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

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

• This refers to how efficient the extraction process is in terms of yield and energy consumed.
• CO2 Cannabis Extraction machines have high yields while Ice Water Extraction is more suited for small scale use.

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

• This refers to the level of human intervention required for the machine. Machines can be manual, semi-automatic or fully automatic.

Research Strategy

New Machines

Pros

• New machines can make use of processes that do not require chemicals such as ethanol for hemp removal. New machine designs can take advantage of the trial and error of past machines and develop custom modifications to address old problems such as bushy plants clogging the machines and causing mechanical problems such as fires and blockage.
• New machines are made to be more environmentally friendly than traditional machines that have to be upgraded or refurbished. New machines have more torque and are better able to break the hemp stalk without the issues of older used machines.
•  New machines and technologies transform the traditional processes of hemp oil extraction and new products such as those offered by Hemp Harvest innovations that have faster processes with "more throughput and decreased costs".
• New machines have the advantage of technological innovations that allows for increased production. An example being the machines produced by PureHemp Technology growing production from 1,2000 pounds of dry, raw hemp per day to now processing 4 tons per day and expectations that, that will increase to more than 40 tons per day by 2021.

Cons

• Comparison of the prices of new and used machines show new machines are considerably more pricey than used machines. New combines can cost hundreds of thousands of dollars, and specialized equipment manufacturers are very few in North America.
• New machines may still have to be modified for the individual farmer's needs, however HempFlax's double cut combine and the increasing number of companies starting to focus on machines specifically for hemp production will start to counter that need.

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

• Customers that buy or used or modified machinery may need to consult with an equipment manager in order to come up with individualized needs to harvest hemp.
• Used machines may get jammed up by the fibers and need to use a decorticator which can cost about $300,000.

Companies That Sell Used Machines

Aaron Equipment

• The company has one of the largest selections of new and used marijuana extraction machinery from major manufacturers, and they add new items every day so the inventory is constantly changing. Customers can feel comfortable knowing they are purchasing from a vendor with an 80+ year old reputation for "professionalism and expertise committed to providing unparalleled service.
• Aaron's terms and conditions makes a disclaimer of all warranties of goods that are purchased "as is" and "with all faults", and the company makes no representation of a warranty. The company strongly recommends buyers conduct an on-site inspection of goods and cannot be held responsible for a prior lack of inspection. Buyers also absolve Aaron's from any responsibility of used goods after purchase.
• The company has an online "Sell Us Your Equipment Form" where sellers enter their name, company name, phone number, state, a description of the equipment being sold, asking price, and upload pictures. The buying department is responsible for reviewing the submissions.
• The company offers replacement parts that are engineered and manufactured to the original company expectations and reduce maintenance and improve uptime. Paul O. Abbe has provided most of the parts for over 50 years, and also completely refurbishes or rebuilds Paul O Abbe process equipment.
• The staff of Service Technicians, Mechanical and Process Engineers provide "installation oversight, machine inspection, process recommendations and parts and maintenance recommendations".

HempFlax

• HempFlax provides used equipment as part of the company's "environmentally friendly approach". The used equipment is refurbished and upgraded to HempFlax's standards that are continually refined to provide even better products with a smaller environmental footprint.
• The machines are comprised of 96% John Deere components and can be serviced by the 2,000 John Deere dealers and specialists around the world. HempFlax makes arrangements with the specialists and provides support and specific knowledge, but if more specific service is required it is taken over by GroeNoord.
• There is no information regarding warranties or guarantees from the company in regard to the equipment. The company's general terms and conditions state that HempFlax guarantees that the goods correspond to the agreement and specifications stated in the offer but does not give guarantees regarding the usability of the goods for the intended purposes of the buyer. The purchaser guarantees the accuracy and completeness of the specifications and other information they provide for HempFlex to base the offer.

NuAxon Bioscience

• The company was founded on May 25, 2012. The company is headquartered at 899 S College Mall Rd Unit 161, Bloomington, Indiana and has strong ties to India and herbs from the Ayurvedic tradition through the ownership of three certified organic farms in the "richest agricultural areas in India".

Pros

• The company supplies "the biggest names in the Natural product industry" with its super-premium ingredients that are sourced from its own certified organic farms and from an organic co-op that the company founded with local farmers to ensure the farmers get fair prices for their work.
• The company practices ‘Just in Time Production’ by only producing extracts on demand ensuring the freshest and most potent products. The full in-house R&D lab provides customers a low cost way to test ideas before investing in a full production run, and the QA and QC departments provide further peace of mind to customers.
• The machines use a single-step extraction tailored to achieve highly concentrated products, "extracts and spent biomass are free of solvent residues", mild temperatures ensures product stability and quality, among other benefits.

Con

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

Precision Extraction

• The company was founded in 2011. The company headquarters is located at 2468 Industrial Row Dr, Troy, MI 48084. It has a California Showcase located at 2230 S Fairview St, Santa Ana, CA 92704.

Pros

• A benefit of buying from this company is the knowledge and comfort that the products come from an award-winning company known for its quality equipment and technology. Precision Extraction was awarded the 2018 Best in Equipment and 2019 Best in Technology by Green Entrepreneur Top 100 Cannabis Companies.
• The company has partnered with top and reputable companies such as Rivers Innovations and Cascade Sciences among others. Precision Extraction has "unparalleled tech support and customer service" and is the "world's only provider of turn-key extraction labs".
•  Reviews support the high customer service perceptions of Precision Extraction. A review states the company went above and beyond to help them with their order even after numerous questions and changes and adjustments they made to the order.

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

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.”