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Patient Zero for Untreatable Depression Begins Groundbreaking Psychedelics Therapy

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psychedelics for depression

In a phase 2b clinical trial, Beckley Psytech has started treating the first subject for BPL-003, an intranasal synthetic formulation of the psychedelic chemical 5-MeO-DMT intended for patients with treatment-resistant depression.

 

With FDA clearance for investigational new medication status in February, this groundbreaking research represents the biggest controlled examination into the potential of 5-MeO-DMT, involving 40 locations throughout Australia, Europe, and the US.

 

The trial, employing a randomized, quadruple-masked design, seeks to identify optimal dosages of BPL-003, complemented by psychological support, in 225 individuals grappling with moderate to severe treatment-resistant depression, compared to a placebo group.

 

Efficacy will be gauged using the Montgomery-Asberg Depression Rating Scale at various intervals throughout the trial, with all participants receiving psychological support before, during, and after dosing. An open-label extension is slated for select sites eight weeks post-initial dosing to evaluate sustained effects following a second dose.

 

Anticipated findings from this phase 2b endeavor, projected by late 2024, will augment insights gleaned from the ongoing phase 2a exploration of BPL-003, as highlighted by the company.

 

Cosmo Feilding Mellen, CEO of Beckley Psytech, expressed confidence in the compound, citing promising safety and pharmacokinetic data. He emphasized its capacity to induce brief yet profound subjective experiences correlating with therapeutic benefits, underscoring the company’s eagerness to advance BPL-003 through the clinical development pipeline.

 

Unprecedented Research Scope

 

An important turning point in the field of psychedelic research, especially in the area of mental health therapy, was reached with the start of Beckley Psytech’s phase 2b clinical experiment. The large-scale nature of this experiment highlights an important development in our knowledge of the therapeutic potential of psychedelic substances, with a particular emphasis on 5-MeO-DMT for patients suffering from depression that does not respond to conventional therapy. This experiment, which spans 40 sites throughout Australia, Europe, and the US, is the biggest controlled investigation into the possible effectiveness of 5-MeO-DMT, in contrast to earlier research. This wide outreach guarantees a varied pool of participants and improves the trial’s outcomes dependability and generalizability.

 

A rising awareness among scientists of the need for novel strategies to tackle the widespread problems associated with treatment-resistant depression is reflected in the decision to launch such an extensive research project. Researchers want to increase the number of therapy choices available for those who have not reacted well to traditional medications by investigating the therapeutic benefits of 5-MeO-DMT in a rigorous clinical environment. The trial’s multi-site design also makes it easier for clinicians and researchers in various areas to collaborate, which promotes a group effort to further our understanding of psychedelic-assisted treatment.

 

The size of this phase 2b experiment not only emphasizes the significance of its findings, but also demonstrates Beckley Psytech’s dedication to pushing the limits of psychedelic research. Through strategic alliances and diligent preparation, the firm has proved its commitment to performing high-quality clinical studies that meet rigorous scientific criteria while investigating novel treatment approaches. This innovative method not only aids the area of mental health treatment, but also helps to de-stigmatize psychedelics by demonstrating their ability to treat significant psychiatric illnesses safely and responsibly.

 

The experiment is expected to yield valuable insights that might influence future research, clinical recommendations, and regulatory choices related to the use of psychedelic substances in mental health therapy. This is because the trial is expected to proceed and data will accrue. Psychedelic-assisted therapy is being promoted as a possible therapeutic option for the intricate problems associated with treatment-resistant depression, thanks to the combined efforts of researchers, physicians, and study participants.

 

Trial Design and Objectives

 

BPL-003’s phase 2b clinical trial has been carefully designed to assess the drug’s potential as a therapy for people with depression who are not responding to conventional treatments. The experiment uses a quadruple-masked, randomized design to reduce biases and guarantee the validity and dependability of the results. This methodological rigor bolsters the foundation for well-informed decision-making on developing BPL-003 and increases the legitimacy of the study’s findings.

 

Central to the trial’s objectives is the identification of optimal dosages of BPL-003 that can effectively alleviate symptoms of moderate to severe treatment-resistant depression. By employing a range of doses and comparing them against a placebo group, researchers seek to discern the therapeutic window within which BPL-003 demonstrates the greatest efficacy while minimizing adverse effects. This dose-finding aspect of the trial is crucial for informing subsequent clinical studies and eventual therapeutic use.

 

The experiment incorporates psychological support as an additional therapeutic component in addition to dose optimization. All patients get thorough psychological care before, during, and following medication since it is acknowledged that depression is a complex condition with psychosocial components that may influence treatment outcomes. To promote complete healing and recovery, this holistic approach emphasizes the need to address not only the biology but also the psychological and emotional elements of depression.

 

Furthermore, the trial’s design includes strong metrics for measuring effectiveness, particularly using the Montgomery-Asberg Depression Rating Scale at several points throughout the research. This validated method enables researchers to systematically assess changes in depression symptoms and track the therapeutic benefits of BPL-003 over time. The trial uses standardized evaluation techniques to improve the consistency and comparability of outcomes across multiple research sites, increasing the reliability and generalizability of the findings.

 

Evaluation Methods and Milestones

 

A wide range of evaluation techniques and milestones are included in the phase 2b clinical study to assess BPL-003’s effectiveness in treating depression that is resistant to therapy. The Montgomery-Asberg Depression Rating Scale, a reliable instrument for gauging depression symptoms and treatment response, is a key component of this evaluation. Researchers can systematically monitor changes in participants’ depressed symptoms and evaluate the therapeutic efficacy of BPL-003 in comparison to placebo by giving this scale to participants at different intervals during the experiment.

 

The study underlines the need to provide psychological support to all participants before, during, and after dosing. This integrated approach stresses the need to meet the holistic needs of patients receiving therapy while also recognizing the complex interplay between biological, psychological, and social factors in depression. The study’s purpose is to improve treatment outcomes and participants’ overall well-being by offering comprehensive psychological support, such as counseling and therapeutic sessions, during the experiment.

 

Furthermore, the trial includes an open-label extension phase at select sites, scheduled eight weeks post-initial dosing, to evaluate the sustained effects of BPL-003 following a second dose. This extension phase allows researchers to assess the durability of treatment response and investigate the potential for long-term therapeutic benefits. By extending the observation period beyond the initial dosing phase, the trial aims to provide insights into the maintenance of treatment effects over time and inform recommendations for the optimal dosing regimen of BPL-003 in clinical practice.

 

Bottom Line

 

Beckley Psytech’s phase 2b clinical trial of BPL-003 for treatment-resistant depression marks a significant milestone in psychedelic research. With its expansive scope, rigorous trial design, and emphasis on comprehensive evaluation methods, the study holds promise for advancing our understanding of psychedelic-assisted therapy. As the trial progresses and data accumulates, it is poised to provide valuable insights that could influence future treatment approaches and regulatory decisions in the field of mental health.

 

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The US Suddenly Has Two Pro-Marijuana Legalization Candidates, But Only One is Believable 60 Days Before the Election

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Trump and Harris both support cannabis legalization

“Don’t Believe the Hype” – Public Enemy

In a surprising move, former President Donald Trump has publicly endorsed the legalization of cannabis, arguing that the criminalization of marijuana “ruins lives” and “wastes taxpayer dollars.” Speaking at a rally in Florida, Trump expressed confidence that voters will support a marijuana legalization initiative on the November ballot, stating, “I really believe it’s the right thing to do.”

Trump’s comments come at a time when public support for cannabis legalization is at an all-time high, with recent surveys indicating that approximately 78% of American adults favor legalization. The economic implications of this shift are significant, with the cannabis industry currently employing around 500,000 people and generating $29 billion in sales last year, a figure projected to rise to $37 billion by 2027.

The Harris camp immediately accussed the Trump camp of a “brazen flip-flop” on marijuana legalization just before the election in order ot try and lure swing voters. Based on Trump’s past presidency and his work with Attorney General Sessions during his first term, he is certainly no fan of marijuana, marijuana legalization, or was in any rush to support states that establisted legal, medical cannabis programs.  As they say in life, “watch what someone does, not what they say 60 days before an election”, Trump had his chance as Commander-In-Chef and put the marijuana movement back 5 steps when he was in office.

This certainly smells fishy from the start based on his track record on drugs, alcohol, and marijuana legalization. Remember, he actually took steps in his Presidency to shut the marijuana movement down in America according to the New York Times.

 

Harris, on the other hand, claims to be for rescheduling cannabis and even legalizatio,n and a large clemency program. While she has been Vice-President for 4 years and legalization has not happened, her boss, President Biden, is no fan of drugs and has been on a founding memeber of the “War on Drugs” for over 40 years in office.  So no, Harris has not “had her chance” the way Trump has had his chance as the actual President. As many know, the Vice-President’s roll in some instances is more for show and to take tours and visits the president does not have time or want to to do. 

 

Harris has a “yet to be determined, yet things look good” on her marijuana legalization report card.

 

As MJBIZ covered in their artice on who would be better for marijuana reform going forward..

During a relatively quiet few years as vice president, Harris stumped for Biden’s generational advances in marijuana reform.

She was out front on the Biden administration’s pardons for former federal marijuana offenders as well as the October 2022 executive order that culminated in the Justice Department’s proposal this spring to move marijuana from Schedule 1 to Schedule 3 of the Controlled Substances Act.

“She’s actually gone further than (Biden),” said Bryan Barash, vice president of external affairs and deputy general counsel at Dutchie, an Oregon-based online cannabis sales platform.

“She’s said, ‘We can’t stop until there’s full legalization,’ which he has never said.”

In other words, Harris has the best record on marijuana reform of any major presidential candidate, including Biden.

 

Economic Implications of Legalization

 

The economic implications of cannabis legalization are substantial. The cannabis industry has rapidly evolved into a multi-billion dollar market, employing around 500,000 people and generating $29 billion in sales in the past year alone. Projections indicate that this figure could rise to $37 billion by 2027, highlighting the potential for job creation and economic growth in states that choose to legalize cannabis.

 

  • Job creation: Legalizing cannabis could create thousands of jobs across various sectors, significantly boosting the economy. In agriculture, the cultivation of cannabis will require a workforce for planting, harvesting, and processing. The retail sector will also expand, as dispensaries will need staff for sales and management roles. Additionally, manufacturing jobs will emerge to produce cannabis-infused products, such as edibles and oils. Overall, legalization can lead to substantial job creation in agriculture, retail, and manufacturing, benefiting local communities and economies.

 

  • Tax Revenue: Legalizing cannabis could create thousands of jobs across various sectors, providing a significant boost to the economy. In agriculture, the cultivation of cannabis will require workers for planting and harvesting. The retail sector will also expand, as dispensaries will need staff for sales and management roles. Additionally, manufacturing jobs will emerge to produce cannabis-infused products like edibles and oils. Overall, legalization can lead to substantial job creation, benefiting local communities and economies.

 

 

  • Economic Growth:  A legal cannabis market has the potential to stimulate economic growth, especially in economically disadvantaged areas. By establishing regulated cannabis businesses, communities can attract investment and create new revenue streams, leading to job creation and increased local spending. This influx of economic activity can revitalize struggling neighborhoods, providing opportunities for entrepreneurship and supporting ancillary businesses, such as suppliers and service providers. Additionally, the tax revenue generated from cannabis sales can be reinvested into public services, infrastructure, and community development projects, further enhancing the overall economic landscape. Ultimately, legalizing cannabis can serve as a catalyst for sustainable growth and revitalization in areas that need it most

 

 Health Benefits and Opioid Reduction

 

Trump also emphasized the health advantages of legal cannabis, particularly its potential role in managing chronic pain and reducing reliance on opioids. This point is especially relevant given the ongoing opioid epidemic, which has claimed hundreds of thousands of lives in recent years.

 

 

 

  • Mental Health Benefits: Emerging research suggests that cannabis may also have therapeutic benefits for mental health conditions, such as anxiety and depression, further supporting its legalization.

 

Disproportionate Impact on Communities of Color

Trump’s advocacy for cannabis legalization also reflects a growing awareness of the disproportionate impact of cannabis criminalization on communities of color. Over 40,000 individuals remain incarcerated for non-violent cannabis offenses, with Black and Hispanic individuals being significantly more likely to face prosecution and harsher sentences for cannabis-related crimes.

 

 

  • Social Equity Programs: Many states that have legalized cannabis have implemented social equity programs aimed at helping communities disproportionately affected by the War on Drugs, providing opportunities for entrepreneurship and economic participation in the legal cannabis market.

 

  • Expungement of Records: Legalization efforts often include provisions for expunging the records of individuals previously convicted of non-violent cannabis offenses, allowing them to reintegrate into society without the stigma of a criminal record.

 

Shifting Political Landscape

 

Trump’s endorsement of cannabis legalization represents a significant shift in the political discourse surrounding the issue. Historically, the Republican Party has been more resistant to legalization efforts, with many conservatives expressing concerns about the potential for increased drug use and public safety risks. However, as public opinion has shifted and the economic and social benefits of legalization have become more apparent, some Republican leaders have begun to reconsider their stance.

 

 

  • Influence of State-Level Legalization: The success of state-level legalization efforts has provided a blueprint for national policy changes, demonstrating that cannabis can be regulated effectively without compromising public safety.

 

Potential Impact on the 2024 Election

Trump’s support for cannabis legalization could have significant implications for the 2024 presidential election, particularly if he decides to run again. By aligning himself with a popular issue that enjoys broad bipartisan support, Trump may be able to attract a wider range of voters, including younger and more progressive-leaning individuals who have traditionally been skeptical of Republican candidates.

 

  • Engaging Younger Voters: Younger voters, who are more likely to support cannabis legalization, could be crucial for Trump’s campaign, potentially swaying their votes in his favor.

  • Broadening the Republican Base: By embracing cannabis legalization, Trump may be able to broaden the Republican base and attract independent voters who prioritize social justice and economic reform.

 

 

Conclusion

Donald Trump’s endorsement of cannabis legalization marks a significant milestone in the ongoing effort to end the criminalization of marijuana in the United States. By acknowledging the negative impact of prohibition on individuals, communities, and taxpayers, and highlighting the potential benefits of legalization, Trump is adding his voice to a growing chorus of advocates who believe that it is time for a new approach to cannabis policy. As the 2024 election cycle approaches, it will be fascinating to observe how Trump’s stance on this issue shapes the political landscape and influences the debate over the future of cannabis in America. With public support at an all-time high and the economic and social benefits becoming increasingly clear, the momentum for cannabis legalization appears poised to continue growing in the years to come.

 

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TRUMP IF HE LEGALIZED WEED, YES OR NO

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What State Just Dropped Below $80 an Ounce for Legal Cannabis? A. Florida B. Michigan C. California D. New York

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cannabis price drops michigan

In a significant development for Michigan’s cannabis industry, retail prices have fallen below $80 per ounce as of September 4, 2024. This historic milestone, reflecting a nearly 14.5% decline from the previous year, signals a major shift in market dynamics.

The price drop is driven by increased competition among licensed dispensaries, a growing supply of cannabis products, and the maturation of the market since the legalization of recreational use in 2018. More dispensaries and cultivation facilities have led to competitive pricing and greater product availability, making cannabis more affordable for consumers and potentially boosting legal sales.

As a leader in the Midwest’s cannabis landscape, Michigan’s regulatory framework supports both medical and recreational markets, generating significant tax revenue and job opportunities. As the industry evolves, stakeholders must navigate challenges and capitalize on emerging opportunities.

 

Factors Behind the Price Drop

The surge in the number of licensed dispensaries in Michigan since the legalization of recreational cannabis in 2018, coupled with the expansion of cultivation facilities, has led to a significant increase in the supply and availability of cannabis products. With more dispensaries offering a wider variety of choices for consumers, the market has become increasingly competitive, with retailers employing pricing strategies to attract customers. This growth in the number of dispensaries and cultivation facilities has enabled dispensaries to offer lower prices to consumers, making cannabis more accessible and affordable.

 

As the cannabis market matures, both producers and retailers have optimized their operations, leading to reduced costs that are often passed on to consumers. Enhanced cultivation techniques and economies of scale have played a crucial role in lowering production expenses, allowing businesses to improve efficiency and increase output. This combination of operational optimization and cost reduction not only benefits producers and retailers but also makes cannabis products more affordable and accessible for consumers, fostering a healthier and more competitive market environment.

The market has become oversaturated with cannabis products, particularly following significant outdoor harvests. This oversupply has led to a decrease in prices as producers and retailers compete to sell excess inventory.

Michigan currently has no statewide cap on the number of cannabis business licenses, resulting in explosive growth in both supply and demand. This unrestricted licensing has intensified competition among businesses, driving prices downward as they vie for market share.

 

 Implications for Consumers and the Industry

The recent drop in cannabis prices has made the product more affordable for a broader segment of the population, enabling consumers to access quality cannabis without financial strain. This increased affordability not only allows more individuals to enjoy legal cannabis but also promotes responsible use and consumption, as people are more likely to make informed choices when quality products are within reach. By removing financial barriers, the industry is fostering a healthier relationship with cannabis among consumers, contributing to a more informed and responsible market.

 

The potential boost in sales volume is another significant implication of the lower cannabis prices in Michigan. As the cost of cannabis becomes more affordable, more consumers are likely to enter the market, leading to an increase in overall sales. Dispensaries may experience higher foot traffic as a result of this increased interest in cannabis products, directly benefiting from the lower prices. This influx of new consumers and higher sales volume could further solidify the industry’s growth and sustainability in the state, as businesses capitalize on the greater demand for their products.

The competitive pricing of legal cannabis products in Michigan has the potential to curb illegal sales by making regulated options more attractive to consumers. As the cost of legal cannabis becomes more affordable and accessible, individuals may be more inclined to purchase from licensed dispensaries rather than the black market. This shift towards regulated products not only supports the legal industry but also enhances public safety and quality assurance. By choosing legal cannabis, consumers can be confident in the safety, purity, and potency of the products they purchase, reducing the risks associated with unregulated, illicit markets. As more consumers opt for legal cannabis due to the competitive pricing, the state can expect to see a decline in illegal sales and an improvement in overall public health and safety.

 

Michigan’s Cannabis Landscape

 

Since the legalization of recreational cannabis in Michigan, the state has become a pioneer in cannabis reform within the Midwest. With a comprehensive regulatory framework in place, Michigan supports both medical and recreational markets, fostering a thriving industry that has generated significant tax revenue and job opportunities.

 

The cannabis industry in Michigan has significantly contributed millions in tax revenue, which is allocated to vital areas such as education, infrastructure, and public health initiatives. Additionally, the industry’s growth has led to job creation across cultivation, distribution, and retail sectors, providing numerous employment opportunities for residents. This dual impact not only supports the state’s economy but also enhances community well-being through improved public services and increased job availability.-

As cannabis prices continue to decrease in Michigan, making the products more accessible to a wider consumer base, there is a growing need for comprehensive consumer education. Dispensaries are increasingly taking on the responsibility of educating their customers on responsible use, product selection, and the effects of various cannabis strains. By offering workshops and informational resources, dispensaries aim to help consumers make informed choices and develop a deeper understanding of the products they consume. This proactive approach to consumer education not only promotes responsible use but also fosters a more informed and engaged cannabis community in the state.

 

Conclusion

The decline in cannabis prices to below $80 per ounce is a significant development for Michigan, highlighting the success of Its regulatory framework and the positive impact on consumers. As the market matures, stakeholders will need to remain vigilant in addressing challenges while capitalizing on the opportunities presented by this dynamic industry.

 

MICHIGAN CANNABIS PRICES PLUMMET, READ ON…

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Loper Comes for the DEA. Will it Matter, Though?

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Earlier this week, the federal Fourth Circuit Court of Appeals, in a case entitled Anderson v. Diamondback Investment Group, LLC, handed the DEA a big loss when it comes to hemp – at least for now. In Anderson, the court held that DEA’s interpretation that a host of hemp-derived products were illegal was essentially wrong. Today I want to talk about why Anderson is – and isn’t really – important.

Anderson, as I wrote more than a month ago, was based in relevant part on Loper Bright Enterprises v. Raimondo, a 2024 US Supreme Court decision. Here’s what I said then:

Loper ended what’s often referred to as “Chevron deference.” To vastly oversimplify, Chevron deference required federal courts to defer to reasonable agency interpretations of ambiguous statutes, even if courts did not agree with those interpretations. With Chevron dead, courts will not be required to defer to agencies and courts can decide, on their own, whether an agency’s interpretation was within its statutory authority.

Ever since Loper was decided, there have been a million different theories on how it could affect the cannabis and hemp industries. [For the record, I agree with folks like Shane Pennington who argue that Loper will not affect rescheduling.]

When it comes to hemp though, Loper may in theory have more of an impact, as my colleague, Vince Sliwoski, argued prior to Loper‘s publication. That’s because the DEA routinely issues what amount to opinion letters as to whether this or that cannabinoid is or is not a schedule I narcotic. Under Loper, if there were any statutory ambiguity, the DEA’s interpretation would no longer be given deference. That’s not to say that the DEA might not prevail, but it means the deck would be less stacked in DEA’s favor.

And that is essentially what happened in Anderson. Without getting into the factual weeds of the case, an employee had been terminated after drug tests allegedly showed marijuana use. She sued, in part claiming that she used legal hemp-derived products. The court ultimately held that she had failed to provide they were legal because she did not introduce sufficient evidence that the hemp products had less than 0.3% delta-9 THC.

However, for purposes of this post, the important part of the Anderson decision was its discussion of the 2018 Farm Bill and DEA’s interpretations of the legality of various cannabinoids under that law. One specific cannabinoid that the court analyzed was THC-O, which does not occur naturally but is created from hemp derivatives.

For years, there has been a heated debate as to whether hemp-derived products like delta-8 THC are considered “hemp” under the 2018 Farm Bill. The debate centers around whether these products are “synthetic” because they are derived from other cannabinoids. This is important because DEA considers synthetic cannabinoids to be controlled substances.

A few years ago, in AK Futures LLC v. Boyd Street Distro, LLC, the Ninth Circuit Court of Appeals addressed the issue (albeit in a much different context), and held that delta-8 THC products derived from hemp with less than 0.3% THC were legal under the 2018 Farm Bill.

Importantly, Anderson found AK Futures persuasive, holding:

“we think the Ninth Circuit’s interpretation of the 2018 Farm Act is the better of the two. And we’re free to make that determination ourselves, despite a contrary interpretation from the DEA, because we agree with the Ninth Circuit that [the 2018 Farm Bill’s definition of hemp] is unambiguous . . ., and because even if it were ambiguous, we needn’t defer to the agency’s interpretation [as a result of the Loper decision].”

Crucially, Anderson held that “rather than originating from organic matter—like the hemp-derived cannabinoids at issue—, synthetic cannabinoids are just that: compounds manufactured entirely out of synthetic materials.”

To summarize all of this, according to the Fourth Circuit, if a product is derived from hemp and does not contain more than 0.3% THC, it is legal. This includes things pulled directly from the plant, or things like delta-8 THC which may take other processes to produce. But, any cannabinoid derived purely from synthetic materials would not be considered “hemp” under the 2018 Farm Bill.

All of that said, Anderson probably won’t matter much. As I noted in in July:

[A]ll of [the discussion about Loper] is almost certainly academic – at least if Congress passes the Farm Bill with proposed amendments that would ban intoxicating hemp products. If that happens, the DEA won’t need to opine on the legality of many (if not most or all) intoxicating hemp products. The law would have already changed to prohibit them expressly.

But what happens if the upcoming Farm Bill doesn’t contain bans on intoxicating hemp products? Things will almost certainly not end there. The FDA, which has been hostile to many hemp products since the day the 2018 Farm Bill was passed, could simply claim products are adulterated or misbranded and seek to pull them from the market. It does this with kratom, which is an unscheduled plant, and there’s no reason why it could not do it here (subject again to FDA having to prove its case in a post-Loper court challenge).

And, as I noted, federal law isn’t the only thing that matters:

Things are also not looking great for intoxicating hemp products at the state and local levels. The State of Virginia, for example, just levied nearly $11 million in fines against more than 300 retailers allegedly selling state-prohibited intoxicating hemp products. Out west, the Colorado attorney general sued a business in June for allegedly selling super-high THC products marketed as federally legal hemp.

We also assume that there is a lot of local enforcement actions that go under the radar – things like state or local public health officials pulling products from shelves or warning stores. That can be harder to track if for no other reason than it doesn’t often make the news. We also assume that a lot of the reports concerning enforcement against alleged illegal marijuana stores or operators, including in places like New York, may miss the legal nuances between intoxicating hemp products and illegal cannabis products.

In sum, the intoxicating cannabinoid industry just won the battle with DEA, but it’s probably not going to win the war.



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