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Will the FDA Regulate CBD? – Cannabis | Weed | Marijuana

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Will the FDA regulate CBD? It’s a question on many minds as the FDA commissioner is to appear before the U.S. House Oversight Committee. Chairman of the Committee, James Comer, wants details on CBD.

He said: “It’s not just their lack of action with respect to CBD and other types of hemp. It’s their inaction regarding a lot of areas of their jurisdiction … We’ve got an agency here that has a big budget, they have a lot of employees, but it doesn’t seem like they are getting a lot of their work done and have a huge backlog there.”

Nearly five years after the 2018 Farm Bill legalized hemp, the official FDA stance is that CBD is not a food or dietary supplement. Until they’ve gathered more safety data, they’re not interested in regulating it as a food or supplement.

Therefore, CBD exists in a wild-west market. But what does this mean for everyday Americans? And what happens when the FDA does move to regulate CBD?

FDA to Regulate CBD?

 FDA Regulate CBD

Conventional wisdom says having the FDA regulate CBD will result in a stabilized, regulatory market. But as with everything government related, there are unintended consequences.

“The “market chaos” right now is that suppliers have a hard time describing their product compared to 325mg aspirin tablets,” writes economist Mark Thornton by e-mail.

He expects that even without FDA regulation, consumers will discover reputable brands from the market process. “Product definition and safety will be refined,” Mark writes, “This creates “market power” and cleans up most of what others call “chaos.” With pure legalization, the black market would disappear leaving only commercial and home production.”

And indeed, this process is already underway. Inesa Ponomariovaite, CEO of Nesa’s Hemp, is one of these reputable brand names. However, she supports the FDA’s move to regulate the industry.

“Let them have it,” she tells CLN by phone. 

When Inesa started her business, she found a “major disconnect” between what the industry was doing and what they were telling consumers. Even lab-tested products are only sometimes reputable. Inesa says even the laboratories themselves can be inefficient or corrupt. 

“From the top, we have no regulations, and that’s what concerns me,” she says. “I’ve personally tested so many products because I was looking for the highest quality product for my clients and patients. I tested these products and I found mould, led, mercury, and that’s why when people say, ‘oh, I took CBD and it actually caused me anxiety, or nausea or whatever,’ well, yeah. It’s because the product is loaded with toxins.”

What Will FDA Regulation Lead To?

 FDA Regulate CBD

What are the unintended consequences of FDA regulation? In the past, FDA regulation has been no guarantor of safety. They’ve recalled many drugs before. People have gotten sick and even died ingesting FDA-approved substances. Not to mention the familiar faces of top-tier FDA personnel and pharmaceutical board of directors.

So what could FDA regulation of hemp and CBD lead to? According to economist Mark Thornton, FDA regulation could lead back to prohibition. But more likely, he writes, “to monopoly power to some extent or another.”

Monopolies, of course, stifle the market’s discovery process and harm patients and consumers in the long run. 

But this doesn’t worry Inesa. Her brand focuses on CBDa, not CBD.

As far as she’s concerned, CBD is a synthetic compound. “The only way to have real CBD is by taking the raw plant… and using a chemical extraction.” 

She says this is what pharmaceutical companies are after. “They’re going after the CBD chemical compound and you know what? Let them have it.”

CBD (cannabidiol) and CBDa (cannabidiolic acid) are compounds found in the cannabis/hemp plant. CBDa is the acidic precursor to CBD, and you find it in the raw, unheated form of the plant.

With or without FDA regulation, Inesa is confident consumers will realize what they want are the acidic precursors to these cannabinoids. “CBDa is the original compound,” she says, “CBDa is not something pharma can ever patent.”

Of course, some would dispute that converting CBDa to CBD constitutes creating a “synthetic compound,” as this process, known as decarboxylation, is fairly common in the cannabis world. It naturally occurs when you heat the plant, such as smoking, vaporizing, or cooking.

However, to Inesa’s point, less-than-reputable manufacturers in the U.S. produce less-than-optimal CBD. “I never trust the marketing materials,” she says.

Alternatives to FDA Regulating CBD

 FDA Regulate CBD

Do you want a CBDa and CBD market with safe products and informed consumers? Then, looking into the alternatives to FDA regulation is not out of the question.

Nesa’s Hemp, for example, uses a reputable laboratory. This laboratory competes with others for quality control. They win private awards for their quality. 

Now, imagine another layer of entrepreneurship. A business that regulates the laboratories to ensure they’re not cutting corners. A private certification agency that competes with other certification agencies for reputation.

The problem with the state is that the buck stops there. If you want to influence the regulations in your favour, you’re best to coax the politicians who make the rules.

As Mark Thornton writes in his book on the economics of prohibition, government bureaucracy “hampers the market’s ability to produce desired solutions.” From the discovery process to product safety and information. 

A private certification agency, says economist Walter Block, works better. 

“The Food and Drug Administration must go. And salt should be sown where once it stood. This organization is costly, is a gargantuan waste of time and causes needless deaths by slowing down innovation. The sooner is it disbanded, the better.”





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More Weed, More Problems? – Cannabis | Weed | Marijuana

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More weed, more problems? As in, if you smoke all day, everyday, your life is likely a hot mess with no hope of redemption? According to recent research from CU Boulder, the answer to “more weed, more problems” is no.

According to researchers, legalizing recreational cannabis at the state level does not lead to an increase in substance use disorders. Or even increased use of illicit drugs among adults. In fact, it may even decrease issues related to alcohol abuse.

A study involving over 4,000 twins from Colorado and Minnesota found no correlation between cannabis legalization and any increases in cognitive, psychological, social, relationship, or financial problems.

“We really didn’t find any support for a lot of the harms people worry about with legalization,” said lead author Stephanie Zellers. “From a public health perspective, these results are reassuring.”

The study, published in Psychological Medicine, was conducted by researchers from the University of Minnesota, CU Boulder and the CU Anschutz Medical Campus. The study used data from two of the nation’s most extensive and longest-running twin studies: one located at IBG and the other at the Minnesota Center for Twin Family Research.

What Are Twin Studies? 

More Weed, More Problems?

Can twin studies prove that more weed doesn’t equal more problems? Well, what are twin studies?

Twin studies are research designs that compare identical (monozygotic) and fraternal (dizygotic) twins. The idea is that identical twins share all their genes, while fraternal twins share only about half of their genes.

So any differences between the two types of twins can help researchers identify which traits or conditions are likely influenced by genetics and which are likely influenced by environment. Researchers can use twin studies to study a wide range of topics, including genetics, development, and health.

IBG stands for Institute of Behavioral Genetics, a research center at the University of Colorado Boulder. The Minnesota Center for Twin Family Research located at the University of Minnesota.

Both centers conduct twin studies and have been collecting data over the years. And both centers are among the nation’s most prominent and longest-running twin studies. They provide researchers with a wealth of data on genetic and environmental factors related to human behaviour and development.

The Problem with Twin Studies

Of course, Twin studies are not without their critics.

  1. Assumption of equal environments: Twin studies sometimes assume that identical and fraternal twins are raised in similar environments, but this may not always be the case. For example, identical twins may be treated more similarly than fraternal twins, which could affect the results.
  2. Limited generalizability: Researchers often conduct twin studies on small, specific samples, such as twins from a particular country or region. This limits the generalizability of the findings to other populations.
  3. Missing heritability: Twin studies estimate the proportion of variation in a trait or condition due to genetics. But they do not account for all the genetic variation that may influence the trait or condition.
  4. Complexity of human behaviour: Many complex human behaviours and conditions, such as mental disorders or intelligence, likely result from multiple genes and environmental factors. Twin studies may not fully capture these interactions.
  5. Selection bias: Twins who volunteer for studies might differ from twins who do not volunteer, which can bias the results.

Twin Studies Disprove More Weed, More Problems? 

More Weed, More Problems?

The researchers of this “more weed, more problems” study compared the 40% of twins who reside in states where recreational cannabis is legal to those who live in states where it remains illegal to understand the overall impact of legalization.

Researchers have been tracking the participants, who are now between the ages of 24 and 49, since their adolescence. They’ve been gathering information on their use of alcohol, tobacco, cannabis and several other illicit drugs, as well as assessing their overall well-being.

By specifically comparing twins within 240 pairs, in which one twin lives in a state with legal cannabis and the other where it is not, the researchers aimed to identify any changes caused by cannabis legalization.

The researchers previously found that identical twins residing in states where recreational cannabis is legal tend to use it around 20% more often than their twins living in states where it remains illegal.

So does that mean more weed, more problems?

To answer this question, the team compared survey results that examined 23 indicators of “psychosocial distress.” Including the use of alcohol and illicit drugs like cocaine and heroin, psychological distress, financial difficulties, cognitive issues, unemployment, and relationship issues both at home and at work.

“We included everything we had data on with the goal of getting a well-rounded look at the impacts on the whole person,” said Zellers. “Big picture, there’s not much there.”

No, More Weed Does Not Equal More Problems

More Weed, More Problems?

So is “more weed, more problems” debunked?

Researchers found no relationship between legal cannabis and an increased risk of “cannabis use disorder” or dependency.

For years, critics have called cannabis a “gateway” drug to harder substances like cocaine and heroin. The researchers found no changes post-legalization.

“For low-level cannabis use, which was the majority of users, in adults, legalization does not appear to increase the risk of substance use disorders,” said co-author Dr. Christian Hopfer.

Not only does this study question the “more weed, more problems” narrative, but it also shows legal cannabis’ benefit. People in legal states are less likely to develop alcohol dependency problems, including driving drunk.

“Our study suggests that we should not be overly concerned about everyday adult use in a legalized environment. But no drug is risk-free,” said John Hewitt, professor of psychology and neuroscience at CU Boulder.

While the study found no adverse effects on the daily lives of cannabis-consuming adults, the study also found no evidence that legal cannabis benefited people’s cognitive, psychological, social, relationship, or financial status.

Overall, the study seems to suggest the same thing we have before. Substances are neutral. It is the person who can choose to use or abuse them. But the drugs themselves have no innate power of control.





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Health Canada: Let’s Ban Potent Cannabis Extracts  – Cannabis | Weed | Marijuana

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Despite a healthcare system already on the verge of collapse pre-COVID, Health Canada bureaucrats have focused on cannabis companies selling extracts.

Health Canada recently requested federally licensed cannabis companies to discontinue the sale of cannabis products the bureaucracy considers mislabeled. Health Canada is concerned adults are consuming products labelled “extracts” as “edibles.”

The move is expected to cost cannabis companies millions of dollars. And it comes at a time when most publicly traded cannabis producers are still losing money.

Why target products that have been on the market for three years? Health Canada has not responded to any media on the topic, including Cannabis Life Network’s request for clarification.

Health Canada: Let's Ban Cannabis Extracts 

While Health Canada’s targeting of cannabis extracts surprises many, others, like CLN, have been expecting this move for a while.

In the letter seen by MJBizDaily, Health Canada said that “upon further review of the products in question, Health Canada has assessed that this product is edible cannabis and, consequently, it contains a quantity of THC that exceeds the allowable limit of 10 mg per immediate container.”

The letter goes on to define “extract,” “edible,” and “food.”

“Health Canada has determined that (the products in question) are consumed in the same manner as food, and therefore fit the definition of edible cannabis,” the Health Canada letter says.

Cannabis extracts cannot exceed 1,000 milligrams per container, one hundred times more than Health Canada permits in the edible class. Ergo, companies would instead produce extracts than edibles.

However, the line has gotten blurred, and this is likely what concerns the bureaucracy’s busybodies. For example, New Brunswick-based cannabis producer Organigram has a “Jolts” product advertised as a lozenge. While each candy is 10mg, the entire pack of 100mg.

Likewise, Redecan has a cannabis extract containing 800 to 1000mg of THC per bottle. However, the oral dispensing syringe caps each “dose” at 8-10mg. 

Are these the products Health Canada wants discontinued?

Health Canada On Extracts: Useless

Health Canada: Let's Ban Cannabis Extracts 

Why Health Canada? And why now? Why at all?

Industry sources expect to lose tens of millions if Health Canada demands extracts and lozenges get pulled from the Canadian cannabis market. They also expect the illicit and legacy markets to fill the void.

Regardless of what you think about public health and safety or an individual’s freedom to consume as much THC as they want, there’s significant concern about how Health Canada is going about this.

This kind of regulatory enforcement is akin to banana republics. Health Canada has already approved these products. Organigram’s “Jolts” have been on the market for over a year.

Producers of these extracts followed all the rules and regulations. And now Health Canada will arbitrarily limit (or ban) these products because… what? Canadian consumers prefer potent extracts over weak-ass edibles?

The lesson here is to remove all THC limits, not bring the hammer down on companies producing legal products. This is not how you regulate an industry.

Infantilizing Adults

While Health Canada hasn’t responded to a request for comment, I suspect the justification will likely be over “public health” and “increased hospitalizations from high-THC products.”

Another way of saying: we’re so bad at delivering health care that instead of improving it, we’re going to start controlling the behaviours that may lead people to need a hospital bed.

That’s the most insulting part of all of this. Health Canada treats adult cannabis consumers like children by limiting their autonomy and decision-making.

Actions speak louder than words. Health Canada bureaucrats (who live off our taxes) lack trust in cannabis-consuming adults to make their own choices and take responsibility for their actions.

When regulations are not based on evidence or are not well-reasoned, they are an infringement on personal liberty and autonomy.

Even with “conventional thinking,” in which government regulations are effective and immune to corruption and politics, it’s essential that regulators balance the need to protect public health and safety with the need to respect adults’ autonomy and decision-making abilities.

Health Canada’s crackdown on cannabis extracts clearly violates that balance. 

This situation would be like if Health Canada discovered that vodka and whiskey were stronger than beer. And so they order distilleries across the nation to arbitrarily limit their alcohol content and take the products off the shelves.

Health Canada has no business regulating cannabis. 

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10 Ways Most Cannabis Research is False – Cannabis | Weed | Marijuana

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Most cannabis research is false. A bold statement. So what does it mean? In 2005, Stanford University professor John Ioannidis published the paper “Why Most Published Research Findings Are False.”

In it, he argued that most published research findings are false due to a combination of factors such as small sample sizes, inadequate adjustment for multiple comparisons, and conflicts of interest.

The paper made quite an uproar in the scientific community. While some criticized Ioannidis for simplifying the problem, most agree there is a replication crisis in scientific literature. For example, one study may find cannabis increases the risk of heart attacks. But if no other research can replicate its findings, is the study telling us anything authentic or valid?

The replication crisis doesn’t only affect sociology, medicine or psychology. It also affects cannabis studies. Leading to an uncomfortable conclusion: most cannabis research is false. 

Most Cannabis Research is False

Most Cannabis Research is False

Is most cannabis research false? The replication crisis has led to calls for more transparency and rigour in the research process. But ultimately, the only way out is to evaluate studies based on their replication rate.

Can adolescent cannabis use lead to psychosis or an increased risk of developing schizophrenia? Are cannabis consumers less likely to abuse opioid-based pain medication? Does cannabis make you a more compassionate person? Can it lead to poor cardiovascular health? Will cannabis impair your driving?

Some studies answer in the affirmative, others in the negative. Prohibitionists and public health busybodies like to cite studies that show cannabis’ negative qualities. Proponents of cannabis tend to mention the positive studies.

But most cannabis research is false, whether it confirms your bias or not.

10 Ways Most Cannabis Research is False

The replication crisis has affected studies on cannabis in several ways, including:

  1. Lack of replication: Many studies on cannabis have been criticized for their inability to be replicated. This calls into question the validity of their findings.
  2. Lack of standardization: There is a lack of standardization in the way cannabis is used and administered in studies (not to mention the strains used, their specific cannabinoid content, etc.). This makes it impossible to compare results across different studies.
  3. Small sample sizes: Many studies on cannabis have small sample sizes, which can lead to unreliable results.
  4. Lack of control groups: Some studies on cannabis have lacked proper control groups. This makes it difficult to determine the specific effects of cannabis.
  5. Uncontrolled variables: Many studies on cannabis have not controlled for other factors that could affect the results, such as tobacco use or poor diet. Sometimes, researchers won’t even account for underlying medical conditions.
  6. Limited generalizability: Some researchers conduct studies on cannabis on specific populations, such as patients with a particular medical condition, which can limit the generalizability of the results to the general population.
  7. Publication bias: There is a tendency for researchers to publish positive or negative results than inconclusive results. This leads to an over-representation of “findings” in the literature.
  8. Funding bias: Studies funded by industry stakeholders, such as pharmaceutical companies. This makes the study more likely to produce favourable results than studies funded by other sources. This ultimately creates a bias in the literature.
  9. Lack of transparency: Some studies on cannabis have been criticized for lack of transparency in their methods and results. This makes it challenging to evaluate the robustness of their findings.
  10. Prevalence of observational studies: There is a high prevalence of observational studies in cannabis research, which are prone to bias and confounding. They are less substantial than RCTs (randomized controlled trials) in determining causality.

This overreliance on observational studies means most cannabis research is false. Just as funding bias results in slogans like “Follow the Science,” which is ultimately synonymous with “Follow the Money.”

Studies Say” is the Modern Equivalent to, “The Scriptures Say…”

Most Cannabis Research is False

We’re not here to bash anyone’s spiritual beliefs. If you find solace in Holy Scripture, then all the best. But if you try and argue that your interpretation of the scriptures is describing a reality we all must follow, we’re going to have a problem.

Likewise, we won’t call out anyone using research studies to help navigate the world. You may be on a vegan diet and, therefore, like reading studies confirming the lifestyle’s benefits.

But, once you begin arguing with others that the vegan lifestyle is the only way to live, and you support these opinions by referring to “studies,” then it’s time to step back and reassess.

Both “scriptures” and “studies” express authority or provide evidence for a particular belief or claim.

Scriptures refer to religious texts or teachings considered sacred or authoritative by those who follow that faith. 

Studies, on the other hand, refer to scientific research findings. These are supposed to be based on empirical evidence and subject to rigorous testing, verification, and replication

The failure of much modern research, including cannabis research, to replicate findings is no small matter. That is why most cannabis research is false.

When you read: “Randomized controlled trials evaluating the therapeutic use and safety of marijuana are lacking, but a growing body of evidence suggests that marijuana consumption may be associated with adverse cardiovascular risks.”

You can roll your eyes. There is no “growing body of evidence” because, without RCTs, there is no evidence. Without replication, all you have is an opinion.





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