Hemp Content

Part
01
of four
Part
01

Non-Winterized CBD

CBD oils present multiple health dangers, including a variety of potential side effects, and unknown consequences from unregulated and untested products. Specifically for non-winterized CBD oils, potential health hazards could include wax build-up in the lungs and throat irritation. Specifically for winterized CBD oils, potential health hazards could arise from solvent contamination, consuming too-potent substances, and not getting the health benefits from the substances removed during the processing.

Potential Harmful Effects of CBD Oils

Unknown Risks from Unregulated/Untested Products

  • CBD oils and other products (for consumption, smoking, or vaping) are currently “under scrutiny on many levels” by the FDA (Food and Drug Administration), WHO (World Health Organization), and multiple other global and US organizations, since so much of it is being released to the public without proper research and vetting, and there are a very limited number of studies having been conducted on it and its effects (both positive and negative). Notably, “the risks to be assessed about CBD products may not have much to do with the pure compound CBD itself, but more with the unknown composition and quality of the products offered.”
  • Additionally, since the source hemp used in production could also be “contaminated with various harmful substances, sometimes leading to severe health issues or hospitalization,” there is inherent danger in consuming or smoking these products. Ensuring that consumers purchase products from only reputable companies with their own research base and proven high-quality methodologies is key to selecting the best oils for consumption.
  • One of the biggest contaminants is pesticides used on the source hemp; its presence there means that it will be likely to end up in the end-product (CBD oil). Other contaminants that were added to the source hemp may include “heavy metals, molds and bacteria, [and] aflatoxins,” all of which could present health issues in those consuming or smoking the oils.
  • Another issue is lack of clear or correct labeling on these products. One recent study in the Netherlands (where all hemp products are legal) showed that “the analyzed cannabinoid content strongly differed from the claimed content on the label,” so consumers may not be able to trust what’s actually in the CBD oil they are consuming.
  • Although this doesn’t apply strictly to non-winterized CBD oils, it is still a danger in all consumable CBD oil products.

Possible Side Effects from CBD Oils

  • General side effects that can come from consuming or smoking CBD oil are “nausea, fatigue, and irritability.” Gastrointestinal issues are also possible for consumers of CBD oils, as is dry mouth, loss of appetite, and light-headness.
  • Additionally, consuming CBDs can increase the Coumadin levels in the bloodstream; since Coumadin is a blood thinner, this could present problems for those already on medications. It works via the same mechanism that grapefruits have, and thus, are a danger to those already taking blood thinner medications.
  • Early research has indicated that those with Parkinson’s disease should not consume CBD oil as it could exacerbate the symptoms of the disease.
____________________________________________

Potential Harmful Effects of Smoking/Consuming Non-Winterized CBD Oil

Possible Build-Up of Wax in the Lungs

  • According to HotJuice, “While there are no formal studies to refer to in order to draw a conclusion, it can be assumed that the removal of the waxes in the CBD substance helps prevent the eventual buildup of residue inside the lungs.” Although they are specifically talking about vaping, which uses lower temperatures and can cause increased wax build-up, this could also apply to smoking the product, as well.

Possible Throat Irritation

  • Winterizing (and other refinement processes, like de-waxing) remove the fats, waxes, and lipids from the end-product. Without removing these, the end-product goes through the process of nucleation, wherein “the waxes and fats actually alter the chemical make-up of the concentrate over time and exposure to elements.” This changes the appearance of the end-produce (making it cloudier), affects the smoothness and flavor of the product, and because “waxes and lipids are not too great to inhale as a vapor,” they “can cause harsh hits that irritate your throat.”
____________________________________________

Potential Harmful Effects of Smoking/Consuming Winterized CBD Oil

Possible Contamination from Solvents

  • Because winterizing uses chemicals, like ethanol, the process can leave behind solvent residue. If additional processes (like short-path distillation) are not used after winterization, then some of the solvents can be left in the product, which would be ultimately harmful to the consumer’s health. Notably, however, one expert notes that using a rotary evaporator for the winterization will “effectively purge ethanol from the concentrate.”

Possible Too-High Potency Levels

  • Since winterizing (and other distillation and refinement processes) create the purest and highest quality CBD oils, those not adept (or trained) in proper dosing could take more than is necessary to address the health concerns for which they are taking the medicine. Some experts note, however, that even at its highest purity, CBD oil should be considered safe.
  • The process of winterization “creates a far superior oil with much higher potency than non-winterized oil.” These products are often highly concentrated “thus having a greater effect on the user,” so ensuring overconsumption doesn’t happen is important.

Possible Removal of Beneficial Substances

  • Some experts believe that winterizing (and other refinement processes) removes beneficial substances from the end-product. One of these is the terpenes (which causes the odor and taste).
  • Terpenes are known to provide consumers with a variety of health benefits, including anxiety and pain relief. When inhaled, they “carry the potential to affect animal and human behavior”. Notably, terpenes are helpful for depression, epilepsy, cancer and heart disease, and fungal and bacterial infections.
____________________________________________

Research Strategy

Notably, there have been no studies done on smoking (or vaping) CBD oil to “determine what health risks may be associated” with the practices, so the information available on potential risks or harmful effects is mostly anecdotal. Other studies (mostly global) have been conducted on CBDs, but not very many, and none specific to this request. Because of this, there was very little information available that was directly relevant to this specific type of treatment in the CBD oil-creation process. To best answer this question, we identified any/all negative effects noted specific to the winterization process (and/or the avoidance of it during oil creation), and combined those with the identified negative effects of CBD consumption itself.

On this research journey, we also identified several potentially harmful effects of smoking/consuming winterized CBD oil, so we have provided those for you, as well.

Part
02
of four
Part
02

CBD Oil Extraction Machines (Part 2)

The cost of production, the effectiveness of the extraction process, and the yield in terms of quality and quantity are the key factors to consider when buying a CBD oil extraction machine. Below is an overview of the findings.

Differences Between Manual, Semi-Automatic and Fully Automatic CBD Oil Extraction Machines

  • The main difference between manual, semi-automatic and fully automatic CBD oil extraction machines is the level of human intervention required. Manual machines constantly require human intervention, semi-automatic machines require human intervention at intervals, and fully-automated machines require no human intervention once the process is started.

Meaning of Certifications/Approvals/Stamps

FDA Approved and FDA Cleared

  • FDA approval means that the Food and Drug Administration (FDA) has determined that the benefits of the product in reference outweigh the known risks for the intended use.
  • FDA clearance means the manufacturer can prove that their product is "substantially equivalent to another (similar) legally marketed device" that the FDA has cleared or approved.

3A Sanitary Standards

  • The 3-A Administrative Symbol Council represents both the USDA and the FDA as 3-A Sanitary Standards, Inc, also known as 3-A SSI.
  • 3-A SSI's mission has two main standards and practices. These standards and practices are: "1) to protect food meant for human consumption from contamination and 2) to guarantee that all product contact surfaces can be mechanically cleaned and dismantled manually for thorough inspections."

Current Good Manufacturing Practice

  • The Current Good Manufacturing Practices consists of FDA's "formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities."

American Society of Mechanical Engineers (ASME) Certification

  • ASME certification and accreditation "certifies that stamped items conform to ASME standards, including the ASME Boiler and Pressure Vessel Code (BPVC), the Bioprocessing Equipment (BPE) Standard, and/or Reinforced Plastic Corrosion Resistant Equipment (RTP-1) Standard."

How A Water Vapor CBD Oil Extraction Machine Works

  • This extraction method uses steam to separate the CBD oil from the hemp plant.
  • The main components of this method are the boiler, the distillation tank, the condenser, and the collecting flack.
  • The distillation tank contains the plant material. Water is heated in the boiler and the steam produced accordingly travels upward to the distillation tank. In the distillation tank, the oil vapors that contain CBD are separated from the plant material due to the steam.
  • The vapors are captured in a tube and condensed into oil and water. In the collection flask, the CBD oil is separated from the water through distillation.

Price Ranges For CBD Extraction Machines

CO2 Cannabis Extraction

  • The cheapest extractor available is the OCO Labs’ SuperC extractor which costs $4,000 while the most expensive is the Apeks Supercritical CO2 System which costs $445,000.

Ethanol Cannabis Extraction

  • The cheapest extractor available is the Source Turbo which costs $599 while the most expensive is Across International Rotovap which costs $19,470.

Hydrocarbon Cannabis Extraction

  • The cheapest extractor available is the Ablaze Mini Closed Loop Extractor which costs $510 while the most expensive is The Io Extractor which costs $225,000.

Water Vapor CBD Oil Extraction

  • The price of water vapor CBD oil extraction machines ranges between $15,500 and $2 million.

Key Factors to Consider When Buying CBD Oil Extraction Machines

  • The main factors to consider when buying CBD oil extraction machines include the cost of the machines, the effectiveness of the extraction process, and the final product yield. The different extraction methods also have different features that have pros and cons.
  • Although CO2 Cannabis Extraction machines are not the cheapest machines, they have high yields.
  • Ethanol Cannabis Extraction is cheaper but ethanol is highly flammable and a change in temperature can significantly change the final product thus it is not the safest method.
  • Hydrocarbon Cannabis Extraction is effective but the method can be undesirable for medicinal products because of the risk of contamination.
  • The advantages of the Ice Water Extraction include its simplicity, it is cheap to run and maintain, and it does not use harmful chemicals. However, this method is more suitable for small scale use than commercial use.

Key Features to Look for When Buying CBD Oil Extraction Machines

1. The Extraction Machine's Safety Profile

  • The safety profile of a machine defines how safe it is to operate the machine.
  • The different CBD oil extraction methods have varying levels of safety. Ethanol Cannabis Extraction is not the safest because it is highly flammable. The Ice Water Extraction, on the other hand, is extremely safe as it involves putting the plant material in ice water and then filtering it.

2. Processing and Commercial Capacity

3. Certifications

  • This indicates that the extraction methods of choice has passed all scrutiny and is deemed safe for manufacturing products fit for human consumption. It includes FDA clearance, FDA approval, 3-A SSI and the Current Good Manufacturing Practices regulations.

4. Automation of the Process


Research Strategy

We began our research by searching for readily available lists on the websites of leading publications and industry databases. During our search we noticed that not all factors requested were present in one source, therefore, each item was researched separately and compiled in the findings above.
Part
03
of four
Part
03

CBD Oil Extraction Machines (Part 3)

Smaller farmers benefit more in the industrial CBD oil extraction businesses by purchasing used machines that are significantly less in expense than the larger machines that are as capable for small lots. Large-scale farmers should buy new machines to avoid the issues that arise with smaller and older machines such as clogs that can lead to fires. Information regarding the pros and cons of new and used machines, companies that sell used oil extraction machines, and information regarding NuAxon Bioscience and Precision Extracting is provided below.

New Machines

Pros

Cons

Used Machines

Pros

  • Farmers already in the grain business can repurpose their existing machines to handle industrial hemp farming for tilling, planting, and harvesting.
  • Purchasing used machines can save customers significant money and are already modified for hemp cultivation.
  • Machines specific to hemp harvesting is lacking in North America due to the infancy of the industry. In addition, it makes sense for farmers with small plots of 10 acres or less to invest in used equipment instead of expensive new machinery.

Cons

Companies That Sell Used Machines

Aaron Equipment

HempFlax

NuAxon Bioscience

Pros

Con

  • Customer reviews and technical publications that review the company do not reveal any cons.

Precision Extraction

Pros

Con

  • The company may be costly especially depending on the project, and that causes some customers to downsize their orders but they still deal with the company.
  • The company has a 4.8/5 rating on Facebook and there is only one negative review that was not about the product.
  • Glassdoor reviews gives cons of the company to be the constant pivoting to remain an industry leader in light of the overall industry growth and constantly changing regulations.

Strategy

NuAxom Bioscience and Precision Extraction Solutions did not have many readily available customer reviews regarding the cons of buying from the specific vendors. Some reviews were provided on Precision's Facebook page and employee reviews on Glassdoor, however there were no reviews for NuAxom on either of these platforms.

As another strategy to find cons of NuAxom, we searched for articles regarding the company in industry-related publications such as Marijuana Business Magazine, Forbes, and Global Newswire among others, but this search did not yield any information.

An additional strategy we attempted was a search for the comparison of NuAxom and other companies like Precision to identify possible cons of the company, however, there were no such comparisons available.

As a final strategy to identify cons of NuAxom we searched for the company's annual report and other publications that may provide insights as to what the company feels they could perform better at, however, no annual report was found and this search did not reveal any other information.

The lack of information of cons for AuXon is likely due to the fact that the company is at the forefront of the industry and is acknowledged that its products are the "best in the industry", and it is one of only a few companies that make hemp extraction machines to scale.
Part
04
of four
Part
04

CBD Isolate, Part 2

Chromatography is one of the most common methods used for CBD extraction from hemp, especially in larger production operations; it’s typically only excluded in smaller productions with less access to equipment or a safe environment in which to conduct the process. Distillation processes, like short-path distillation and winterization, are used both before and after chromatography, to increase the purity of the end product. The crystallization of CBD is a long process involving a solvent (like pentane) and stirring, heating, and cooling processes.

Chromatography Inclusion or Exclusion

  • There are several primary methods for extracting CBD from hemp; one uses ethanol and another uses carbon dioxide. A third uses hydrocarbons, like butane or propane. Chromatography is used for the extraction / isolation of certain compounds (like the psychoactive ingredient, THC, as well as CBD) from hemp. It also “takes out all the terpenes, which are responsible for scent [and] flavor,” and pulls out all cannabinoids (like THC), as well as removing all/most plant matter.
  • The purification methodology of chromatography separates and purifies chemical compounds “taking advantage of their differences in properties.” This is a “practical and straightforward way to purify a substance from a complex mixture.”
  • Not all methods of isolating CBD from hemp use chromatography, however, it is one of the most common methods in use today. Four of the most common types of chromatography were mentioned in our previous research: supercritical CO2 chromatography, high pressure liquid chromatography (HPLC), flash chromatography, and rotary chromatography. Of these, only the first type does not include the use of “toxic solvents such as pentane or hexane to isolate the product.” Both HPLC and flash chromatography use pentane as a solvent in the process, while a special liquid solvent mix is used in the rotary type.
  • Another method of chromatography used to isolate CBD is called centrifugal partition chromatography, which one researcher stated is “the key to achieving high-purity, high-throughput cannabidiol production.” The same researcher stated that, because of the impact of using solvents and the expensive consumable silica resin, those methods are not ideal CBD production, especially for human consumption, whereas this is not an issue with centrifugal partition chromatography.
  • The choice to use either chromatography or skip it and use only distillation processes (like multiple short-path distillations) seems dependent on multiple factors, including how much product is being used and the equipment available to the engineer/chemist. Of note, using distillation-only processes is significantly cheaper and requires less specific machinery and supplies than chromatography, so it’s ideal for smaller operations. Notably, not using chromatography can result in a less-refined product.

Purpose of Distilling CBD Oil Before/After Chromatography

  • The process of making CBD oil from hemp involves extraction processes followed by distillation procedures (the more of these, the more refined the product) followed by chromatography. Then, analytics are performed to gauge what’s left in the products and other distillation methods may be used to extract other compounds from the distillate.
  • Distillation procedures can take place both before and after chromatography (or in place of for smaller operations), if the engineer/chemist has the equipment and is seeking a truly clarified set of products. In fact, “distillation can be performed multiple times to increase the purity level; it simply depends on what the manufacturer is looking for in terms of the final product.”
  • Short-path distillation, or “molecular distillation,” is one of the most common methods of distillation used in CBD-from-hemp processes, and also one of the most efficient. This process results in cannabis/hemp distillates that can be up to 99% pure.
  • Winterization, another type of distillation process, is also used, often before short-path distillation. As noted previously, this process removes the extras or “undesirable elements” from the CBD oil through an alcohol-and-freezing process.

Additional Purification for CBD Isolate

  • The process for creating CBD isolate starts with extraction processes (like those detailed above). After the initial extraction process, the “concentrated CBD is still full of all the plant material contained in the hemp plant itself.” So, a purifying process is then applied. This includes filtration processes, “where all plant material is filtered out of the extract.” Next, comes winterization, which further removes impurities and which produces the “fine, white powder that is 99% pure CBD.”
  • These filtrations and distillations are repeated until the end-product is as pure as possible.

Crystallization of CBD

  • To crystallize CBD, “the starting material should be extracted CBD that has been winterized and distilled.” It should be clear (without the cloudiness indicative of contaminants), and if it is not, should be re-distilled until it is clear, as “crystallizing oil with contamination will lead to poor yields.”
  • The extracted CBD will then be added to a “glass jacketed vessel with stirring” capabilities that has a heating/cooling bath connected to it to “control the temperature of the vessel.” In some cases, pentane is used as the solvent.
  • Add three parts CBD to one part pentane into the vessel, turn on the stirring mechanism, and set the temperature to 45* C (or 113 *F). Once the solution reaches the top temperature and the oil has dissolved, the temperature will be reduced to 5 *C and the stirring slowed. The solution will cool and become more viscous. Once this happens (it’s called “precipitation”), the stirring is adjusted to a high speed (120 RPM), which will force the CBD crystals to “spontaneously form or ‘crash out’ of the pentane solution.” The temperature is continually reduced for continued crystallization. The growth of the crystals will depend on the temperature used, so testing is necessary to reach optimum crystal production.
  • After the precipitation phase, the CBD crystals can be collected from the vessel, and the slurry removed. The crystals are then rinsed in “ice-cold pentane to rinse impurities from the crystal surfaces.” The more rinses that are used will improve color but reduce yield.
  • If the starting CBD distillate is 70 75% pure, crystallizing can produce isolate that has a purity rate of 90% or higher. If the starting distillate is less than 70%, the crystallized isolate will have 85+% purity. “CBD crystals can be redissolved and then recrystallized to improve the potency even further.”
Sources
Sources

From Part 02
Quotes
  • "There's a big distinction between a drug or medical device that's been FDA approved and those that are FDA cleared"
  • ""FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use." Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval."
  • "Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval"
Quotes
  • "The main standards and practices that adhere to 3-A SSI’s mission are 1) to protect food meant for human consumption from contamination and 2) to guarantee that all product contact surfaces can be mechanically cleaned and dismantled manually for thorough inspections"
Quotes
  • "Current Good Manufacturing Practices (cGMP) are the Food and Drug Administration's (FDA) formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities"
Quotes
  • "ASME’s Conformity Assessment program is the leading, universally recognized, independent Quality Assurance (QA) program that certifies that manufacturing, power generation, stamped products and parts fulfill the requirements of relevant ASME codes and standards"
  • "It certifies that stamped items conform to ASME standards, including the ASME Boiler and Pressure Vessel Code (BPVC), the Bioprocessing Equipment (BPE) Standard, and/or Reinforced Thermoset Plastic Corrosion Resistant Equipment (RTP-1) Standard"
Quotes
  • "With steam distillation, steam causes the CBD oil to separate from the hemp plant. "
Quotes
  • "And just like any other piece of kit, an inevitable question arises when considering extraction machines: which one’s the best value for money"
  • "CO2 might not be the cheapest solvent going, but its benefits can be worth the price tag."
  • "alcohol is one of the most commonly used solvents for cannabis extraction."
Quotes
  • "OERS equipment from Cannabis Oil Tech, for example, can run for hours or even for days without the need of an operator"
  • "Equipment can be fully automated and operated by a touchscreen interface that will start the automatic extraction process"
From Part 03