Cannabis News
Marijuana as Schedule III: Woe is Me?
Published
1 year agoon
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admin
Unless you’ve been living under a rock, you know that a pretty historic announcement was made last week by the U.S. Department of Health and Human Services (HHS). HHS officially recommended that marijuana be rescheduled from Schedule I to Schedule III of the federal Controlled Substances Act (CSA).
The HHS news means that the country’s top health agency has finally conceded that cannabis has medical value, and isn’t a drug of abuse on par with fentanyl or heroin. Many people in the cannabis industry are convinced that this HHS recommendation to the Drug Enforcement Administration (DEA) means that the DEA will undertake this rescheduling (and fairly quickly, too–which would be a huge departure from its refusal to reschedule back in 2016).
If cannabis goes from a Schedule I to a Schedule III, the cannabis industry as we know it will forever change. We recently wrote about three facts and myths from this massive development, but in this post I want to cover what I think legal cannabis looks like in the U.S. if the plant is moved to Schedule III. While all existing cannabis companies will benefit from axing I.R.C. 280E from their business plans and medical research will finally open up, I think the longer game ultimately spells trouble for our current state-legal cannabis industry. Just my two cents; feel free to disagree.
Schedule III is not a free-for-all
Schedule III controlled substances are classified by the DEA as drugs with low to moderate potential for physical and psychological dependence. According to the DEA, when misused, these drugs can still lead to abuse or addiction, even if less dangerous than Schedule I or II controlled substances. Schedule III’s are not available over-the-counter; you can only secure them via a prescription from your treating healthcare provider. This is the reason, for example, that you can’t go to your local gas station and pick up suboxone next to the beer aisle.
Furthermore, states have their own mini-CSAs that are pretty much lock-step with the federal CSA. This means that under both state and federal laws, only certain healthcare providers or licensed pharmacists can dispense (or even refill) Schedule III controlled substances. And, of course, a Schedule III controlled substance can only be prescribed for a “a legitimate medical reason”, which entails maintaining a valid record of care through a treating healthcare provider.
Needless to say, cannabis being re-classified as a Schedule III tees it up for an endless amount of healthcare regulation, from how it will be produced, stored, and dispensed to applicable standards of care. I personally work with ketamine clinics, and ketamine is a Schedule III controlled substance. All of those clients have to deal with a myriad of healthcare law and regulatory issues under both federal and state law, and the cost of compliance is not cheap. We should also see other professional conduct rules for the physicians, healthcare providers, and pharmacists who prescribe and supply approved forms of cannabis, including mandatory drug monitoring programs.
All of this will be a wild departure from the medical cannabis dispensaries that mainly exist today (with the exception of maybe a handful of states that basically have a de facto pharmacy model in place now). As a footnote, since the early 2000s, physicians have had a constitutional right to discuss with their patients the medical benefits and use of cannabis, but they’ve only ever been able to “recommend” its use under state law, which spared everyone the immense headache of dealing with existing healthcare laws and regulations.
Existing healthcare laws and regulations
If you’re still thinking that pursuit of a cannabis enterprise is for you after its reschedule to a III, you need to consider the bevvy of healthcare regulation you’ll now face. The first hurdle is probably the corporate practice of medicine doctrine (CPOM). Cannabis businesses are used to cottage-style rules where there are residency restrictions or other barriers to entry to keep things local and/or small, but the CPOM doctrine is a different and much harsher animal altogether.
In the CPOM sandbox, licensed healthcare providers can only form certain kinds of business entities through which to practice medicine, and they can only go into business with a short list of other healthcare providers with extremely limited exceptions. Generally, healthcare providers also cannot pay for referrals, engage in kickbacks, or fee split across the board, again with very limited exceptions. And if you plan on taking Medicaid, Medicare, or any other government-based or private insurance money, depending on the state you’re in and what reimbursement you seek, you’re also facing the Anti-Kickback Statute, Stark Law, other fraud and abuse laws, and their state law equivalents.
I think I can safely say that no state-legal cannabis company in existence today is dealing with these issues right now, and I haven’t even scratched the surface on things like the application of HIPAA, dealing with electronic health information, or compliance with the Food, Drug & Cosmetic Act when it comes to production. That is a much longer post. And, again, it’s not like no cannabis company could get in line with this kind of compliance, but the question is how much do they want to spend to do so and can they legally enlist the proper healthcare providers to accomplish the end game without violating the endless spiderweb of existing healthcare laws in the U.S.
Cannabis drug development
With potentially moving to Schedule III, cannabis research will become easier almost overnight. Right now, as a Schedule I, research is still nearly impossible. Moving to a III undoubtedly means more drug development exploration. This will introduce the Food and Drug Administration (FDA) and its Center for Drug Evaluation and Research (CDER) into the game, too. Depending on who you are in the regulatory pipeline, this makes you either very excited or very upset. Per the FDA’s own website:
Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling. If this independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale. The center doesn’t actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it’s likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.
There are multiple different tracks and timelines for drug approval in the U.S. Unbelievably, per Wikipedia, “in an analysis of the drug development costs for 98 companies over a decade, the average cost per drug developed and approved by a single-drug company was $350 million. But for companies that approved between eight and 13 drugs over 10 years, the cost per drug went as high as $5.5 billion.” It is absurdly expensive and incredibly time-intensive to get a drug to market in the U.S., barring emergency circumstances (essentially). I believe that there will be strong interest in cannabis drug development from existing pharmaceutical companies even with the length of time and costs involved. And the truth is, right now, they’re probably the only ones that can truly afford to develop any kind of cannabis drug after it’s rescheduled.
Adult use and schedule III
I’ve seen a few opinions on this topic. Most say that the current state-legal programs won’t be impacted by a reschedule. And in the short term, this is probably true–there still won’t be lawful interstate commerce, state laws and rules for adult use cannabis licensing will still apply, and cannabis companies (including the medical ones) will still be violating federal law minus the application of I.R.C. 280E where cannabis will no longer be a Schedule I or II controlled substance.
However, I don’t think this “holiday” will last very long. I say that because I think most states will have to make the determination that cannabis is a Schedule III in line with federal law pursuant to their own mini-CSAs. Further, because you cannot acquire Schedule IIIs over the counter, I don’t see pharmaceutical companies largely tolerating these state-by-state experiments as they generally fight and lobby to keep existing drug prices high. And it’s no secret that “Big Pharma” has incredible influence with the FDA already. So, you do the political math there. I don’t think it would surprise anyone that our large pharmaceutical companies would like to develop and fully occupy the field of cannabis-based drugs to the exclusion of any other competition. And unless we get some federal law carve out or enforcement memo supporting and protecting an entirely separate adult use industry outside of this new scheduling, I’m not sure how adult use cannabis escapes Schedule III reprecussions.
What happens now?
Well, we wait. It’s not a done deal that DEA will in fact re-schedule to a III. And, even if the DEA make rules to do so, that will take an incredible amount of time to accomplish. There will be a lot of public comment, and maybe even lawsuits, which will keep state-legal cannabis in tact “as is” for that much longer. I sincerely hope I’m wrong about the impact of a Schedule III decision, but I do not see how state-legal markets can square in the long run with existing healthcare laws and rules, as well as the pharmaceutical industry and lobby in the race for new (and lucrative) drugs. It would take some federal exception to those existing laws to keep adult use free and clear. And for those who believe or hope that this initial reschedule could lead to descheduling altogether, I think that is a pipedream once cannabis hits Schedule III.
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Cannabis News
Webinar Replay: Post-Election Cannabis Wrap – Smoke ’em if You’ve Got ’em
Published
14 hours agoon
November 13, 2024By
admin
On Thursday, November 7th, Vince Sliwoski, Aaron Pelley and Fred Rocafort held a post election discussion “Post-Election Cannabis Wrap – Smoke ’em if You’ve Got ’em”. Watch the replay!
Key Takeaways from the “Smoke ’em if You’ve Got ’em – 2024 Post Election Cannabis Wrap” Webinar:
- Panelists:
- Vince Sliwoski: Oregon Business lawyer specializing in cannabis and commercial real estate.
- Aaron Pelley: Experienced in cannabis law since Washington’s legalization in 2012.
- Fred Rocafort: Trademark attorney working closely with the cannabis team.
- Election Results Overview:
- Most 2024 cannabis ballot measures did not pass.
- Florida, South Dakota, and North Dakota saw failures.
- Nebraska became the 39th state to legalize cannabis for medical use when it passed two cannabis initiatives, Initiatives 437 and 438.
- Federal and State-Level Developments:
- Medical use is currently legal in 38 states, and 24 states allow recreational use.
- Republican support for marijuana legalization is growing.
- Federal Policy Implications:
- Schedule III Rescheduling: The process to move cannabis to Schedule III is ongoing, which could significantly impact the industry.
- Importance of Federal Appointments: The future of cannabis policy depends heavily on who is appointed to key positions in the administration.
- International and Domestic Trade:
- Schedule III status could ease import/export restrictions on cannabis.
- Unified control of House, Senate, and presidency might expedite legislative progress.
- Economic and Industry Impact:
- Cannabis stocks experienced volatility post-election, reflecting investor uncertainty.
- Federal legalization and banking reforms are crucial for industry stability and growth.
- Future Outlook:
- The potential for federal rescheduling remains strong, with hearings scheduled for early 2025.
- State-level initiatives and regulatory developments will continue to shape the industry.
“How Long Does One Puff of Weed Stay in Your System?”… This topic can be difficult to answer since it is dependent on elements such as the size of the hit and what constitutes a “one hit.” If you take a large bong pull then cough, it might linger in your system for 5-7 days. A moderate dose from a joint can last 3-5 days, whereas a few hits from a vaporizer may last 1-3 days.
The length of time that marijuana stays in the body varies based on a number of factors, including metabolism, THC levels, frequency of use, and hydration.
Delta-9-tetrahydrocannabinol, or THC, is the primary psychoactive component of cannabis. THC and its metabolites, which remain in your body long after the effects have subsided, are detected by drug tests.
Since these metabolites are fat-soluble, they cling to bodily fat molecules. They could thus take a while to fully pass through your system, particularly if your body fat percentage is higher.
THC is absorbed by tissues and organs (including the brain, heart, and fat) and converted by the liver into chemicals such as 11-hydroxy-THC and carboxy-THC. Cannabis is eliminated in feces at a rate of around 65%, while urine accounts for 20%. The leftover amount might be kept within the body.
THC deposited in bodily tissues ultimately re-enters the circulation and is processed by the liver. For frequent users, THC accumulates in fatty tissues quicker than it can be removed, thus it may be detectable in drug tests for days or weeks following consumption.
The detection time varies according to the amount and frequency of cannabis usage. Higher dosages and regular usage result in longer detection times.
The type of drug test also affects detection windows. Blood and saliva tests typically detect cannabis metabolites for shorter periods, while urine and hair samples can reveal use for weeks or even months. In some cases, hair tests have detected cannabis use over 90 days after consumption.
Detection Windows for Various Cannabis Drug Tests
Urine Tests
Among all drug tests, urine testing is the most commonly used method for screening for drug use in an individual.
Detection times vary, but a 2017 review suggests the following windows for cannabis in urine after last use:
– Single-use (e.g., one joint): up to 3 days
– Moderate use (around 4 times a week): 5–7 days
– Chronic use (daily): 10–15 days
– Chronic heavy use (multiple times daily): over 30 days
Blood Tests
Blood tests generally detect recent cannabis use, typically within 2–12 hours after consumption. However, in cases of heavy use, cannabis has been detected up to 30 days later. Chronic heavy use can extend the detection period in the bloodstream.
Saliva Tests
THC can enter saliva through secondhand cannabis smoke, but THC metabolites are only present if you’ve personally smoked or ingested cannabis.
Saliva testing has a short detection window and can sometimes identify cannabis use on the same day. A 2020 review found that THC was detectable in the saliva of frequent users for up to 72 hours after use, and it may remain in saliva longer than in blood following recent use.
In areas where cannabis is illegal, saliva testing is often used for roadside screenings.
Hair Tests
Hair follicle tests can detect cannabis use for up to 90 days. After use, cannabinoids reach the hair follicles through small blood vessels and from sebum and sweat surrounding the hair.
Hair grows at approximately 0.5 inches per month, so a 1.5-inch segment of hair close to the scalp can reveal cannabis use over the past three months.
Factors Affecting THC and Metabolite Retention
The length of time THC and its metabolites stay in your system depends on various factors. Some, like body mass index (BMI) and metabolic rate, relate to individual body processing, not the drug itself.
Other factors are specific to cannabis use, including:
– Dosage: How much you consume
– Frequency: How often you use cannabis
– Method of consumption: Smoking, dabbing, edibles, or sublingual
– THC potency: Higher potency can extend detection time
Higher doses and more frequent use generally extend THC retention. Cannabis consumed orally may remain in the system slightly longer than smoked cannabis, and stronger cannabis strains, higher in THC, may also stay detectable for a longer period.
How Quickly Do the Effects of Cannabis Set In?
When smoking cannabis, effects appear almost immediately, while ingested cannabis may take 1–3 hours to peak.
The psychoactive component THC produces a “high” with common effects such as:
– Altered senses, including perception of time
– Mood changes
– Difficulty with thinking and problem-solving
– Impaired memory
Other short-term effects can include:
– Anxiety and confusion
– Decreased coordination
– Dry mouth and eyes
– Nausea or lightheadedness
– Trouble focusing
– Increased appetite
– Rapid heart rate
– Restlessness and sleepiness
In rare cases, high doses may lead to hallucinations, delusions, or acute psychosis.
Regular cannabis use may have additional mental and physical effects. While research is ongoing, cannabis use may increase the risk of:
– Cognitive issues like memory loss
– Cardiovascular problems including heart disease and stroke
– Respiratory illnesses such as bronchitis or lung infections
– Mood disorders like depression and anxiety
Cannabis use during pregnancy can negatively impact fetal growth and development.
Duration of Effects
Short-term effects generally taper off within 1–3 hours, but for chronic users, some long-term effects may last days, weeks, or even months. Certain effects may even be permanent.
Bottom Line
The amount of time that cannabis remains in your system following a single use varies greatly depending on individual characteristics such as body fat, metabolism, frequency of use, and mode of intake. Frequent users may maintain traces of THC for weeks, whereas infrequent users may test positive for as little as a few days. Hair tests can disclose usage for up to 90 days, while blood and saliva tests identify more recent use. Urine tests are the most popular and have varying detection durations. The duration that THC and its metabolites are detectable will ultimately depend on a number of factors, including dose, strength, and individual body chemistry.
PEE IN A CUP COMING UP, READ ON..
Cannabis News
Is Kratom Addictive? Understanding Dependence, Risks, and Safe Usage
Published
2 days agoon
November 12, 2024By
admin
Is kratom addictive? Discover the potential for dependence on Kratom, the risks involved with its use, and how to approach its consumption responsibly.
From 2011 to 2017, over 1,800 calls to poison centers involved kratom in the U.S. This significant number highlights the concern regarding kratom addiction.
However, without Food and Drug Administration (FDA) oversight, and due to various consumption methods like teas and capsules, there are significant health risks. Safe use of kratom is now in question due to these issues.
Research debates how dependence develops, outlining signs like loss of control and withdrawal symptoms. These signs are seen in regular kratom users. Ironically, some people switch from drugs like heroin to kratom, looking for a legal alternative.
Understanding Kratom: Origins and Prevalence
Kratom comes from the Mitragyna speciosa tree in Southeast Asia. It can act like a stimulant or like opioids, based on how much you take. People use it in different ways, for a small energy boost or stronger effects at higher doses.
The legal status of kratom in the U.S. is complicated and changing. It’s a hot topic because some worry about its misuse. It’s still legal in several states. This shows how different places handle drug rules. The National Institute on Drug Abuse is looking into its medical benefits. But, the FDA hasn’t approved it for medical use yet. The DEA calls it a “drug of concern,” which means policies might change.
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From 2011 to 2017, poison control centers in the U.S. got over 1,800 reports about kratom. This shows it’s widely used and might pose health risks.
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Kratom’s main ingredients bind to opioid receptors very strongly, stronger than morphine even. This fact is key to understanding its effects.
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As more people use kratom, more are reporting serious health problems. These include liver and heart issues, and tough withdrawal symptoms, particularly in those already sick.
The statistics show mounting worries about kratom in the U.S. As its use grows, it’s becoming more important to health policies and laws. What happens next will depend on further research and legal decisions.
Is Kratom Addictive: Investigating the Substance’s Nature
The question of kratom’s addictiveness focuses on how it affects brain receptors and its long-term health implications. The ongoing debate highlights concerns about dependence and the risk of addiction. Scientists are closely looking at these issues.
How Kratom Works in the Brain
Kratom’s main alkaloids, mitragynine and 7-hydroxymitragynine, bind to the brain’s opioid receptors, similar to painkillers and narcotics. This connection suggests a potential risk of dependence. These alkaloids are key to kratom’s pain relief but also point to possible addiction concerns, especially with frequent, high-dose usage.
Patterns and Consequences of Long-term Use
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Using kratom often, especially in large doses, can increase the risk of dependence and intense withdrawal symptoms, similar to opioid withdrawal.
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Although some use it for pain or to improve mood, long-term kratom users might see serious health problems, like liver damage and mental health issues.
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Withdrawal symptoms, including irritability, nausea, and sleep problems, show kratom’s impact on one’s physical and mental health.
Assessment of Addiction Risks
Studies indicate a significant risk of addiction to kratom, especially with high doses or frequent use. Dependence develops as the body gets used to kratom, leading to tolerance and a need for more to feel its effects. Withdrawal symptoms emphasize this risk, as highlighted by health experts.
Physiological Effects: Kratom’s Impact on the Body
There is a lot of debate about the safety and use of kratom. This herbal extract comes from the Mitragyna speciosa plant. It has drawn attention for its possible harmful effects on the body. The FDA has issued many warnings about kratom, raising safety concerns.
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Kratom Adverse Effects: Kratom users have reported side effects like nausea, vomiting, and confusion. More serious issues include high blood pressure and liver damage. These problems highlight the risks of using kratom.
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Herbal Extract Safety: Some kratom products contain heavy metals and pathogens. These can cause severe health issues, including death. This shows the importance of safety in herbal products.
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FDA Warnings and Regulations: The FDA has linked kratom to over 35 deaths and warns against using it. They point out the lack of medical uses and the risk of addiction.
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Physiological Impact: Kratom’s effects depend on the dose and the user’s body. Yet, it can lead to dangerous outcomes like liver damage and seizures.
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Safety Concerns from Authorities: Federal agencies like the DEA are worried about kratom’s safety. Although not a controlled substance, monitoring suggests users should be careful.
Kratom might offer temporary relief for some ailments, but it comes with significant risks. The FDA’s warnings should make people think twice. If considering kratom, it’s crucial to talk to a doctor first. Experts stress the need for safety and caution with herbal extracts.
Conclusion
Kratom’s role in health and regulation is complex, with views and research findings widely varied. Some people use kratom for its claimed health benefits, but it’s a hot topic. Experts advise caution and suggest consulting a doctor before using kratom due to the unclear effects.
Clinical studies using scores like SOWS and COWS haven’t confirmed withdrawal symptoms from kratom. This adds to the debate, especially when some users report withdrawal. This makes kratom a controversial subject among different findings and user experiences.
When it comes to treating opioid addiction, kratom can be both helpful and harmful. Some have used it successfully to fight addiction. Yet, some states have banned it. This highlights the need for regulations and consistent product quality. It also raises questions about kratom’s legal status due to mixed actions by authorities.
The situation shows how complex kratom is in the realm of substance use and law. Without clear evidence supporting either its benefits or risks, it poses a challenge. More research is needed to guide regulations and health advice. For now, anyone thinking of using kratom should be careful, seek medical advice, and keep up with laws and health guidelines.
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