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  • 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 20, 2019

    A widely reported study appearing today in the British journal The Lancet alleges that an estimated 30 to 50 percent of psychosis cases in Europe are due to cannabis exposure, and that exposure to elevated levels of THC increases this risk.

    NORML has previously written on the data showing a multi-directional association between cannabis and psychiatric illnesses, and we have cautioned that those predisposed to psychosis or other disorders may be at higher risk for adverse events.

    That said, it remains premature at best, and sensational at worst to claim that a causal relationship exists between marijuana use and psychiatric disorders on the basis of this new paper. That is because, by the observational nature of its design, this study at best can only demonstrate a correlation.

    Nonetheless, despite this limitation, the authors boldly “assume causality.” Given the fact that such a cause-and-effect relationship remains unproven and there as of yet exists no consensus among experts that such causation exists, their assumption is, at best, highly questionable.

    Moreover, it is well established that those with psychiatric illness typically use all intoxicants at greater rates than do the general public, so the fact that those admitted to institutions for first-episode psychosis are more likely to consume cannabis than are those in the general population is hardly surprising. But it is not evidence that marijuana in any way causes the condition. Rather, this association may exist because many psychiatric patients are self-medicating with cannabis. Or, this relationship may persist because many people predisposed to psychosis are similarly predisposed to also using cannabis — a theory that is supported by many experts in the field.

    Perhaps most importantly, the fact that cannabis has been used by various populations for decades at disparate rates, yet rates of psychosis and other psychiatric disorders have generally remained static over this same period of time, strongly argues against a direct causal relationship.

    Finally, authors’ presumptions specific to the supposed disparate effects of cannabis based upon THC potency are also highly questionable. This is because subjects in the study self-reported their cannabis use. As a result, authors had no ability to verify the THC content of the marijuana consumed by participants. Further, the cannabis consumed by subjects in the study was largely obtained via black market channels — leaving the users equally in the dark with regard to its actual cannabinoid content.

    Nonetheless, despite these limitations, the concerns raised in this paper and others ought to be taken seriously, and they provide an argument in favor of greater regulation of the plant so that it can be better kept out of the hands of young people and those who may be at higher risk for an adverse reaction. But maintaining cannabis prohibition, unfortunately, achieves neither result. Placed in this context, these latest scare-mongering claims — even if taken at face value — do little to advance arguments in favor of tightening prohibition, and provides ample ammunition to wage for its repeal.

  • by Paul Armentano, NORML Deputy Director March 1, 2019

    The American Psychological Association (APA) is urging US Attorney General William Barr to review more than two-dozen pending applications for federal marijuana grow licenses. In a letter dated Wednesday, February 27, the association urged the Justice Department to “act immediately” on 26 applications pending before federal officials – applications which were initially submitted to the agency over two years ago.

    Currently, the sole federally licensed producer of cannabis for clinical research is the University of Mississippi. The University has held the exclusive license for more than four decades.

    In August 2016, the US Drug Enforcement Administration announced in the US Federal Register that the agency was “adopting a new policy that is designed to increase the number of entities registered under the Controlled Substances Act to grow (manufacture) marijuana to supply legitimate researchers in the United States.” The agency said that the policy change was necessary because the existing system provided “no clear legal pathway for commercial enterprises to produce marijuana for product development.”

    Last year, however, former DEA director Robert Patterson testified to Congress that the agency believed that approving additional applicants would likely violate international anti-drug treaties. Patterson said that DEA could not move forward granting any new applications until the Justice Department clarified the issue.

    In its letter to the newly appointed Attorney General, APA CEO Arthur C. Evans urged the Department “to take immediate action on the existing pool of cannabis grower applications so that the United States scientific community can continue to expand the study of both the harmful and potential therapeutic effects of cannabis and its derivatives. … Without access to an expanded range of cannabis products engineered under FDA-approved Good Manufacturing Practices, scientific research cannot hope to keep pace with the ever expanding recreational and medicinal cannabis marketplace.” The APA represents nearly 120,000 researchers and clinicians.

    Also on Wednesday, Rep. Barbara Lee (D-CA) asked US Food and Drug Commissioner Scott Gottlieb whether he believed that it is possible for a US-based company to bring a marijuana plant-derived drug to market in light of the existing federal prohibitions on licensing. The Commissioner answered equivocally, stating “It depends.” He later acknowledged that these restrictions have led many “companies [to] go overseas to conduct research with foreign-grown product that is more easily sourced for the purposes of clinical trials.”

    The longstanding federal prohibition on privately licensed cannabis producers exists despite a 2007 ruling by the DEA’s own administrative law judge striking down the ban as not “in the public interest.” Although that ruling ordered DEA to lift the ban, the agency failed to do so.

  • by NORML February 13, 2019

    Today, Senator Brian Schatz (D-HI) and Representative Barbara Lee (D-CA) introduced legislation, The Veterans Medical Marijuana Safe Harbor Act, to expand and facilitate medical cannabis access to military veterans suffering from chronic pain, PTSD, and other serious medical conditions.

    Under existing regulations, VA doctors are not permitted to fill out the mandatory paperwork necessary to recommend cannabis therapy in those 33 states that regulate it. Passage of The Veterans Medical Marijuana Safe Harbor Act ends this discrimination against veterans and prevents sanctions against VA doctors who wish to recommend medical cannabis treatment to their patients.

    Click here to send a message to your federal lawmakers now!

    “The Veterans Medical Marijuana Safe Harbor Act would provide crucial medical and civil protections for the men and women who put their lives on the line to serve this country. It is unconscionable that these brave individuals who protect our nation’s freedoms would be treated as criminals when they return home just for treating their medical ailments with a safe and effective option,” said Justin Strekal, NORML Political Director. “We applaud and appreciate the leadership by Senator Schatz and Rep. Lee in putting forward this legislation.”

    “Historically, veteran and military communities have long been at the forefront of American social change, catalyzing the widespread acceptance of evolving cultural norms and perceptions surrounding racial, gender, and sexual equality. The therapeutic use of cannabis by veterans follows this trend and members of Congress should follow their lead and pass the Veterans Medical Marijuana Safe Harbor Act,” Strekal concluded.

    “In 33 states, doctors and their patients have the option to use medical marijuana to manage pain—unless those doctors work for the VA and their patients are veterans,” Senator Schatz said. “This bill gives VA doctors in these states the option to prescribe medical marijuana to veterans, and it also promises to shed light on how medical marijuana can help with the nation’s opioid epidemic.”

    “As the daughter of a veteran, I am committed to ensuring that our veterans have access to the quality and comprehensive medical care they deserve – including medical marijuana. The current federal prohibitions on cannabis are unnecessary, harmful, and counterproductive,” said Congresswoman Lee. “The federal government should never stand between our veterans and their medicine. This critical legislation is a long overdue step to empower veterans and their doctors to make informed health care decisions, without political interference.”

    You can read NORML’s Fact Sheet on Marijuana and Veterans Issues HERE.

    A copy of the bill is available here.

    A recent American Legion poll found that nearly one in four veterans use marijuana to alleviate a medical condition. A 2017 review of over 10,000 studies by the National Academy of Sciences concluded, “There is conclusive or substantial evidence that cannabis and cannabinoids are effective for the treatment for chronic pain in adults.”

    Send a message to your federal lawmakers in support of the Veterans Medical Marijuana Safe Harbor Act by clicking here now.

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