Tag: cbd

  • 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.

  • 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.

  • U.S. FDA Could Drop CBD Guidance ‘Within Months’

    U.S. FDA Could Drop CBD Guidance ‘Within Months’

    Credit: Sofia

    The U.S. Food and Drug Administration is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements, the Wall Street Journal reported, citing agency officials.

    After weighing the evidence on the compound’s safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress, according to the report.

    In an interview, Janet Woodcock, the FDA’s Deputy Commissioner and leader of the agency’s cannabis regulation efforts, expressed concern about the safety of CBD and whether current regulatory pathways for food and dietary supplements are suitable for this substance.

    However, the agency is interested in determining whether it is safe to consume CBD on a daily basis for extended periods of time or during pregnancy.

    Woodcock mentioned concerns about potential effects on fertility in the future, but, at the same time, her comment signaled that the agency is working to establish regulatory frameworks for the legal sale of appropriate cannabis and cannabis-derived products.

    CBD is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.

    The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the market for CBD products. These products, sold as dietary supplements, are believed to have health benefits. As a result, many businesses in the cannabis industry are now selling CBD products across the country.

    In recent months, the FDA posted warning letters to at least nine companies for illegally selling products containing CBD. The companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD or were making medical claims about their CBD products.

    In 2021, The FDA told Charlotte’s Web Holdings Inc., one of the world’s largest CBD companies, that its cannabidiol product cannot be sold as a dietary supplement, signaling that CBD reform may have to wait for congressional action.

    The FDA has not approved any CBD-based products for use as dietary supplements. The only CBD-based product the FDA has approved is Epidiolex, a prescription medication used to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in children two years of age and older.

  • Costa Rica Authorizes Country’s First Hemp Farm

    Costa Rica Authorizes Country’s First Hemp Farm

    Credit: Gian

    Costa Rica has for the first time has given an agricultural conglomerate authorization to grow and process hemp under a recently signed resolution from the country’s agriculture ministry.

    Ingenio Taboga SA, a farming and food company, said it plans to plant hemp and build a processing factory on a 150-acre site.

    Taboga, based in Bebedero de Cañas, Guanacaste, lists products in alcohol-based sanitizers, specialty sugars, natural sweeteners, protein powders and CBD on its website, according to Hemp Today.

    “For the Ministry of Agriculture and Livestock, the development of responsible and efficient agricultural activities with significant agro-export potential is extremely important,” said Agriculture Minister Víctor Carvajal, adding that seven hemp more projects are being considered for authorization, with approval expected soon.

    Under rules approved by agriculture and health officials in September, hemp farming and production licenses are intended to be inexpensive and widely available in Costa Rica. Individuals and legal entities can be authorized to grow and process hemp, and rules are set for post-harvesting, storing, transporting, product manufacturing, marketing, importing and export of health, food and industrial products.

    Costa Rica’s rules set the limit for THC in hemp plants at 1.0 percent. Most countries follow a generally accepted limit of 0.3 percent THC as the dividing line between hemp and marijuana.

    Industry advocates in Costa Rica say establishing a robust hemp sector can spark development of agricultural value chains by bringing economic and social opportunities to the country’s rural areas, and contribute to the growth of the pharmaceutical industry.

  • FDA Warns 5 Companies for Marketing CBD Edibles

    FDA Warns 5 Companies for Marketing CBD Edibles

    Credit: Simone

    The U.S. Food and Drug Administration today posted warning letters to five companies for illegally selling products containing cannabidiol (CBD).

    These companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD. This could result in unintentional consumption or overconsumption of CBD.

    “CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning,” the FDA stated in a release.

    Warning letters were sent to the following companies:

    The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm, according to the agency.

    “This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products,” the agency states.

    The warning letters also outline additional violations of the Food, Drug & Cosmetics Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.

    “The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law,” the agency wrote. “Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”

  • Marijuana Research Bill Heads to U.S. President’s Desk

    Marijuana Research Bill Heads to U.S. President’s Desk

    Credit: Jose

    For the first time, a standalone piece of marijuana reform legislation has been sent to the U.S. president’s desk. The “Medical Marijuana and Cannabidiol Research Expansion Act” is just one signature away from historic enactment.

    Just weeks after President Joe Biden issued a mass marijuana pardon and directed a review of the drug’s scheduling status, the U.S. Senate approved a House-passed bipartisan cannabis research bill on Wednesday.

    Senate Majority Leader Chuck Schumer said he is continuing to have “productive talks” about a broader package of cannabis reforms. He hopes to pass them before the end of Congress’ lame duck session, according to Marijuana Moments.

    The bill “would eliminate the red tape that hinders cannabis research, opening the door for new innovative treatments derived from cannabis,” Schumer said ahead of the vote. “If you’re one of the millions of Americans who deals with conditions like Parkinson’s or epilepsy or post-traumatic stress, or any number of other conditions, cannabis might hold promising new options for managing these diseases.”

    “We need to do the research first,” he said. “And the federal government, sadly, has been woefully behind the times on this front. This bill will help fix that.”

    Numerous marijuana measures have been filed and advanced in each chamber in recent sessions, however, reform has consistently stalled before reaching the president.

    The bill was filed in July and quickly moved through the House before being taken up by the Senate, which approved the legislation under unanimous consent.

  • Thailand: Decriminalized Cannabis to Begin Thursday

    Thailand: Decriminalized Cannabis to Begin Thursday

    Credit: Art Proximo

    Thailand’s Courts of Justice announced that suspects and prisoners on charges related to cannabis use and possession would be freed after cannabis and hemp are removed from the Public Health Ministry’s Category 5 drug list beginning June 9.

    The cultivation and smoking of recreational marijuana, even for personal use, will still not be legalized, according to The Haiger.

    On Saturday, spokesperson of the Courts of Justice, Sorrawit Limparangsi, confirmed that all suspects and prisoners charged with production, import, export, distribution, use and possession of cannabis even before June 9 would be released.

    The Ministry of Public Health is working to decriminalise the use and possession of cannabis in Thailand in a bid to develop medical tourism and the economy in Thailand. Starting Thursday, people are allowed to grow cannabis at home for medical use without asking for government permission. The only requirement, those said people have to download an app called Plook Ganja and register.

    Every part of cannabis and hemp, including leaves, stems, fibers, branches, seeds, inflorescences, and roots, can be legally used at home for medical purposes if the amount of THC, tetrahydrocannabinol, or CBD, cannabidiol, is less than 0.2%. That means you are not legally allowed to get high in Thailand, for now anyway.

    Smoking cannabis is considered a public nuisance. People can file a complaint against cannabis smokers and those users face a 3-month jail sentence and a fine of up to 25,000 baht if they are found guilty of a public nuisance charge.

    The Public Health Ministry says this would help prevent the recreational use and other abuses of cannabis that are currently in conflict with existing Thai laws.

  • 22nd Century Acquires Manufacturer GVB Biopharma

    22nd Century Acquires Manufacturer GVB Biopharma

    Photo: cendeced

    22nd Century Group has acquired GVB Biopharma. As a contract development and manufacturing organization, GVB is believed to be one of the largest providers of hemp-derived active ingredients for the pharmaceutical and consumer goods industries worldwide based on total tonnage.

    GVB’s strengths complement 22nd Century’s existing upstream and downstream value chains, which includes expertise in cannabinoid receptor science with CannaMetrix, plant research and proprietary genetics through its KeyGene partnership, breeding expertise with Extractas, and cultivation capabilities at Needle Rock Farms.

    GVB expects 2022 revenue of approximately $48 million, a 58 percent increase year-over-year, gross margin in excess of 44 percent and positive cash flow. Upon closing, the transaction is expected to more than double 22nd Century’s revenue, be immediately accretive to adjusted EBITDA, and generate positive cash flow from the acquired assets in the near term.

    “GVB represents a transformational acquisition for 22nd Century that will enable us to rapidly grow our hemp/cannabis franchise,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.

    “GVB is one of the largest CBD suppliers globally, possessing innovative, vertically integrated cannabinoid product manufacturing technologies driving industry leading scale and cost efficiency. In addition to immediately expanding our hemp/cannabis franchise capabilities, GVB represents an opportunity to double our revenue and internalize a comprehensive contract manufacturing and extraction platform which can be used to directly and exclusively monetize our differentiated and proprietary hemp/cannabis plant genetics and intellectual property. We are enthusiastic to begin working with the highly regarded and very experienced management team at GVB.”

    “We are excited to combine with 22nd Century group, pairing our production and manufacturing capabilities together with the best hemp/cannabis plant science in the world,” said Phillip Swindells, chief executive officer at GVB. “Since 2017, we have built a loyal customer base and continue to add new, rapidly growing customers as demand in our industry accelerates. We sold more than five billion doses of CBD in 2021, and we look forward to further scaling our business as a part of 22nd Century’s comprehensive platform.”

    GVB operates three U.S. manufacturing facilities in Oregon and Nevada, including a 30,000-square-feet hemp ingredient manufacturing facility in Central Oregon, a 40,000 square-feet white-label, finished product manufacturing facility in Las Vegas, and an industrial-scale hemp extraction facility in Prineville, Oregon.