Tag Archives: extracts

From The Lab

I Was Wrong… und das ist auch gut so!

By Dr. Markus Roggen
3 Comments

I was wrong. And that’s a good thing! Based on all available data, I assumed that evaporating ethanol from a cannabis oil/ethanol solution would result in terpene loss. As it turns out, it doesn’t. There are so many beliefs and assumptions about cannabis: Cannabis cures cancer!1 Smoking cannabis causes cancer!2 Sativas help you sleep; Indicas make you creative!3,4 CBD is not psychoactive!5 But are these ‘facts’ backed by science? Have they been experimentally tested and validated?

I postulated a theory, designed experiments to validate it and evaluated the results. Simply putting “cannabis backed by science” on your label does not solve the problem. Science is not a marketing term. It’s not even a fixed term. The practice of science is multifaceted and sometimes confusing. It evolved from the traditional model of Inductivism, where observations are used in an iterative process to refine a law/theory that can generalize such observations.6 Closely related is Empiricism, which posits that knowledge can only come from observation. Rationalism, on the other hand, believes that certain truths can be directly grasped by one’s intellect.7 In the last century, the definition of science was changed from the method by which we study something, such as Inductivism or Rationalism, and refocused on the way we explain phenomena. It states that a theory should be considered scientific if, and only if, it is falsifiable.8 All that means is that not the way we study something is what makes it scientific, but the way we explain it.

I wonder how can we use empirical observations and rational deliberations to solve the questions surrounding cannabis? And more importantly, how can we form scientific theories that are falsifiable? Cannabis, the plant, the drug, has long been withheld from society by its legal status. As a result, much of what we know, in fact, the entire industry has thrived in the shadows away from rigorous research. It’s time for this to change. I am particularly concerned by the lack of fundamental research in the field. I am not even talking about large questions, like the potential medical benefit of the plant and its constituents. Those are for later. I’m talking about fundamental, mundane questions like how many lumens per square centimetre does the plant need for optimal THC production? What are the kinetics of cannabis extraction in different solvents? What are the thermodynamics of decarboxylation? Where do major cannabinoids differ or align in terms of water solubility and viscosity?

The lack of knowledge and data in the cannabis field puts us in the precarious position of potentially chasing the wrong goals, not to mention wasting enormous amounts of time and money. Here’s a recent example drawn from personal experience:Certainly, I cannot be the only one who has made an incorrect assumption based on anecdotes and incomplete data?

Some of the most common steps in cannabis oil production involve ethanol solutions. Ethanol is commonly removed from extraction material under reduced pressure and elevated heat in a rotary evaporator. I expected that this process would endanger the terpenes in the oil – a key component of product quality. My theory was that volatile terpenes9 would be lost in the rotary evaporator during ethanol10 removal. The close values of vapor pressure for terpenes and ethanol make this a reasonably assumed possibility.11 In the summer of 2018, I finally got the chance to test it. I designed experiments at different temperatures and pressures, neat and in solution, to quantify the terpene lost in ethanol evaporation. I also considered real life conditions and limitations of cannabis oil manufacturers. After all the experiments were done, the results unequivocally showed that terpenes do not evaporate in a rotary evaporator when ethanol is removed from cannabis extracts.12 As it turns out, I was wrong.

We, as an industry, need to start putting money and effort into fundamental cannabis research programs. But, at least I ran the experiments! I postulated a theory, designed experiments to validate it and evaluated the results. At this point, and only this point, can I conclude anything about my hypothesis, even if that is that my working theory needs to be revised. Certainly, I cannot be the only one who has made an incorrect assumption based on anecdotes and incomplete data?

There is a particular danger when using incomplete data to form conclusions. There are many striking examples in the medical literature and even the casual observer might know them. The case of hormone replacement therapy for menopause and the associated risks of cardiovascular diseases showed how observational studies and well-designed clinical trials can lead to contradicting results.13 In the thirties of the last century, lobotomy became a cure-all technique for mental health issues.14 Dr. Moniz even won the Nobel Prize in Medicine for it.15 And it must come as no surprise when WIRED states “that one generation’s Nobel Prize-winning cure is another generation’s worst nightmare.”16 And with today’s knowledge is impossible to consider mercury as a treatment for syphilis, but that is exactly what it was used as for many centuries.17 All those examples, but the last one in particular should “be a good example of the weight of tradition or habit in the medical practice, […] of the necessity and the difficulties to evaluate the treatments without error.”18 There is the danger that we as cannabis professionals fall into the same trap and believe the old stories and become dogmatic about cannabis’ potential.

We, as an industry, need to start putting money and effort into fundamental cannabis research programs. That might be by sponsoring academic research,19 building in-house research divisions,20 or even building research networks.21 I fully believe in the need for fundamental cannabis research, even the non-sexy aspects.22 Therefore, I set up just that: an independent research laboratory, focused on fundamental cannabis research where we can test our assumptions and validate our theories. Although, I alone cannot do it all. I likely will be wrong somewhere (again). So, please join me in this effort. Let’s make sure cannabis science progresses.


References

  1. No, it does not. There are preliminary in-situ studies that point at anti-cancer effects, but its more complicated. The therapeutic effects of Cannabis and cannabinoids: An update from the National Academies of Sciences, Engineering and Medicine report, Abrams, Donald I., European Journal of Internal Medicine, Volume 49, 7 – 11
  2. No, it does not. National Academies of Sciences, Engineering, and Medicine. 2017. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC: The National Academies Press. https://doi.org/10.17226/24625.
  3. No, it does not. The chemical profile of the plant dictates the biological effects on humans, not the shape of the leaf.  Justin T. Fischedick, Cannabis and Cannabinoid Research, Volume: 2 Issue 1: March 1, 2017
  4. Indica and Sativa are outdated terms. Piomelli D, Russo EB. The Cannabis sativa versus Cannabis indica debate: An Interview with Ethan Russo, MD. Cannabis Cannabinoid Res 2016; 1: 44–46.
  5. No, it is. CBD’s supposed “calming effects” is indeed a psychoactive effect. However, it is not intoxicating like THC. Russo E.B., Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects.Br. J. Pharmacol. 2011; 163: 1344-1364
  6. As attributed to Francis Bacon.
  7. See the work by philosopher Baruch Spinoza.
  8. As theorized by Karl Popper.
  9. Monoterpenes have a vapor pressure in the low to mid hundreds of Pascals at room temperature.
  10. Vapor pressure of 5.95 kPa at 20˚C.
  11. Furthermore, there is always the possibility of azeotropes in complex mixtures. Azeotropes are mixtures of two or more liquids that have different boiling points individually, but in mixture boil together.
  12. Terpene Retention via Rotary Evaporator Application Note, Heidolph North America
  13. https://www.pharmaceutical-journal.com/research/review-article/establishing-the-risk-related-to-hormone-replacement-therapy-and-cardiovascular-disease-in-women/20202066.article?firstPass=false
  14. https://psychcentral.com/blog/the-surprising-history-of-the-lobotomy/
  15. https://en.wikipedia.org/wiki/António_Egas_Moniz
  16. https://www.wired.com/2011/03/lobotomy-history/
  17. https://www.infezmed.it/media/journal/Vol_21_4_2013_10.pdf
  18. https://www.ncbi.nlm.nih.gov/pubmed/11625051
  19. Canopy Growth funds a professorship of cannabis science at UBC. Tilray collaborates with UCSD on a phase I/II clinical trial.
  20. For examples see: NIBR, PMISCIENCE.
  21. For examples see: CEMI, theAIRnet, Future Sky.
  22. Research that does not lead to short-term stock value spikes but long-term progress

Farm Bill Analysis: Is Hemp Legal Now?

By Aaron G. Biros
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On December 20, President Trump signed the Agriculture Improvement Act of 2018 (the Farm Bill) into law, which included an important change to the way federal agencies regulate hemp farming and production. The Farm Bill essentially removes hemp-derived cannabidiol (CBD) from the Controlled Substances Act in states that choose to regulate it. It strips the Drug Enforcement Agency’s (DEA’s) authority from outlawing hemp and gives states the ability to regulate hemp markets on their own, with approval from the United States Department of Agriculture (USDA).

This gives the USDA the authority to regulate hemp farming, providing for things like access to banks, insurance, grants, certifications and gets rid of the need for a pilot program, which was previously the case under the 2014 Farm Bill. It also defines hemp a little better, to include cannabinoids, derivatives and extracts.

According to Aaron Smith, executive director of the National Cannabis Industry Association (NCIA), the signing of the Farm Bill is a crucial step towards full legalization. “The lifting of the federal ban on non-psychoactive hemp is a concrete sign that the ‘reefer madness’ which first led to its criminalization is finally coming to an end,” says Smith. “This Farm Bill is a step in the right direction for comprehensive cannabis policy reform and will help fuel discussions in Congress about the best ways to end federal prohibition and create a regulated national cannabis market.”

FDAlogoHowever, one particularly important caveat needs to be mentioned: The Food and Drug Administration (FDA) still retains regulatory authority over CBD products. In a statement released the same day that the Farm Bill was signed, the FDA addressed their oversight capabilities. “We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities,” reads the FDA statement. “The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act [Federal Food, Drug and Cosmetics Act] because they were marketed as dietary supplements or because they involved the addition of CBD to food.”

The Farm Bill signing opened the doors for hemp cultivation and production in the United States.What the FDA said in their statement is crucial information for those developing hemp-derived products. They recommend that companies use traditional pathways to get approval from the FDA to market their products, providing the Epidiolex example where the drug manufacturer used clinical studies to prove the drug’s efficacy.

The FDA also notes that there are circumstances “in which certain cannabis-derived compounds might be permitted in a food or dietary supplement.” That means they are exploring opportunities for companies to develop, manufacture and market legal CBD products without going through the extensive drug approval process.States need to establish programs approved by the USDA and companies need to cooperate with the FDA, taking the necessary steps to get their products and marketing approved.

In the food ingredients realm, they have already taken steps to approve hulled hemp seeds, hemp seed protein and hemp seed oil as generally recognized as safe (GRAS). “Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims,” reads the FDA statement.

The Farm Bill signing opened the doors for hemp cultivation and production in the United States. It allows farmers to access the same goods and services extended to other commodities farming, it makes conducting business easier across state lines, it will pave the way for more research into hemp as an effective medicine and helps to end the debate over hemp’s legality. But this doesn’t mean any business can just start producing and selling CBD products. States need to establish programs approved by the USDA and companies need to cooperate with the FDA, taking the necessary steps to get their products and marketing approved.

In the coming months and years, we will see which states decide to develop hemp cultivation programs and how the proliferation of hemp-derived products will evolve under FDA regulatory oversight.

World Health Organization November Meeting To Review Cannabis

By Marguerite Arnold
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In a sign that cannabis reform is now on the march at the highest level of international discussion, the World Health Organization (WHO) will be meeting in November to formally review its policies on cannabis. This will be the second time in a year that the organization has met to review its policies on the plant, with a direct knock-on effect at the UN level.

According to documents obtained by Cannabis Industry Journal, including a personal cover letter over the committee’s findings submitted to the Secretary-General Antonio Guterres by Dr. Tedros Adhanom Ghebreyesus, Director-General of the WHO, the November review will “undertake a critical review of the…cannabis plant and resin; extracts and tinctures of cannabis.”

What Exactly Will The WHO Review?

The November meeting will follow up on the work done this summer in June – namely to review CBD. According to these recommendations, the fortieth meeting of the Expert Committee on Drug Dependence (ECDD) in Geneva will include the following:

  1. Pure CBD should not be scheduled within International Drug Control Conventions.
  2. Cannabis plant and resin, extracts and tinctures of cannabis, Delta-9-THC and isomers of THC will all be reviewed in November.
  3. Finally, and most cheeringly, the committee concluded that “there is sufficient information to progress Delta-9-THC to a critical review…to address the appropriateness of its placement within the Conventions.” In other words, rescheduling.

Industry and Patient Impact

Translation beyond the diplomatic niceties?

The drug war may, finally, and at a level not seen for more than a century, come to a close internationally, on cannabis.

Here is why: The WHO is effectively examining both the addictive impact and “harm” of the entire plant, by cannabinoid, while admitting, already that current scheduling is inappropriate. And further should not apply to CBD.

This also means that come November, the committee, which has vast sway on the actions of the UN when it comes to drug policy, is already in the CBD camp. And will finally, it is suspected, place other cannabinoids within a global rescheduling scheme. AKA removing any justification for sovereign laws, as in the U.S., claiming that any part of cannabis is a “Schedule I” drug.

What this means, in other words, in effect, is that as of November, the UN will have evidence that its current drug scheduling of cannabis, at the international level, is not only outdated, but needs a 21stcentury reboot.

International Implications

From a calendar perspective, in what will be Canada’s first recreational month, Britain’s first medical one and presumably the one in that the German government will finally accept its second round of cultivation bids, the world’s top regulatory body will agree with them.

This also means that as of November, globally, the current American federal justifications and laws for keeping cannabis a Schedule I drug, and based on the same, will have no international legal or scientific legitimacy or grounding.

Not that this has stopped destructive U.S. policies before. See global climate change. However, and this is the good news, it is far easier to lobby on cannabis reform locally than CO2 emissions far from home. See the other potentially earth-shaking event in November – namely the U.S. midterm elections.

The global industry, in other words, is about to get a shot in the arm, and in a way that has never happened before in the history of the plant.

And that is only good news for not only the industry, but consumers and patients alike.

Dr. Ed Askew
From The Lab

Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 4

By Dr. Edward F. Askew
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Dr. Ed Askew

In the last three articles, I discussed the laboratory’s responses or defenses used to reply to your questions about laboratory results that place stress on the success of your business. The Quality Control (QC) results can cause this stress if they are not run correctly to answer the following questions:

  1. Are the laboratory results really true?
  2. Can the laboratory accurately analyze sample products like my sample?
  3. Can the laboratory reproduce the sample results for my type of sample?

Now let’s discuss the most important QC test that will protect your crop and business. That QC sample is the Matrix Sample. In the last article in this series, you were introduced to many QC samples. The Matrix Sample and Duplicate were some of them. Take a look back at Part 3 to familiarize yourself with the definitions.

The key factors of these QC sample types are:

  1. Your sample is used to determine if the analysis used by the laboratory can extract the analyte that is being reported back to you. This is performed by the following steps:
    1. Your sample is analyzed by the laboratory as received.
    2. Then a sub-sample of your sample is spiked with a known concentration of the analyte you are looking for (e.g. pesticides, bacteria, organic chemicals, etc.).
    3. The difference between the sample with and without a spike indicates whether the laboratory can even find the analyte of concern and whether the percent recovery is acceptable.
    4. Examples of failures are from my experiences:
      1. Laboratory 1 spiked a known amount of a pesticide into a wastewater matrix. (e.g. Silver into final treatment process water). The laboratory failed to recover any of the spiked silver. Therefore the laboratory results for these types of sample were not reporting any silver, but silver may be present. This is where laboratory results would be false negatives and the laboratory method may not work on the matrix (your sample) correctly. .
      2. Laboratory 2 ran an analysis for a toxic compound (e.g. Cyanide in final waste treatment discharge). A known amount of cyanide was spiked into a matrix sample and 4 times the actual concentration of that cyanide spike was recovered. This is where laboratory results would be called false positives and the laboratory method may not work on the matrix (your sample) correctly.
  2. Can the laboratory reproduce the results they reported to you?
    1. The laboratory needs to repeat the matrix spike analysis to provide duplicate results. Then a comparison of the results from the first matrix spike with its duplicate results will show if the laboratory can duplicate their test on your sample.
      1. If the original matrix spike result and the duplicate show good agreement (e.g. 20% relative percent difference or lower). Then you can be relatively sure that the result you obtained from the laboratory is true.
      2. But, if the original matrix spike result and the duplicate do not show good agreement (e.g. greater than 20% relative percent difference). Then you can be sure that the result you obtained from the laboratory is not true and you should question the laboratory’s competence.

Now, the question is why a laboratory would not perform these matrix spike and duplicate QC samples? Well, the following may apply:

  1. These matrix samples take too much time.
  2. These matrix samples add a cost that the laboratory cannot recover.
  3. These matrix samples are too difficult for the laboratory staff to perform.
  4. Most importantly: Matrix samples show the laboratory cannot perform the analyses correctly on the matrix.

So, what types of cannabis matrices are out there? Some examples include bud, leaf, oils, extracts and edibles. Those are some of the matrices and each one has their own testing requirements. So, what should you require from your laboratory?

  1. The laboratory must use your sample for both a matrix spike and a duplicate QC sample.
  2. The percent recovery of both the matrix spike and the duplicate will be between 80% and 120%. If either of the QC samples fail, then you should be notified immediately and the samples reanalyzed.
  3. If the relative percent difference between the matrix spike and the duplicate will be 20% or less. If the QC samples fail, then you should be notified immediately and the samples should be reanalyzed.

The impact of questionable laboratory results on your business with failing or absent matrix spike and the duplicate QC samples can be prevented. It is paramount that you hold the laboratory responsible to produce results that are representative of your sample matrix and that are true.

The next article will focus on how your business will develop a quality plan for your laboratory service provider with a specific focus on the California Code Of Regulations, Title 16, Division 42. Bureau Of Cannabis Control requirements.

Annual AOCS Meeting Spotlights Cannabinoid Analytics

By Aaron G. Biros
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The AOCS Annual Meeting is an international science and business forum on fats, oils, surfactants, lipids and related materials. The American Oil Chemist’s Society (AOCS) is holding their meeting in Orlando, Florida from April 30 to May 3, 2017. Last year’s meeting included discussions on best practices and the pros and cons of different extraction techniques, sample preparation, proficiency testing and method development, among other topic areas.

Posters on display for the duration of the Annual Meeting will discuss innovative solutions to test, preparing samples, discovering new compounds and provide novel information about the compounds found in cannabis. David Egerton, vice president of technical operations at CW Analytical (a cannabis testing laboratory in Oakland, CA), is preparing a poster titled Endogenous Solvents in Cannabis Extracts. His abstract discusses testing regulations focusing on the detection of the presence of solvents, despite the fact that endogenous solvents, like acetone and lower alcohols, can be found in all plant material. His study will demonstrate the prevalence of those compounds in both the plant material and the concentrated oil without those compounds being used in production.rsz_am17-editorialpic-cij

The conference features more than 650 oral and poster presentations within 12 interest areas. This year’s technical program includes two sessions specifically designed to address cannabinoid analytics:

Lab Proficiency Programs and Reference Samples

How do you run a lab proficiency program when you cannot send your samples across state lines? What constituents do you test for when state requirements are all different? Are all pesticides illegal to use on cannabis? What pesticides should be tested for when they are mostly illegal to use? How do you analyze proficiency results when there are no standard methods? Learn about these and other challenges facing the cannabis industry. This session encourages open and active discussion, as the cannabis experts want to hear from you and learn about your experiences.

Method Development

The need for high-quality and safe products has spurred a new interest in cannabinoid analytics, including sample preparation, pesticide, and other constituent testing. In this session, a diverse group of scientists will discuss developing analytical methods to investigate cannabis. Learn the latest in finding and identifying terpenes, cannabinoids, matrix effects, and even the best practice for dissolving a gummy bear.

Cynthia Ludwig speaking at last year's meeting
Cynthia Ludwig speaking at last year’s meeting

Cynthia Ludwig, director of technical services at AOCS, says they are making great progress in assembling analytical methods for the production of the book AOCS Collection of Cannabis Analytical Methods. “We are the leading organization supporting the development of analytical methods in the cannabis industry,” says Ludwig. “Many of the contributors in that collection will be presenting at the AOCS Annual Meeting, highlighting some of the latest advances in analyzing cannabis.” The organization hopes to foster more collaboration among those in the cannabis testing industry.

In addition to oral and poster sessions, the 2017 Annual Meeting will feature daily networking activities, more than 70 international exhibitors, two special sessions, and a Hot Topics Symposia which will address how current, critical issues impact the future of the fats and oils industry.

AOCS Highlights Cannabis Lab Standards, Extraction Technology

By Aaron G. Biros
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The American Oil Chemists’ Society (AOCS) held its annual conference in Salt Lake City this week, with a track focused on cannabis testing and technology. Cynthia Ludwig, director of technical services at AOCS and member of the advisory panel to The Emerald Test, hosted the two-day event dedicated to all things extraction technology and analytical testing of cannabis.

Highlights in the discussion surrounding extraction technologies for the production of cannabis concentrates included the diversity of concentrate products, solvent selection for different extraction techniques and the need for cleaning validation in extraction equipment. Jerry King, Ph.D., research professor at the University of Arkansas, began the event with a brief history of cannabis processing, describing the physical morphologies in different types of extraction processes.

J. Michael McCutcheon presents a history of cannabis in medicine
J. Michael McCutcheon presents a history of cannabis in medicine

Michael McCutcheon, research scientist at Eden Labs, laid out a broad comparison of different extraction techniques and solvents in use currently. “Butane is a great solvent; it’s extremely effective at extracting active compounds from cannabis, but it poses considerable health, safety and environmental concerns largely due to its flammability,” says McCutcheon. He noted it is also very difficult to get USP-grade butane solvents so the quality can be lacking. “As a solvent, supercritical carbon dioxide can be better because it is nontoxic, nonflammable, readily available, inexpensive and much safer.” The major benefit of using supercritical carbon dioxide, according to McCutcheon, is its ability for fine-tuning, allowing the extractor to be more selective and produce a wider range of product types. “By changing the temperature or pressure, we can change the density of the solvent and thus the solubility of the many different compounds in cannabis.” He also noted that, supercritical carbon dioxide exerts tremendous pressure, as compared to hydrocarbon solvents, so the extraction equipment needs to be rated to a higher working pressure and is generally more expensive.

John A. Mackay, Ph.D., left at the podium and Jerry King, Ph.D., on the right
John A. Mackay, Ph.D., left at the podium and Jerry King, Ph.D., on the right

John A. Mackay, Ph.D., senior director of strategic technologies at Waters Corporation, believes that cannabis processors using extraction equipment need to implement cleaning SOPs to prevent contamination. “There is currently nothing in the cannabis industry like the FDA CMC draft for the botanical industry,” says Mackay. “If you are giving a child a high-CBD extract and it was produced in equipment that was previously used for another strain that contains other compounds, such as CBG, CBD or even traces of THC extract, there is a high probability that it will still contain these compounds as well as possibly other contaminants unless it was properly cleaned.” Mackay’s discussion highlighted the importance of safety and health for workers throughout the workflow as well as the end consumer.

Jeffrey Raber, Ph.D., chief executive officer of The Werc Shop, examined different testing methodologies for different applications, including potency analyses with liquid chromatography. His presentation was markedly unique in proposing a solution to the currently inconsistent classification system for cannabis strains. “We really do not know what strains cause what physiological responses,” says Raber. “We need a better classification system based on chemical fingerprints, not on baseless names.” Raber suggests using a chemotaxonomic system to identify physiological responses in strains, noting that terpenes could be the key to these responses.

Cynthia Ludwig welcomes attendees to the event.
Cynthia Ludwig welcomes attendees to the event.

Dylan Wilks, chief scientific officer at Orange Photonics, discussed the various needs in sample preparation for a wide range of products. He focused on sample prep and variation for on-site potency analysis, which could give edibles manufacturers crucial quality assurance tools in process control. Susan Audino, Ph.D., chemist and A2LA assessor, echoed Wilks’ concerns over sample collection methods. “Sampling can be the most critical part of the analysis and the sample size needs to be representative of the batch, which is currently a major issue in the cannabis industry,” says Audino. “I believe that the consumer has a right to know that what they are ingesting is safe.” Many seemed to share her sentiment about the current state of the cannabis testing industry. “Inadequate testing is worse than no testing at all and we need to educate the legislators about the importance of consumer safety.”

46 cannabis laboratories participated in The Emerald Test’s latest round of proficiency testing for potency and residual solvents. Cynthia Ludwig sits on the advisory panel to give direction and industry insights, addressing specific needs for cannabis laboratories. Kirsten Blake, director of sales at Emerald Scientific, believes that proficiency testing is the first step in bringing consistency to cannabis analytics. “The goal is to create some level of industry standards for testing,” says Blake. Participants in the program will be given data sets, judged by a consensus mean, so labs can see their score compared to the rest of the cannabis testing industry. Proficiency tests like The Emerald Test give labs the ability to view how consistent their results are compared to the industry’s results overall. According to Ludwig, the results were pleasantly surprising. “The results were better than expected across the board; the vast majority of labs were within the acceptable range,” says Ludwig. The test is anonymous so individual labs can participate freely.

The AOCS cannabis working groups and expert panels are collaborating with Emerald Scientific to provide data analytics reports compliant with ISO 13528. “In the absence of a federal program, we are trying to provide consistency in cannabis testing to protect consumer safety,” says Ludwig. At the AOCS annual meeting, many echoed those concerns of consumer safety, proposing solutions to the current inconsistencies in testing standards.

Marijuana Matters

Let’s Talk CBD

By David C. Kotler, Esq.
2 Comments

Let’s talk about cannabidiol, CBD, a non-psychoactive component of cannabis. Let’s not talk about CBD from the whole plant. This is a conversation about the proliferation of hemp-based CBD marketed everywhere from gas stations to specialty health and wellness stores. Heck, “its legal in all 50 states”, right?

On the Federal Level, pursuant to Title 21 USC 802 Section (16) The term “marijuana” means all parts of the plant cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. The term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

Proponents of the position that hemp-derived CBD is legal point to the lack of a specific definition under the above description (often asserting that their oil is not processed from the flower) and the Ninth Circuit’s opinion in Hemp Indus. Ass’n v DEA, 333 F.3d 1082 (9th Cir. 2003). They buttress their belief by citing the DEA’s clarification of hemp in the Federal Register released in October 2001 and the 2013 Farm Bills’ adoption of the following definition of industrial hemp (adopted from plant scientists research in the 70’s: “The term ‘industrial hemp’ means the plant, cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol H. R. 2642—265 concentration of not more than 0.3 percent on a dry weight basis.” Much of the foregoing has been extended to even support opinions that hemp-derived CBD from domestic sources under the 2013 Farm Bill is legal for distribution nationwide.

Opponents of the hemp-derived CBD is legal argument (putting aside the issues with imported hemp and contaminants, etc.) point to the exception in the definition of “marijuana” i.e. to actually get a workable form of CBD from hemp, the preparation of the stalk puts you into the resin category which is excepted from the terms that are specifically not included in “marijuana.” In regard to HIA v. DEA cited above, opponents posit that the court decision, never mentions CBD, and the HIA maintain that this ruling did not legalize CBD.

In February 2015 and again in February 2016 the FDA issued warning letters to CBD companies. The overall context of the letters dealt with mislabeling and improper claims in addition to the most recent round of letters addressing CBD products’ exclusion from the dietary supplement definition under the FD&C act and how that is affected by CBD’s consideration as a new drug in one or more new drug applications. What has not been addressed or asserted by the FDA is the legal status of CBD under the Controlled Substances Act.

Although I have seen many commentators and attorneys opine on the legality as the case may be of hemp-derived CBD and its ability to be shipped to and sold in all 50 states (often with a caveat that readers should consult them for further advice), I have never seen the issue addressed from a practitioner that deals with the United States Patent and Trademark Office. I am not that practitioner. However, I do represent a company that has recently made application. I, not being a trademark attorney, but being sensitive to the federal government’s position collectively on CBD, found the examiner’s questions in her Office Action Letter surrounding CBD to be quite interesting. They were as follows:

  1. Do applicant’s identified goods contain marijuana, marijuana based preparations, or marijuana extracts or derivatives, synthetic marijuana, or any other illegal controlled substances?
  2. If the applicant’s goods contain Cannabidiol (CBD), is this derived from marijuana or from industrial hemp?
  3. Are the applicant’s goods lawful pursuant to the Controlled Substances Act?

I searched for another application and Office Action Letter from 2016 for another CBD product (both were vaporizer products rather than the lotions, balms, etc. that have been the subject of other applications). The questions to that applicant mirrored those above.

What I take from the questions that trademark examiners are asking is that perhaps the debate raging in academic and legal circles is for naught. It looks like at least the USPTO has resigned itself to there being a difference between cannabis or whole plant and hemp-based CBD in terms of definition and proscription under the federal controlled substances act.

So we have come full circle in my question, ‘Is it legal in all fifty states?’ If you answer yes to that question then please provide me the definition of marijuana/cannabis from the Controlled Substance Act from each of the fifty states individually and a copy of the documentation from a source showing how the industrial hemp was grown and processed and verifiable lab reports of the particular product’s contents.

Wellness Watch

Solventless Flower Oil – The Luxury Concentrate

By Dr. Emily Earlenbaugh, PhD.
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As the high-end cannabis market continues to grow, dispensary owners and product manufactures alike seek to fill the growing niche for high-end, luxury cannabis products.

When it comes to concentrates, many people are looking to rosin to fill this luxury niche. But not all rosin is the same, and poorly processed rosin can range from a dark almost burnt tasting sap, to something that’s almost bright orange in color. A poor rosin experience can leave a bad taste in a consumer’s mouth, and discourage them from trying more in the future.

For dispensary operators looking to expand their luxury concentrates, skip the hair-straightener rosin and look for SFO. When it comes to concentrates, nothing is more luxurious than solventless flower oil (or SFO). Like most luxury items, SFO comes at a higher price point than the average gram of oil. But for those in the know, the price is well worth it.
 
What is so great about SFO?
 

Clean: Most concentrates are made using dangerous chemical solvents like butane or propane. This can leave behind toxic heavy metals. SFO is solventless. It is made using a modified Rosin process, which uses only low heat and pressure in the extraction process.

Made From Flowers: Safety is one huge bonus of the method, and I always suggest that patients and recreational users alike avoid concentrates made with solvents. But SFO is also special in that it is made directly from the flowers of the cannabis rather than the trim, hash, or kief, and the process preserves the flowers’ natural terpenes.
 
Feels Better: Terpenes are the compounds in cannabis that give it its smell and taste. Each strain has a unique smell and taste because of it’s terpenes. They also affect the feel of the strain. If you love the way sour diesel tastes and feels, but hate lemon haze, it’s probably because of the terpenes in each.
 
Terpenes can also modify the effects of THC, lessening some of its negative side effects like accelerated heart-rate, paranoia, dry mouth and mental confusion.
 
In most extraction processes, most of the flower’s natural terpenes are destroyed. If you have ever excitedly bought a concentrate of your favorite strain only to find that it doesn’t taste or feel like the flower, it is likely because the terpenes weren’t retained.  
 
Smells and Tastes Amazing: SFO has unprecedented natural terpene retention. This means it tastes incredible and feels like the flower it was made from.
 
Pressed at Low Temperatures: It’s important to note that not all Rosin is SFO. SFO is made using lower temperatures than the hair straightener and t-shirt press rosin that has flooded the market. High temperatures burn off the terpenes that make SFO so delicious. So, if you are making a purchase for your dispensary and you want a concentrate that will really knock your customer’s socks off, make sure the rosin is pressed at low temperatures and made from flower, not hash or kief.
 
Best Terpene Retention: When checking terpene analytics, beware of concentrates that have terpenes added back in. While we can isolate the terpenes we know about, we have only researched a subset of the terpenes in the cannabis plant. If we want to recreate the effect of a particular strain, we need to know all the compounds in it or the recipe won’t be right. Rosin with terpenes added back in tends to taste artificial and take on a brighter orange hue.
 
The most effective way of getting complex flavors and effects like those in the flower, is to preserve the compounds as they are in nature. That is exactly what SFO does.
 
If you are looking for that luxurious concentrate, SFO is bound to be a crowd pleaser with its potent, pleasant effects and clean, fragrant taste. Like many luxury items it is also rare, so finding a good supplier can be tricky.
 
For a great tasting SFO in CA, try out Fleurish Farm’s line of SFO. These Sonoma County rosin makers have perfected the art of terpene retention. Each flavorful option has a unique and complex aroma. And their terpene percentages are some of the highest around ranging from 3-9%.
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BEST Extractions

Busting the Myth: Examining CO2 versus Butane Extraction

By John A. Mackay, Ph. D.
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The basis of anecdotal controversy continues about the use of hydrocarbons versus carbon dioxide. It is important to note that hydrocarbons span a range of phases on the planet earth.

It is important to eliminate the cost of the instruments and the cost of the facilities from this comparison to keep the discussion on specifically the extraction principles.

Source: (https://en.wikipedia.org/wiki/Butane#Isomers)
Source: (https://en.wikipedia.org/wiki/Butane#Isomers)

Butane is a gaseous hydrocarbon. As you add more carbons to hydrocarbons, they move from gaseous to liquid.

It is also important to note that the same is true of carbon dioxide in its natural form on the earth’s atmosphere, it is a gas. It is nonflammable and used in fire extinguishers.

At typical conditions, carbon dioxide in the supercritical range is similar to hexane (C6H14) and ethyl acetate in its solubility characteristics. Propane (C3H8) and butane (C4H10) are gases at normal atmospheric conditions. Both must be manipulated for the extraction of CBDA and CBD. For example, both CO2 and C4H10 must be placed under pressure and then passed through the material to extract the lipophilic terpenes and cannabinoids.

For this short discussion, let’s remove the concern about the different volatilities of the compounds. Hydrocarbons with a spark will be significantly more powerful of an explosion than carbon dioxide (note it could be used to put out the butane fire). The hydrocarbons can be in more configurations and therefore the getting the correct form initially is critical. For example, butane can have all the carbons in a row like a train, or branched like a tree. Those are very different and have different characteristics too. Getting pharmaceutical grade butane is essential to ensure safety. The concern that people have expressed with butane is what is in the other 0.1% for 99.9%. Checking for residual butane is less of a concern than the polyaromatic hydrocarbons in the untested cylinder. Furthermore, in the wrong hands it can be more volatile.

Source: (https://en.wikipedia.org/wiki/Carbon_dioxide)
Source: (https://en.wikipedia.org/wiki/Carbon_dioxide)

The critical premise that needs to be considered is the final formulation. Is one solvent significantly more applicable than the other? No. They have different characteristics.

Propane is a common solvent in the spices, flavors and fragrances industry. For example, the extraction of lipids and oils from vegetables and the fatty oils from seeds, it would be an advantage to have a solvent that is totally miscible, i.e. will be totally soluble in a fluid. This is similar to the idea of sugar in hot water versus in water in ice. If an example of cardamom were used comparing CO2 and propane (which is similar to butane), the pressure needed for CO2 would be 100 bar, while propane would be only 20 bar. However the increasing the pressure of the propane from 20 to 50 bar at a constant 25 C, also increases the chlorophyll from 3.4 g/g oil to 10.8 g/g oil. Meanwhile with the more finely tunable CO2 from 80 to 100 to 200 the amount of chlorophyll is negligible (0.36 g/g oil) but at 300 bar it dramatically increases to 4.53 g/g oil.

Additionally the CO2 is a better extraction for the terpenes in the cardamom. The beta-pinine, Cineole, linalool, alpha-terpinol and bornelole. The increase in the propane pressure will allow us to increase the yield of the CO2 (Illes, V, et. al. Proceedings of the Fifth Meeting of Supercritical Fluids, Nice, France, Tome 2, 555-560).

This example is the same with the butane and cannabis. Butane is a stronger solvent and if left too long will continue to pull out more and more polar compounds like chlorophyll. With the fine-tuning of CO2, you can eliminate or you can pull out the chlorophyll if you choose the wrong conditions.

So fast extractions are possible with butane but little control of all the material, while CO2 can be tunable and therefore is able to collect all of the same material, just through a segmented process.