The U.S. Food and Drug Administration is still inching its way towards developing consumer protection standards relating to CBD.
Back in 2019, it appears it came as a shock to many Americans federal standards for cannabidiol (CBD) hadn’t been developed. The FDA has repeatedly stated this has been due to gaps in its knowledge and it’s a situation that continues today.
But the agency hasn’t quite been sitting on its hands as some might suggest – for example, last year it revealed some interesting results from testing of 147 CBD and hemp products it purchased.
Last week, the FDA provided an update on its efforts to “CBD” (Collect Better Data) on the use of cannabidiol and its safety profile.
While the FDA says it has appreciated input from various parties in helping develop better data on the use and safety of products containing CBD, these efforts are “generally not adequate” – citing observational studies that are too small or using poor techniques for ensuring data quality. But in the months to come, the FDA intends developing and refining plans for research projects to address the gaps in current CBD data research capabilities.
There’s an ancient botanical that millions of Americans take for epilepsy, cancer pain, Parkinson’s disease, post-traumatic stress disorder, multiple sclerosis and other serious and debilitating conditions.
The drug is cannabis. But American researchers who want to study cannabis are thwarted at every turn. Federal law still classifies cannabis as a Schedule 1 drug, a list that includes highly dangerous and addictive drugs such as heroin. The government says cannabis has no accepted medical use and a high potential for abuse. Even cocaine is not a Schedule 1 drug.
The U.S. Drug Enforcement Administration limits research to poor quality cannabis from a sole supplier. Researchers who want to study the cannabis that patients are actually taking today are out of luck.
The majority of Americans now live in a state where medicinal cannabis is legal. Yet objective research into what strains help — or hurt — specific conditions, as well as the best dosages, is hindered by federal restrictions. Don’t blame researchers. Can we expect them to jeopardize their research grants, even their medical licenses, to study cannabis?
The time to change the classification of cannabis and open the door to quality research is now. The U.N. Commission on Narcotic Drugs voted recently to reclassify cannabis. In Washington, D.C., the House of Representatives voted to pass the MORE Act, which would remove cannabis from the Controlled Substances Act. The House also passed the Marijuana Research Act, which would allow scientists to obtain cannabis for research from states that have legalized the drug. Right now, the University of Mississippi is the only federally approved source of cannabis.
The cannabis plant is arguably the most dynamic plant on earth. It can be used for medical purposes, it can be converted into fuel, and it can be made into countless types of textiles.
In many ways it would be easier to come up with a list of things that the cannabis plant cannot do versus compiling a list of everything that it can do.
The cannabis plant’s versatility has been on display for many centuries across the globe, with a number of civilizations incorporating cannabis into their cultures.
It wasn’t until cannabis prohibition was implemented in the 20th century that the human use of cannabis for various purposes started to decline, and with it, humanity’s quest to know more about the cannabis plant.
Prohibition’s Impact On Research
During the 20th century most countries around the world expressly prohibited all things cannabis.
The Hemp Act of 2020 proposes four significant amendments to the federal laws currently governing the production of hemp, including increased THC concentrations.
As reported by Hemp Grower magazine, Senator Rand Paul of Kentucky introduced legislation on December 15 that would amend the definition of hemp from .3% THC to 1% THC. The bill would also make other major changes to the USDA’s interim final rule, which would affect hemp growers, processors, manufacturers, and shippers. The legislation is titled the Hemp Economic Mobilization Act (the “Hemp Act of 2020”). The Hemp Act of 2020 proposes four significant amendments to the federal laws currently governing the production of hemp.
First, the Hemp Act of 2020 would amend the federal definition of hemp by striking “.3 percent” and inserting “1 percent.” As hemp businesses know, the 2018 Farm Bill defines hemp as cannabis sativa with a delta-9 THC concentration of not more than .3 percent on a dry weight basis. The USDA then adopted a “total THC” testing requirement that further burdened growers and others in the industry.
As we wrote back in January 2019, the .3% threshold was created by a Canadian researcher in the 1970s who set a dividing line of .3% between hemp and marijuana for purposes of establishing a biological taxonomy. The dividing line was never intended to be used as a practical measure for countries to differentiate between hemp and marijuana for commercial purposes. We at the Canna Law Blog wholeheartedly support changing the threshold from .3% to 1%.
Second, the Hemp Act of 2020 would require testing of hemp-derived products rather than the hemp flower or plant itself. The USDA interim rule requires that growers test hemp plants within 15 days of the anticipated harvest. As we have explained, this can prove an impossible obstacle for growers in some circumstances. The Hemp Act of 2020 proposes a significant statutory fix. Current law requires a State or Tribal plan to include a “procedure for testing . . . delta-9 tetrahydrocannabinol concentration levels of hemp produced in the State or territory of the Indian tribe” (italics added). The Hemp Act of 2020 would replace “hemp” with “products derived from hemp plants” (italics added again.)
Rocky Mountain Extraction Services (RMES) has come a long way since incorporating 18 months ago.
The 2018 Hemp Farming Act was the catalyst, although opening their doors wasn’t quite so simple.
“Originally, we felt like [the Hemp Farming Act] was a green light,” says CTO Jerry Van Sickle. “What we found was that it was more of a yellow light.”
RMES office in the morning. Photo courtesy of RMES.
Because of hemp’s association with recreational marijuana, Van Sickle and CEO Scott McWhorter discovered challenges in commercial property leasing and banking for RMES — even though they were specializing in manufacturing organically-sourced CBD extracts and distillates rather than THC.
Drug development today is a long, arduous and expensive proposition. Since the first half of the 20th century, the standard of care in medicine and the pharmaceutical industry  is developing medications using nationally standardized protocols for medication safety and efficacy along with precision dosing for any new drug. Formulation development of drugs is key to ensure standardized quality, control over precision dosing, safety, accurate quantities delivered as well as the delivery to the correct site of action.
Using botanically derived medicines with their high degree of variability is why most drugs today, despite them being derived originally from compounding natural substances from plants, are now chemically synthetic versions made in laboratories. For example, the drug digitalis (or digoxin) which was originally derived from the foxglove plant is now synthetically made. Cannabis, like many botanicals presents challenges to drug development and formulation. One of the biggest challenges is the ability to fully demonstrate and prove consistency in its chemical composition due in part to its complexity.
Cannabis is composed of over 100 cannabinoids and about 500 other compounds such as terpenes and flavonoids. Additionally, there are over 550 different strains/chemovars of the plant all with differing ratios and combinations of these cannabinoids such as THC and CBD and compounds such terpenes. And efficacy for one chemovar does not establish efficacy for another due to the interaction of the varied and different ratios of components in each. It practically requires individual testing and proof that each particular chemovar variety of cannabis be evaluated for efficacy for a specific health conditions.
Additionally, the federal illegality of cannabis does not allow for nationally systemized controlled agricultural practices and growth conditions to guarantee more consistency in the final product. This is left to each separate state’s government requirements, therefore creating overall quality issues that make formulation development difficult but important.
When we look at cannabinoid drug development, accurate dosing is major issue. And since oral administration is usually the preferred route for drug compliance and use, this is the first hurdle to overcome. All cannabinoids are lipophilic and have poor water-solubility. When there is poor water solubility there is potentially slow oral drug absorption and that can cause variable bioavailability, which can become a rate-limiting step to achieve therapeutic plasma concentrations and ensuing pharmacologic response.
For the diehard cannabis connoisseur, one whose only mission in life is the quest for the eternal buzz, tracking down that one marijuana strain that really kicks them in the boo-boo can be tough. It means visiting one dispensary after another, where, often, none of the staff ever seems willing to break out the secret stash from the back. And we know they’ve got one! So there is a lot of trial and error in this process. And this search for perpetual highness can also dwindle away at the old bank account, too, which really sucks, because it can be difficult to hold down a steady job when one’s life’s work consists of only hunting down the strongest marijuana in the land.
If only there were a way to determine the potency of a plant without having to dedicate so much time, money and lung power to the cause.
Well, it turns out there are some old school physical properties of a cannabis plant that are meant to tell us just how mighty the marijuana is before we ever put in our pipes and smoke it. A study published in the Plant Journal finds that the frostier the buds, the more likely it is for the pot to pack a punch.
These crystalized hairs (trichomes) that have been held in high regard for decades by marijuana aficionados are what produces the chemicals that give the plant all of its psychoactive and medical properties, the study, which was conducted by the University of British Columbia, has confirmed.
This means that the more tiny, mushroom-shaped fibers on the cannabis flower, the more cannabinoids are present. These frosty attributes, which are a defense mechanism to protect the cannabis plant from UV rays and animals, also give the plant its pungent aroma, the study finds. In other words, cultivators that are hellbent on producing the best, stickiest, stinkiest cannabis known to mankind are going to need to be well-versed in manufacturing plants that are abundant in trichomes.
Australia’s Neurotech International Limited (ASX: NTI) has reported final results of in-vitro studies indicate its DOLCE/NTI cannabis strains exhibit potent anti-inflammatory activity.
Neurotech acquired an exclusive worldwide license to utilise proprietary cannabis strains from Dolce Cann Global, which it hopes could potentially be used to treat neurological disorders including autism, epilepsy and ADHD.
Neurotech’s analysis of 80 cannabis samples from the Dolce Cann Global revealed varying amounts of cannabinoids including CBDV, CBDA, CBGA, CBG, CBD, THCV, CBN, THC, d8-THC, CBC and THCA – some of the many cannabinoids found in cannabis. CBDA was found to be present in particularly high levels.
The company has been undertaking a series of in-vitro* studies to assess the neuroprotective, anti-inflammatory and neuro-modulatory activities of the strains. Neurotech says the final results indicate DOLCE/NTI strains examined have shown to significantly improve neuronal cell health, cell viability and have the potent ability to reduce inflammation.
“Preclinical studies suggest that these strains exhibit potent and unique properties when compared to CBD alone and warrant the further assessment of these strains in phase 1 clinical trials,” said Assoc. Prof. Fahey.
Pests and contaminates are a given in the cultivation of cannabis, and most standards developed to control these on other agricultural products don’t apply. This is why the U.S. Pharmacopeia has stepped in to provide analytical methods and risk-based limits for the industry to help protect public health, including looking at how cannabis is grown, not just at how it hits the shelves.
“Cannabis is susceptible to pest infestation whether grown indoors or outdoors, which means cultivators often turn to pesticides to ensure their harvest. However, pesticides can be quite dangerous if not used appropriately to make sure residue levels are not higher than they should be. This could be especially true if consumed by someone with a health condition who may be taking the plant for medicinal purposes” said Robin Marles, Ph.D., chair of the U.S. Pharmacopeia (USP) Botanical Dietary Supplements and Herbal Medicines Expert Committee.
USP has assembled an expert panel of clinicians, scientists and industry representatives from around the world to provide necessary information and guidance all laid out in the Journal of Natural Products, Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes.
Recent cases in the U.S. and Canada of consumers being exposed to residues of pesticides unauthorized for use or used off-label on cannabis have resulted in recalls and increased public and regulatory concerns. In the U.S., crop-specific pesticide limits are established by the U.S. Environmental Protection Agency (EPA) for foods, but no approved pesticide or pesticide limits exist for cannabis. And levels of pesticides deemed appropriate to protect public health and safety for food products may not necessarily apply to cannabis, since cannabis is typically smoked or vaped.
Although U.S. state requirements may provide some guidance to control specific pesticide contaminants, additional pesticide residues that are not expressly permitted by these states may also be detected on cannabis due to environmental drift or persistence or through incidental contamination.
Unlike the breathalyzer, which can detect alcohol impairment within seconds, Indiana’s new drug test experiment only shows that a motorist has used drugs.
As more states work to loosen their marijuana laws, and in many cases, make it part of legal society, some are still clinging to antiquated Drug War concepts in an attempt to disrupt progress. Indiana is one of those states. Not only are officials refusing to consider legitimizing cannabis for medicinal or recreational purposes, they are also, at the same time, imposing policies that will undoubtedly lead to more marijuana-related arrests.
The state recently announced that law enforcement agencies are now using a new roadside drug detection tool to stop drugged driving. However, the test is seriously flawed and could put innocent people in jail.
More than 50 police forces all over the state (including Evansville, Fort Wayne, Indianapolis, Lake County and Muncie) have started using a roadside drug detection device that can determine, within minutes, whether a person has illegal substances coursing through their veins.
The device, known as the SoToxa Mobile Test System, is supposed to sniff out drivers high on cocaine, opiates, meth, and, of course, marijuana. The test’s manufacturer touts its ability to flag stoned motorists within five minutes by testing their saliva. The problem with this technology is that it scans explicitly for the presence of illegal drugs, not intoxication, making it possible for more sober motorists throughout Indiana to be prosecuted for stoned driving in 2021.
Blue Dream, Purple Haze, Girl Scout Cookies, Red Headed Stranger, Acapulco Gold, Fruity Pebbles or Pineapple Express… all classic strain names and all of them meaningless.
“Strain names are absolutely misleading with considerable variation in the same cannabinoid content among different specimens of the same strain. You can get the same color and the same smell, but actually levels of the THC and CBD and some of the other compounds could be quite different,” says Robin Marles, Ph.D., chair of the U.S. Pharmacopeia (USP) Botanical Dietary Supplements and Herbal Medicines Expert Committee.
USP has assembled an expert panel of clinicians, scientists and industry representatives from around the world to provide necessary information and guidance on critical quality attributes, including recommendations for naming , all laid out in an article in the Journal of Natural Products, Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes.
“USP recommendations are entirely focused on the inflorescence of the cannabis plant, popularly known as the flower or ‘the bud.’ And as with any plant product, the first challenge was to determine how to classify the various varieties and subtypes that are currently in use.” said Ikhlas Khan, Ph.D., USP’s Cannabis Expert Panel chair.
USP has elected to recognize cannabis as a single plant species, Cannabis sativa L., with different varieties or subtypes that can then be classified based on their THC and CBD content. The expert panel provided guidance for organizing the plant material into three “chemotype” categories: THC-dominant, CBD-dominant, or intermediate varieties that contain physiologically meaningful levels of both – intending to give prescribers or consumers greater clarity about what substances they are using.
Boffins have created a revolutionary anti-ageing skin spray - made from super-strength cannabis.
Scientists at Australian cannabis company Dolce Cann Global have developed a number of strains which boast a mix of cannabinoids with much stronger anti-inflammatory properties than standard CBD.
Wellness company Wellfully has teamed up with Dolce Cann Global to secure rights to use these strains for products to fight ageing, skin blemishes, acne and arthritis, via its proprietary drug delivery systems.
By merging beauty, science, technology, and proprietary cannabis strains, they aim to create products that use 'ultrasonic diffusion', 'magnetic misting' and other enhanced delivery systems to allow greater absorption and better penetration of the super-strength cannabinoids.
Ultrasonic diffusion allows the skin to absorb droplets, which are 50 times smaller than traditional spray, leaving no undesirable residue on the skin and hair.
The U.S. Pharmacopeia (USP) has decided to bring cannabis back into the fold and has provided guidelines for labs and cultivators around the globe to utilize to help provide consumers with quality cannabis products.
“There is a critical and growing need for the scientific articulation of quality attributes for cannabis and related products to help protect patients and consumers from harm. As more products become available and sourced more broadly, and states continue to adopt initiatives allowing the use of cannabis for medical purposes, potential exposure to and associated risk of harm from contaminated, substandard, or super potent products is increasing and we must do what we can to mitigate that risk,” said Jaap Venema, Ph.D., Chief Science Officer at USP.
The organization’s goal in this area is to provide suitable methods and reference standards that can help the industry and regulators ensure cannabis quality, laid out in an article in the Journal of Natural Products, Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes. Nomenclature is at the top of USP’s “to-do list,” an important quality attribute for labeling the ingredients, to help patients and healthcare professionals assess whether a product is suitable for particular needs.
“The thousands of so-called ‘strains’ are not consistent in either morphological or chemical profiles and cannot be relied upon for consistent categorization of different kinds of cannabis. Identity of cannabis and cannabis-derived products should be linked with clear nomenclature, including reference to plant part, product, and/or herbal preparation,” said Robin Marles, Ph.D., chair of the USP Botanical Dietary Supplements and Herbal Medicines Expert Committee.
USP has elected to recognize cannabis as a single plant species, Cannabis sativa L., with different varieties or subtypes that can be classified based on their THC and CBD content. The guidelines in the Journal of Natural Products article organize the plant into three ‘chemotype’ categories: THC-dominant, CBD-dominant, or intermediate varieties that contain physiologically meaningful levels of cannabinoids.
Cannabidiol (CBD) is arguably the most popular cannabinoid on the planet right now. Whereas THC is associated with intoxication, CBD is not.
That is a significant distinction because while many consumers are fans of THC’s effects, not everyone is.
Someone that has no interest in experiencing the euphoric effects of THC, and thus has avoided consuming cannabis, may still want to experience the wellness benefits of CBD.
The market for CBD is larger than the market for THC. That is not a knock on THC – the market size for THC is massive, and increasing as reform victories pile up across the globe.
With that being said, it is no secret why CBD is growing in popularity at an exponential rate because it is appealing to a wider audience.
The time is nigh for the DEA to cooperate in ensuring that medical marijuana research can move forward. Finally.
On December 3, 2020, MAPS (the Multidisciplinary Association for Psychedelic Studies) issued a press release regarding a lawsuit filed against the DEA and the Attorney General to “compel issuance of licenses to manufacture marijuana for clinical trials and potential FDA approval.” We have written about MAPS and its 35 years of advocacy and engagement with DEA before, and we are big fans of the nonprofit.
The announcement of this lawsuit comes on the heels of the United Nations Commission for Narcotic Drugs (CND) voting to accept the World Health Organization’s (WHO) recommendation to remove cannabis and cannabis resin for medicinal purposes from Schedule IV of the 1961 Single Convention on Narcotic Drugs. The U.S. had already confirmed it would support the WHO recommendation and published a statement about its rationale for the vote:
“The vote of the United States to remove cannabis and cannabis resin from Schedule IV of the Single Convention while retaining them in Schedule I is consistent with the science demonstrating that while a safe and effective cannabis-derived therapeutic has been developed, cannabis itself continues to pose significant risks to public health and should continue to be controlled under the international drug control conventions. Further, this action has the potential to stimulate global research into the therapeutic potential and public health effects of cannabis, and to attract additional investigators to the field, including those who may have been deterred by the Schedule IV status of cannabis.”
In MAPS’ announcement of the lawsuit, it points out that “[e]fforts to conduct meaningful research into cannabis medicines have been blocked for decades; the continued obstruction is causing suffering for people with serious conditions,” which indicates the timeliness of this lawsuit in relation to the CND’s recent vote. According to MAPS and the lawsuit, the DEA has failed to process more than thirty outstanding applications to develop cannabis for research purposes for more than four years despite administrative guidance. The press release outlines the nature of the lawsuit as follows:
The US National Institute of Justice has ponied up a bundle of bucks to fund the development of simpler and cheaper THC testing.
The 2018 Farm Bill created a few headaches for law enforcement at a federal level when it legalised industrial hemp. Where previously all cannabis was (incorrectly) considered marijuana, it now had to be determined if seized cannabis was hemp or marijuana – the difference being hemp is cannabis with less than 0.3 % decarboxylated-Δ9-THC (total THC).
This can’t be distinguished easily – it all looks the same and smells the same. Lab testing used to be reasonably straightforward, but now more complex, time-consuming and costly laboratory tests are required in order to make accurate THC determinations.
The National Institute of Justice is looking to address this. Last week it announced it had awarded a USD $350,000 grant to the National Institute of Standards and Technology (NIST) for it to develop simpler yet robust and more cost effective analytical methods.
“This effort will focus on the development of isotope dilution GC-MS methods, extraction protocols, a single laboratory validation study, and evaluations of benchtop and portable infrared spectrometers,” states NIJ.
The cannabis industry is booming all over the globe, mostly from a medical cannabis standpoint.
Dozens of countries now allow some form of legal medical cannabis industry to operate within their borders, and some of those countries also have some type of legal import/export industry.
Adult-use is far more limited.
Fortunately, a number of countries are exploring the idea of full legalization, and multiple countries such as Mexico are working to implement adult-use court-ordered mandates.
Anti-drug laws are putting a damper on fully exploring marijuana’s potential with respect to its possible health-helping benefits and how cannabis genomics may contribute to meeting that goal.
Researchers at Australia’s La Trobe University’s reviewed a raft of international studies of cannabis genomics and confirmed what many already believe.
Despite the many decades that cannabis has been studied, anti-drug laws are creating hurdles to identifying what scientists expect are weed’s unique medicinal properties, Mathew Lewsey, an associate professor at the university and the study’s lead researcher, suggests in a university statement.
That has left understanding of cannabis in the dust compared with some of its other plant brethren. “These rules have meant that while our understanding of the basic biology and properties of other crop species has advanced through the use of genomics, for example, our knowledge of cannabis has lagged,” says Lewsey.
“There is ample anecdotal evidence and an increasing number of clinical trials about the benefits of cannabis, but there remain challenges around the production of high-quality plant-based therapeutic grade products and their provenance,” Tony Bacic, a professor at the university and the paper’s co-author.
For many years cannabis consumption methods were fairly rudimentary.
The most common forms of cannabis consumption were typically a hand-rolled joint or a common smoking pipe.
Cannabis consumed in edible form was fairly rare, and more often than not involved brownies, cookies, or other sweet treats.
Cannabis topicals were extremely rare for most consumers and cannabis concentrates were often scarce.
When people could find concentrates, there wasn’t a lot of variety.
As part of an on-going consumer product safety investigation, the Oregon Liquor Control Commission has identified that marijuana products sold in Oregon’s recreational marijuana market during the last two years contained additives, squalene and squalane, that have been linked to safety concerns similar to Vitamin E Acetate when vaped and inhaled. The OLCC is working to trace products and when necessary remove them from sale. OLCC will be considering immediate action at its December 2020 Commission meeting to prohibit future use of squalene and squalane, institute a mandatory recall of affected products, and create a more stringent and transparent review process of cannabis vaping products going forward.
The products under investigation by OLCC contained Viscosity, a non-cannabis diluent manufactured and sold by a third-party (non-OLCC marijuana licensee). Some of the product remains on the market, and the OLCC is working to trace and remove it.
Bulk Naturals LLC., dba True Terpenes, sold Viscosity that solely contained squalene, squalane, and an unidentified olive extract to OLCC recreational marijuana licensees between at least January 2018 and November 2019. Squalene is a “botanically-derived terpene” that can be derived from olives; squalane is the hydrogenated version of squalene. Following OLCC’s confirmation of the presence of squalane in Viscosity via independent laboratory analysis by ChemHistory and SC Labs, True Terpenes has complied with all of OLCC’s requests for information. Viscosity has since been reformulated, and according to True Terpenes, none of their products have contained squalene or squalane since November 2019.
As a result of its investigation the OLCC has identified recreational marijuana licensees that potentially used Viscosity in their products. Because of their purchase of Viscosity, OLCC has requested additional information from several licensees about products they have manufactured.
One licensee – Oregrown, a vertically integrated cannabis company based in Bend – swiftly provided the requested documentation. Oregrown was the first licensee to confirm its use of the Viscosity formula under investigation, and since then has been working with the OLCC to voluntarily recall the limited amount of its remaining product containing Viscosity. OLCC has provided Oregrown with the information regarding affected items still on the market and their current location.