SPOKANE — Researchers at Washington State University are teaming up with the Puyallup Tribe of Indians in an effort to chart the tribe’s outcomes prescribing medicinal marijuana to patients.
The partnership between the land grant institution in Pullman and the Tacoma-based native tribe is intended to create a standard to evaluate treatment plans at a natural healing clinic the Puyallups opened in October, and to determine the effectiveness of the drug as an alternative to opioids in managing pain.
“We’ll hand them an iPad, and ask them to fill out a couple quick surveys,” said Michael McDonell, chair of WSU’s Collaboration on Cannabis Policy, Research and Outreach. “Some of the outcomes we’re interested in looking at, is what kind of cannabis are they using? What effect is it having on their pain or well-being, and their quality of life?”
The Puyallup tribe has staked several claims in the state’s legal marijuana industry, opening two recreational stores in the Tacoma area. One opened its doors last month with celebrity guests Cheech Marin and Tommy Chong, the comedians responsible for several stoner-inspired comedies of the 1970s and 1980s. The clinic is named “Qwibil,” a native word for fixing one’s self mentally, physically or spiritually, and is in the tradition of the Puyallup people, said its chairman.
“From time immemorial, the Puyallup have practiced traditional healing,” said Bill Sterud, chairman of the Puyallup Tribe of Indians, in a news release from WSU announcing the team-up. “This partnership with WSU and Qwibil will help us research the safety and efficacy of cannabis as medicine for our patients’ use.”
The clinic serves native and non-native patients, according to the news release.
McDonell said research institutions are limited in their access to cannabis users by federal laws that could affect funding. The partnership will allow researchers at the university to gather data that can be used to develop treatment strategies based on strain, the effectiveness of cannabidiol in treating pain and other disorders and the method of delivery, be it smoked or ingested, McDonell said.
“They’re in a unique space,” McDonell said of the Puyallup tribe. “They want to know the answers, and they want to be doing something that’s positive for the community.”
McDonell said he was approached by the tribe to work with them following a presentation at an addiction conference. Research into the effectiveness of medicinal marijuana has been hindered by the federal government’s classification of marijuana as illegal in all instances under drug enforcement laws. Bills have been repeatedly introduced in Congress to end that classification, as more and more states move to legalize the drug for recreational and medicinal purposes and lawmakers push for other reforms, including allowing pot businesses access to banking services.
Collecting patient data is an important step in legitimizing cannabis as a potential therapeutic drug, said Debbie Churgai, interim director for the national group Americans for Safe Access, which pushes for reform of marijuana laws to allow for medicinal uses. While there are methods available for collecting that data, including a smartphone app called “Releaf,” there are still patients who are wary of sharing information, even anonymously, due to federal laws, she said.
“This medicine has grown on people telling stories of how it helped them,” Churgai said. “We’re finally at that point where we need to actually put these stories into something quantitative, and look at the numbers and see how it really is affecting people.”
Jake Felice, a naturopathic medicine practitioner who consults for cannabis businesses in Washington state seeking medicinal approval, said any data collection system for patients should be far-reaching. The role or roles of the body’s endocannabinoid system, which interacts with the chemical compounds in marijuana, is not yet completely understood and many of the effects of those chemical interactions remain unknown.
“We are dealing with a very new system that’s extremely important biologically, that we hardly know anything about,” Felice said. “It’s like we just discovered a new ocean, and it’s time to go and explore.”
The tribe is scheduled to fund the research project for a year. McDonell said he hopes enough patients will submit their health data so that the research team can begin to develop theories about successful medical marijuana treatment plans, leading to more grant funding and a greater understanding of the drug’s potential therapeutic effects.
“We need a good chunk of people,” he said. “We’re hoping it’s an ongoing effort.”
It's been six months since Congress passed the Farm Bill legalizing hemp for cultivation. It's high time that we rectify some common myths about this plant.
Praise be to all things hemp! Faithful friend of humanity since before the written word, a versatile source of food, fiber, fuel, and pharmacy, a plant with a patriotic pedigree prized by America’s Founding Fathers.
After languishing for eight decades in the wilderness of marijuana prohibition, hemp is making a big comeback thanks in no small part to cannabidiol(CBD), the mischievous, nonintoxicating cannabis compound that has upended the drug war establishment.
There’s no denying that CBDhas catalyzed the rebirth of the U.S. hemp industry. In response to overwhelming public demand for CBD, Congress passed the groundbreaking 2018 Farm Bill, which legalized (or, more accurately, re-legalized) the cultivation of hemp on domestic soil. Many American farmers are jumping on the CBDbandwagon, imagining a bright future of Colossal Big Dollarsnow that hemp is once again a legitimate cash crop. But along with the rush of enthusiasm for CBD as an economic opportunity, a number of fallacies about industrial hemp have taken root.
FALLACY #1 – THE FARM BILL LEGALIZED CBD COMMERCE.
Not quite. The 2018 Farm Bill defined as hemp as cannabis with no more than 0.3 percent tetrahydrocannabinol and legalized its cultivation in the United States. The Farm Bill also removed various derivatives of hemp, including CBD, from the purview of the Drug Enforcement Administration (DEA) and the Controlled Substances Act.
So now farmers can grow and sell hemp, but the Food and Drug Administration (FDA) views CBD strictly as a pharmaceutical. And because it had already approved CBD as a prescription drug (Epidiolex) for treating two kinds of pediatric seizure disorders, the FDAasserts that it is illegal to sell hemp-derived CBD as a dietary supplement or over-the-counter drug.
Several states have followed the FDA’s lead and explicitly banned CBD-infused edibles and beverages, though there has been little effort to enforce this policy. The recent decision by Visa, the world’s largest credit card company, to stop processing CBD-related payments underscores the uncertain legal status of CBD.
The DEA, meanwhile, retains jurisdiction over CBD extracted from “marijuana” (cannabis with more than 0.3 percent THC), which is still prohibited under federal law. Rooted in reefer madness racism and enforced disproportionately against ethnic minorities, marijuana prohibition is akin to the Confederate statue still standing, a sign of ongoing social injustice. By carving out a legal loophole only for hemp, the Farm Bill perpetuates this shameful scandal.
The Farm Bill – which a cynic might refer to as the ‘Keep Marijuana Illegal Bill’ – is seriously flawed. It solves some problems, while creating others. Like a patch designed to correct defective software, the Farm Bill attempts to fix the unfixable. In this case, the defective software is the Controlled Substances Act, an odious edifice built upon a mountain of lies. Consequently, the legal status of CBD commerce remains mired in contradiction.
FALLACY #2 – THE DEFINITION OF HEMP AS DISTINCT FROM MARIJUANA IS BASED ON SOUND SCIENCE.
The molecular structure of CBDis the same irrespective of its botanical source, but CBD extracted from a hemp plant is no longer a controlled substance while CBD extracted from marijuana is federally illegal. CBD is currently both a Schedule One drug, a category reserved for dangerous drugs with no medical value, and a Schedule Five pharmaceutical, the safest designation possible for a controlled therapeutic substance.
There is no logical basis for distinguishing between hemp with 0.3 percent THC and cannabis with 0.4 percent THC, as stipulated according to federal law. The ‘0.3 percent THC or less’ definition for hemp is a political distinction without a scientific foundation.
Where did the 0.3 percent THCqualifier come from? It stems from a 1976 taxonomic reportby Canadian plant scientists Ernest Small and Arthur Cronquist, who never meant for 0.3 percent THC to function as a legal demarcation between hemp and other forms of cannabis. But that’s what has happened.
To cut to the chase, the 0.3 percent THC legal limit for hemp is an arbitrary, impractical, irrational relic of reefer madness. Although it lacks scientific validity, it has become the cornerstone of cannabis prohibition, a discredited, anachronistic policy that impedes medical discovery and patient access to effective therapeutic options, including herbal formulations with various mixtures of CBD and THC, both of which have important remedial properties, especially when combined.
FALLACY #3 –THE FEDERAL GOVERNMENT CONSPIRED WITH BIG BUSINESS TO MAKE HEMP ILLEGAL.
Why did hemp become illegal in the first place? The notion of an anti-hemp conspiracy involving corporate and government collusion has become Holy Writ among some cannabis proponents. The operative assumption is that anything made from trees or petroleum could also be made from hemp. Thus, DuPont, a manufacturer of plastics, supposedly sought to eliminate hemp because it was a natural competitor to the emergent plastics industry.
This theory also posits that the Hearst newspaper chain railed against “marihuana” because Hearst wanted to vanquish a paper business rival. But the Hearst syndicate always needed more paper for newsprint and, if anything, it would have been in Hearst’s interest to grow lots of hemp as a source for making paper.
There’s no smoking gun, let alone much evidence, showing that Federal Bureau of Narcotics chief Harry Anslinger was acting at the behest of DuPont or press baron William Randolph Hearst when America’s top narc launched the “reefer madness” crusade to outlaw marijuana in the 1930s.
When it comes to conspiracies – and, yes, they’re everywhere to the point of banality – better to look first for the lowest common denominator, the mundane explanation, to see what’s plausible. Screaming headlines and scare stories sell newspapers. Hearst’s anti-marihuana hyperbole was racist and opportunistic to the core. Ditto for Anslinger, whose entire government department was on the chopping block during the Great Depression.
Anslinger had sufficient motive and means to demonize marihuana, “the evil weed,” in order to preserve and expand his bureaucratic fiefdom. Reefer madness, a racist propaganda campaign, was his way of avoiding budget cuts and inflating his self-importance. He had a key ally in Hearst, an outspoken supporter of fascism and anti-Mexican ethnic cleansing.
Hearst and Anslinger were the main engines behind marihuana prohibition, a policy that some speculate was implemented to benefit the business interests of DuPont, a major client of Mellon Bank. Ex-Treasury Secretary Andrew Mellon was Anslinger’s former boss and his uncle by marriage. All these associations are intriguing and suggestive. But covert corporate machinations in this case probably account for much less than endemic racism, boardroom bigotry, and bureaucratic self-interest.
FALLACY #4 - INDUSTRIAL HEMP DOESN’T NEED PESTICIDES AND THEREFORE IT’S NOT NECESSARY TO REGULATE OR RESTRICT THE USE OF PESTICIDES ON HEMP.
Hemp is a hardy, adaptable botanical that feasts on sunlight and thrives in various climates. It acts as a “bio-remediator” that can remove heavy metals and other toxins from a polluted landscape. But this eco-friendly, soil-rejuvenating plant is not immune to mold or pest infestation.
Hemp and psychoactive cannabis (marijuana) have innate defense mechanisms that protect against predators and disease. The sticky gooey resin that is concentrated on the leaves and flower tops of psychoactive cannabis contains a treasure trove of medicinal and aromatic compounds – including cannabidiol (CBD) and tetrahydrocannabinol (THC) – and some of these compounds have antifungal, antibacterial, and insecticidal properties. The stickiness of cannabis resin adds another defensive layer by trapping bugs.
But sometimes the plant’s innate defense capabilities aren’t sufficient to save a crop, as many cannabis farmers have learned from bitter experience. Industrial hemp grown for fiber or seed oil are low-resin plants compared to high-resin drug plants. Resin-deficient industrial hemp is more vulnerable to mold and pests – and is therefore more likely to require pesticides and fungicides – than high-resin cannabis.
FALLACY #5– INDUSTRIAL HEMP IS A GOOD SOURCE FOR EXTRACTING CBD OIL.
The CBD molecule is exactly the same whether extracted from industrial hemp or other forms of cannabis. But the quality of the CBD products made from industrial hemp that’s grown for fiber or seed protein is typically inferior to the products made from CBD-rich “drug” plants that are grown specifically for medicinal oil extraction.
CBD is the most common cannabinoid present in industrial hemp, but the CBD levels top out at about 3.5% by dry weight – much less than the remarkable varieties of CBD-rich cannabs flower grown for medicine that can reach as high as 20% CBD by dry weight. Because industrial hemp produces relatively small amounts of CBD, a huge amount of hemp biomass is necessary to produce a significant quantity of CBD oil.
Such a large amount of plant material means there’s a greater likelihood that toxic contaminants will be concentrated in the CBD oil extracted from industrial hemp, which will suck up and absorb any pesticides or heavy metals present in the soil through a process known as “bioaccumulation.” This is excellent for cleaning up a toxic waste site, but not so good for medicinal oil extraction and production. Industrial hemp and its extracts usually aren’t subject to stringent (state-level) regulations governing pesticide and solvent residues, and these contaminants end up in CBD products manufactured by unscrupulous producers.
It’s noteworthy that the phrasing of the 2018 Farm Bill refers to “hemp” rather than “industrial hemp.” The decision to drop the word “industrial” from legislative parlance is a reflection of the primacy of CBD in the brave new world of legal hemp. Industrial hemp cultivated for fiber and seed isn’t CBD-rich. But new high-resin cannabis cultivars are becoming available that have been bred specifically to produce copious quantities of CBD with less than 0.3 percent THC, thereby satisfying the federal government’s absurd legal criteria for hemp.
A change to South Africa’s medicines law means the country is the first in Africa to carve out a federally approved market for non-prescription CBD.
Health Minister Aaron Motsoaledi amended the country’s Medicines and Related Substances Act, 1965, to remove certain cannabidiol preparations for nonserious health claims on the recommendation of South Africa’s Health Products Authority (Sahpra).
Details of the law’s amendment were announced this week via the Government Gazette – an official bulletin where legal notices are formally publicized.
Medical CBD products are already widely available in South Africa, however almost all of the market had fallen outside of legal channels.
The rule change pertains to preparations that contain a maximum daily dose of 20 milligrams of CBD.
Those products are allowed to have an “accepted low risk” claim or health claim, which only refers to health maintenance, general health enhancement without any reference to specific diseases or relief of minor symptoms unrelated to a disease or disorder.
The change also allows CBD preparations that “consist of processed products made from cannabis raw plant material and processed products, where only the naturally occurring quality of cannabinoids found in the source material are contained in the product, and which contain not more than 0.001% of THC and not more than 0.0075% total CBD.”
The law change is valid for only the next 12 months.
CBD was also removed from the highly restricted Schedule 7 designation and added to Schedule 4.
All cannabis-containing products in South Africa – including CBD and high-THC products – are subject to the Medicines and Related Substances Act, so medicines containing either or both of the cannabinoids require a prescription.
But by excluding certain CBD preparations from the Act, the country has essentially removed legal barriers to commercializing those preparations.
(CBD products outside the new boundaries intended for therapeutic purposes would still require a prescription.)
“The market for CBD products in South Africa will be tremendous,” said Materia Ventures CEO Deepak Anand.
“The fact that they are allowing limited health claims is pretty significant,” he said. “It acknowledges health benefits of CBD, albeit in a limited fashion.”
No medical cannabis products have been registered in the country, so the only way to acquire legal medical marijuana has been to import it. That means none of the products procured in the local market are legal.
Cultivation licenses
A legal framework for the cultivation and processing of cannabis as an ingredient for the production of registered medicines was approved back in 2017, however no company has been approved to manufacture medical products containing cannabis, such as oil extracts.
The South African regulator received 21 applications for the cultivation of medical cannabis, one of which was later withdrawn.
After inspections were conducted for various compliance requirements, just three made the final cut.
Cultivation licenses will be valid for up to five years, and once issued will include cultivation conditions.
No companies have yet applied for permission to manufacture medical products containing cannabis.
Marijuana cultivation sites in South Africa are required to comply with the “Guide to Good Manufacturing Practices for Medicines.”
The 2017 guidelines allow for the import and export of medical cannabis.
“The cultivation of cannabis for medicinal use and the manufacturing of cannabis-containing pharmaceutical products shall be subject to strict monitoring to avoid any diversion for unapproved purposes,” the regulator said in a statement.
“Sahpra inspectors will conduct compliance investigations and inspection of sites applying for a licence to conduct regulated activities as well as licensed sites.”
Questions remain
Nathan Emery, a former executive in South Africa, questions how the government plans to enforce the restriction limiting maximum daily dosage of CBD to 20 milligrams.
“There is no infrastructure specifically designed to manage the thresholds given in the proclamation by the Ministry of Health; no mandate on testing. Maybe they will task the retail outlets with this, but it is also difficult to police,” he said.
It is also unclear whether regulations could be introduced for retail, labeling, advertising, distribution and quality control.
Nor does the change address if or how CBD products that were considered illegal can be brought into the legal market.
“I wonder how they will enforce this new proclamation as I have heard of no shop owner being arrested for selling CBD products in South Africa,” Emery – now COO of Precision Cannabis Therapeutics Zimbabwe – said.
Matt Lamers can be reached at mattl@mjbizdaily.com
FDA to hold its first hearing on CBD as industry leaders and experts demand e cannabidiol craze has exploded into a frenzy never before seen inupplement industry.
In 2018, Congress took hemp off the controlled substances list, leading to the sale of CBD (Cannabidiol) hemp oil products.Adam Berry / Getty Images file
By Erika Edwards
The Food and Drug Administration is set to take its first step Friday toward regulating cannabidiol, or CBD.
The CBD product craze — with its myriad oils, capsules, gummies, lotions and potions — has exploded into a frenzy never before seen in the supplement industry.
On Friday, the FDA will hold its first public hearing on cannabis and cannabis-derived compounds, the most popular of which is CBD.
The goal of the hearing is to gather information on a wide range of topics related to products containing these compounds. Dozens of interested parties are scheduled to speak, including doctors, consumers and members of the cannabis industry.
"This is definitely setting a new precedent," said Andrew Shao, interim senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition, a trade association for dietary supplements.
"It's an important first step, and a number of stakeholders, including members of Congress, are looking to this meeting to inform the pathway forward on CBD," Shao told NBC News.
The FDA's principal deputy commissioner, Dr. Amy Abernethy, recently sent out a string of CBD-related tweets, writing in part: "We are reviewing available databases and medical literature about CBD’s safety. Thus far, the data appear insufficient."
There are many open questions about CBD, incl. safety questions. In particular, we’re working to learn more about the potential risks of CBD, such as toxicity to the liver, when someone ingests it regularly over a long period of time, perhaps from several types of CBD products.
For example, what happens if you eat food with CBD in it, use CBD-infused skin cream, and use other CBD-based products on the same day? What if you use these products daily for a week or a month, or longer? What if someone taking CBD is also taking medications?
"What happens if you eat food with CBD in it, use CBD-infused skin cream, and use other CBD-based products on the same day? What if you use these products daily for a week or a month, or longer?" she tweeted.
By itself, CBD does not cause users to become "high." (Marijuana's high comes from a different compound, THC, or tetrahydrocannabinol.)
Of course, people have been ingesting or inhaling CBD in the form of recreational marijuana for many years. What's different now is that CBD has been isolated as an ingredient and incorporated into supplements and various products.
That's led a number of experts to question the compound's safety.
"In terms of safety, we really don't know," said Dr. Pieter Cohen, who studies drug ingredients in the marketplace at the Harvard Medical School and the Cambridge Health Alliance. "We don't have a mechanism in the United States to effectively regulate [supplements] and ensure those products are safe."
Those products — and there are many — are marketed as ways to treat a slew of health problems, including insomnia, anxiety and chronic pain. Some CBD products even tout their ability to make the hair shiny and the skin glow.
The majority of those claims remain unproven. There have been a few small studies on CBD, but none of the large and robust clinical trials needed to prove that a medication is A, safe, and B, effective, leaving most of CBD's alleged abilities purely theoretical, according to experts.
And that can have harmful consequences.
"People may be avoiding truly effective treatments because of their belief that CBD will benefit them," said Dr. Peter Lurie, president of the Center for Science in the Public Interest, a consumer watchdog group.
Lurie said CBD was a topic of discussion when he was with the FDA in the early 2000s. "That was always one of our concerns, that [the products] promise the earth and there’s just really no science to back them up, except for some very isolated claims."
One use of CBD for which there is strong science to back it up is Epidiolex, which is the first and only FDA-approved cannabidiol medicine. The drug, which was approved last year, treats two rare and severe forms of epilepsy that affect children. (The FDA previously approved a few marijuana-based drugs, such as Marinol and Syndros, used to treat severe appetite loss and nausea in diseases like AIDS.)
But the approval of Epidiolex threatens the use of CBD in other, unapproved products. That's because current law states that if an ingredient is first developed as a drug — like Epidiolex — it cannot be sold in foods and supplements. This is why the FDA has repeatedly said CBD products sold over the counter are illegal. The agency has also sent warning letters in the past to companies selling CBD products that claimed to prevent or treat serious diseases like cancer.
Supplement industry groups are urging the FDA to take action on CBD. "We’re concerned there are a number of companies just taking advantage of the wave, really not knowing what they're doing," Shao, of the Center for Responsible Nutrition, said.
The financial implications are enormous. According to a study from cannabis researchers BDS Analytics and Arcview Market Research, CBD sales in the U.S. are expected to exceed $20 billion by 2024.
The market really took off in 2018, when Congress passed the Farm Bill, removing hemp from the controlled substance list. But even though hemp was legalized, products derived from it, like CBD, were left to the FDA to regulate.
None of this, however, has stopped the influx of new CBD products. "You have a situation where there are a lot of products in the marketplace, but they’re not necessarily legal," Shao said. The companies "may not be following existing regulations around labeling, around good manufacturing practices, and that can potentially place consumers at risk."
"At least with Epidiolex, you have a strong reason to believe that what the company says is in the product really is. But who's to know what is in some gummy bear?" Lurie said. "For all you know, there's no CBD, or for that matter, there could be too much," he added. Indeed, a 2017 study in the journal JAMA found that many CBD products contain higher or lower amounts of the compound than what's listed on the label.
The intent of Friday's hearing is to gather information only; no decisions will be made. It could take years for any kind of CBD regulation to be put in place, frustrating industry insiders.
"Our members are sitting on the sideline because they want to be in compliance," Shao said. "They are waiting for a framework so they can legitimately and legally develop high-quality products with CBD."
