drug Abuse, has held the only available federal license to legally cultivate cannabis for FDA-approved research.

    Authors reported that samples available via the U-Miss program shared genetics typically associated with industrial hemp, not commercially available cannabis. They concluded: “NIDA research grade marijuana was found to genetically group with hemp samples along with a small subset of commercial drug-type cannabis. A majority of commercially available drug-type cannabis was genetically very distinct from NIDA samples. These results suggest that subjects consuming NIDA research grade marijuana may experience different effects than average consumers.”

    A separate study published in 2017 reported that U-Miss samples contain far lower levels of both THC and CBD than do commercially available cannabis. Clinicians wishing to conduct FDA-approved clinical trials on cannabis have long complained that federally-provided samples are of inferior quality.

    According to the program’s current marijuana menu, no available samples contain more than seven percent THC and all samples contain less than one percent CBD.

    In 2016, the US Drug Enforcement Administration publicly announced that it would, for the first time, begin accepting applications from private entities wishing to grow research-grade cannabis. However, since that time, neither the agency nor the Justice Department have taken any action to move this application process forward.

    Full text of the study, “Research grade marijuana supplied by the National Institute on Drug Abuse is genetically divergent from commercially available Cannabis,” appears online here.

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

    Marijuana FieldState lawmakers have approved a series of bills reducing penalties for marijuana possession offenses and strengthening and expanding legal protections for medical cannabis patients. The measures now await action from Democratic Gov. Michelle Lujan Grisham, who is supportive of the changes.

    DECRIMINALIZATION

    Senate Bill 323 amends minor marijuana possession penalties. The measure reduces first-time penalties for the possession of up to one-half ounce of cannabis from a criminal misdemeanor — punishable by up to 15 days in jail — to a ‘penalty assessment,’ punishable by a $50 fine. Subsequent offenses, or in instances where the defendant possesses greater amounts of marijuana, remain punishable by the possibility of jail time.

    Once signed into law, the reduced penalties take effect on July 1, 2019.

    MEDICAL CANNABIS

    Senate Bill 406 expands medical cannabis access and provides important new patient protections. It expands the pool of patients eligible for cannabis therapy to include those diagnosed with post-traumatic stress, severe chronic pain, Crohn’s disease, Lou Gehrig’s disease, sleep apnea, and neuropathy, among other newly specified conditions. It also enacts explicit legal protections prohibiting employers, social service workers, and hospitals from arbitrarily discriminating against patients solely for their medical cannabis status and/or for their failure to pass a drug test. The measure prohibits regulators from placing limits on the percentage of THC or other cannabinoids in therapeutic products and it establishes reciprocity with other states’ medical cannabis programs.

    Separate legislation, Senate Bill 204 establishes regulations and procedures for the storage and administration of certain medical cannabis products to students in school settings.

    INDUSTRIAL HEMP

    House Bill 581 regulates the commercial production of industrial hemp and hemp-extract products in a manner that comports with provisions in the 2018 federal Farm Act. Under the legislation, “The department of environment shall issue permits … to extract, process or engage in other manufacturing activities regarding hemp, including manufacturing intermediate hemp-derived products and hemp finished products.” The effective date of the Act is July 1, 2019.

    LEGALIZATION

    House-backed legislation that sought to legalize the possession of marijuana by adults and regulate its commercial production and sale stalled in the Senate Finance Committee, after the Chair failed to call the bill for a vote. Nonetheless, Gov. Lujan Grisham has announced that she will add the issue to the agenda of the 2020 legislative session.

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