With the emerging yet still nascent hemp industry and growing demand for hemp products of all kinds, an abundance of over-priced CBD items on the market is preventing some struggling businesses from moving current inventory. Ironically, trends show that people are buying these types of products at an exponentially increasing rate. At the same time, ensuring quality and overall efficacy are critical components that are too often overlooked by consumers and partnering businesses.
Let’s take a look at why patients and those utilizing cannabis-derived products need to be aware of the nuances within CBD product development, and how being educated helps drive more informed decisions leading to better outcomes.
Not All CBD Products Are Alike
There are a number of complexities and potential pitfalls consumers can prevent when navigating the CBD space, especially given the fact cannabis-based products are currently not regulated by the FDA. For example, there are products marketed as CBD when in fact they only contain hemp seed oil. Hemp seed, while a beneficial source of omega fatty acids and protein, do not contain cannabinoids or other therapeutic constituents since those compounds are predominantly produced in the floral material of cannabis.
The three main preparations found in cannabidiol products include CBD isolate, broad spectrum and full spectrum extract. There are a number of processing methods with varying levels of complexities, and each of the different forms of CBD concentrations come with their own characteristics. Full spectrum extracts preserve all plant constituents from waxes and polyphenols to terpenes and flavonoids, while a broad spectrum extract contains these components as well excluding a major cannabinoid, THC. When comparing products, it is sometimes difficult to identify whether they contain isolates or may even be manufactured using a blends of isolates. Labeling can be misleading or not comprehensive which leaves consumers wondering what’s actually inside or what it might do. Isolating terpenes can be inexpensive and blending them with other ingredients is also becoming more popular as manufacturers seek to differentiate themselves from others on the market.
It is important to recognize that while an isolated cannabinoid may be considered the “purest” and can serve pharmacological purposes; this form is a single extracted compound from the cannabis plant. Based on available scientific evidence, we know that isolates carry multiple impacts (some of which are adverse) that are uniquely different from broad or full spectrum preparations. What this also means is due to a demonstrated bell curve in some quantities, isolates can produce undesirable effects given their elevated potency. In addition, given a lack of synergistic interactions producing what’s known as the entourage effect, the potential does exist for isolates to not be as effective at addressing certain conditions as demonstrated in studies on epilepsy and breast cancer. This theorized yet established process could still benefit from open label, blinded human clinical trials; however it has been researched extensively. The landmark research conducted by Dr. Ethan Russo states the following:
In 1998, Professors Raphael Mechoulam and Shimon Ben-Shabat posited that the endocannabinoid system demonstrated an “entourage effect” in which a variety of “inactive” metabolites and closely related molecules markedly increased the activity of the primary endogenous cannabinoids, anandamide and 2-arachidonoylglycerol. They also postulated that this helped to explain how botanical drugs were often more efficacious than their isolated components. Although the single molecule synthesis remains the dominant model for pharmaceutical development, the concept of botanical synergy has been amply demonstrated contemporaneously, invoking the pharmacological contributions of “minor cannabinoids” and cannabis terpenoids to the plant’s overall pharmacological effect…These studies and others provide a firm foundation for cannabis synergy, and support for botanical drug development vs. that of single components, or production via fermentation methods in yeast or other micro-organisms.
How Cannabis-Based Products Affect Us:
Possible Interactions to Consider
Endocannabinoid system activation is how CBD works through metabolism, and we have much to learn still about its long-term effects. However, it has been widely established that CBD is generally recognized as a safe, effective and potent inhibitor of specific enzymes including CYP3A4 and CYP2D6. When taking drugs metabolized by the CYPP3A4 enzyme, CBD products increase serum concentrations of drugs including: macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil (and other PDE5 inhibitors), antihistamines, haloperidol, antiretrovirals, and some statins (atorvastatin and simvastatin, but not pravastatin or rosuvastatin). The other impacted enzyme CYP2D6 metabolizes antidepressants and CBD many increase serum concentrations of SSRIs, tricyclic antidepressants, antipsychotics, beta blockers and opioids (including codeine and oxycodone).
Additional source: Delta-9-Tetrahydrocannabinol and Cannabidiol Drug-Drug Interactions: 10.1159/000507998
As a result of CBD interacting this way, and with these types of medications, patients have been known to decrease or even replace entirely their original medication with CBD. (This of course should be done using the guidance and recommendations from a medical professional.) The overall takeaway about drug-drug interactions involving cannabidiol can be summarized here:
The safety profile of CBD is well established with study after study showing that it is well tolerated and safe to use, while at the same time rarely producing any serious side effects. Similarly, CBD is a compound that has a profound impact on a wide variety of systems within the body which is what makes it such an effective therapeutic agent for so many conditions. But at the same time it is good to remember that is the reason why it has the potential to interact with other drugs and why CBD should be consumed with care and respect.
Best Practices in Quality Measurements
The good news about the industry needing to self-regulate is there are now a number of evaluative measures consumers and practitioners can go by when selecting the right product for their needs. Standard operating procedures are crucial for producers and manufacturers of any cannabis-derived product. These internal processes are paramount to create transparency, not to mention safe and effective products. It is important to make sure there are mechanisms in place to document quality assurance or prevention of defects, as well as quality control or the detection of defects. Being vertically-integrated can allow for increased control over processes and elimination of potential gaps in oversight. A few of the key differentiators that indicate higher quality products and established internal processes include the following:
- Independent Testing & List of Ingredients: CBD products should be tested by a third party laboratory to meet specific standards for consumption. In addition to the details below, ingredients should be listed on labels and include every compound contained in the product with preference given to all natural and chemical-free ingredients.
- Certificate of Analysis: COAs document the exact levels of active constituents including cannabinoids and other plant compounds. Full panel analyses show products are free from chemicals, pesticides, insecticides, herbicides or fungicides, molds, heavy metals, solvent residues and other microbial contaminants.
- QR Code & Batch Specific COA: All products should carry verified and accurate certificates of analyses to ensure the contents of each container. One way to show transparency is through easily-accessible QR codes on labels which must be an active link going to a legitimate, original source where necessary information can be found.
- Guaranteed Amount of CBD: Some products contain less CBD or fewer active ingredients than what is printed on the label. Suppliers that ensure there is no less than what is on the product take special care to evaluate levels throughout standard operating procedures.
- Product Liability Insurance: Due to documentation of inputs and processes utilized in crafting products, this provides an added peace of mind when considering possible events that could increase risk to established practices or intellectual property.
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