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Pharmaceutical Companies Win Big with Schedule 3 Classification of Cannabis

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Pharma wins in Schedule III – De-scheduling is the only way for true Equity!

The Biden Administration has been loudly touting diversity, equity and inclusion as top priorities since taking office, particularly when it comes to cannabis policy reform. However, their recent proposal to reschedule cannabis from a Schedule I to a Schedule III controlled substance reveals that promoting true equity is far from their primary concern.

For decades, Joe Biden has been cozy with Big Pharma, accepting millions in campaign contributions from drug companies over his long political career. It’s no secret that the pharmaceutical industry vehemently opposes cannabis legalization, as legal weed represents a major threat to their profits from opiate painkillers and other drugs. Pharma much prefers that cannabis remain illegal, or barring that, placed into a restrictive category like Schedule III that they can control and corner the market on.

Rescheduling cannabis to Schedule III would allow the drug to be legally prescribed, but with strict controls and oversight from the FDA. This plays right into the hands of major drug companies, who have the resources to navigate the complicated federal approval process and bring cannabis-derived pharmaceuticals to market. Smaller entrepreneurs, especially minorities who have been disproportionately impacted by the War on Drugs, would be largely shut out from participating in the industry.

If the Biden administration truly cared about diversity, equity and inclusion in cannabis, they would push to completely deschedule the plant, rather than shifting it to Schedule III. Descheduling would open up opportunities for a much wider range of individuals and small businesses to enter the legal industry. It would begin to repair the harms of the drug war and create more equitable access.

But Biden has never been a real ally to cannabis reform or racial justice. His proposed rescheduling is a pharma market grab disguised as incremental progress. Allowing a corporate oligopoly to further enrich itself will do nothing to help the marginalized communities who have suffered the most under prohibition. Only full descheduling can pave the way for true equity in the cannabis space. The administration’s “diversity and inclusion” rhetoric around this issue rings completely hollow.

Rescheduling cannabis to Schedule III would place it under the strict purview of the FDA, subjecting the industry to onerous regulations and compliance burdens that disadvantage minority small business owners. The costs of operating a Schedule III business are prohibitively high for most entrepreneurs. Companies must navigate an arduous FDA approval process for each cannabis-derived product, which can take years and cost millions of dollars in research and legal fees.

According to a 2017 survey, only 4% of cannabis businesses are owned by African Americans, and less than 2% by Latinos. These numbers are unlikely to improve under a Schedule III system that favors deep-pocketed corporations. Existing minority-owned cannabis businesses, already facing capital access challenges, would struggle immensely to shoulder the regulatory costs of FDA compliance, likely driving many out of business entirely.

Businesses would have to implement robust quality control systems, conduct expensive clinical trials, and maintain meticulous production records to meet FDA standards. The agency’s Good Manufacturing Practices are notoriously difficult to comply with, requiring significant investments in specialized facilities and equipment. Companies would also face extensive labeling and marketing restrictions, with the FDA tightly controlling allowable claims and product information.

While Schedule III substances can be legally prescribed and sold, they are still considered illegal outside of FDA-approved channels. Cannabis would remain a federally illegal substance, with businesses still facing the threat of raids and asset forfeiture. This “Regulatory Prohibition” would likely be weaponized against minority operators, as the drug war has been for decades. Those without the means to fight regulators could find themselves criminalized under the new system.

The pharmaceutical industry, through lobbying and campaign contributions, would inevitably seek to shape the FDA’s cannabis regulations in their favor. This could lead to policies like dosage limits and bans on whole-plant products that benefit patented drugs while hindering small producers. Pharma’s influence would further tilt the playing field against minority owners.

For minority entrepreneurs, the costs of entry and compliance under Schedule III would be backbreaking. Without serious equity initiatives to provide resources and technical assistance, a Schedule III industry would be dominated by Big Pharma and exclude people of color, doing little to repair the injustices of the drug war.

As we debate the future of cannabis policy in America, we must first ask ourselves: why are we even considering legalization in the first place? The answer is clear – it is the will of the people. For over a decade, a steadily growing majority of U.S. citizens have believed that cannabis should be legal. A recent poll found that a staggering 91% of Americans support legalizing medical marijuana, and 7 out of 10 are in favor of recreational legalization as well. The public has spoken, and they have resoundingly rejected the failed policies of prohibition.

So why, then, are we wasting time debating incremental “rescheduling” measures like moving cannabis to Schedule III? The only rational discussion to be having at this point is how to deschedule marijuana entirely and implement full legalization nationwide. Anything less is a slap in the face to the supermajority of Americans who want the freedom to consume cannabis without fear of arrest or stigma.

Activists like RAW Josh on X (formerly Twitter) are absolutely right to be outraged at the suggestion of Schedule III as some kind of victory.

It is not a win for the cannabis community, who have fought for decades to end prohibition entirely. It is not a win for those who have had their lives ruined by the cruel excesses of the Drug War, disproportionately people of color. It is not a win for medical patients, who would still face significant federal restrictions on their medicine. And it is certainly not a win for entrepreneurs and small businesses, who would be steamrolled by the pharmaceutical industry under a Schedule III paradigm.

What Schedule III represents is the iron grip of corporate pharma influence on our political system. It is a calculated maneuver to co-opt the legalization movement and steer the industry into the waiting hands of a few powerful drug companies. Roughly half of the funding of the FDA comes from Pharmaceutical companies through a scheme called “User Fees”.  Since Pharma loses roughly $10 billion annually in a region where Medical Cannabis is legal…what do you think happens to these “fees” that the FDA receive.

By maintaining strict federal control over cannabis, the government can pick and choose winners in the market, and rest assured those winners will not be mom-and-pop pot shops or minority-owned startups. They will be the multinational corporations with the lobbying power to write the regulations in their favor.

We cannot allow this to happen. We cannot allow the will of the people to be subverted by special interests yet again. The cannabis community must stand firm and demand nothing less than full descheduling and an end to federal prohibition once and for all. We must reject half-measures like Schedule III that are designed to fail us while enriching a corrupt pharmaceutical industry.

If that means we have to completely overhaul the DEA, or dismantle the incentive structures that allow corporations to buy off politicians, so be it. The war on drugs has been one of the most destructive and wasteful policy failures in American history, and it will not end until we take bold, uncompromising action. The people are ready for change, and we will continue to fight for it, against all odds and all opposition, until our work is finished. Descheduling is the path to justice, to equity, to individual liberty. We cannot settle for anything less.

When it comes to cannabis policy, the sticky bottom line is this: Schedule III is not what activists and advocates have been fighting for all these years. It is a far cry from the full legalization and normalization we seek. As citizens, it is imperative that we make our voices heard on this issue, not just in who we elect as president, but perhaps more importantly, in who we choose to represent us in Congress.

The unfortunate reality is that many of our current elected officials are political dinosaurs, beholden to special interests like Big Pharma who line their campaign coffers with cash. They are out of touch with the will of the people and more concerned with serving their corporate masters than doing what’s right. It is time we vote these compromised individuals out of office and replace them with representatives who will stand up to the pharmaceutical lobby and fight for true cannabis freedom.

What we demand is nothing less than complete descheduling of this miraculous plant. Because that’s what cannabis is at the end of the day – a plant. It is a seed that we can sow into the earth, a gift from nature that grows abundantly without human intervention. For centuries, humans have cultivated cannabis for food, fiber, medicine and spiritual purposes. Who are we to criminalize a plant that has served us so well?

The right to grow our own sustenance and healing herbs is fundamental to our autonomy as free people. Without that right, can we truly call ourselves free? Or are we merely slaves, dependent on the permission of corporations and governments to access the necessities of life? That is the question each of us must ask ourselves as we contemplate the future of cannabis in America.

In the end, the sticky bottom line is a matter of principle. Will we stand up for what we believe in, even in the face of powerful opposition? Will we fight for our sovereignty and self-determination, no matter how long it takes? Or will we compromise our values for the sake of political expediency and allow ourselves to be subjugated by those who seek to control us? The choice is ours to make, and the consequences will be ours to bear. Let us choose wisely, and let us never give up until the battle is won.

 

MORE ON SCHEDULE 3, READ ON…

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California Appeals Court Rejects Marijuana Grow Permit, Citing Federal Illegality

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In a landmark decision that highlights the tension between state and federal cannabis laws, a California appellate court ruled on October 29th that property owners can refuse to allow the transportation of cannabis across their land via easements, even when the cannabis operation is approved by local authorities.

The Second District Court of Appeal’s unanimous decision draws attention to private property rights in a context where cannabis remains federally illegal, but state law allows licensed cultivation, distribution and sale. Presiding Justice Albert Gilbert stated, “No matter how much California voters and the Legislature might try, cannabis cultivation and transportation are illegal in California as long as it remains illegal under federal law.” JCCrandall LLC v. County of Santa Barbara, Case No. B333201, 2024 WL 4599304, Oct. 29, 2024.

Unless the California Supreme Court grants review – which I would not rule out – the decision empowers private property owners to refuse to contract with cannabis businesses, and restricts local government from approving cannabis operations that implicate the property rights of neighbors who object.

The case at hand

The dispute centered around a cannabis cultivation operation in Santa Barbara County, where JCCrandall LLC challenged a conditional use permit granted by the County to its neighbor, Santa Rita Holdings Inc. The critical issue was that Santa Rita Holdings could only access its 2.5-acre cannabis farm via an unpaved road crossing JCCrandall’s property through a pre-existing easement. JCCrandall grows oats and barley.

JCCrandall’s primary concern? It raised a number of complaints with the Santa Barbara County Supervisors about truck traffic and night operations, which did not gain traction, but in the Court of Appeal JCCrandall focused on what it claimed was potential liability associated with having federally illegal substances transported across its property, even though County regulators found that the Santa Rita operation was fully compliant with state and local laws.

Key legal findings

The appellate court’s decision hinged on several crucial points:

  1. Property Rights: The court emphasized that “the right to exclude others is the essence of the right of property ownership” and classified it as a fundamental vested right.
  2. Federal Supremacy: The panel determined that allowing cannabis transportation across private property “defies the Supremacy Clause” of the U.S. Constitution.
  3. State vs. Federal Law: While cannabis might be legal under California law, the court ruled that federal law’s prohibition takes precedence in this context.

California cannabis industry implications

Legal experts suggest this ruling could have far-reaching consequences for California’s cannabis industry. Section 1550.5(b) of the California Civil Code makes contracts within California involving cannabis lawful and enforceable, and Santa Rita Holdings bet the ranch on that argument. But the Court of Appeal held that the statute could not compel a landowner to allow cannabis to travel across its property on a pre-existing easement. Licensed operators may find it harder to do business because neighbors who have property rights affected by a cannabis business can object, and, under the JCCrandall ruling, local government must yield to those objections.

An example might be a cannabis dispensary that depends on access to its parking lot via an easement or is located in a shopping center where other lessees have rights to object to tenants notwithstanding the approval of the landlord. In cultivation, many cannabis farms depend on vehicular access through easements because they are remote and do not always have direct access to public thoroughfares, or they depend on water sourced from other properties pursuant to agreements made by prior owners who grew traditional crops. These neighbors might not need to show any negative impact on their property, but can argue that they could be found complicit in federally illegal activities.

I think the most problematic language in the JCCrandall ruling is the following, which might draw the attention of the California Supreme Court and cause it to grant review: “For as long as an easement is enjoyed, its mode and manner of use shall remain substantially the same as it was at the time the easement was created. The County argues the easement was used for agricultural purposes. But there is a vast difference between legal and illegal agricultural purposes.” (Emphasis added.) If California has determined that cannabis cultivation is legal – as it has – and state courts routinely enforce contracts involving cannabis, it is a pretty bold step to declare the use of a lawful pre-existing easement illegal simply because the agricultural crop is cannabis and take away easement access from Santa Rita.

Looking ahead

This decision creates new challenges for cannabis businesses in California, and will result in more disputes among neighbors. While the Biden administration has shown signs of easing federal marijuana restrictions, this ruling demonstrates that the federal-state law conflict continues to create significant legal hurdles for the cannabis industry.

California court decisions also can be persuasive authority in other states, so we might see similar litigation (and decisions) elsewhere in the country where cannabis has been legalized.

The case serves as a reminder that despite California’s progressive stance on cannabis, federal prohibition continues to cast a long shadow over the industry’s operations and development. As the cannabis landscape continues to evolve, this ruling may prompt businesses to reassess their property arrangements and local governments will certainly have to reconsider their permitting processes to give more careful consideration to objections by neighbors who claim that their property rights are implicated by cannabis operations.

Note: This post was first published earlier this month on the Alger ADR Blog.



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Autoimmune Conditions Are Rising Fast in American Medicine, Can Cannabis Help?

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Why Are Autoimmune Conditions On The Rise? And How Cannabis Can Help

 

Autoimmune diseases refer to a group of medical conditions that occur as a result of the immune system attacking your own tissues.

 

In a normal human body, the immune system is responsible for protecting the body by producing antibodies that prevent toxins, cancer cells, and viruses from harming the body. However, when one is struck by an autoimmune disorder, the immune system is no longer able to distinguish the difference between dangerous cells and healthy cells. As a result, the healthy cells are attacked, too.

Today, we know of around 100 different kinds of autoimmune conditions. Some of the most common examples of autoimmune conditions include rheumatoid arthritis (RA), lupus, inflammatory bowel disease, celiac disease, Type 1 diabetes, multiple sclerosis (MS), and the Guillain-Barre syndrome (GBS) to name a few. Others include Graves’ disease, Hashimoto’s thyroiditis, psoriasis, and vasculitis.

 

According to the National Health Council, around 50 million Americans are affected by autoimmune diseases today. This is a conservative estimate, considering that several autoimmune conditions are tricky to treat and so many people go undiagnosed for long periods of time. It’s worrisome to note that there are more people developing autoimmune diseases these days, many of which have reached levels comparable to epidemics.

 

But cannabis can help!

 

How Cannabis Can Help Curb And Manage Autoimmune Diseases

 

Not one single cause is responsible for the alarming growth of autoimmune diseases, though there are several factors at play. While there isn’t just one cause we can point at, it’s certain the reasons lie in our environment. After all, human genetics haven’t changed significantly yet the chemicals, toxins, and pollutants in our food and everyday items have risen dramatically.

 

In addition, people are getting less sleep than ever; stress rates are through the roof, and people are constantly worried. There is a clear link between psychological stress and physical health as well as immunity, which is why it isn’t unusual – it’s even common – to see many autoimmune disease cases flare up after people experience severe stress caused by grief, an accident, job loss, or the death of a loved one. These highly stressful and traumatic conditions wreak havoc on the body’s immune response, causing inflammation all over the body.

 

Conventional treatments prescribed to treat autoimmune conditions are focused on taming inflammation; these usually include steroids but also some non-steroidal drugs. These drugs often come with unwanted side effects, but research has shown that cannabis can work with the endocannabinoid system through THC and CBD, as well as other cannabinoids, to simulate similar results. In one study for example, we can see the clear association of the endocannabinoid system for neurodegenerative and inflammatory processes seen in Multiple Sclerosis and Amyotrophic Lateral Sclerosis.


There has also been an increasing number of studies proving the efficacy of cannabis for treating several autoimmune conditions.

 

Cannabis For Multiple Sclerosis

 

Multiple sclerosis is one of the autoimmune conditions where a growing number of studies have come out supporting the therapeutic benefits of cannabis for. In a 2024 study, patients with multiple sclerosis reported several improvements in quality of life after using cannabis-based medical products (CBMPs). For the study, British investigators analyzed the impact of cannabis based medicinal products made from either oil or extracts in 141 patients who were enrolled in the UK Medical Cannabis Registry.

 

The researchers then analyzed the changes in patient outcomes after a month, then three and 6 months after. According to the patients themselves, they were able to sustain improvements in their mental and physical health after marijuana therapy.

 

“This case series demonstrates a potential association between the initiation of CBMPs and improved patient reported outcomes in sleep, anxiety, and general HRQoL [health-related quality of life] measures, over six months,” said the study authors. “Additional measures for HRQoL, including various physical and mental health subdomains, also exhibit improvements up to six months when compared to baseline,” the authors concluded.

 

In another study from 2023, patients with multiple sclerosis reported significant improvements in symptoms after cannabis use. For the study, researchers from the Dent Neurologic Institute in Buffalo, New York, analyzed the medical records of 141 patients with multiple sclerosis, who were also legally authorized to consume medical marijuana products. They then analyzed data from the patients after one up to 4 follow-up sessions after the initial session of cannabis therapy. Sixty-five percent of patients consumed 1:1 THC:CBD tinctures.

 

According to the authors: “The results of this study indicate that use of MC [medical cannabis] to alleviate symptoms of MS is largely efficacious, with improvement in pain (72 percent of patients), muscle spasticity (48 percent of patients), and sleep disturbance (40 percent of patients) frequently reported.”

 

“More than half of opioid users at baseline were able to either discontinue or decrease their opioid use after starting MC. The mean daily MME [morphine milligram equivalents] was significantly reduced from the initial visit (51 mg) to the last follow-up visit (40 mg). This is consistent with previous literature showing that MC legalization is associated with decreased opioid use and that MC use is associated with decreased opioid use in patients with chronic pain. These findings indicate that MC may represent an alternative analgesic to opioids for some patients,” they wrote. 

 

Anecdotal Evidence

 

While more studies are needed to determine cannabis’ effect on other autoimmune conditions such as rheumatoid arthritis, we can rely on anecdotal evidence. In 2020, data from the medical journal, Rheumatology, revealed that patients who have this condition, along with those who have lupus and fibromyalgia, consume cannabis.

 

In fact, it was reported that marijuana was extremely common especially for patients with fibromyalgia. “In this meta-analysis, we found that one in six patients suffering from rheumatologic disease actively consumes cannabis, reducing pain reduction… A favorable effect of cannabis on pain in our meta-analysis reinforces the idea that cannabis could be used for analgesic purposes,” the authors concluded.

 

Conclusion

Cannabis is a safe and natural way to help prevent and treat the symptoms of autoimmune disease. It targets inflammation at its root, and is a proven natural way to help cope with stress, pain, insomnia, and inflammation all while protecting the brain. However, it’s important to ensure you medicate with clean, organic sources of marijuana.

 

AUTOIMMUNE AND CANNABIS, READ ON…

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Hemp and the New Senate Farm Bill

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The U.S. Senate’s version of the Farm Bill finally landed this week. They’re calling it the Rural Prosperity and Food Security Act of 2024 (the “Senate bill”). The Senate bill follows on the House’s proposal, called the Farm, Food and National Security Act of 2024 (the “House bill”), offered in May. Neither the Senate bill nor the House bill would preempt state or Indian law regarding hemp or the regulation of hemp products. This means states and tribes will retain a lot of latitude in regulating hemp and hemp-derived products– which gets people fired up.

Aside from giving states some runway, the Senate bill and the House bill differ in key respects regarding hemp. Therefore, these august bodies must confer and reconcile their sundry proposals. That could happen in 2024, but seems more likely in 2025 when the new Congress convenes. As of this week, though, we finally have a framework.

The Senate Bill re-defines “hemp” and defines “industrial hemp”

Section 10016 of the Senate bill (“Hemp Production”) amends the definition of “hemp.” Hemp was defined in the 2018 Farm Bill and removed from the federal Controlled Substances Act (CSA), taking us on a truly wild ride. See: What Happened to Hemp? (“What Happened”). The Senate bill also gives us a definition for “industrial hemp.” Here are those definitions, with points of emphasis in bold:

(1) Hemp. The term “hemp” means (A) the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 total tetrahydrocannabinol concentration (including tetrahydrocannabinolic acid) of not more than 0.3 percent on a dry weight basis; and (B) industrial hemp.

(3) Industrial Hemp. The term “industrial hemp” means the plant Cannabis sativa L. if the harvested material (A) is only (i) the stalks of that plant, fiber produced from those stalks, or any other manufactured product, derivative, mixture, or preparation of those stalks (except cannabinoid resin extracted from those stalks); (ii) whole grain, oil, cake, nut, hull, or any other compound, manufactured product, derivative, mixture, or preparation of the seeds of that plant (except cannabinoid resin extracted from the seeds of that plant); or (iii) viable seeds of that plant produced solely for production or manufacture of any material described in clause (i) or (ii); and (B) will not be used in the manufacturing or synthesis of natural or synthetic cannabinoid products.

The new regime

Again, the definitional stuff in bold is what I want to emphasize.

First, the Senate bill keeps the THC threshold at 0.3 percent, which is an arbitrary number we’ve been advocating against for years. The Senate bill mirrors the House bill in this respect, though, so we are stuck with this, unless Ron Paul gets his way.

Second, the Senate bill keeps the 2018 Farm Bill’s total THC standard, including THCA. The House bill does this too. This was fairly predictable: in What Happened, I wrote that we could “expect the total THC standard to remain, which means that actual Delta-9 THC won’t be the only metric for calculating THC content.”

We’ve also explained on this blog that the 2018 Farm Bill and USDA rules mandate total THC testing on pre-harvest hemp batches, but do not mandate such testing on post-harvest hemp or hemp products. The Senate bill doesn’t change this paradigm, which means the “loophole” for gas station weed remains open. This proposal is a big win for opponents of the House bill’s “Miller Amendment,” which would narrow the definition of “hemp” to exclude intoxicating hemp-derived substances.

Third, the Senate bill introduces a new definition and framework for industrial hemp. The House bill does this too, albeit slightly differently. The idea here is to invite farmers to grow hemp for fiber and grain purposes, while freeing them from regulatory burdens with the Department of Agriculture and criminal exposure with the Department of Justice. More specifically, for “industrial hemp” growers, the Senate bill:

  • removes background check requirements;
  • instates “relaxed regulatory requirements” for sampling and inspection methodologies (which will need to be adopted by rule); and
  • develops a certified seed program. 

The Senate bill also makes any hemp producer ineligible to grow hemp for five years if that producer, “with a culpable mental state greater than negligence, produces a crop of hemp that is inconsistent with that license.”(Hint: use the seed program.) The proof standard here seems like it could be an issue, and even if anyone has been adjudicated as growing marijuana under the guise of hemp, Farm Bill ineligibility seems like a far-off concern.

Bottom line

The big takeaway for me is that the Senate bill leaves the door open for intoxicating hemp products, whereas the Miller Amendment to the House bill does not. Something’s gotta give. And it needs to happen soon, because we’re already long overdue. As I explained in a webinar last week, the Farm Bill deals with the nation’s entire food supply, not just hemp. Therefore, this is not like with the SAFE Banking Act, where we have a proposed law specific to cannabis that may or may not ever pass. The Farm Bill must pass, and soon.

Stay tuned and we’ll keep you updated on any major happenings. For more on this topic, check out our massive hemp and CBD archive, or these specific, recent posts:



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