Is CBD Psychoactive?

By Roger Chriss, PNN Columnist

The CBD boom is making Dutch Tulip Mania seem dull. CBD water is becoming a thing, and Ben & Jerry’s may soon introduce a CBD-infused ice cream. Basically, CBD is in everything.

The boom is built on the assumption that CBD, the cannabis cannabinoid known as cannabidiol, is not psychoactive. The FDA isn’t so sure and the DEA demurs, putting the CBD-based seizure drug Epidiolex into Schedule V last year.

So is CBD psychoactive? The answer hinges on the definition of the term psychoactive.

According to the World Health Organization: "Psychoactive substances are substances that, when taken in or administered into one's system, affect mental processes, e.g. cognition or affect.”

The National Institute on Drug Abuse explains psychoactive drugs this way: “Drugs in this category act on the central nervous system and alter its normal, everyday activity, causing changes in mood, awareness, and behavior.”

The term “psychotropic” is used with a similar meaning. MedicineNet states that a psychotropic drug is “any drug capable of affecting the mind, emotions, and behavior.”

But does CBD affect mental states, alter everyday activity, or change mood, awareness, or behavior?

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The FDA last year approved Epidiolex -- the first CBD-based medication -- for the treatment of two rare and severe forms of childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. CBD potentially has many other uses, including neurological conditions such as Alzheimer’s and dementia, and neuropsychiatric illness such as autism, ADHD, and PTSD.  It could also be beneficial for anorexia, anxiety, and mood disorders.

Purveyors of commercial CBD products go further, claiming that CBD may help with insomnia, social anxiety, and panic attacks. Although most product labels avoid specific claims of treatment efficacy to avoid FDA scrutiny, clear statements of possible benefits are easy to find online.

The FDA recently sent a warning letter to a New Jersey company for claiming that CBD can treat anxiety, depression, PTSD, schizophrenia, psychosis and obsessive compulsive disorder.

In order for CBD to do even half of this, it would have to have an effect on mental states, mood and awareness. In other words, CBD could not do what its proponents claim without being psychoactive, at least in the narrow, technical sense of the term.

Dose Matters

But details matter here. First, psychoactive does not mean intoxicating, hallucinogenic or dissociative. And many prescription drugs have benefits precisely because they are psychoactive. Even caffeine is arguably psychoactive, though only very weakly.

Second, dose matters. The pharmaceutical Epidiolex is administered in doses that have 10 to 100 times more CBD than a typical over-the-counter or commercial CBD product. So CBD may be psychoactive in therapeutic doses, but not in “commercial” doses. Of course, this assumes the product actually contains CBD, which in practice is not necessarily the case.

Third, route of administration matters. CBD is only weakly bioavailable and unstable in light or temperature extremes. A clear bottle of CBD water or CBD bath oil could easily lose much of the CBD it may contain, and the remaining CBD may not even be absorbed. And if the CBD is applied to non-vascularized tissue, as is the case with CBD mascara, then it cannot be psychoactive because of a lack of blood vessels for transport to the brain.

Thus, whether or not CBD is psychoactive depends on the amount and method that CBD is introduced to the human body. Since most of the claims from proponents remain unverified and in many cases untested even in animals, it could be premature to state that CBD is psychoactive in a specific way.

On the other hand, the existing work on CBD argues for calling CBD psychoactive. Recent findings by Yasmin Hurd showed that CBD, specifically Epidiolex, reduces cravings in people addicted to heroin. Ongoing research is demonstrating possible benefits of CBD for seizure disorders in humans and even in dogs.

Project CBD noted in 2016 that “as our scientific understanding and therapeutic experience deepens, the description of CBD as non-psychoactive may fall by the wayside.”

For now, it would be reasonable to say that CBD is probably “weakly psychoactive” at commercial doses but more “strongly psychoactive” at therapeutic doses. As more studies are completed on what CBD actually does, the pharmacological description of CBD can be updated accordingly.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Feds Warn CBD Marketers About False Medical Claims

By Pat Anson, PNN Editor.

The Food and Drug Administration and the Federal Trade Commission are tapping the brakes on the fast growing market for cannabidiol (CBD), warning companies not to make false claims that CBD products can be used to treat fibromyalgia, migraine, arthritis and other chronic illnesses.

The agencies sent warning letters to three companies — Nutra Pure, PotNetwork Holdings, and Advanced Spine and Pain — for making false and unsubstantiated health claims about a variety of CBD oils, extracts and edibles.

The FDA and FTC sent the warning letters on March 28 and gave the companies 15 days to respond.

Nutra Pure’s website, according to regulators, claimed that “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”

Claims were also made that CBD is “an effective and safe treatment alternative” for inflammatory conditions such as lupus, Celiac disease and rheumatoid arthritis.

Nutra Pure, which makes a line of hemp oil, has a small disclaimer on its website stating that “these products are not intended to diagnose, prevent, treat, or cure any disease.”

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PotNetwork has a similar disclaimer on its website, where it sells everything from CBD infused gummy bears and energy drinks to moisturizers and pet care products. According to the FDA, the company falsely claimed that CBD “blocked the progression of arthritis” and “has also shown the ability to kill cancer cells directly.”  

In addition to marketing CBD products, Advanced Spine and Pain also offers stem cell therapy, steroid injections, trigger point injections and ketamine infusions at its “Relievus” clinics in New Jersey and Pennsylvania.

‘Open Questions’ About CBD Safety

The federal crackdown on CBD marketing comes at a time when CBD products are starting to appear in mainstream stores. CVS Pharmacy and Walgreens started selling cannabis-based lotions, tinctures, edibles and lozenges in stores last month. The CBD products are being sold over-the-counter and without a prescription.  

The FDA and FTC announced no actions against CVS, Walgreens or other retailers selling CBD products, but they sent a clear message that the marketing of CBD will be closely watched.

“We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce,” FDA commissioner Scott Gottlieb, MD, said in a statement. “Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements.”

The 2018 Farm Bill removed hemp – a less potent strain of marijuana – from the Controlled Substances Act. That made hemp products legal to sell, but left the FDA in charge of regulating dietary supplements containing CBD. The agency is still trying to figure out how to regulate a product for which there is growing consumer demand, but little scientific evidence to support its use.

“While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use,” Gottlieb said. “There are also unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products.”

Gottlieb has announced plans to hold a public hearing on May 31 to review the safety and effectiveness of CBD products. The FDA is also forming an internal working group within the agency to explore what regulatory changes would be needed for CBD products to be marketed legally.  

CVS Begins Selling Cannabis Products

By Pat Anson, PNN Editor

You may not be able to get your opioid prescription filled at a CVS pharmacy, but you can stock up on medical marijuana. The nation’s largest drug store chain has begun selling cannabis-based products in eight states, despite lingering concerns about their effectiveness and legal status.

The move was announced by cannabis retailer Curaleaf Holdings, which carries a line of cannabis lotions, tinctures, edibles and lozenges that CVS started carrying in its stores last week. The CBD products are being sold over-the-counter without a prescription.

(Update: Walgreens has also announced plans to sell CBD products in 1,500 of its stores.)

CBD stands for cannabidiol, a chemical compound in marijuana that does not produce euphoria but is believed to reduce symptoms of chronic pain and other health conditions.  

“We have partnered with CBD product manufacturers that are complying with applicable laws and that meet CVS’s high standards for quality,” a CVS spokesman said in an email to MarketWatch.  

CVS said that it was selling CBD products in Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee. Curaleaf executives said CVS would eventually carry its products in 800 stores in ten states.

“We’re going to walk slowly, but this is something we think our customers will be looking for,” CVS Health CEO Larry Merlo told CNBC.

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‘Treated Like Criminal’ at CVS

The move is somewhat puzzling for CVS, which was one of the first pharmacy chains to crackdown on opioid prescriptions due to concerns about addiction and overdose. In 2017, CVS began restricting initial opioid prescriptions to 7 days’ supply and aligned its polices with the CDC opioid guideline.

Pain sufferers now complain they’re treated like drug addicts by CVS pharmacists.

“I submit to monthly drug tests and do everything I am supposed to do and I am treated like a criminal at the doctor and CVS pharmacy. My two pills a day barely touches the pain, but I need to work,” one patient recently told us.

“Some pharmacies, such as CVS, have taken it upon themselves to deny my prescriptions that I have been having filled there for 15 years. They first took it upon themselves to adjust my dosage. I didn’t realize that pharmacist were allowed to change a prescription,” said another patient.

“Why does CVS, a drug store that sells NSAIDs without restriction, have control of how I treat my patient?” asked one practitioner.

Although most Americans now support the use of medical marijuana and it is legal in dozens of states, the safety, effectiveness and legality of CBD is still very much up in the air.  Marijuana remains classified as a Schedule I controlled substance by the DEA, alongside heroin and LSD.

“Societies have jumped far, far ahead of science,” Dr. Margaret Haney, a professor of neurobiology at Columbia University Medical Center, told NBC News. “So it’s showing up in lotions and pretty much any form of product one can use. There’s a lot of different ways one could use CBD, but the ways we have studied CBD is much more limited.”

According to MarketWatch, Curaleaf only list its shares on the Canadian Securities Exchange because major exchanges in the U.S. and Canada will not list shares of marijuana companies due to their hazy legal status.

Study: THC More Effective Than CBD in Treating Pain

By Pat Anson, PNN Editor

The psychoactive ingredient in marijuana -- tetrahydrocannabinol (THC) – is more effective than cannabidiol (CBD) in treating chronic pain and other medical conditions, according to a new study that challenges the widespread belief that THC is harmful and has limited value in medical cannabis products.

Researchers at the University of New Mexico used the Releaf App, a mobile software program, to analyze self-reported data from over 3,300 people who logged their responses in nearly 20,000 user sessions to a variety of cannabis products, including natural dried flower, edibles, tinctures and ointments.

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Dried flower was the most commonly used product and was generally associated with greater pain relief than other cannabis products, regardless of the amount of THC.

"Despite the conventional wisdom, both in the popular press and much of the scientific community that only CBD has medical benefits while THC merely makes one high, our results suggest that THC may be more important than CBD in generating therapeutic benefits,” said Jacob Miguel Vigil, PhD, a professor in UNM’s Department of Psychology.

“In our study, CBD appears to have little effect at all, while THC generates measurable improvements in symptom relief. These findings justify the immediate de-scheduling of all types of cannabis, in addition to hemp, so that cannabis with THC can be more widely accessible for pharmaceutical use by the general public.”

Hemp is a strain of marijuana that was legalized by Congress in the 2018 Farm Bill. It has very low levels of THC, but is being grown commercially as a source for CBD.

UNM researchers found that indica strains of cannabis were more effective than sativa strains in treating pain and insomnia. Both strains have substantially higher levels of THC than hemp, but are illegal Schedule I controlled substances under federal law.

“Only THC potency levels showed independent associations with symptom relief and experiences of both positive and negative side effects, with higher levels (of THC) resulting in larger effects,” Vigil said.

Researchers say the relative weakness of CBD in treating symptoms may be due to inaccurate labeling of CBD content in cannabis products, which is a widespread industry problem. It’s also possible that THC simply heightens the experience or awareness of symptom relief.

Vigil published his findings in the journal Scientific Reports. Three of his co-authors developed the Releaf App, which has collected information from cannabis users since 2016. The app is an important data source for researchers, who are currently limited in conducting clinical studies of cannabis because of federal regulations.

Two previous studies by Vigil using data from the Releaf App found that cannabis provides significant relief from a wide range of symptoms associated with chronic pain, including insomnia, seizures, depression, anxiety and fatigue.

CBD Is Now Regulated and That May Be a Good Thing

By Roger Chriss, PNN Columnist

The legal status of cannabidiol (CBD) is changing. Once classified exclusively as a Schedule I drug under the Controlled Substances Act, CBD is now legal under federal law. And this means regulation.

The 2018 Farm Bill removed hemp from Schedule I. Hemp is a strain of marijuana with very low levels of THC, but high amounts of CBD.  This has opened the door to a legal market for CBD products, including food and supplements. But there’s a catch. The FDA has strict regulations about CBD being used in dietary supplements or promoted as medical treatments.

“It’s unlawful under the FD&C Act (Federal Food, Drug, and Cosmetic Act) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived,” FDA commissioner Scott Gottlieb, MD, said in a December 2018 statement.

“Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use.”

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 The FDA has a FAQ page about cannabis that answers some basic questions:

"Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements? A. No."

"Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added? A. No."

The FDA has reason to be concerned. Product quality for CBD products is iffy at best. An investigation by the NBC affiliate in Miami (see “Patients Are Being Duped”) found that 20 of 35 CBD products tested had less than half the amount of CBD advertised on the label. Some samples had no CBD at all.

Other recent analyses have found THC, pesticides, synthetic cannabinoids and toxic solvents in CBD products.

Moreover, a lack of regulatory oversight has led to an abundance of false, misleading or unsubstantiated claims. A recent review of CBD in the Journal of Clinical Pharmacology found that “CBD has been touted for many ailments for which it has not been studied, and in those diseases with evaluable human data, it generally has weak or very weak evidence.”

There is a lot of research on CBD going back years. The FDA’s approval of the CBD-based drug Epidiolex for rare childhood seizure disorders and a 2018 review that found potential for treating multiple sclerosis symptoms are important indicators of CBD’s medical value. At the same time, researchers have found no benefit in treating spinal cord injury, Crohn’s disease and osteoarthritis.

Yet CBD is now being widely promoted as a wellness product, and added to everything from coffee and pastries to bath oils and mascara. So it is not surprising that the FDA is concerned that people may be duped or put at risk.

The FDA is not alone in this. The New York City Department of Health has banned CBD products from being sold in bars and restaurants. Maine, New York, and Ohio are also banning CBD edibles.

For medically complicated people with chronic illness, regulation could be beneficial. At present these patients face significant risks with CBD products. Tainted CBD may cause unexpected allergic reactions or drug interactions. And contaminated CBD could trigger a positive result on a urine drug test, a common part of pain management amid the opioid crisis. Regulatory oversight could help reduce these risks. 

The legal and regulatory landscape surrounding CBD is shifting quickly. The FDA and state government agencies are watching closely and starting to intervene. This may flush out bad actors in the CBD marketplace and improve product quality and reliability. A stable marketplace with reliable products may be a net gain for the people who stand to benefit the most from CBD.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Will Cannabis Change the Candy Industry?

By Crystal Lindell,  PNN Columnist

A bag of Heady Harvest CBD Gummies sold by CBD Genesis doesn’t look that much different than any other bag of gummies in the candy aisle — sleek packaging, a clear front panel to show the product and a well-designed logo. And you can find bags just like them hanging right there on the shelf in many gas stations, not too far from the energy drinks and lottery tickets.  

It’s exactly the type of packaging that’s making CBD go mainstream. In fact, the only thing that makes them any different than a regular bag of gummies is the price — $24.99 for just 20 bears.

CBD, which stands for cannabidiol, is a compound found in marijuana plants, and the product is typically sold over the counter in the form of drops, candy and other products.

“The natural compound, called cannabidiol, is one of more than 100 cannabinoids found in the cannabis plant,” says BDS Analytics. “On its own it won’t get people high. But researchers are finding more and more medical applications for CBD, and consumers and companies increasingly are exploring the compound.” 

The firm says that while the broad marijuana edibles category grew by 36 percent for much of last year in Colorado, Oregon and Washington, high-CBD edibles expanded by 110 percent. 

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And high-CBD chocolates reached 217 percent growth on $11.45 million in sales, while high-CBD candy grew by 169.5 percent last year, compared to 51 percent for candy in general, according to BDS.  

Legally, it's still very much a gray area, though. 

According to recent article in the Wall Street Journal, “DEA spokesman Melvin Patterson says CBD-containing product appearing on shelves ‘is there illegally,’ but enforcement is not a priority for the agency, which is focused on the opioid crisis. In the states that have legalized cannabis use, ‘DEA is not after that. That would take a lot of manpower that DEA doesn’t have,’ he says.” 

And with the product being sold over the counter in many places, it can be confusing for consumers who think they’re buying something that’s totally above board. 

It’s that kind of murky gray area that understandably makes it hard for more mainstream candy companies to get involved in the market. But as the products grow in popularity, it’s hard to ignore their potential financial impact. 

It’s not that crazy to picture a day when Hershey, Mars or other major manufacturers are launching their own lines of CBD candy. How long that takes may only depend on how long for-profit companies want to ignore what is clearly becoming a for-profit market segment. 

This article originally appeared in Candy Industry and is republished with permission.

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Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. Crystal has hypermobile Ehlers-Danlos syndrome. 

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

UK and Canada Legalizing Cannabis

By Pat Anson, PNN Editor

There’s a lot of hype this week about Canada becoming the second and largest country to legalize recreational marijuana. The first was Uruguay.

But the bigger news for the pain community may be in the United Kingdom, which has some of the strictest marijuana laws in Europe. Home Secretary Sajid Javid made a surprise announcement last week that medical cannabis products would be rescheduled on November 1 and become available by prescription to treat chronic pain, epilepsy and chemotherapy-induced nausea.

Javid agreed to review the scheduling of medical cannabis in June, after a public outcry over the seizure of CBD oil flown into Heathrow Airport for a 12-year old boy who has epilepsy. Although the oil primarily contained cannabidiol – the non-psychoactive ingredient in marijuana – it was still technically illegal under UK drug laws.

“I stressed the importance of acting swiftly to ensure that where medically appropriate, these products could be available to be prescribed to patients,” Javid said in a statement.

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“I have been clear that this should be achieved at the earliest opportunity whilst ensuring that the appropriate safeguards were in place to minimise the risks of misuse and diversion.”

Javid was also clear he has no intention of supporting the legalization of recreational marijuana in the UK. Smoking cannabis in any form will also remain illegal. Even so, it was a big step forward for marijuana supporters..  

“This is a major victory for our campaign and will mean a lot of people will have a much better quality of life,” Clark French, a multiple sclerosis patient and cannabis activist, told Leafly.

“It does look that this could be the most open, accessible medical cannabis policy in Europe, if they get it right and we keep guiding them in the right directions,” said Jon Liebling of United Patients Alliance, a medical marijuana advocacy group.    

The rollout of CBD-based medicines in the UK will go slowly. It could take up to a year before the National Health Service comes up with guidelines to govern the distribution of CBD-based products. Initially, only medical specialists will be allowed to prescribe cannabis, although the guidelines are expected to eventually include general practitioners.

Activists are urging the Home Office to allow medical cannabis for all patients, not just those with pain, epilepsy or nausea.

“We do believe that everybody should have access,” said Liebling. "When you're talking about cannabis as a medicine, you really do have to compare the risks associated with cannabis that we're aware of versus the risks of those drugs that patients are already taking.” 

Legalization Worries Canadian Medical Association

Medical cannabis has been legal in Canada since 2001 and about 330,000 Canadians are registered and already have access to it.  But some health officials are less than enthused about the October 17 legalization of recreational cannabis.

"Given the known and unknown health hazards of cannabis, any increase in use of recreational cannabis after legalization, whether by adults or youth, should be viewed as a failure of this legislation," wrote Dr. Diane Kelsall, interim Editor-in-Chief, in an editorial in the Canadian Medical Association Journal.

Kelsall points to the stampede of Canadian and American companies looking to get into the cannabis industry and predicts many will brazenly advertise their products to young people.

“Cannabis companies may initially focus on attracting current consumers from black-market sources, but eventually, to maintain or increase profits, new markets will be developed as is consistent with the usual behaviour of a for-profit company. Marketing efforts may include encouraging current users to increase their use or enticing a younger demographic. The track record for tobacco producers has not been encouraging in this regard, and it is unlikely that cannabis producers will behave differently,” Kelsall warned.

Kelsall said the Canadian government needs to carefully track cannabis use and should have the courage to amend the law if problems arise.

Cannabis Somewhat Effective in Treating MS

By Pat Anson, PNN Editor

Medical cannabis is mildly effective in relieving pain and other symptoms in patients with multiple sclerosis (MS), according to a new study published in JAMA Network Open.

Spanish researchers analyzed 17 clinical trials involving over 3,100 patients – one of the largest reviews to date on the efficacy of cannabinoids in treating MS. Overall, they found that cannabis was safe, but had limited effectiveness in relieving pain, muscle spasticity and bladder dysfunction.

“Small but statistically significant differences were found in favor of cannabinoids for all 3 symptoms,” Marissa Slaven, MD, and Oren Levine, MD, of Ontario’s McMaster University said in a JAMA commentary. “The authors conclude that cannabinoids provide a mild reduction in subjective outcome assessment of uncertain clinical significance and that they are safe.”

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MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain.

Medications and disease modifying drugs currently used to treat MS can cost tens of thousands of dollars a year – so a low-cost alternative treatment would be welcomed by many patients.

Four different medical cannabinoids were used in the 17 trials that were evaluated. They contained different levels of cannabidiol (CBD) and tetrahydrocannabinol (THC), the active ingredient in marijuana that makes people high. A lot of uncertainty remains about whether CBD or THC are more effective in relieving MS symptoms – something the JAMA study failed to resolve.

“It is critical that researchers gain a deeper understanding of both of the major (THC and CBD) and minor components of this therapy to unlock its full potential,” said Slaven.

“Given the relative safety of these agents, lack of strong evidence of other effective treatment options, and increasing access in some jurisdictions, it may seem appealing to include cannabinoids in the armamentarium of therapies for MS. But carefully conducted, high-quality studies with thought given to the biologic activity of different cannabis components are still required to inform on the benefits of cannabinoids for patients with MS.  

"The bottom line is there is certainly something happening with cannabinoids in regard to symptoms," Nicholas LaRocca, vice president of healthcare delivery and policy research at the National Multiple Sclerosis Society, told HealthDay. "In spite of very strong interest in cannabinoid therapy, we really have relatively little in terms of good research to guide us in terms of what does and what doesn't work, what works for which types of individuals, and so forth."

A small study was recently launched in Australia that might answer some of those questions. Emerald Health Pharmaceuticals of San Diego is using a synthetic version of CBD – called EHP-101 -- to treat about 100 people who suffer from MS or scleroderma, another autoimmune disease. The placebo controlled Phase I trial is meant to determine whether EHP-101 is safe and has any side effects. Results are expected next year.

Ohio Banning Sales of Kratom and CBD  

By Pat Anson, PNN Editor

At a time when many pain sufferers are turning to natural supplements to relieve their pain, the state of Ohio is moving to ban two of the most popular ones.

The Ohio Board of Pharmacy voted Monday to classify kratom as a Schedule I controlled substance alongside heroin, LSD and other dangerous drugs. The move came two months after the board issued an advisory warning that sales of CBD-infused products are illegal under Ohio’s new medical marijuana program.

The pharmacy board considers kratom – which come from the leaves of a tree that grows in southeast Asia – a “psychoactive plant” that can cause hallucinations, psychosis, seizures and death. State health officials have identified six recent deaths in Ohio in which kratom “was indicated as the primary cause of death.”

A recent report from the Ohio Substance Abuse Monitoring Network (OSAM) raised the demonization of kratom to a new level by comparing it to heroin — and falsely claiming it was common for people to inject kratom.

“Participants reported that the drug looks similar to brown powdered heroin, produces similar effects as heroin, and is primarily used by individuals subject to drug screening and by people addicted to heroin who use the drug to alleviate opiate withdrawal symptoms,” the OSAM report warns.

“Participants reported that the most common route of administration for kratom is intravenous injection (aka “shooting”). Participants in the Akron-Canton region estimated that out of 10 kratom users, seven would shoot the drug and three would orally consume the drug (including drinking it as a tea).”

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Monday’s vote by the pharmacy board starts a months-long process of drafting new regulations for kratom. Public comments will be accepted until October 18.  Over 1,500 comments have already been received, most of them from kratom users asking the board to keep the supplement legal.

"The findings of the Ohio Board of Pharmacy… parrot the false propaganda of the U.S. Food and Drug Administration in their crusade to ban kratom," said Dave Herman, chair of the American Kratom Association, which represents kratom vendors and consumers. "The FDA has flooded state regulators, including the Ohio Board of Pharmacy with false claims and disinformation about the addiction profile and safety of this safe botanical plant.

“The nearly 5 million kratom consumers, and the tens of thousands of Ohio citizens, who safely consume kratom as a part of their health and well-being regimen should not have that freedom infringed upon by any regulation that is premised on bad science, inaccurate data provided by the FDA, and a deliberate attempt to manipulate the scheduling process by a federal agency.”

Kratom has been used for centuries as a pain reliever and stimulant, particularly in rural areas of Indonesia and Thailand.  In recent years, millions of Americans have discovered kratom and started buying it online or in “head shops” as a treatment for pain, addiction, anxiety and depression.

The Food and Drug Administration maintains that kratom is not approved for any medical use and insists on calling the plant an “opioid,” although its active ingredients are mitragynine and 7-hydroxymitragynine, two alkaloids that act on opioid receptors in the brain.

Kratom is already banned in Alabama, Arkansas, Indiana, Vermont, Wisconsin and the District of Columbia. There is speculation that the FDA and DEA may also seek to classify kratom as a Schedule I controlled substance, which would make sales and possession of the plant illegal nationwide. The DEA withdrew a plan to ban kratom in 2016 after a public outcry.

CBD Sales Banned

Ohio’s crackdown on CBD sales is not as restrictive as the ban on kratom. CBD infused products such as edibles, tinctures and oils usually contain little or no THC – the psychoactive ingredient in marijuana that makes people high. Many people use CBD to relieve pain and help them sleep.

Under state law, marijuana is defined as “all parts of a plant of the genus cannabis” and only state-licensed dispensaries can sell products made with CBD (cannabidiol). There will eventually be 56 dispensaries across the state, although none are expected to open until later this year.

Some retailers pulled CBD products from their shelves after the warning from the pharmacy board, but many have chosen to sell off their supplies first. One retailer in Dayton predicts the price of CBD products will soar once they are no longer widely available.

“The prices, if they’re going to skyrocket, are going to hurt customers’ pockets,” Rabi Ahmad told WHIO.com. “Senior citizens mostly buy the CBD. The young kids, they don’t buy CBD at all.”  

A spokesman for the pharmacy board said there are no state plans to enforce the ban on CBD sales, although local law enforcement agencies could. Also unclear is how the ban will affect online sales and shipments from out-of-state vendors.

“The public should have uninhibited access to hemp-derived products no matter what state you live in. We will continue to produce these products and support our retailers and customers through this moment of confusion,” Nic Balzer, CEO of QC Infusion, a Cincinnati-based manufacturer of CBD products, told Cincinnati.com.

Coke Considering Cannabis Drinks

By Pat Anson, PNN Editor

These are heady times in the beverage industry, with dozens of companies introducing cannabis-based drinks – from sparkling water to herbal teas to cold brew coffee. After decades of being ostracized on Main Street and Wall Street, marijuana is suddenly trendy.

The largest beverage company in the world – Coca-Cola -- is even thinking about entering the rapidly growing cannabis market. According to BNN Bloomberg, Coke is in serious talks with Aurora Cannabis of Canada to develop a cannabis-infused beverage that would be marketed as a “recovery drink” that eases inflammation, pain and muscle cramps.  

It’s not clear if Coke is interested in a joint venture with Aurora or if it would buy a stake in the Edmonton-based company. Coke said it would not comment on “speculation.”

“We have no interest in marijuana or cannabis. Along with many others in the beverage industry, we are closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world. The space is evolving quickly. No decisions have been made at this time,” Coke said in a statement.

Could a CBD-infused drink provide pain relief? Marijuana researcher Yasmin Hurd, PhD, told NBC News it's unlikely that a beverage made with CBD could have health benefits because a high dose of about 200 milligrams is needed to be effective.

“CBD gets broken down and metabolized quickly in the body,” said Hurd, who is director of the Addiction Institute at Mount Sinai Hospital. “The amount that would get in the bloodstream from a drink would not have an effect.”

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The efficacy of CBD-infused drinks may not be proven, but the potential profits are. According to a new report by Ameri Research, the global medical cannabis market was valued at $8.9 billion in 2016 and is projected to grow to nearly $33 billion by 2024.

Twenty-eight U.S. states currently allow the sale of medical marijuana, while 9 states allow recreational sales. Marijuana is still illegal at the federal level, but products made from cannabidiol (CBD) – the non-psychoactive ingredient in marijuana – are being sold in all 50 states.

Canada already permits medical usage and next month recreational use will be legalized nationwide. Because of that, several beverage makers besides Coke are interested in partnering with Canadian cannabis companies.

Last month, Corona beer brewer Constellation Brands announced it would spend $3.8 billion to increase its stake in Canopy Growth, a Canadian marijuana producer. Molson Coors Brewing is starting a joint venture to develop cannabis drinks in Canada. And Heineken has launched a craft-brew label specializing in non-alcoholic drinks infused with THC, the psychoactive ingredient in marijuana.

“Interest has spiked from the beer industry on mounting evidence of a substitution relationship between cannabis and alcohol, while large soda companies increasingly view CBD as a natural fit within their strategically important wellness offerings,” wrote Canaccord Genuity analyst Bobby Burleson in a research note.

Canaccord projects that CBD and THC infused drinks could become a $600 million market in the U.S. within the next four years.

“Medical and wellness benefits include suppression of seizures, pain relief, reduction of anxiety and a host of other therapeutic effects,” said Burleson. “We note that that the medical benefits of CBD have recently been bolstered by the FDA’s approval of Epidiolex, a CBD based drug developed to treat epilepsy. It follows that CBD also offers significant potential as the basis for a wellness beverage.”