Connect with us

All about Cannabis

FDA Releases Guidance for Cannabis – Cannabis | Weed | Marijuana

Published

on


The U.S. Food and Drug Administration (FDA) has issued final instructions for creating medications derived from cannabis. Including information on the specific differences between cannabis and hemp.

The FDA published a guidance document entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.”

This document is the final version of the 2020 guidance that went through a White House review. This reformed guidance is necessary, says the FDA, because hemp, now legal at the federal level due to the 2018 Farm Bill, has different drug development protocols than cannabis.

Cannabis is still a Schedule I controlled substance under the Controlled Substances Act (CSA).

“This guidance outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived human drugs, including the source of cannabis for clinical research,” the FDA said. Adding, “this guidance is being issued to support clinical research for development of cannabis and cannabis-derived human drugs.”

The FDA provided several suggestions for scientists seeking to create cannabis-based medications. These recommendations are not mandatory.

Details on FDA Guidance for Cannabis

FDA Releases Guidance for Cannabis

Among the recommendations made by the FDA regarding cannabis is to “address the legal definitions and regulatory controls related to cannabis, and to address certain questions raised about drugs containing cannabis.”

The FDA considers cannabis hemp so long as it has a THC content of 0.3% or less by dry weight. It is not a controlled substance like cannabis, which is still under the DEA’s jurisdiction.

The guidance document has changed since the FDA first released it in draft form. It now includes more detailed information on where researchers can legally obtain cannabis for drug development.

As well the guidance document allows for more options for obtaining federally legal hemp for research purposes.

Researchers no longer need to rely on a limited number of National Institute on Drug Abuse (NIDA) contracted suppliers for cannabis as long as the FDA has deemed the hemp to be of adequate quality.

In the past, scientists could only obtain cannabis from one NIDA-approved farm at the University of Mississippi. However, the DEA has approved more manufacturers, providing researchers with new options for sourcing cannabis for research purposes.

Cannabis Vs. Hemp

FDA Releases Guidance for Cannabis

While technically, cannabis and hemp are the same plant genus, the FDA’s new guidance defines how they’re separate. The guidance addresses how to distinguish hemp from cannabis based on THC content.

The FDA primarily defers to the DEA on this matter. But they advise researchers to calculate the delta-9 THC content in their proposed cannabis or cannabis-derived investigational drug product. Preferably, says the FDA, early in the development process.

The FDA notes that even if the starting materials meet the definition of hemp, intermediates or drug products that contain more than 0.3% THC may no longer meet that definition. And, therefore, may be considered Schedule I controlled substances.

Farmers and researchers have pointed out that this could be problematic. Environmental factors and manufacturing processes can affect THC levels and potentially make a legal crop into a controlled substance. They have called for more flexibility in the total THC concentration.

FDA & Cannabis: The Takeaway

FDA Releases Guidance for Cannabis

Overall, the FDA’s guidance aims to provide an overview of its regulatory mechanisms and explain how investigational new drugs work. It covers basic standards for clinical studies, how combustible drug products differ from oral preparations, storage requirements for researchers and more.

However, everyone is still waiting for the FDA to take steps to approve the sale of hemp-based products such as CBD oil as food or dietary supplements.

FDA officials have said that they are evaluating whether CBD can be used safely over a long period. Also, what effects might it have during pregnancy? The recent increase in the popularity of delta-8 THC products, which the DEA says aren’t controlled substances, has added complexity to the regulation process, says the FDA.

All this is taking place as part of the Biden administration’s slow crawl to legalization. The FDA’s recommendation will not be mandatory. Officials anticipate that the DEA will soon provide a scheduling recommendation that aligns with the FDA’s guidance about cannabis.





Source link

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

All about Cannabis

Health Canada on Extracts vs Edibles – Cannabis | Weed | Marijuana

Published

on

By


Where does Health Canada come down on extracts vs edibles? Last week, Canada’s federal bureaucracy caught the cannabis industry by surprise. Some licensed producers have been marketing “chewable extracts,” which Health Canada says are actually edibles.

In an email to CLN, a Health Canada spokesperson said:

“Health Canada has identified edible cannabis products erroneously being classified and marketed as cannabis extract products. These non-compliant products do not meet the controls in the Cannabis Act and Cannabis Regulations which serve to mitigate against public health and public safety risks associated with edible cannabis.”

Aurora Cannabis, for example, has a product called “Glitches.” These chewable extracts typically come in a pack of ten. Every single extract contains 10mg of THC. So when you buy an entire package, you buy up to 100mg.

But according to Health Canada, this product is an edible, so an entire pack shouldn’t exceed 10mg of THC. In other words, each chewable extract should be 1mg.

“We take compliance seriously and developed our Aurora Drift Glitches in accordance with the regulations and fulfilled all requirements by Health Canada prior to market launch,” said a spokesperson from Aurora. “We respect Health Canada’s oversight and continue to have regular, open dialogue about moving forward.”

Health Canada on Extracts vs Edibles

So where does Health Canada come down on extracts vs edibles? Beyond the issue of THC limits, which are a product of bad laws, there is the issue of food-borne illnesses.

Extract products do not go through the same regulatory framework as edible products. Ergo, there’s a problem when LPs are using edible ingredients and labelling the product “extracts.”

This is what concerns HEXO’s CEO, Charlie Bowman. When Health Canada first announced the change, some Canadian cannabis connoisseurs feared the federal bureaucracy was coming after any potent extracts.

After all, HEXO, which owns Redecan, produces an MCT-oil-based cannabis extract that can yield up to 800mg of THC. Was Health Canada concerned that individuals like myself were discarding the 8mg dispenser and downing half the bottle?

Fortunately, HEXO did not receive one of these letters. “We don’t have any products that would be considered mislabeled or misrepresented,” Charlie told CLN. 

Regulating Food

Health Canada on Extracts vs Edibles

Health Canada’s issue stems from ingredients. “I think Health Canada is doing the industry a big favour by pulling it back and saying what you can and cannot put in those,” said Charlie.

“My whole career has been in the food industry. I take food safety and food issues pretty seriously. Because if you get something wrong, you can hurt a lot of people just from the mass amount of product that’s produced on a daily basis.”

Redecan stays away from lozenges, or anything consumers could construe as an edible. This is to keep children away, but it also has to do with product quality.

For Charlie, product consistency is essential. That’s his issue with producers who may label edible products as extracts.

“You can get 2,000 products made up and if you tested them you might get at least 1500 different answers of what the concentrate was in those products,” Charlie said. 

“The way to do this properly is through nanoemulsion.”

Nanoemulsion is a technique entrepreneurs can use to extract cannabinoids from cannabis plants. Nanoemulsion breaks down the compounds into tiny droplets suspended in water, creating a stable mixture. 

This increases the bioavailability of the active compounds and makes them easier to incorporate into various products, such as edibles and beverages. This also allows for greater consistency. 

Health Canada on Extracts vs Edibles

Health Canada on Extracts vs Edibles

While one can argue that Health Canada’s concern over food-borne illnesses justifies their action, one has to wonder, what are they smoking over there?

Of course, as a federal bureaucracy, they follow the rules and regulations. There is no profit motive or competition from other businesses. Obedience to the political hierarchy is what drives action at government bureaus. 

But the people at the top who make the rules don’t know the first thing about cannabis. If they did, there wouldn’t be a THC limit, period. 

According to George Smitherman of the Cannabis Council of Canada, THC limits are basically a “$500 million gift to the illicit market.”

Government officials cite public health and safety reasons for the THC limit. Yet, what are these alleged harms? Dry mouth? The munchies?

Meanwhile, anyone in Canada over 19 years old can go to their local liquor store and buy enough whiskey to kill themselves (while potentially seriously harming others in the process).

Anyone with even a little common sense can see that alcohol is objectively more dangerous than THC.

So why the THC limits? It’s ideology. It’s not science because it’s certainly not “evidence-based.” Like everything else from this government, adherence to doctrine trumps reason.

Footnote(s)





Source link

Continue Reading

All about Cannabis

FDA Will Not Regulate CBD – Cannabis | Weed | Marijuana

Published

on

By


The U.S. Food and Drug Administration (FDA) will not regulate CBD after a “careful review” of the subject.

Instead, the FDA is asking Congress to create a regulatory system that balances “risk” with access to CBD products.

This announcement hasn’t changed the status of CBD products, which are legal but not regulated as food or dietary supplements.

Some businesses were disappointed to hear that the FDA will not regulate CBD. Many people associate the federal bureaucracy with consumer-friendly standards and practices.

2018 Farm Bill

FDA Will Not Regulate CBD

CBD, or Cannabidiol, is one of the major cannabinoids of the cannabis plant. Although technically psychoactive, you can take CBD and stay clearheaded. Consumers like CBD for its anti-inflammatory effects, as well as its neuroprotective properties.

CBD is also popular among cannabis connoisseurs for its ability to attenuate THC‘s effects. Some say cannabinoids work better when they’re all present, a process called the entourage effect.

CBD’s popularity in the United States grew after President Donald Trump signed the 2018 Farm Bill, which legalized cannabis production so long as the plants were below 0.3% of THC.

According to a report by CannIntelligence, the U.S. CBD market is expected to reach $1.9 billion this year, with a projected value of well over $3 billion by the decade’s end.

However, a lot of those projections depend on how the FDA and Congress decide to regulate CBD.

FDA Only Approves Patented-CBD 

FDA Will Not Regulate CBD
Epidiolex. Photo courtesy of CNN.

The announcement that the FDA will not regulate CBD as a dietary supplement or food-based product leaves many wondering: what’s next?

So far, the FDA has only approved one CBD-based product: Epidiolex.

Approved in 2018 for treating seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, Epidiolex was given the thumbs up for patients as young as two-years-old.

The FDA approved Epidiolex based on clinical trials they claimed showed its efficacy and safety in treating these forms of epilepsy. Of course, other studies show CBD’s efficacy with epilepsy. One doesn’t need Epidiolex, per se.

But, of course, Epidiolex is patented. GW Pharmaceuticals developed and marketed it. That’s how they justify the high cost of the drug.

(There’s also been issues around misrepresenting their clinical trial data on Epidiolex and long-term side effects like liver issues. Note that none of these cost, safety or side effect issues are present in the raw form of cannabis).

FDA on CBD: Passing the Buck to Congress

The FDA expressed concern about “CBD exposure” to “vulnerable populations” like pregnant women and children.

Ergo, they’ve passed the buck to Congress. Currently, nothing has changed. And if Congress’ reputation holds, nothing will likely change. At least not in the short term.

There is talk about classifying CBD as a dietary supplement in the 2023 Farm Bill, but nothing has come of it so far.

That said, the states of Colorado, Oregon, Washington, Maryland, and Virginia already have regulations concerning CBD products.





Source link

Continue Reading

All about Cannabis

This Activity is Dangerous – Cannabis | Weed | Marijuana

Published

on

By


This activity is dangerous. Full stop. On average, approximately 42,000 people in North America die of it every year.

Lack of experience plays a critical role. Newcomers may not have the skills or knowledge to handle certain situations. They may not anticipate the hazards we associate with this activity. They may have difficulty navigating unfamiliar experiences.

A lack of knowledge of the laws and regulations can lead to mistakes. A lack of confidence in their abilities can lead to unwise decisions.

A newcomer to this activity needs experience to make good judgment calls consistently. But even veterans of it can overcompensate, leading to mistakes and increased danger.

Newcomers aren’t always aware of their blind spots. And even veterans may need help understanding all the costs and benefits of the activity.

Because, make no mistake, this activity is dangerous. You don’t have to be new to it to risk dying from it. It doesn’t even have to be your fault.

This Activity is Dangerous

This activity is dangerous whether you’re new to it or a veteran. In fact, when you’ve been doing it for a while, it’s more likely to have become a habit—leaving your conscious mind to wander and get distracted.

Regardless of how long you’ve been doing it, you may increase the likelihood of an accident if you’re not fully conscious of the experience. You increase the danger if you’re not careful with your reaction time or aware of your surroundings.

In fact, if you’re reckless with it, you could:

  • damage property
  • increase the likelihood of fatal mistakes and serious accidents
  • increase the risk of injury to yourself or even others
  • increase the possibility of receiving criminal charges
  • reduce your ability to react to the unexpected
  • reduce your situational awareness
  • increased likelihood of death

This activity is dangerous.

Why Do We Do This?

This Activity is Dangerous

You may find yourself walking down a city street. You may find yourself asking, “why is it like this?”

Of course, some people have always enjoyed the adrenaline rush or excitement that comes with dangerous activities. Others may lack awareness or understanding of the actual risks.

Some may feel pressured into doing it by friends, family, or co-workers. Others think they must do it because that’s how you play the game. That’s how the world works. 

Others feel they were born to do this.

Of course, some people may have no self-control. They engage in the activity because it’s fun or convenient, but they have trouble controlling themselves. Almost like they become a different person.

Others may be more likely to engage in the behaviour due to their socioeconomic status. It may be a status symbol.

Regardless, this behaviour doesn’t only affect them. It can affect you too.

Is it a Choice?

This activity is dangerous, but ultimately it’s a choice. Often, it feels necessary due to the lack of alternatives or the practical needs it serves. But engaging in this dangerous activity is a choice.

What about brain changes? Well, what about them?

The brain can change and adapt to new habits, becoming more efficient at performing repeating tasks. This is known as neuroplasticity, which is the brain’s ability to change and adapt in response to new experiences and learning.

The process works the same way whether the habits we’ve picked up are safe or dangerous.

Driving a Car is a Dangerous Activity

Driving a car is a dangerous activity. Full stop. What did you think I was talking about? Drugs?

Footnote(s)





Source link

Continue Reading
Advertisement

Trending

Copyright © 2021 The Art of MaryJane Media