CBD is largely an unregulated field globally. Consumers have no solace in the oversight of government industries to guarantee the accuracy of the CBD content on the labels of the products they buy or absolute confidence these products do not contain THC in products that advertise they are THC free or comply with local legal standards relevant to THC content or absence thereof.
Because of a lack of regulation, there is little to keep unscrupulous companies from taking advantage of an unwitting public. A US study, for example, showed that 7 out of 10 CBD oil products did not contain the amount on the label and one in five contained THC when the product was labeled to contain only CBD. Another study done in 2017 showed 70% of products to be mislabeled.
Is CBD Product Labeling Regulated?
Examples of organizations that can provide oversight CBD COA quality control
International Laboratory Accreditation Cooperation (ILAC)
The standards for CBD accreditation followed are put out primarily by the International Laboratory Accreditation Cooperation or ILAC. ILAC stresses international consistency for performing CBD/THC analysis and lists the responsibilities of the manufacturer in producing what is called a Certificate of Analysis. The organization also calls for greater standardization of methodology and conformity to a standard of quality. While other organizations exist for accreditation, ILAC is by far the most credible accreditation facility internationally.
InterAmerican Accreditation Cooperation (IAAC)
In the US (as well as internationally) the InterAmerican Accreditation Cooperation or IAAC is one of the largest corporations responsible for stressing the consistency of lab testing and equipment calibration procedures.
Currently, testing is not regulated or standardized despite the encouragement to get accredited. This leads to a variability in testing results from lab to lab even with the same sample. Needless to say, not only is this a safety concern for citizens it is a legal issue for those companies who must remain in compliance with the THC level restriction. These two are just two examples of several groups encouraging standardization and calibration.
CBD Lab Accreditation
Labs can go through an accreditation process which involve a mandated core training program, a documented quality assurance program and the payment of a fee. ILAC would like to see a standardized training program in place with everyone using the same testing procedure with quality control procedures set up for equipment calibration. Equipment calibration involves ensuring the equipment is testing a sample correctly according to a predefined “test sample” and that all equipment parts are in working order according to manufacturer’s guidelines.
It also means that it is difficult, if not impossible, to obtain a COA with the pertinent chemical breakdown of the CBD product for all elements the ILAC or other accrediting bodies would like to make standard on a testing label. Currently, regulations for what goes on a COA may be state specific in the case of the US or governed by other local regulations pertinent to the area of the country where the product is being tested.
ISO/IEC 17025:2017 and CBD COA Regulation
Laboratories conducting testing of cannabis products need to adhere to general competence, consistency and impartial organization of all laboratories under the ISO/IEC 17025:2017 requirements which mandate all labs become compliant with by the year 2020. In most countries, ISO/IEC 17025 is the gold standard by which most labs must hold accreditation in order to be determined technically competent. Implemented in 1999 it is considered the most comprehensive standard in the world for lab testing and equipment calibration. More than 50,000 labs are accredited under this provision globally.
Current studies support the notion of strict and standardized testing.
What is a Certificate of Analysis?
This is a quality assurance document that indicates that a regulated product contains what it says it contains and meets product specifications. For CBD a Certificate of Analysis (COA) should contain the contents of the product including total cannabinoids, microbiological levels, terpenes, and possible contaminants such as pesticides, solvent residue or heavy metals. This information does not always come conveniently packaged in a single report but is often shown on several reports.
How Do You Read A COA?
The first part of the COA will tell you basic information. The first thing to notice is that the lab is not the manufacturer, it is a third-party lab. The name of the lab is not the name of the customer. The total THC is listed as well as the CBD content. The bar graph square is called a QR code which tells us that a third party did the testing which makes it difficult to falsify reports. You can also see that the laboratory is different than the customer again indicating third party testing. Using the QR code on the product one can scan it into their phone and get the COA directly that way.
What does LOQ mean?
Also found on this COA is the specimen type, the type of product, the batch creation date, and, hopefully, the expiration date. The total THC is listed as well as the CBD content for the label posted in Sample 1. You might notice the term “LOQ” on the COA for Samples 1 and 3. This refers to “limits of quantification”. That is the lowest substance concentration that can accurately be detected with the testing method used.
Other important definitions that you should know
LoD (Limit of Detection), LoQ (Limit of Quantitation), and LoB (Limit of Blank) are scientific terms that are used to describe the smallest concentration of a measurand that can be reliably measured and calculated by an analytical procedure.
What is the difference between LoD, LoB, and LoQ?
- LoD is the lowest analyte concentration likely to be reliably distinguished from the LoB and at which detection is achievable. LoD is determined by utilizing both the measured LoB and test replicates of a sample known to accommodate a low concentration of analyte.
- LoQ is the lowest concentration at which the analyte can not only be reliably identified but at which some predefined goals for bias and imprecision are reached. The LoQ may be equivalent to the LoD or it could be at a much higher concentration.
- LoB is the highest apparent analyte concentration expected to be located when replicates of a blank sample containing no analyte are tested.
(Each sample COA is labeled and come from different CBD products)
The batch numbers are important should there be a problem with the product that needs reporting. The lot number and expiration date do not show. This is another reason for standardization.
THC vs. CBD
This lab identifies that the THC is below the legal cut-off for the presence of THC in this product and delineates the dosage of the CBD per unit of measure. This product is below the UK cut off of .2% THC and the US cut off of .3%. This information be found on a separate portion of the COA or listed in with the total cannabinoids. This example is from the COA of a broad spectrum product.
There are over 100 cannabinoids but only the ones in the product are listed. Individual cannabinoids are found to have unique effects of their own contributing to the synergy of other molecules in the cannabinoid mixture.
For example, if we look at the COA we see CBN listed as one of the cannabinoids. This is probably one of the most researched cannabinoids aside from CBD and THC being known for its ability to induce sleep in its subjects. CBN is a desirable cannabinoid if you wish a more sedating effect or one that may induce a state of rest or sleepiness.
Most Common Cannabinoids (aside from THC/CBD) To Know About
|CBG||Analgesic, anti-inflammatory, bone stimulant, anti-bacterial, anti-parasitic|
|CBC||Analgesic, anti-inflammatory, anti-bacterial, anti-fungal, anti-depressant|
|CBN||Analgesic, antispasmodic, anti-insomnia|
Third Party Testing
Sample 3- Learning from a “Bad” COA
Noticing the conflict of interest
You can easily see from looking at this COA Sample 3 from “Confident Cannabis” that it was not tested by a third party lab. The fine print indicates that it was tested by the dispensary .
It is amusing that even on the label it states “unclear labeling”. It is confusing to determine how many drops are in the bottle since the label says 1 ml = 1.2 ml. In one place there are 54 drops and in another place there are 45 drops.
Calculating the right dose of CBD
This is a good example of how to determine if a lab sample falls within legal limits of THC. It is stated that Delta 9 THC is listed as 2.4 mg/unit with a unit being a 30 ml. Bottle. The CBD content is 10 mg per ml or 300 mg per bottle showing no added cannabinoids besides the CBD (and 0.6 mg CBDa) and a trace amount of THC.
Calculate out 2.4 mg divided by 303.4 mg total cannabinoids = 0.0079 mg THC x 100 (to make percentage) = 0.079 % THC. The amount of THC conforms to legal standards in both the US and Europe.
Full Spectrum Broad Spectrum and Isolate CBD Products
Terminology is important when it comes to THC levels. The two terms, full-spectrum and broad-spectrum are very similar. Yet, full-spectrum means THC is present and broad-spectrum means the cannabinoid profile does not include THC but includes a variety of cannabinoids. A CBD isolate contains only CBD and no THC or other cannabinoids. Sample 3 is a full spectrum product.
Pesticides in CBD oils
You do not want to see any pesticides in your COA report. These are toxic and dangerous. Your best oils and products will be free from these contaminants. Such products are low quality and not worth the health risk. The Environmental Protection Agency or EPA regulates pesticides in the US. Various countries have differing pesticide requirements that each country must abide by.
On the sample 4 COA you can see that the formula contains MCT from Coconut Oil and CBD Hemp Oil. The formulation is important to know for purposes of allergies and safety. MCT are medium chain triglycerides and act as a “carrier” oil for the CBD oil. It is actually a nutritional supplement and is quite safe.
These often originate from the manufacturing process and from the soils. Cannabis buds are particularly rich in heavy metals that they have sucked up through the soil and from contact with any type of manufacturing equipment used in processing the plant. The extraction method itself can contribute heavy metals to the product.
The WHO sets regulations on the amounts of heavy metals that can be present in cultivated crops and you can see the allowed limits on the right-hand column with the left-hand column showing the heavy metals and either ND (none detected) or the actual amount present. In this case, there was a .06 ppm lead concentration in Sample 4. Lead has been associated with poor learning and memory and tends to be a problematic contaminant. The presence of a small amount of lead does not mean the product is unsafe as we have safety standards in place. Lead absorption is a cumulative process, however. Heavy metals may continue to accumulate from contamination from leaking metal coils that seep into the elixir in vape tubes. This is an ongoing quality control issue found mostly in unregulated CBD products. Acceptable metal levels are set by the World Health Organization Food and Agriculture Organization of the United Nations.
Microbes in Hemp extracts
You don’t want them in your food, and you don’t want them in your CBD products. You see on this label both the testing method and the plate counts were provided and limits are in the safe range for that geographical area.
So if in safety area, why include them on the CBD COA?
There are individuals with medical conditions that prohibit them from consuming even “safe” levels of these microbes.
So what should we look for in the microbe test?
ND refers to “none detected” while <10 cfu/g (less than 10 cfu/g) refers to the bacterial colony count for the sample with cfu standing for “colony forming units”. If the level were unsafe it would have been indicated as such but the customer wouldn’t see it because it wouldn’t be allowed on the market. You can view microbial counts in COA Sample 4.
What are considered safe microbiological levels? Each state in the US has its own cut-offs for microbial growth and failed tests are indicated on the COA and do not pass inspection and thus do not make it to market. The COA is an assurance that the tests stated were run and the results passed as either undetectable ND or below the safety cut off.
While molds and yeasts generally may be tested for, an area of contention is that some countries or states do not test for Aspergillus mold, a potentially dangerous mold contaminant of cannabis. You ask why even list the colony counts if they pass inspection? Some people are immunocompromised and cannot stand any contamination. Others do not agree with the limits set in their region. Allergies to mold may prohibit even safe levels to be consumed. And, not all species are tested for and this can be determined by looking at the COA.
What are Terpenes?
Terpenes are a little bit like essential oils. They give your product the aroma and flavor it exudes. Terpenes have beneficial uses just like cannabinoids do, but milder. They contribute to the entourage effect, or the synergism between all the cannabinoids. Terpenes do not act at the CB1 or CB2 receptors and it is assumed that they modulate chemistry in the neuronal circuitry of the behavioral effects of cannabis.
What do terpenes do?
Myrcene and linalool are known independently for their sedative qualities. You can basically pick out a special blend of medicinals for yourself based on the composition of cannabinoids and terpenes.
Regarding anxiety, looking on the COA for terpenes such as linalool, limonene, myrcene, and Β-caryophyllene may help determine if the product may be effective for nervous conditions.
Not all labs test for terpenes, which doesn’t mean they aren’t there, just that they weren’t tested for. The terpene fingerprint may indicate the quality of the cannabis plant and is more reflective of its genetics than its growing environment.
When cannabis is extracted several toxic chemicals can be formed in the process. Testing for solvent residues is paramount to the health of the consumer. For example, if too high of a level of ethanol is left in the residue it can harm the livers of children. Solvents to avoid are any form of glycol including polyethylene glycol (PEG), and propylene glycol (PG). These solvents break down into cancer-causing aldehydes, formaldehyde, and acetaldehyde. PG can aggravate allergies and asthma. Another solvent to watch out for is glyphosate, a cancer causing agent also found in the infamous pesticide “Round Up”. A solvent report can be seen in Sample 6 from Green Leaf Labs. Here in Sample 6 we see a COA with a third party testing and a score of zero for all solvent residues.
So, when you are out shopping for a CBD product, look for third-party lab testing. Remember, its harder to be fooled if you have third party testing. Look at the levels of CBD, THC, and terpenes to determine just the right mixture for you and what you want out of a product. Be wary of products that contain solvents, pesticides or microbial growth as these aren’t good for your health and they represent poor quality control.