The 2018 Farm Bill removed CBD from the controlled substance list as long as the THC levels were less than 0.3%, but the Farm Bill also gave the FDA the authority to regulate CBD and all hemp or cannabis-derived substances. But the FDA hasn’t provided any further guidance to date so the hemp industry, labs, and consumers are flying blind.
At the very least, here at Leafreport we advocate that all CBD products should be rigorously tested to make sure they contain less than the 0.3% amount of THC.
There are hundreds of cannabinoids in a hemp extract along with hundreds of terpenes. Terpenes give hemp and cannabis their distinctive taste and odor and research is just beginning to determine the specific health benefits of individual or groups of terpenes. These components are believed by many to benefit your health through the “entourage effect”—the hypothesized health benefit derived from a mixture of hemp components.
Most facilities test for cannabinoids beyond CBD and THC, including THCA, THCVA, CBDA, CBL, CBG, CBC, Δ8- and Δ9- THC, CBDV and various terpenes including the more common ones like β-caryophyllene, humulene, myrcene, limonene, linalool, α and β-pinene, bisabolol and eucalyptol. As an aside, hemp contains over 200 different terpenes—so this is a short list!
Each product should also be tested and labeled for potency. Most commonly, this is listed either in mg of CBD /mL or serving or as the total amount (in mg) of CBD in a container. Each product should also give you assurance that the amount of THC is less than 0.3% of the total.
Why is this important?
Let’s define two terms you may see in a lab analysis:
Level of Quantitation: the LoQ is the lowest level the substance tested for can be detected in a reliable, reproducible way—in another way of looking at LoQ, it is the lowest level of Contaminant A can be detected without confusing it with Contaminant B
Level of Detection: the LoD has a bit more to do with the specific type of assay used—some assays are more sensitive that others and can detect lower levels of Contaminant A or B.
The LoQ can’t be lower than the LoD—in other words, it has to be detected before it can be counted, but you want to see contaminants as less than the LoQ.
Products should be tested for pesticides such as bifenthrin, diazinon, permethrin, malathion, pyrethrins, and many others (most labs can test for between 50-70 different pesticides). Product manufacturers will want to ensure that these are “below action levels”.
Microbial contaminants include both microbes like bacteria (eg. Salmonella, E Coli), fungus or mold, but can also include microbial products like mycotoxins or bacterial toxins.
The heavy metals most commonly tested for are cadmium, lead, arsenic and mercury—these you definitely want to see listed as <LoQ.
A solvent is a gas or a liquid in which the hemp extract may be dissolved in order to extract the CBD. Most companies use either an ethanol or CO2 extraction procedure, but some earlier portions of hemp processing may involve solvents to, for example, ensure that the levels of THC are below that all-important 0.3% level. These solvents are often dangerous and potentially harmful substances so the testing for residual solvents—another long list—is important in determining safety and quality of the product you end up buying and putting into or onto your body. A “short” list of possible solvents which are tested for include dioxane, acetone, ethylene glycol, ethyl acetate, propane, hexane, methanol and toluene.
We interviewed the head of “Canalysis Laboratories” and the result is a detailed video guide on how 3rd party testing are done and how to get the important information out of the document. Watch the video below:
LR: How does the lack of clear federal regulations and/or consistent state regulations affect the analysis of hemp-based CBD products?
Canalysis: As mentioned above, without standardized methods, regulators must rely on labs to develop reliable methods. This leads to labs having different methods (for both extraction and analysis) that yield varying results. If clients cannot get consistent results from lab to lab, that leads to “lab shopping” where clients pick the lab that gives them the results they want/expect. Also, if regulations are not clear, labs are left to interpret them as they see fit. This often leads to an interpretation that favors clients wants/needs over public safety and public health.
LR: Based on your professional experience and expertise, does the lack of federal standards (beyond the 0.3% THC limit) for hemp testing concern you as either a scientist or potentially as a consumer?
Canalysis: As hemp/CBD products and use become more widespread, we would like to see at least as much regulation as is required for marijuana. Increased regulation would benefit the consumers by not only verifying the potency of the product, but also assuring the safety regarding contaminants. We have tested many CBD products, with varying results for cannabinoid potency compared to the labeling, and have seen high levels of pesticides and heavy metals in some hemp samples.
LR: Would you support labeling regulations so that all labels reported “potency” as mg/dose or mg/mL rather than total amount of CBD in the product? Why or why not?
Canalysis: I would prefer to see labeling guidelines similar to FDA nutrition guidelines (e.g. “Calories per serving” or “Calories per ____”). The total amount of CBD in the container may be handy for a quick review of which product (among similar products) has the highest potency, but additional labeling to show mg CBD per dose (or per one dropperful, for example) would be more useful for the consumer.
LR: Do you see a significant variance in the potency claimed vs. the potency assayed?
Canalysis: It depends on the manufacturer. We have tested products (e.g. edibles) that are very consistent from certain manufacturers. We have also tested products that tested significantly lower (sometimes higher) than the claimed potency on the label. This may be due to errors in calculation when dosing the batch, homogenization of the batch, and solubility/stability of cannabinoids in the matrix (not necessarily due to willful deception).
LR: Technically, what is your greatest challenge in determining quality or quantity in CBD products. Is it in the assays themselves, the equipment, the specificity/sensitivity of the assays? Or, is it with other issues? What techniques are used in your lab and why are they your preferred assay methods?
Canalysis: In the cannabis testing industry, there are two main challenges that we face. The first is research and development to handle odd matrices. We receive many different types of samples, from flower to gummies to balms to infused beverages, to bath bombs, and everything in between. An extraction method that works well with cannabis plant material may not be appropriate for a gummy or balm. There is much R&D involved in finding the right extraction procedure for a particular matrix. The second is getting consistent results compared to other labs. The cannabis (both marijuana and hemp/CBD) testing industry is fairly new, and as no standardized methods exist, each lab develops their own methods. A client may send the same sample to say, 3 different labs, and get 3 different results. This may come down to technique, or instrument operating parameters, or both.
LR: The industry recently had experience with the deleterious effects of additives in vape products. What procedures do you have if you, for example, see an unidentified peak in your analysis of a CBD product?
Canalysis: Currently, we can only quantitatively identify analytes for which calibrate. Without knowing more about the chemistry of cannabinoids and the by-products of reaction, it would be difficult to identify unknown compounds. If specific additives are suspected, we would need to investigate how to properly identify and quantitate those compounds on the HPLC or LC. It may be possible to qualitatively identify a peak with a mass spectrometer (e.g. LC-MS), however the current industry standard for potency is HPLC (with no mass spec).
At Leafreport, recommend that all products be tested using the most rigorous standards — and these include testing for pesticides, heavy metals that can be pulled up from the soil, residual solvents, the presence of plant toxins from various molds and fungi (mycotoxins) and the presence of bacteria or bacterial toxins. The standards used by California labs tend to be the most rigorous because the standards for compliance in California tend to be higher.
This is just to ensure customer confidence but is also an opportunity to remind people to buy from reputable CBD sources—one of the main reasons we are here!