Category: Cannabis

  • Medicinal Cannabis Research Act Survives Senate Committee

    Medicinal Cannabis Research Act Survives Senate Committee

    Credit: EKKAPON

    The Senate Committee on Veterans’ Affairs advanced the VA Medicinal Cannabis Research Act on Thursday, marking the first-ever standalone cannabis bill to be passed out of a Senate committee.

    If passed, it would be only the second standalone marijuana legislation to be passed federally.

    The bipartisan bill, which advanced in a markup session that occurred off the floor, would direct the Secretary of Veterans Affairs to conduct both a study and clinical trials on the “effects of cannabis on certain health outcomes of veterans with chronic pain and post-traumatic stress disorder,” as well as for other conditions. 

    The Senate legislation is sponsored by Montana Sen. Jon Tester, also the chair of the committee, and co-sponsored by Alaska Sen. Dan Sullivan; House Reps. Lou Correa and Jack Bergman have introduced the House version, Cannabis Wire reports. 

    “I’m particularly proud we cleared a number of my bills allowing VA to increase the number of providers in rural areas, authorize important VA projects, and conduct research into medicinal cannabis as an alternative treatment to treating the wounds of war,” Tester said in a statement after the advancement of three veterans bills on Thursday.

    The VA has been an ongoing example of where state and federal cannabis laws clash. While medical cannabis is now legal in a majority of states, cannabis remains a Schedule I substance under federal law. VA doctors, beholden to federal law, have been unable to recommend these products to patients. 

     “Medicinal cannabis is already in use by thousands of veterans across the country, but we don’t yet have the data we need to understand the potential benefits and side effects associated with this alternative therapy,” Sullivan said in a statement when introducing the bill.

    Last year, for the first time, a standalone piece of marijuana reform legislation was signed into law by a U.S. president. The “Medical Marijuana and Cannabidiol Research Expansion Act” is just one signature away from historic enactment.

  • DEA: Two Cannabinoids ‘Do not Occur Naturally’ in Hemp

    DEA: Two Cannabinoids ‘Do not Occur Naturally’ in Hemp

    Credit: piter2121

    In an expected move yesterday, the U.S. Drug Enforcement Administration (DEA) says that two cannabinoids with a growing market presence do not meet the federal definition of legal hemp and are therefore considered illegal controlled substances.

    Attorney Rod Kight inquired about the legal status of delta-8 THC-O and delta-9 THC-O with the federal agency last year and followed up earlier this month.

    DEA sent a response letter on Monday, saying the two cannabinoids “do not occur naturally in the cannabis plant and can only be obtained synthetically, and therefore do not fall under the definition of hemp,” according to Marijuana Moment.

    “Delta-9-THCO and delta-8-THCO are tetrahydrocannabinols having similar chemical structures and pharmacological activities to those contained in the cannabis plant,” the letter from Terrence L. Boos, chief of DEA’s Drug & Chemical Evaluation Section, continued.

    Kight responded to DEA’s letter in a blog post on Monday, writing that “although I do not always agree with the DEA’s view on cannabis matters, I agree with this opinion and, frankly, am not surprised. This is what I have been saying for a while.”

    “I have been concerned about the proliferation of THC acetate ester (THCO) for a while. It has always been my view that THCO is a controlled substance under federal law,” he said. “Although it can be made from cannabinoids from hemp, THCO is not naturally expressed by the hemp plant. It is a laboratory creation that does not occur in nature, at least not from the hemp plant.”

  • New York City Cracks Down on Illegal Cannabis Shops

    New York City Cracks Down on Illegal Cannabis Shops

    Credit: Rob

    The illicit marijuana market in New York City is thriving. In a renewed push to snuff out the city’s growing illegal cannabis market, Mayor Eric Adams and Manhattan’s top prosecutor announced last week that they would go after landlords who allow hundreds of illicit shops to operate.

    During a news conference with the mayor, Manhattan District Attorney Alvin Bragg said his office has sent notices to more than 400 smoke shops that illegally sell cannabis, warning them of potential eviction proceedings. If shop owners do not cease operation, his office would seek to force property owners to evict the shops, reports the Associated Press.

    It was the latest effort by authorities to force the closure of illegal dispensaries that could undermine the state’s nascent legal cannabis market, which began rolling out in recent months and is expected to quickly grow as more state-sanctioned shops open.

    When the state legalized recreational marijuana two years ago, “many people took it that you can just open up a location any way you want,” Adams said.

    Unauthorized pot shops have cropped up in droves, operating out in the open — and offering cheaper prices than the legal stores, where the products are highly taxed. The number of illegal shops across New York’s five boroughs could exceed 1,200, according to some estimates.

  • Kansas State Senators File Medical Marijuana Bill

    Kansas State Senators File Medical Marijuana Bill

    A new push to legalize medical marijuana in Kansas is picking up some steam. The bill, if passed, would also make vaping cannabis illegal.

    According to Marijuana Moment, state senators filed a new measure – SB 135 – that seeks to provide legal access to medical cannabis for people with debilitating conditions.

    Backed by the Senate Federal and State Affairs Committee, the new legislation would regulate the cultivation, processing, distribution, sale and use of medical cannabis.

    “The patients of Kansas have been eagerly anticipating the opportunity for a program and to join the 37 other states that have adopted comprehensive medical cannabis programs,” Kevin Caldwell, a legislative manager at the Marijuana Policy Project told Marijuana Moment’s Kyle Jaeger. “Patients have been forced for too long to have to go to the illicit market for products that have not been tested for contaminants as well as face legal repercussions for possessing medicine that can greatly improve the quality of their lives.”

    The licensing process would be overseen by a Division of Alcohol and Cannabis Control, while a Medical Cannabis Advisory Committee would supervise the implementation of the marijuana program.

    Taxed at 10 percent, medical marijuana products would have to contain less than 35 percent THC for flower, while tinctures, oils and concentrates could not exceed 60 percent THC.

  • Connecticut AG Sues 5 Companies for Delta-8 Sales

    Connecticut AG Sues 5 Companies for Delta-8 Sales

    Credit: Andy Dean

    The Attorney General in Connecticut is suing five retailers for some of the most “egregious violations” related to the illegal sale of delta-8 products.

    Attorney General William Tong filed the suits for alleged violations of the Connecticut Unfair Trade Practices Act over the sale of illegal delta-8 THC products mimicking popular youth-oriented snacks and candies.

    Tong is additionally in the process of sending warning letters to all Connecticut-licensed retailers of electronic vaping products, according to a statement from Tong’s office.

    The letters advise that sale of delta-8 THC by unlicensed retailers may be illegal in Connecticut. Products that exceed .3 percent THC on a dry weight are considered cannabis products and may only be sold in the regulated market.

    Cannabis products sold outside of the regulated market continue to be illegal and may subject sellers to civil and criminal penalties.

    “If you offer delta-8 THC products for sale in your establishment that exceed .3 percent THC on a dry weight basis and you do not hold such a license, you are in violation of Connecticut law,” Tong states. “For your information, we have included below photographs of products that were recently purchased from retailers in Connecticut that purport to contain delta-8 THC.

    “The sale of such products may expose you to criminal and civil liability. Please remove any such products from your shelves and dispose of them immediately.”

    Cannabis products in Connecticut cannot be sold by unlicensed retailers and must meet rigorous testing and packaging requirements.

    Tong also recently submitted testimony concerning House Bill 6488 stating that he fully supports the state’s proposed ban on flavored vaping and other tobacco products.

  • Japan Poised to Allow Medical Marijuana Sales

    Japan Poised to Allow Medical Marijuana Sales

    Credit: Alona

    The government in Japan is poised to allow the use of medical marijuana to treat patients with intractable diseases, according to the outline of bills revealed last week.

    The government is considering submitting bills including one to revise the Cannabis Control Law during the current Diet (the national legislature of Japan) session, according to Japan News.

    The proposed revision would also criminalize the use of marijuana without a prescription.

    In countries including the United States and Britain, medicine made from cannabis plants is used to treat patients with intractable epilepsy and other diseases for which existing drugs are ineffective. In Hong Kong, however, THC and non-intoxicating CBD are both banned.

    Cannabis plants contain a substance that has an intoxicating effect, which is one of the reasons why the use of marijuana in medicine is prohibited in Japan. The proposed revision would enable such patients to use drugs made from cannabis plants.

    On the use of marijuana, there are currently no penalties for using it because farmers who cultivate cannabis with permission from prefectural governors might intake substances from the plant during harvesting.

  • Cannabis Regulators Could Learn From Nicotine

    Cannabis Regulators Could Learn From Nicotine

    Photo: Darren415

    Nicotine’s lessons for cannabis regulation

    By Cheryl K. Olson and Willie McKinney

    From the industry perspective, regulation of tobacco products by the U.S. Food and Drug Administration went from impatient foot-tapping to a lurching roller-coaster ride. The recently released “operational evaluation” of the FDA’s tobacco program, requested by Commissioner Robert Califf, lays out in sedate but clear terms some causes of industry’s frustrated exhaustion: years of delay in establishing requirements. Sudden major shifts in policy. Cycles of litigation and reprieve.

    Based on feedback from FDA employees, and people from industry and public health, the independent Reagan-Udall Foundation for the FDA made recommendations to start repairing the regulatory mess. After “observ[ing] that CTP [Center for Tobacco Products] has been forced to operate primarily in a reactive mode, moving from one challenge to the next,” the first recommendation to the agency is to get proactive. The Reagan-Udall panel encouraged the CTP to make time now to “think strategically about where it is today and where it needs to go in the next several years.”

    This advice might apply equally to whatever future the FDA faces with regulation of cannabis products. The FDA has authority over cannabis and its dozens of biologically active chemical compounds, including CBD and THC. Although marijuana falls under the federal Controlled Substances Act, the 2018 Farm Bill removed hemp (a low-THC cannabis plant and its derivatives) from that definition.

    Principal Deputy Commissioner Janet Woodcock recently announced in a press release that existing regulatory frameworks for food and supplements are not appropriate for CBD. “The agency is prepared to work with Congress” on a new pathway, she stated.

    What might we take from the U.S. tobacco experience to ease headaches for future cannabis regulation? Below are some points to ponder in three areas: regulatory structure, medical versus recreational use, and the effects of misinformation on regulation.

    What Should a New Structure Look Like?

    First, what regulatory structure makes sense: Should the FDA create an all new one for cannabis products, or should it employ some existing channels? Consider the tobacco parallel.

    “Safe and effective” is the FDA’s traditional standard for evaluating drugs and medical products. In the 1990s, then Commissioner David Kessler tried to assert the FDA’s authority to regulate nicotine as a drug—intended by industry to affect the body’s structure or function—and cigarettes as delivery devices. A 2000 Supreme Court ruling found that the “s and e” standard left no room for regulation of tobacco.

    In 2009, when Congress chose to place tobacco under FDA jurisdiction, a novel department was created. But this promising, fresh science-based regulatory approach for tobacco faced headwinds. This Center for Tobacco Products was largely staffed by people rotated from elsewhere in the FDA. The “appropriate for the protection of public health” (APPH) tobacco standard was a difficult departure from their accustomed ways and views. The combination of suspicion from past industry misbehavior and the political uproar over youth vaping fostered an “us versus them” mindset. The founding legislation’s focus on cigarettes, the most deadly of tobacco products, affected attitudes toward emerging alternative nicotine products with the potential to greatly reduce disease risks for people who smoke.

    Perhaps there is light at the end of the tunnel. The FDA appears to recognize that shoehorning cannabis into existing structures has its own problems. Each type of intended use must find a fit in an existing department, such as human food, veterinary products, cosmetics or drugs. Under the Federal Food, Drug and Cosmetic Act, a drug is any product (including marijuana or hemp) intended to affect the structure or function of the body or intended to diagnose, cure, mitigate, treat or prevent disease.

    What factors will influence staff mindset about cannabis in these various departments? How will that affect regulation?

    Medical vs. Recreational Pathways

    Another issue: How best to regulate cannabis for medical versus recreational use? Like tobacco, cannabis has been used historically for medical purposes, such as treating pain. Both nicotine and cannabis are reportedly used to self-medicate for mental health disorders. Use of marijuana to manage mood disorders is reportedly higher in states with medical marijuana laws. But there currently is no such thing as “medical” marijuana. (This is not unlike the confusion over what constitutes “natural” food.) The FDA drug pathway would create medical cannabis. A standardized product would be evaluated for quality, safety and efficacy for a particular medical indication.

    We lack randomized, controlled clinical trial data on whether cannabis effectively treats disorders such as depression. However, such studies could be done by industry and submitted to the FDA’s Center for Drug Evaluation and Research. Several specialty products containing THC or CBD (e.g., for chemotherapy-related nausea or severe forms of epilepsy) have emerged from this path.

    But what regulatory pathway might recreational cannabis take? And what complications arise from product format and route of administration: smoked, vaped, applied to skin or eaten? Where would combusted flower fit?

    Nicotine is regulated by the FDA as a drug and as a recreational product. Two paths for cannabis also make sense. Although there is overlap (to get technical: Gum bases that contain nicotine are regulated as both pharmaceuticals and recreational tobacco products), combusted tobacco products that contain nicotine are only regulated by the Center for Tobacco Products.

    We propose that Congress modify the 2009 Tobacco Control Act to give the CTP authority over combusted and vaped cannabis. Such products are very unlikely to pass the “safe and effective” drug standard, but the APPH standard may be applicable to recreational cannabis. And the CTP has built up expertise in combusted and vaped products.

    Keep Moral Panic Out of Regulation

    A third issue deserving of thought is how to prevent moral panic and misinformation from derailing the potential benefits of cannabis. One lesson from nicotine is how these can fog the ability of regulators, politicians and the public to see data clearly.

    Research shows that youth use of nicotine and cannabis (as well as alcohol and other substances) overlap. A 2022 analysis of Population Assessment of Tobacco and Health study data found that more than half of e-cigarette users aged 15 to 24 had vaped cannabis. At the population level, teen cannabis youth has been fairly stable for the last quarter century. However, there will be concerns that the spread of state laws legalizing cannabis for adults could ease access for youth.

    Once it takes hold, misinformation is hard to uproot. Witness stubborn rates of misbelief that the outbreak of vaping-related lung injuries (e-cigarette or vaping product use-associated lung injury, or EVALI) were caused by e-cigarettes instead of THC vapes adulterated with vitamin E acetate.

    We see signs of a potential moral panic over cannabis. When the Centers for Disease Control and Prevention noted that marijuana vaping was most often linked to EVALI, the Wall Street Journal editorial board decried the “risky social experiment [of] legalizing and especially destigmatizing cannabis”—a drug that “could be damaging young brains for a lifetime.” News reports tout studies suggesting higher potency cannabis could mean higher risks of addiction and health harms.

    Research to clarify the specific nature of cannabis risks to youth is needed. We also need research on the current state of cannabis misinformation, including overly rosy views of risk that could create a backlash when problems are publicized. Using the results of this research for outreach ASAP, before the pot panic gets rolling, could soften the impact.

    Scrutinize and Enforce

    To avoid repeating mistakes of the past, we also need rigorous oversight. The FDA has been criticized for reluctance to use its powers to remove illegal nicotine vapes from the market. Some companies continue to sell despite warning letters. We need to study what cannabis products drive youth use and proactively target those makers and distributors.

    Products likely to attract underage users deserve particular scrutiny. Although no deaths were reported, a study in the journal Pediatrics2 documented a worrisome increase in child poisonings from edible cannabis products. To protect both adult access and child well-being, it’s common sense to require that edibles come in clearly marked, child-resistant packaging with no resemblance to candy.

    We have tools to unmask the bad actors. Youth will tell us in surveys what products they buy. The FDA’s own National Youth Tobacco Survey identified products not legally on the market, such as Puff Bar and Hyde, as favorite brands (Hyde was identified through write-in responses).

    With nicotine, regulatory delays and gray areas (such as regulation of synthetic nicotine) were abused by companies willing to skirt the law for quick profit. We see analogous situations with cannabis. One example is hemp-derived delta-8 THC products, said to produce a milder high similar to that from marijuana-derived delta-9 THC. Sales are rising fast. So are concerns. There are safety risks from impurities created during delta-8 manufacturing. And public confusion over delta-8’s legal status could complicate marijuana legalization efforts.

    The Reagan-Udall Foundation review of the CTP highlighted the need for “truthful and accurate information to help adult consumers make informed decisions about the role of nicotine” and product-specific risks. This applies equally to cannabis.

    This article first appeared in Vapor Voice‘s sister publication Tobacco Reporter.

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
    Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.
  • FDA Issues Final Guidance on Clinical Cannabis Research

    FDA Issues Final Guidance on Clinical Cannabis Research

    Credit: Nocturnal

    The U.S. Food and Drug Administration today issued the final guidance on clinical cannabis research. The “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry” guidance provides the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds, according to a press release. 

    FDA considered comments received on the draft guidance, issued in July 2020, as the agency worked to finalize the suggested rules. Changes from the draft to the final guidance include clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for investigational new drug (IND) applications in various stages of drug development, and providing guidance on quality considerations for INDs.

    The final guidance also:  

    • Lists applicable United States Pharmacopeia chapters on quality testing, including the assessment of leachables from packaging and delivery systems. 
    • Identifies relevant International Council for Harmonisation guidelines, FDA guidances, and considerations for devices used in combination with a drug. 
    • Addresses the calculation of delta-9 THC content, which is relevant to determine control status for cannabis and cannabis-derived compounds. 

    “It is critical FDA continues to support robust scientific research needed to develop new drugs from cannabis,” the release states. “FDA believes the drug development and approval process represents the best way to ensure that safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.”

    Earlier this month, The FDA said it is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements.

  • New Zealand has First Home-Grown Cannabis Vapes

    New Zealand has First Home-Grown Cannabis Vapes

    Helius CEO Carmen Doran

    In New Zealand, two new medicinal cannabis products have been verified as meeting the quality standard for legal sale. This follows Helius, a week earlier, being the first New Zealand company to receive GMP certification to produce THC extracts and manufacture medicines containing THC.

    “We are very pleased to bring more NZ grown, NZ made medicinal cannabis products to Kiwi patients,” says Carmen Doran, chief executive of Helius Therapeutics. The launch of two new medicines into the New Zealand market makes a total of four new medicines from Helius in 2022. It brings Helius’ portfolio of products to six, according to an email sent to Vapor Voice.

    “In mid-December we were able to announce GACP certification, and since then we’ve also obtained GMP certification for four more processes at our East Auckland site. Such progress is testament to the culture of teamwork Helius is building,” she says.

    Helius is New Zealand’s only company to have GMP certification for extraction and manufacture of CBD and THC medicines. What’s more, it is now one of two companies (the other being Nubu Pharma) who have six products verified as meeting the minimum quality standard in New Zealand.

    The latest products will be exported in 2023 to Helius customers in Europe.

    “The THC containing products have had considerable interest internationally, with GMP manufactured products gaining a lot of attention globally as the medical markets continue to grow. We have seen particular interest in balanced, full spectrum medicinal cannabis formulations,” says Doran.

    With the launch of these products, New Zealand patients now have access to NZ made products across the spectrum of oral solutions. No longer do they have to rely on imported products which have had supply delays throughout 2022 and can be priced considerably higher.

  • U.S. and European Cannabis Laws are Changing

    U.S. and European Cannabis Laws are Changing

    Credit: Fresh Ideas

    By Vapor Voice staff

    Marijuana laws are always changing across the globe. After elections in the United States, more states have had voters decide on the legality of marijuana in their state. Rules in Europe are changing more slowly, but many countries are becoming more accepting of cannabis regulation.

    Several U.S. states had recreational marijuana on the ballot in 2022. Maryland and Missouri became the 20th and 21st states, respectively, to legalize marijuana for adult recreational use in November, but cannabis reform efforts met defeat in Arkansas, North Dakota and South Dakota.

    Maryland voters approved a constitutional amendment that legalizes recreational marijuana for people aged 21 and older. It will go into effect on July 1, 2023, and allow possession of 1.5 ounces or two plants. Possession of small amounts of marijuana was already decriminalized in Maryland. Under the amendment, those previously convicted of cannabis possession and intent to distribute will be able to apply for record expungement, according to media reports.

    Missouri voters ended prohibitions on marijuana in the state and allowed personal use for those over the age of 21. It will allow for personal possession of up to 3 ounces and allow individuals with marijuana-related nonviolent offenses to petition for release from prison or parole and probation and have their records expunged.

    North Dakota voters rejected a citizen-initiated ballot measure that aimed at allowing the use of marijuana in “various forms” for those who are at least 21 years old. It would have allowed marijuana possession of up to an ounce and all marijuana to be tested in a facility “for the potency of products and the presence of pesticides” and subject to random inspection.

    South Dakotans rejected legalizing cannabis in the state too. Legalization for recreational marijuana use had passed in South Dakota in 2020, but the results were nullified by state courts. According to the proposed 2022 ballot measure, marijuana possession of up to an ounce would have been legal. It also would have legalized possession of marijuana paraphernalia, use and distribution.

    Additionally, Arkansas voters rejected a constitutional amendment that would have allowed cannabis possession and recreational consumption by adults as well as the sale by licensed facilities. Had it passed, cannabis possession of up to an ounce would have been legal, and some tax revenue from marijuana sales would have contributed to funding law enforcement.

    In Europe, many experts expect most countries to legalize cannabis in some way over the next 20 years to 25 years. Complicating the process is that Europe, like the U.S., currently has a patchwork of marijuana laws. Italy, for example, requires its army to grow marijuana for the country’s medical program. Switzerland is launching its first legal recreational program in Basel. And the Netherlands is only now authorizing the country’s first legal cannabis cultivation.

    In Germany, Health Minister Karl Lauterbach presented a cornerstone paper on planned legislation to regulate the controlled distribution and consumption of cannabis for recreational purposes among adults. Acquiring and possessing 20 grams to 30 grams of recreational cannabis for personal consumption would also be made legal. The coalition government struck an agreement last year to introduce legislation during its four-year term to allow the controlled distribution of cannabis in licensed shops.

    The Czech Cabinet is considering a draft plan to establish a regulated recreational cannabis market, according to Politico. A final proposal is expected in March, and it would go into effect in 2024 if enacted, Radio Prague International reports. Medical marijuana has been legal in the country since 2017. France has been experimenting with medicinal cannabis since 2021. Malta just passed a law allowing a person to carry 7 grams of cannabis. Finland has also recently taken small steps toward legalization. In 2019, a public initiative collected more than 59,000 signatures in favor of decriminalizing the personal use of cannabis, clearing a threshold that would require Parliament to consider the initiative in its current term that ends in 2023.