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CBD Toxicity Study Guiding FDA Regulation to Kick Off this July

A study protocol, being developed by clinical research company ValidCare, will commence this July and determine any potential liver toxicity and the safety of CBD. The study—with generous support from several top CBD brands—is being interpreted as a critical stepping stone as it will help to guide the U.S. Food and Drug Administration (FDA) on CBD regulation.

ValidCare will investigate whether or not CBD demonstrates any hepatotoxicity or effects on the liver. The Colorado-based company typically conducts and outsources clinical research for the healthcare and hemp industries. The company’s research was designed with heavy input from a branch of the FDA, and the study will answer specific questions from the organization. 

From July through September, 1,000 people will be observed, and their liver health will be monitored.

Hemp Industry Daily reports that because CBD is currently not being considered an investigational new drug (IND), the team will still have to rely mostly on observational data.

ValidCare’s study would have begun last March, but COVID-19, and presumably ongoing protests, pushed the schedule behind several months. 

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This doctor’s insight on treating the pandemic with cannabis

One medical research team in Israel believes they have a small piece to the coronavirus puzzle. In an exclusive interview with The Fresh Toast, Dr. Igal Louria-Hayon, head of the Medical Cannabis Research and Innovation Center at the Rambam Health Care Campus in Haifa, Israel, says the healing properties in cannabis may be able to help the body fight against COVID-19.

Announced in May, Dr. Louria-Hayon and his team of researchers announced they would begin a clinical trial in studying how cannabis aids in inflammation within the body and if that could decrease the effects of COVID-19. One of the main causes of death with the disease is “cytokines” — proteins that signal cells to turn on to fight — that are released, causing the body to react in uncontrollable ways against the virus. As a part of the body’s endocrine signal process, once cytokines are turned on past their maximum, the proteins become difficult to control and can cause a shockwave of effects, leading to death.

In some studies, cannabis was proven to help regulate inflammation and cytokines, offering better signalling to the body. The goal of the upcoming study is to “examine the receptors to which these substances bond, the cellular messages that are communicated and the extent to which cannabinoids reduce the inflammatory response.”

Especially important to note, Dr. Shlomit Yehudai-Reshef, director of the Rambam Medical Research Institute, shared that her team was able to identify a key method to understanding the virus and the human body’s subsequent reaction: white blood cells. “Despite the complexity and high risk, we found a safe way to separate the white blood cells, including the immune cells from verified patients,” explained Dr. Yehudai-Reshef, clarifying that when the cells were separated, they were easier to study and manipulate.

FILE: University of Lethbridge researcher Igor Kovalchuk is leading a study on medical cannabis as a potential therapy for COVID-19. / Photo: Supplied. Summited photo

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Drug Trial Planned For Synthetic Cannabinoid COVID-19 Treatment

By using this powerful anti-inflammatory, a Philadelphia cannabis company believes it can mitigate the immune response triggered by COVID-19.

A Philadelphia cannabis firm has joined the race to create a COVID-19 cure using cannabinoids. FSD Pharma announced last week that the Food and Drug Administration (FDA) had approved the company’s application proposal to conduct clinical trials around the medicine. The treatment will use a drug called ultramicronized palmitoylethanolamid (or micro PEA) that includes synthetic molecules that mimic cannabinoids.

Micro PEA is a unique drug. It’s believed to act as an anti-inflammatory and promoted between 1969 and 1979 in former Czechoslovakia as treatment for influenza and the common cold. Clinical trials conducted at the time showed PEA was an effective prophylactic in respiratory infection, with no registered side effects. According to scientists behind the research, it could act as a quick therapeutic answer should a flu epidemic occur.

Today, the drug is promoted as a prescription nutraceutical in Italy and used to treat chronic inflammation. Pharmaceutical firm Epitech Group owned the rights to the drug and sold it under the names Normast and Pelvilen. Earlier this year, FSD, which is headquartered in Toronto, Canada, purchased the worldwide rights from Epitech for $17.5 million and re-branded it as FSD-201.

“We contacted the FDA in late-March 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID-19, based on the drug’s mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines,” Philadelphia-based physician and FSD CEO Raza Bokhari said in a statement.

The Latest On FDA Clinical Trials During COVID-19 Pandemic
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Dark Web Marijuana Sales Soar During Pandemic

The continued global crisis makes it difficult to know how black-market consumer behavior will change in the future.

The coronavirus pandemic caused an uptick in doomsday hoarding behavior, with Americans stocking up on toilet paper, frozen poultry, and hand sanitizer. They also bought a bunch of marijuana.

Previous data showed legal cannabis sales skyrocketed when Americans became serious about the pandemic around mid-March. But now we have a better idea of how COVID-19 affected black market sales.

The European Monitoring Center for Drugs and Drug Addiction (EMCDDA) studied dark web marijuana sales with findings published in the Journal of Addiction Medicine, as WIRED first reported. The number of dark web cannabis sales increased more than 30% in the first three months of 2020, which coincided with when the pandemic first impacted Europe. EMCDDA analysts aren’t sure why this jump in sales began as early as it did in Europe.

“It’s possible that buyers were trying to stock up for the weeks to come, or there’s just a larger group of cannabis users discovering online as a convenient distribution channel when social contact is limited and they have limited means to reach out to their usual dealer,” EMCDDA’s principal scientific analyst, Teodora Groshkova, told WIRED.

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Are Amazon, Uber, etc. the future for delivering post-pandemic cannabis?

It’s hard to say where we are in the COVID-19 pandemic right now, as infections and deaths continue to rise. But there have been movements in the cannabis industry that are changing the way the industry operates amid the pandemic that may stay post-pandemic.

Being allowed to operate as an “essential” business in the U.S. — which had a few bumps in the road between including both medical with recreational as essential businesses in states such as Colorado (that state quickly changed and added recreational) and Massachusetts — was one positive result that gave the industry some needed respect.

Sales have been strong, and delivery options were expanded as well.

Many U.S. states with legal medical and recreational cannabis have been allowing deliveries since they legalized. But because of COVID-19, dispensaries are now adjusting to curbside or drive-thru window sales to adapt to the new contactless, social distancing way of conducting business.

California licenses more than 150 legal cannabis delivery companies, the most of any state, including Eaze (now scaling back operations), Puffy, CaliExpress and more. The scaling back of Eaze may be just a delivery service experiencing hard times during the pandemic, or it may represent a harbinger of things to come, leaving the door open for more of these adapted dispensary-centered curbside/drive-thru sales.

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The Cannabis Beverages of Summer

The summer of 2020, like the rest of the past year, is shaping up to be fraught with tension, unrest, and anxiety, but at least one thing is certain. There will be hot days (in the northern hemisphere, at least) and people will be thirsty, not just for cold, refreshing beverages, but for the opportunity to relax, unwind, and connect in whatever form is available to us in the months to come.

Sometimes soda, iced tea, or a tangy lemonade do the trick when temperatures rise, but sometimes an “adult beverage” is in order to take the edge off of these very edgy days. With favorite local watering holes either closed or restricted by limited seating and social distancing, grocers and liquor stores are stocking up on wine, beer, cocktail mixers, and alcohol-enhanced sodas to enjoy at home. Meanwhile, some companies are hatching more innovative ways to beat the heat. Enter mood33, House of Saka, and Cann Social Tonics.

Mood33 heralds the debut of its new hemp-infused herbal tea line with descriptives like “soulfully delicious” and “mindfully sweetened”, a surefire way to attract all of the hemp-minded Whole Foodies out there. Boasting 33mg of organic, American-grown hemp extract per bottle in blends that include botanicals, tea, and real fruit juice, mood33’s beverages offer more than a way to slake your summer thirst. With names like “Joy”, “Passion”, and a “Wellbeing” blend that includes 133mg of caffeine from guayusa and green tea, these drinks offer an alternative to the intoxicating effects of that IPA or chilled martini, and all at 70 calories or less.

House of Saka takes a different approach, as a Napa-based company focusing on “wine-style” libations for those disinclined to give up the grape. House of Saka is an all-female-run company focused on crafting alcohol-free, cannabis-infused wines for the luxury market. Their first release, the rosé-inspired Saka Pink, is “rosé-inspired”, and at 5mg of THC, 1mg of CBD, and only 16 calories per serving, consumers can feel good about that second glass.

As an herbalist and dedicated Whole Foodie myself, Cann Social Tonics caught my eye with its attention to wholesome ingredients and inventive infusions like Grapefruit Rosemary and Cardamom Blood Orange. Each beverage in the line is sweetened only with 100% organic agave nectar from Mexico and juices that are not from concentrate. With 2mg of THC and 4mg of CBD per can, Cann Social Tonics promises a fizzy summer fix with plenty of feel-good ingredients to ensure that the next morning is as pleasant and brain fog-free as the night before.

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How To Reduce Odor When Growing Indoors

Everyone who has grown a substantial crop in their basement will attest to the strong odor the crop produces as the plant matures. Most people have been busted simply because of the strong smell of a mature plant permeating the air around the home in question.

There are a few things that can be done to keep the smell of cannabis down both within and outside the house where it is being grown. Running a hepa filter in the growing area will stop a large amount of the odor, but not all. While the activated charcoal in a hepa filter will stop most of the smell, some ventilation to the outside will also be needed.

Hepa filters come in many sizes and shapes. Some are just the filter, while others incorporate a of fan. If you have the choice, choose the filter with the fan. Most basements have at least one small window, so use it is as the output of the filtered hepa filter. Remove the glass and replace the window with a board with the hepa filter shape cut in. Choose a window that vents to the backyard or a window on the side of the house with low traffic.

Another way to keep the scent down is with eucalyptus. Eucalyptus is great for covering odors and replacing them with the cool scent of the plant. Eucalyptus is also great for keeping the humidity down, an action which negates the growth of mold and fungus, since they both need a damp environment to grow in.

The eucalyptus needed is usually in the form of an oil, which won’t do its job if the surface area is as small as the diameter of the jar it came in. To that end, pour the oil in a wide, shallow pan. This will result in a decreased marijuana odor. The eucalyptus will also reduce the humidity due to its very efficient moisture retention properties.

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U.S. researchers will study hemp’s potential to clear algae

Researchers in the U.S. state of Florida are studying how hemp plants could help in the battle against toxic algae, a persistent problem at the state’s two coasts.

Steven Edmonds, founder of Hemp4Water and a political science instructor at Valencia College in Orlando, has teamed up with researchers from Florida State College on the initiative. The group said it will test grow hemp mats in Florida waterways to check their potential to clear nutrient pollution that feeds toxic blue-green algae and red tide algae.

Algae a serious problem

Scientists have found that decades of farming, development and canal dredging has overloaded Lake Okeechobee, the state’s biggest fresh-water body, and other Florida waters with the nutrients that feed toxic blue-green algae and red tide algae in coastal waters. The researchers suggest the mats could provide a source of hemp fiber in addition to cleaning the water.

A severe outbreak of red tide algae in southwest Florida in 2018 hit the fishing and tourism industries. Blue-green algae in 2016 left harbors full of dead fish in the Indian River Lagoon along the Atlantic Coast. And in 2013, a severe bloom of red tide algae in southwest Florida killed more than 240 manatees, prompting Edmonds to seek a solution.

“I know that hemp growers spend a lot of money creating a water supply that’s rich in nitrogen and phosphorus because cannabis needs that,” Edmonds told UPI. “It just makes sense to try this.”

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Using Tech to Increase Employee Health and Safety

From cultivators to dispensaries, cannabis operators are required to get creative and deploy new ways to manage day-to-day business activities as the coronavirus pandemic shapes the “new normal”.

While some have seen an increase in demand, others are facing tough decisions when it comes to production and staff. Either way, cannabis companies are doing everything they can to avoid furloughing staff.

No matter the situation, it’s important to make data driven decisions. That’s why many are turning to cannabis-specific technology to better manage their operations. With the right tools in place, cannabis operators have been able to alter protocols and adjust processes to keep employees safe and maintain an efficient workflow.

From plants to people, here are the key adjustments taken by the industry that can greatly impact your business:

Labor Planning

Many cannabis operators are turning to reduced staff and staggered schedules. This is a necessary step for the health and safety of employees, but if not done properly, can be detrimental to production.

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4 Reasons Smart Entrepreneurs Should Be Thirsting To Get Into The Cannabis Beverage Industry

Consider for a moment the three most widely used drugs on earth: caffeine, nicotine, and alcohol. Collectively, they represent a nearly $2.7 trillion global market —$420 billion in the United States alone. Each has been socialized into our collective consciences and even enjoy a sanctioned time for daily use: the coffee break, the smoke break, and happy hour. Two of the three are beverages.

Cannabis has quickly emerged as the fourth leg of this legal-use psychoactive stool. This has tremendous implications for investors and operators alike, as consumer preferences are migrating from artificial and invigorating products to natural and calming. Twenty-five of the top food and beverage companies in the US had an $18 billion loss in market share in just the last five years. Consumers want functional benefits, craft appeal, natural ingredients, experimental flavors, and low caloric counts. These trends, when combined with the health benefits of cannabis, are likely to drive outsized growth in infused beverages in the decade ahead.

1. Cannabis beverages have been around for centuries.

While it may appear that cannabis drinkables are a relatively new idea, cannabis has been used in medicinal beverage preparations throughout history. The Chinese have enjoyed Mafeisan for thousands of years, while Indians have long referred to bhang as the ancient Nectar Of the Gods. Bhang is sold today at government-licensed stores in India, having never been made illegal due to its religious ties as the official drink marking the arrival of spring. As public opinion and the stigma associated with recreational cannabis throughout the world continues to soften, consumers search for social and innovative ways to consume their favorite cannabinoids.

2. Cannabis-beverage science is getting better.

Infused drinkables currently hold a market share of under 1 percent in the US, a figure that is far too low when compared with industry estimates for a $2.8 billion global cannabis beverage market by 2025. Advances in cannabis science is a factor behind this anticipated growth.

Up until recently, crafting cannabis beverages has been challenging. Cannabinoids are oily, fat-soluble substances that do not mix easily in water-based beverages. Oral consumption has thus traditionally been facilitated with oil and butter infusion. That's why gummies, brownies, and confectionaries comprise the majority of infused edibles today. The opposing nature of cannabinoids and water has challenged product developers with taste masking, dosing uniformity, and shelf-life stability. Formulation technologies honed in the pharmaceutical (60 percent of newly marketed pharmaceutical drugs demonstrate poor water solubility) and food industries can help circumvent some of these challenges while bringing infused beverage ‘onset’ closer to the 7 to 10 minutes that alcohol enjoys, instead of the 75 to 120-minute traditional edible average.

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THC breathalyzer program could help police detect marijuana impairment

Oklahoma law enforcement officers patrolling the state’s roads and highways may soon have a new tool for testing drivers who they believe may be under the influence of marijuana.

Signed by Gov. Kevin Stitt on May 2, HB 4161 directs the Oklahoma Department of Public Safety to spend $300,000 to create a pilot program to explore the use of breathalyzers to detect tetrahydrocannabinol (THC), which is the primary psychoactive component of marijuana.

Rep. Scott Fetgatter (R-Okmulgee) is among the most engaged state legislators on the topic of Oklahoma’s medical marijuana industry. He said he had first raised the idea of a breathalyzer program at “a meeting in February with representatives from city police, county sheriffs and the Department of Public Safety.”

“We took them through the science behind the breathalyzer, and I took a vote among those in the room if they were interested, and it was unanimous,” he said. “They were all in favor of the idea of a pilot program.”

The development of a device to detect THC from a user’s breath has puzzled scientists for years. Having a dependable breathalyzer would solve a sticky problem for officers in the field, who lack the ability to accurately and quickly test impaired drivers rather than using drug recognition experts and blood tests.

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The Endocannabinoid System and Clinical Endocannabinoid Deficiency

The discovery of the endocannabinoid system in the mid-1980s was a major breakthrough in modern medicine. Yet, if you looked at the curriculum for most medical schools, you might not know it. The finding would not have been possible without the help of the cannabis plant, which remains illicit in most countries around the world. After wide-spread legalization of medical cannabis and over three decades of research, knowledge about the endocannabinoid system and its associated pathologies, like clinical endocannabinoid deficiency, remain sorely overlooked.

The Endocannabinoid System: The Find of the Century?

Two decades before the discovery of the endocannabinoid system, a team of scientists led by Dr. Raphael Mechoulam, a professor of medical chemistry a the Hebrew University of Jerusalem, had finally isolated the primary psychoactive constituent of the cannabis plant—tetrahydrocannabinol (THC). After the discovery, researchers around the globe began the quest to figure out exactly how the compound worked.  A group led by Dr. Allyn Howlett, a neuroscientist then with St. Louis University, finally cracked the mystery: THC produced its psychoactive effects through engagement with specialized cell receptors.

A cell receptor can be thought of as a lock that is embedded on the surface of a cell membrane. These locks only respond to specific chemical keys. In this case, THC was the key that engaged a cannabinoid receptor. As research would soon reveal, cannabinoid receptors are part of a larger endocannabinoid system (ECS), a neurotransmitter and cell signaling network like none other.  Made up of receptor sites, their respective chemical activators, and the enzymes that deactivate these compounds, scientists quickly unveiled that the ECS was ubiquitous throughout the human body. Cannabinoid receptors are nearly everywhere — connective tissue, the brain, the spinal cord, internal organs, the digestive tract, the skin, and immune cells.

After what surely was many long hours in the lab, Howlett and her team landed on something big. Why on earth would these receptors be found in so many places? Nearly three decades down the line, scientists are still exploring the wide-reaching ramifications of the endocannabinoid system, Howlett included. In the time since its first discovery, the ECS has been found to be a potent regulator of brain activity, hormonal function, and immune response, linking the three main regulatory systems together. It’s this pervasive modulatory network that responds to THC and other cannabis constituents. When a person consumes intoxicating forms of cannabis, THC hijacks the cannabinoid receptor sites that are normally inhabited by compounds that the body produces naturally.

These compounds are called endocannabinoids. The prefix endo- refers to endogenous or internal cannabinoids. In contrast, the cannabinoids found on the cannabis plant are phytocannabinoids with the prefix phyto referring to plants. As it turns out, endocannabinoids are molecules that help maintain a state of equilibrium, or homeostasis, throughout the nervous, endocrine, and immune systems. Endocannabinoids play the part of harmonizers or middlemen, managing how each of these systems responds to stressful stimuli and communicates with the others.

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CBD vs. THC – Helping You Choose Your Favorite Cannabinoid

Cannabis is gaining momentum as a wellness trend. Preclinical studies have shown it can help treat epilepsy, depression, anxiety, inflammation, and can make living with cancer much more bearable.

One of the hemp plant’s substances – CBD or cannabidiol – is causing the most hype. Today we can find it almost anywhere – from food and drinks, through decorative cosmetics, to oils and topicals that can be purchased legally in physical or online stores. 

The situation is a bit different with THC, the second of the two predominant cannabis compounds. That’s why there’s often a comparison between these two cannabinoids – the CBD vs. THC argument.

But let’s back up a bit. 

Cannabinoids 101

Cannabinoids are active organic chemical compounds that affect cannabinoid receptors in the human body. 

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