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Federal Hemp CBD Policy Is Taking Shape: How Will Products Be Tested and Labeled?

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fda cbd testing labeling

This is the second post in a two-part series. The first is available here

Last week, the Food and Drug Administration (FDA) submitted a CBD enforcement policy to the White House. We do not yet have the text of that document but we anticipate that it will have a significant impact on hemp-derived CBD (Hemp CBD) products. In my last post, I summarized the FDA’s current enforcement policy and briefly discussed the FDA’s recently released guidance for drug manufacturers interested in cannabinoid research. An issue that came up in the FDA’s guidance for drug manufacturers was testing finished and intermediary products for cannabinoids.

Here’s how the FDA frames the issue of testing hemp products in the drug guidance document:

In general, the composition of a botanical raw material is calculated as the amount of the compound(s) of interest naturally present relative to the dry weight of botanical raw material prior to extraction or other manufacturing steps. However, this type of dry weight calculation has limited utility for intermediates such as solutions, extracts in solution (whether aqueous or nonaqueous), and for finished products. Therefore, FDA recommends that sponsors, investigators, or applicants evaluating intermediates or finished products that contain cannabis or cannabis derived compounds base the calculation of delta-9 THC percentage on the composition of the formulation with the amount of water removed, including any water that may be contained in excipients.

Remember, this guidance is only intended to speak to drug manufacturers and even then it’s non-binding. But I think the FDA’s drug guidance could creep into its more general guidance. For example, the FDA provided the following guidance for determining delta-9 THC levels in liquid products:

For a solution-based material (intermediate, in-process material, or final drug product):
1. Determine the density of the liquid formulation and convert 1 mL of the formulation to mass units (mg).
2. Calculate water content (in mg) of each active and excipient component present in 1 mL of the formulation.
3. Sum the water content (in mg) for all components present in 1 mL of the liquid formulation and subtract this amount from the total mass of 1 mL (from step 1). This is the water-adjusted total mass of 1 mL of the formulation.
4. Calculate the mass, or mg amount, of delta-9 THC present in 1 mL of the liquid formulation.
5. Calculate the percentage delta-9 THC by dividing the mass of delta-9 THC from step 4 by the total water-adjusted mass in step 3 and multiplying by 100.

The FDA provides similar guidance for solid forms:

For a solid oral dosage form (e.g., tablet or capsule), this percentage is similarly calculated and would be the weight of delta-9 THC in the dosage unit divided by the total water-adjusted formulation weight multiplied by 100.

— For oral capsules, the mass of the capsule itself should not be included in the denominator weight. Include only the capsule fill.
— The water-adjusted formulation weight used in the calculation should reflect the removal (in mass units such as mg) of all water content present for each of the components, whether active or inactive, in the formulation.

A while back, I chastised the FDA for reporting on the fact that many Hemp CBD products sold on the market are listed with inaccurate levels of THC and CBD when the agency itself has the ability to implement industry-wide standards for labeling. To have accurate labels you need accurate testing and methodology. The FDA’s guidance for cannabinoid drug manufacturers touches on this issue by giving guidance on testing cannabinoids, specifically delta-9 THC, in solid and liquid form. I hope the agency will do the same when it issues broader CBD enforcement guidance.

Luckily, other federal agencies are also making moves in the testing world. Last week the National Institute for Standards and Technology (NIST) “launched a program to help laboratories accurately measure key chemical compounds in marijuana, hemp and other cannabis products including oils, edibles, tinctures and balms.” You can read NIST’s press release on the Cannabis Quality Assurance (CannaQAP) program here.

The NIST’s CannaQP testing program, once operational, will have an immediate impact on a problem that has plagued the Hemp CBD industry for years: inaccurate product labeling. Here is how NIST frames the issue:

The labels on most cannabis products list the concentration of at least two chemical compounds: tetrahydrocannabinol, or THC, the psychoactive ingredient that produces a high, and cannabidiol, or CBD, which is not intoxicating but is sought after for its many purported health benefits. However, most laboratories have limited experience making these measurements, which can sometimes be unreliable as a result.

The goal of the program, said NIST research chemist Brent Wilson, is to help labs produce consistent measurement results. “When you walk into a store or dispensary and see a label that says 10% CBD, you want to know that you can trust that number.”

Testing for THC percentages is a relatively new operation for most labs in the US. THC testing developed long before hemp was made legal, first by the 2014 Farm Bill for research purposes, and then by the 2018 Farm Bill for commercial purposes. The goal of THC testing prior to hemp legalization was to determine whether or not plant material was marijuana or whether a processed product contained marijuana. THC testing was mainly performed in the law enforcement context. Police would seize a product, test it for the presence of THC, and then charge for marijuana-related crimes.

NIST’s CannaQAP is designed to establish standards for labs testing processed hemp products:

Here’s how CannaQAP will work. In the first round of exercises, NIST will send hemp oil samples — all with the same, very carefully measured concentrations of THC, CBD and 15 other cannabinoid compounds — to participating labs. Those labs won’t be told the concentrations of those compounds but will measure them and send their results back to NIST, along with information about the methods they used to do the analysis.

After collecting responses, NIST will publish the measurements the labs obtained. That data will be anonymized so that the names of the individual labs are not revealed. However, the results will show how much variability there is between labs. Also, NIST will publish the correct measurements, so each lab will be able to see how accurate its measurements were and how it performed relative to its peers.

[. . . ]

NIST is also working on a hemp reference material — that is, a material that comes with known, accurate measurement values. Labs will be able to use that material to validate their measurement methods. One reason these measurements vary so much from lab to lab is that, currently, there are no reference materials for cannabis.

The CannaQAP will enable labs to better test for cannabinoids like THC and CBD. That will allow for accurate labeling of the CBD, along with other cannabinoids, in hemp products.

Hopefully, the CannaQAP and the eventual report from the FDA on CBD enforcement will bring clarity to the industry. We’ll keep monitoring but won’t hold our breath.

Source: https://harrisbricken.com/cannalawblog/federal-hemp-cbd-policy-is-taking-shape-how-will-products-be-tested-and-labeled/

Cannabis

An in-depth look at the study that discovered THCP, a cannabinoid more potent than THC

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A new cannabinoid has been discovered, and the ramifications could be massive. Scientists funded by the UNIHEMP research project have discovered a new psychoactive molecule: Δ9-Tetrahydrocannabiphorol, or THCP; and they believe that there are great scientific implications for the phytocannabinoid

Phytocannabinoids are cannabinoid molecules that are specifically produced by plants. There are several types of cannabinoids, including endocannabinoids, synthetic cannabinoids, and phytocannabinoids. 

Endocannabinoids are compounds that are produced within the body by an organism’s endocannabinoid system; and synthetic cannabinoids are man-made chemicals that cannot be found in nature. Phytocannabinoids, on the other hand, are a different beast altogether. They are those that naturally occur in plants and are found in a variety, including echinacea. However, the plant species in which phytocannabinoids are most prominent is cannabis.

Because of cannabis’ status as a Schedule I controlled substance in the US, there are several barriers that prohibit the scientific study of the plant and its constituents. Thus, a considerable portion of cannabis research takes place abroad. Many clinical and laboratory studies of cannabis take place in Israel and Canada, where there is federal research funding to support this work; but, the newly discovered THCP was characterized by a group of Italian scientists.

Unlike the US, government funding for cannabis research is relatively commonplace in Europe. The discovery of THCP was enabled by the UNIHEMP project, which is sponsored by the European Regional Development Fund. A multi-disciplinary team of Italian scientists was responsible for the discovery of this novel cannabinoid, led by Giuseppe Cannazza of the University of Modena and Reggio Emilia.

The researchers’ findings were published in late 2019 in the journal Nature.

THCP is 33-times more active than THC

Throughout the duration of the project, the group studied a medicinal cannabis cultivar, dubbed FM2, which was supplied by the Military Chemical Pharmaceutical Institute in Florence. Using a variety of scientific characterization techniques, the researchers observed two novel cannabinoids, THCP and CBDP, and isolated them from other cannabinoids that were present. Following this discovery, the group artificially synthesized THCP and CBDP to create reference materials, and the synthesized versions were successfully used to verify the natural expression of the two cannabinoids in the FM2 cultivar.     

After the confirmation of the identity of the two cannabinoids, the group turned its focus to THCP. To study the compound, they pursued an in vitro experiment with cultured cells. This experiment tested the binding affinity of THCP with CB1 and CB2 receptors, using synthetic cannabinoids as reference materials. It was shown that, when comparing THCP-related results to the previously reported data of other cannabinoids against the CB1 receptor, THCP is 33-times more active than delta-9 THC. 

This finding is critical because the group also found that the chemical was present in FM2 at 0.0029%, whereas THC was found to be expressed at 3.9%; so, even in smaller amounts, THCP is more active than THC.

They also tested the cannabimimetic activity of the molecule. Cannabimimetic activity is a measure of how well a substance replicates the effects of more well-characterized cannabinoids which bind to the CB1 receptor. An in vivo experiment involving mice was performed. Herein, the influence of THCP on body temperature, spontaneous activity, immobility, and pain was determined — the results of these tests confirmed that THCP acts similarly to other cannabinoids like delta-9 THC.

Will THCP be important?

According to the study, even at lower doses, THCP has more cannabimimetic activity than THC. Further, the group posits that THCP could account for the wide variability of patient responses in cannabis-based therapies, even amongst cultivars with equal THC doses. This means  that cannabis’  psychotropic effects, which the scientific community attributes to THC, may actually be due to the presence of THCP. 

Unfortunately, none of the original researchers could be reached for comment. However, experts in the field do have varying opinions regarding the study. Dr. Cecilia J. Hillard of the Medical College of Wisconsin said, “I think it is well designed.” She goes on, “[The study] has two important gaps, in my opinion. First, they should have compared the in vivo effects of THCP to that of THC ‘head to head’ so that relative potencies could be assessed. Second, I would like to know whether THCP has greater efficacy to activate the [CB1 receptor] in particular. THC is relatively safe because it has low efficacy at the receptor. If THCP has high efficacy (like the synthetic analogs that have also increased the tail length), it is a more concerning finding, as it would suggest that strains making a lot of THCP could be more dangerous to use than those that do not.” 

Expanding on how THCP could be more dangerous, Hillard continued, “The so-called ‘spice’ compounds are synthetic agonists of the CB1 receptor. They are full agonists, meaning that they are very strong activators of the CB1 receptor. Compared to THC, these drugs have significant adverse effects and produce significant dependence (addiction). So, my issue is that we do not know yet whether THCP is like THC, a partial agonist, or like the synthetic compounds, a full agonist. And my concern is that, if it is the latter, cannabis strains high in THCP will have more adverse effects than those that are low.”

Dr. Samuel Banister of The University of Sydney states, “[The study] was well designed and executed,” concurring with Dr. Hillard. However, he goes on to disagree with the group’s assessment that THCP may account for the variability of psychotropic effects across various cannabis cultivars: “While this possibility cannot be ruled out, the known potency differences for THC and THCP at cannabinoid receptors is relatively small, while the difference in abundance of each in cannabis is enormous. The same is true of CBD and CBDP, although CBD requires even higher doses to achieve many of its pharmacological effects. For this reason, I do not feel that minor or trace phytocannabinoids like THCP or CBDP contribute significantly to the psychoactive effects of different cannabis strains.” 

How this novel cannabinoid plays out in both medical and recreational use is yet to be determined, as much more research is needed. Nonetheless, this new evidence suggests that analytical laboratories in US regulated markets may need to expand their testing panel to include THCP.

Featured graphic by David Lozada/Weedmaps

Source: https://weedmaps.com/news/2020/08/an-in-depth-look-at-the-study-that-discovered-thcp-a-cannabinoid-more-potent-than-thc/

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Arizona Legalization Initiative Survives Lawsuit

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An Arizona voter initiative that would legalize the recreational use of cannabis by adults has survived a legal challenge by opponents, who argued that the ballot summary for the measure failed to properly inform voters. In a ruling released on Friday, Judge James Smith rejected all arguments of attorneys for Arizonans for Health And Public Safety.

The group filed the lawsuit last month, arguing that the 100-word word summary for the Smart and Safe Arizona Act ballot act did not accurately describe the initiative and therefore misinformed voters. If passed, the measure would legalize possession of up to one ounce of cannabis by adults and create a tax and regulatory framework for commercial marijuana production and sales. The office of the Arizona Secretary of State is now in the process of verifying the signatures to ensure that enough registered voters have signed petitions to include the initiative on the ballot for the general election.

“The proponent’s summary of the initiative is confusing and deceptive in numerous ways, beginning with the very definition of marijuana,” John Shadegg, a former congressman and one of the attorneys who filed the suit, said at the time.

The suit alleges, among other things, that a passage of the summary that says the initiative would “protect employer and property owner rights” is misleading. The plaintiffs also challenged the fact that the summary did not specify that the measure would legalize not just marijuana flower, but all forms of cannabis including extracts and concentrates. 

“The summary misled signatories and will mislead voters who may support the legalization of ‘marijuana’ but not the more potent forms of ‘cannabis,’” Shadegg said.

The suit also maintained that the summary should have noted that the 16% tax rate imposed by the initiative on cannabis sales could not be raised without another vote of the people. The summary also should have included information about a  provision of the initiative that makes possession of marijuana by a person younger than 21 a civil infraction instead of a felony, the suit alleged.

“These omissions and statements misled voters who signed the petition about what the initiative would do,” said Lisa James, the chairwoman of Arizonans for Health and Public Safety.

Judge Rejects Prohibitionists 

In his ruling, Smith said that the opponents of the initiative were attempting to impose their personal beliefs on the content of the summary without a legal basis.

“Petitioners may believe the initiative should put more limits on possessing, using, or cultivating marijuana,” he wrote. “Those are policy arguments for the voters. That competing policy perspective does not mean the summary violates the law.”

The judge also noted that the plaintiffs’ assertion that the initiative reduced the penalties for minors convicted of cannabis offenses was untrue.

“In fact, (the initiative) includes penalties for underage possession,” Smith wrote. “Yes, minors possessing marijuana now may face charges that are more serious.”

At a hearing on the lawsuit earlier in the week, Smith suggested how he might rule, noting that “there’s nothing in this description that is actually wrong.”

With Smith’s ruling, the initiative is one step closer to making it to November’s ballot. The plaintiffs have five days from Friday, the day the judge’s decision was handed down, to file an appeal.

Source: https://hightimes.com/news/arizona-legalization-initiative-survives-lawsuit/?utm_source=rss&utm_medium=rss&utm_campaign=arizona-legalization-initiative-survives-lawsuit

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Canada is Allowing Psilocybin Access For Terminally Ill Patients

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Canada just announced that four patients who have been diagnosed with terminal cancer will receive therapy from psilocybin, the psychoactive component in mushrooms.

The idea is for the patients to come to terms with their lives ending through the use of psilocybin. This comes over 100 days after a plea from patients with the government. Finally, the plea for medicine has been approved by Patty Hajdu, minister of health in Canada. It’s the first exception to the rule for psychedelic treatment since 1974. 

“The acknowledgment of the pain and anxiety that I have been suffering with means a lot to me, and I am feeling quite emotional today as a result,” said Laurie Brooks, one of the patients able to receive her treatments. “I hope this is just the beginning and that soon all Canadians will be able to access psilocybin, for therapeutic use, to help with the pain they are experiencing, without having to petition the government for months to gain permission.”

“I would like to personally thank the Hon. Minister Hajdu and the team at the Office of Controlled Substances for the approval of my section 56 exemption. This is the positive result that is possible when good people show genuine compassion. I’m so grateful that I can move forward with the next step of healing,” added patient Thomas Hartle. 

Dr. Bruce Tobin, Founder and Chairman of TheraPsil, the group behind providing psilocybin to end-of-life patients, said, “We would like to extend our incredible gratitude to the Honorable Minister of Health, Patty Hajdu, and to our government. Although it has taken a long time we are impressed with their willingness to listen to patients who have not been heard and to shift focus and policy to accommodate their interests and protect their needs. We also thank the brave Canadian patients who have been public in their fight for psilocybin access, along with the honourable Canadian MPs who have demonstrated courage, standing up for patient rights, including Marcus Powlowski,  Ed Fast, Elizabeth May, Paul Manley, Nathaniel Erskine-Smith, Helena Jaczek, and Hedy Fry”

Compassionate Care Through Plants

End-of-life anxiety can often be one of the most severe side effects of a terminal diagnosis, and traditional anxiety medicine often doesn’t help with that. For that reason, the patients approved of this treatment specifically asked for an alternative to the medicines they were being prescribed. 

“It gives you a rapid heart rate. It makes you feel terrible,” Hartle said. 

Based on this, the patients decided on psilocybin, as recent research reveals how much it can help with end-of-life healing. A study by NYU Langone Health revealed that 60 to 80 percent of the 29 people who participated found that psilocybin, in combination with psychotherapy, helps soothe distress about death. Most of the patients reported positive life changes after going through the treatment. 

While terminal diagnoses still exist in Western medicine, it’s incredibly important for end-of-life care to be prioritized, and this will help give the patients who need it the peace of mind they are craving.

Source: https://hightimes.com/news/canada-allowing-psilocybin-access-terminally-ill-patients/?utm_source=rss&utm_medium=rss&utm_campaign=canada-allowing-psilocybin-access-terminally-ill-patients

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