Here’s what’s next now that the FDA has approved a cannabis drug for seizures

The US Food and Drug Administration approved the first cannabis-derived drug this week, but it can’t be sold until the Drug Enforcement Administration changes how it classifies the specific compound used. So what’s next?

Epidiolex treats serious forms of childhood epilepsy and contains the compound cannabidiol (CBD). Though CBD comes from cannabis, it won’t cause anyone to get high; it’s the compound THC that is psychoactive. But because it comes from cannabis and cannabis overall is classified as a Schedule I drug with “no currently accepted medical use and a high potential for abuse,” pharmaceutical companies aren’t allowed to sell it unless the DEA reclassifies CBD.

It is likely that the DEA will reclassify CBD in the next 90 days, says Stephanie Yin, an analyst at Informa Pharma Intelligence. (Epidiolex manufacturer GW Pharmaceuticals has said the same.) Most likely, according to Yin, it will be changed to Schedule IV or Schedule V, which are schedules that include other anti-seizure medications and anxiety drugs like Xanax and Klonopin.

THIS WILL ENCOURAGE OTHER COMPANIES TO DEVELOP CBD DRUGS FOR EVERYTHING FROM PAIN TO MULTIPLE SCLEROSIS

This doesn’t mean that cannabis as a drug will be removed from Schedule I though. Yin points out that the FDA already approved two nausea drugs — dronabinol and nabilone — that use synthetic versions of THC. The DEA scheduled these drugs as Schedule III and II, respectively, but still didn’t reschedule cannabis. Plus, FDA Commissioner Scott Gottlieb said in a press release that Epidiolex approval “is not an approval of marijuana or all of its components.”

If these synthetic THC drugs can be approved and rescheduled, and CBD can be rescheduled, what’s keeping the DEA from rescheduling cannabis itself? “Cannabis contains so many different compounds and strains,” explains Yin. “The FDA has just approved this singular product through stringent testing and doses and specific concentrations. It’s gone through rigorous clinical reviews and FDA review, but the FDA is likely to still crack down on claims made with other products.”

To be clear, there are already plenty of CBD products easily available, from supplements to oils to various beauty products like soap. But it’s one thing to sell them as supplements, and another to sell them as drugs. “You can get vitamin C from oranges at the grocery store, or you can get a clinical preparation of vitamin C to treat a disease, and those two items are treated very differently,” says Chris Stubbs, chief science officer of hemp farming and genetics company GenCanna. Clinical CBD is much more tightly regulated.

Still, the reclassification will likely make medical cannabis more legitimate. Rite Aid, for example, has already said it will fill prescriptions for Epidiolex, which is likely to be available at pharmacies in the fall. (It won’t be available in dispensaries because FDA-approved drugs can only be sold at places with a pharmaceutical license.) And GW Pharmaceuticals is already investigating other CBD-derived drugs to treat different forms of epilepsy, as well as forms of brain cancer and schizophrenia. “This approval is definitely going to encourage other companies to investigate [other cannabis] compounds for different diseases,” she says, “from pain to Alzheimer’s to multiple sclerosis to Tourettes’. Basically a whole spectrum of diseases.”

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Is CBD a threat to THC-focused marijuana companies?

 

CBD products are often marketed as having similar health benefits to medical marijuana without the psychoactive properties – essentially all of the medicine but none of the high.

That growing mainstream appeal has some cannabis business owners concerned that CBD is a threat to the THC-reliant marijuana market.

According to cannabis research firm Brightfield Group, the CBD market could be worth more than $2 billion a year by 2021. Two-thirds of that CBD would come from hemp, not marijuana, the company projects.

Part of the concern comes from market access. In states like Colorado, consumable products – including CBD – can only be sold through marijuana retail stores if the product contains at least some THC.
But CBD products not containing THC are sold online and in natural products stores around the country.

Marijuana Business Daily surveyed about two dozen cannabis industry professionals across the country – business owners, consultants and analysts – to get their take on whether CBD and THC can coexist in the market.

More than half said they didn’t see CBD products as a threat to THC-focused businesses, but there is concern about the rise of the CBD market.

CBD isn’t a threat to the THC market

Tim Keogh

Tim Keogh, CEO, AmeriCann: “I see the proliferation of CBD-only products as a compliment to the full-spectrum, whole plant cannabis market rather than a threat. The news around CBD and its availability is opening up new consumers that do not have any relationship with cannabis as a therapeutic solution to try new products. This changes the perception and decreases the stigma of cannabis.”

Adrian Sedlin

Adrian Sedlin, CEO, Canndescent: “Each compound has unique properties, so whether it’s the medical market or the adult-use market, the cannabinoids address very different needs and desires. Moreover, there is the entourage effect, which supports the idea of symbiotic, dual consumption. Like most things with the plant, it’s harmonious.”

Avis Bulbulyan

Avis Bulbulyan, cannabis consultant: “The CBD-focused industry has its own set of problems, but at least for the immediate future, they’re very different markets. At some point this will probably change, but probably not in the near future.”

Karen Freese

Karen Freese, cannabis consultant: “There’s plenty of space for CBD products to coexist in the marketplace with THC products. People want them. Each person has a unique reason and need for why they choose one over the other.”

Kris Krane

Kris Krane, president, 4Front Advisors: “I don’t see it as much of a threat. I think there’s a market for CBD products, and I’m sure there’s some overlap. But I haven’t seen any evidence at this point that CBD sales in a legal market are cutting into the sales of a state-regulated cannabis market. I just don’t see it. The CBD market is not that big.”

 

Reason for concern

John Andrle

John Andrle, owner, L’Eagle Services: “Obviously, CBD is a threat to the THC market. For starters, CBD is marketed as having all the same medicinal benefits as THC without the ‘crazy high’ (as one Facebook video proclaims). It doesn’t. There are hardly any barriers to selling CBD – any 10-year-old can buy it online, in vending machines, at pet shops and in salons and spas. Marketing can be conducted without (the same restrictions as marijuana). Respective of IRS taxes, there is no 280E for CBD-based companies to deal with, yielding profits automatically 25%-39% higher.”

Matt Karnes

Matt Karnes, founder, GreenWave Advisors: “It’s a legitimate concern. The CBD market has a more-focused product offering a broader consumer appeal as it relates to different ailments, appealing to a broader range of people.”

Matt Sampson

Matt Sampson, owner, North Coast Growers: “The segment of the market that will be most impacted is the ‘no smoke, no smell’ crowd who also prefer mellows highs or no high at all – the people who like to relax and know they are doing something beneficial for their health and wellness without going on the unpredictable adventure that can often be the experience people have getting high on today’s medical and recreational cannabis products. There is a huge segment of the population who would consume non-psychoactive CBD but would never consume cannabis with THC.”

Michael Mayes

Michael Mayes, CEO, Greenwave dispensary: “Yes, the CBD-focused market is a threat to the THC market for those just looking for CBD. I have about 100 patients that only buy hemp-derived CBD products. It’s because of their sensitivity to THC. Epileptics and pediatric patients don’t want any psychoactive effect whatsoever. But you absolutely need some part of THC for CBD to work effectively.”

Donald Morse

Donald Morse, chairman, Oregon Cannabis Business Council: “THC-focused companies should be scared. A lot of people selling CBD are making outrageous claims about what it does for people. We all know it doesn’t. But we’re selling it in dispensaries. We’re helping the CBD industry by promoting their product alongside the THC industry’s product, which is like shooting yourself in the foot.”

 

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Hemp-based CBD company wants approval to open store in downtown Naperville

A company that sells CBD food products, lotions, oils, pain relievers and other products extracted from hemp is seeking permission to open a store in Naperville.

David Palatnik, who owns nine CBD Kratom stores in Chicago, St. Louis, Dallas and Los Angeles, said the market for such items is expanding because they are nature-based products.

“Hemp is something used for years. It is not psychoactive. It doesn’t get you high. CBD or cannabidiol is extracted from hemp. Our shops specialize in it,” Palatnik told the Naperville Liquor Commission at a recent meeting.

Mayor Steve Chirico said the liquor commission will make a recommendation on the store, proposed for Chicago Avenue and Washington Street in downtown Naperville, because the city has the authority to reject businesses that sell “restricted products,” like CBD.

“If the CBD product line is considered safe, we’d recommend it to council,” said Chirico, who heads the commission.

Commissioner Joe Vozar expressed concern that CBD edibles are not approved by the U.S. Food and Drug Administration.

Palatnik said there’s a political reason for that.

“The FDA doesn’t want to approve CBD because of the marijuana industry, and they tie it together,” he said. “You can sell products not approved by the FDA.”

CBD is misunderstood because it is often sold in stores that cater to marijuana users, sometimes called “head shops,” Palatnik said.

CBD and marijuana are part of the cannabis family, but hemp and marijuana are different plants, experts say. Hemp has less than 1 percent THC, the ingredient that makes people high when consumed, and its seeds are used to make ingestible medicinal powders sold in retail outlets like Walmart. CBD is made from the flowers, leaves and stalks of hemp and it’s added to a wide variety of products, from gummy candy to capsules to lotions and oils, which are sold online and at some retail outlets.

Palatnik said he opened his first CBD shop three years ago and the business has been “expanding fast” since then.

“We have a lot of customers from this area that drive to our shop in the city, he said. “This is a great location for us. The strip mall (where the Naperville store is located) has four vacancies. Our business can help the center, bring new customers to the center,” he said.

CBD products are already being sold in smoke shops, health food stores and specialty outlets, such as CBD American Shaman on Maple Avenue in Lisle, which opened in January and requires customers to be at least 18 years old to make a purchase.

Palatnik said his shops only sell to customers who are 21 or older, and many people like purchasing in person because they can consult with his employees, who are knowledgeable about the products.

“It’s a pretty new product in the U.S. It got popular in 2015 and 2016,” he said. “All our products labeled. We never got sued. We never had any major complaints. We never had anyone that went to the hospital. … In Dallas, police came and checked and tested. And I sent them lab work, and I never heard from them again.”

The CBD products sold in his stores are independently tested, he said, adding he would provide lab results to the commission.

His stores also sell items using kratom, an herbal supplement made from a tropical evergreen tree, which is part of the coffee plant family and native to Southeast Asia, where Palatnik said he grew up. The FDA has not approved kratom, which is often ground into a powder and added to smoothies and teas.

“The FDA is warning consumers not to use kratom. The effects could be risk of abuse and dependence,” Commissioner Chuck Maher said at the meeting. “I’d say I would not support this at all, a business focused on that. Walgreens products (like hemp soap) are products not absorbed in the chemistry in the brain. We’ve got enough problems with opioids.”

“I don’t want to rush to judgment,” countered Commissioner Mitch Stauffer. “I think there is a stigma. FDA choosing not to endorse is by no means condemnation. I’m inclined to proceed cautiously.”

The FDA looked into banning kratom, and the U.S. Drug Enforcement Administration considered placing kratom in the Schedule I category of controlled substances, which include heroin and other deadly synthetic opioids. Neither agency moved forward with those plans after public backlash, although they are still under consideration.

Naperville Senior Assistant City Attorney Jennifer Lutzke said kratom is banned in five states, “including Indiana and Wisconsin, and two municipalities in Illinois. We could implement (a ban) if council decided.”

“A majority of our business is CBD,” said Palatnik, who offered to exclude kratom from any CBD store he opens in Naperville.

Chirico told Palatnik the commission will look at kratom separately and will consider making a recommendation on a CBD store at their next meeting, after commissioners and staff have a chance to do their own research on cannabidiol.

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What Exactly Is CBD Oil & How Can It Fight Anxiety?

You’re seeing it in supplements, beauty products, and even chocolate bars, but what the heck is CBD oil, and what is all the fuss about? You know it has something to do with marijuana, so is the wellness world just a bunch of potheads? Well, not exactly.

 

The basics of CBD oil: hemp vs. marijuana.

CBD is short for cannabidiol, a cannabinoid compound that is found in hemp and marijuana. Both hemp and marijuana are part of the plant family known as Cannabis. The main difference between marijuana and hemp is the level of THC in each. THC, like CBD, is a cannabinoid compound. There are 60 different known cannabinoids, but THC is the most well-known—the Beyoncé of cannabinoids, if you will. The reason THC is so famous is because it’s associated with the psychoactive high that people experience after smoking or ingesting weed.

The definitions of hemp and marijuana can get pretty confusing, but for basic purposes, marijuana contains high levels of THC, and hemp contains low levels of THC. The ratios of CBD to THC in hemp oil can vary, depending on the product and the specific plant the oil was extracted from. CBD oil, a concentrated version of the cannabidiol compound, is typically derived from hemp but can be extracted from marijuana as well. CBD oil products on the market have varying levels of CBD and THC. Many have little to no THC, while some contain small amounts.

The health benefits of CBD oil.

OK, so CBD oil won’t get you high, turn you into a drug addict, or give you the munchies, so why is everyone talking about it? If THC is the Beyoncé of cannabinoids, then CBD is the Adele: Both you and your grandma will love it. CBD is just as talented as THC but safe for the whole family. CBD oil can provide amazing health benefits naturally, and there is a growing body of research to support it.

While there are many different pathways driving the positive health benefits of CBD, the center of its awesome abilities seems to be that CBD is a very effective natural anti-inflammatory. Chronic inflammation is really the commonality between most (and by most, I mean basically all) chronic health problems that we face today as a modern society. Cancer, heart disease, diabetes, autoimmune conditions, digestive issues, and hormonal problems are all inflammatory in nature. What the heck, right?

Despite this, it’s important to know that inflammation is not inherently bad; in fact, it’s a brilliant aspect of our immune system. When balanced, inflammation heals wounds and fights off infections. The problem with inflammation arises when it increases and never calms down. Like a forest fire burning on in perpetuity, people get hurt. Same goes with the fiery squall of insidious, chronic inflammation. As a natural anti-inflammatory, CBD can help quell the flame and fight chronic inflammation.

CBD oil, inflammation, and anxiety.

Anxiety disorders are the most common mental health concern in the United States. An estimated 30 percent of adults in the United States (that’s 66 million people) and an estimated 25 percent of teenagers and preteens are affected by anxiety. As a functional medicine practitioner, I see many people who struggle with anxiety and panic attacks, and from these statistics, it should be no surprise. But just because something is common doesn’t make it normal. Fortunately, new insights into the cause of anxiety may help with the development of more effective treatment options.

Most people do not associate cognitive health issues like anxiety, depression, brain fog, ADD, ADHD, and autism with inflammation, but it turns out that is exactly what the research is finding. There is actually a whole field of research known as the cytokine model of cognitive function studying how inflammation messes with our brains and may cause anxiety disorders. One finding is that elevated levels of NF kappa B (NFkB), an inflammatory bad guy, is associated with anxiety while people with lower levels of NFkB often have lower rates of anxiety.

Enter CBD oil: an anti-inflammatory and anti-anxiety compound. I have seen in my own life, and many of my patients’ lives, the positive impact CBD oil can have on anxiety. Studies have found that CBD oil is a natural anxiolytic (anxiety calmer) and is effective in treating social anxiety. CBD calms anxiety naturally without the potential side effects of pharmaceutical anti-anxiety medications.

In addition to fighting inflammation in the body, CBD oil may reduce anxiety by directly affecting the brain. Studies have found that CBD actually lowers activity in the amygdala and increases prefrontal cortex activation, two parts of the brain involved in anxiety. There is also evidence that CBD is able to activate hippocampus neurogenesis, aka regenerate new neurons! This activates CB1 receptors, which has a positive balancing impact on GABA and glutamate levels, associated with reducing anxiety.

CBD Oil: How much should you take?

The studies done on CBD oil have a pretty wide dose range (anywhere from a few milligrams to hundreds of milligrams). I suggest starting at the lower end (around 10 milligrams) and slowly increasing over a few weeks or months to see what works for you. Some people also do well with splitting the dosage throughout the day instead of taking the dose all at once. As with everything, it is always a good idea to talk with your prescribing doctor if you are on any medications. CBD is generally very safe, but there are some pharmaceutical medications CBD oil could potentially interact with and increase or decrease the pharmaceutical drugs’ effectiveness.

There are a growing number of quality CBD oils on the market. Just make sure the product you buy is getting third-party tested for quality and potency—and that the hemp was organically grown.

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