Written by Dr. Jamie Corroon ND, MPH, Founder & Medical Director of the Center for Medical Cannabis Education and Medical Advisor to CV Sciences
In the past year, despite confusion surrounding their safety and legality, sales of hemp-derived dietary supplement products containing Delta-8 THC (i.e., Delta-8) have spiked throughout the United States, by as much as 144% according to some reports. At best, these Delta-8 products may benefit consumers while elucidating loopholes in existing regulations. At worst, they may put consumers at risk and damage the legitimacy and reputation of the fledgling hemp-derived dietary supplement industry.
Healthcare professionals like myself, along with hemp industry stakeholders, are not only concerned about the lack of safety data, but also about the unwanted attention, and possible regulatory oversight, that these products may generate. The hemp-derived dietary supplement industry is embryonic, with many players taking painstaking measures to comply with complex federal and state regulations. Additional oversight brought on by Delta-8 THC concerns could stall the careful progress of an emerging industry.
What is Delta-8?
Delta-8 is a minor, and relatively rare, phytocannabinoid that naturally occurs in Cannabis spp.. It is virtually identical to Delta-9 THC in terms of its chemical structure. In plant material, Delta-8 occurs in concentrations significantly below 1%. Delta-8 is either biosynthesized directly by the plant or formed as a degradation product from the oxidation of Delta-9 THC. Because its naturally occurring concentrations are so low, extracting Delta-8 for dietary supplement products is not economically viable.
Delta-8 can also be chemically synthesized in a lab, however, either de novo (i.e., from new) or by using other phytocannabinoids, like CBD, as a starting point. This process is more economically efficient, especially given the stockpiles of CBD leftover from the rush to build the supply chain for a rapidly growing industry of hemp-derived CBD products.
Risk of Contamination
This later approach introduces the potential for contamination from residual reagents, catalysts and byproducts involved in the chemical transformation, however. While some of the byproducts may be naturally occurring in Cannabis itself (i.e., other phytocannabinoids), others may not, making the safety profile of these products unknown.
Heavy metals, pesticides and microbes are also potential sources of contamination, although the presence of these contaminants is a risk in any plant derived extract.
While FDA regulations mandate that manufacturers of dietary supplements comply with current Good Manufacturing Practices (cGMPs), including analytical testing of ingredients and qualify control, the lack of enforcement resources puts the safety of hemp-derived Delta-8 products into question.
Delta-8 or Delta-9?
Independent of the risk of potential contamination by compounds not found in the Cannabis plant, or in nature for that matter, there is additional risk related to these products. One study found that over 50% of hemp-derived Delta-8 products tested contained illegal levels of Delta-9.
Labeling accuracy of hemp-derived products was already a concern prior to the emergence of Delta-8 products. Widespread mislabeling of hemp and cannabis (i.e., marijuana) products has been documented by both independent researchers, the FDA and other organizations. Under-labeling and over-labeling of both CBD and Delta-9 THC content have been reported. These studies have documented that the actual contents can vary considerably from what is disclosed on the label.
Inadequate label information also poses risks of unintended, unwitting or overconsumption of Delta-9, which could lead to accidental impairment and/or failed drug tests; two outcomes that could have important implications on one’s professional and/or personal life. As the old saying goes, “caveat emptor”—buyer beware.
Given all these uncertainties, more than 10 states have banned the sale of hemp-derived Delta-8 products to date.
Lack of Research
Beyond the risk of contamination and unwitting consumption of Delta-9, there is a dearth of experimental research supporting the efficacy of Delta-8 THC in mitigating any of the various signs, symptoms or medical conditions claimed by proponents. Pre-clinical studies in lab animals and clinical studies in humans are dated and limited. Randomized, controlled trials aimed at investigating health-related benefits in humans are virtually non-existent.
Pharmacology of Delta-8 & the “Legal High”
Delta-8 is often reported in the media to result in a milder “high” than Delta-9. It is deemed “less potent” and some think that Delta-9 dosages can be used as a proxy for Delta-8. While this unscientific guiding principle may help recreational users avoid or pursue intoxication, it is by no means adequate for medical use.
Like Delta-9, Delta-8 is a partial agonist of cannabinoid receptors (CB1 and CB2). This means that the physiological effects of Delta-8 are mediated through the activation of these receptors, for the most part. Importantly, this includes the capacity to produce intoxication and impairment via the CB1 receptor. Not surprisingly, consumption of Delta-8 products is becoming especially prevalent in states where marijuana-derived Delta-9 THC products are not legally accessible.
This has been referred to as a “legal high” by some in those states, claiming that the 2018 Farm Bill inadvertently legalized Delta-8 THC. It is unlikely that products containing synthetic Delta-8 would be deemed “legal” by law enforcement or the courts, however. In fact, the DEA explicitly states that “synthetically derived tetrahydrocannabinols” are schedule I controlled substances, although they don’t define exactly what that means.
What Should Consumers Do?
As a general rule, consumers should only purchase Delta-8 products from credible vendors in states that allow such products, and from companies that are transparent about the contents of their products. Transparency should come in the form of certificates of analyses (CoAs) from third-party laboratories. These CoAs document the presence, or absence, of contaminants as well as the actual amounts of Delta-8 and Delta-9 THC, along wtih other ingredients (Note: analytical labs only test for certain compounds, so just because a CoA doesn’t indicate a contaminant is present, doesn’t mean the product is free of contaminants. They can’t find what they aren’t looking for.) The bottom line: avoid companies that are unwilling to make these CoAs available in a timely manner. In addition, given the absence of relevant clinical research, it’s wise to avoid products that make health-related claims, especially claims that mention specific symptoms or diseases.
Delta-8 products are exploiting regulatory loopholes and have the potential to harm consumers, as well as the broader hemp dietary supplement industry. At best, they may have therapeutic effects, but these effects are likely elusive for the average consumer given the absence of clinical research demonstrating safe and effective dosing. At worst, these products may be unsafe, and may create harm through inaccurate labeling, especially with regard to understating the amount of various psychoactive ingredients (i.e., Delta-9, Delta-8, CBN, etc.). Ultimately, the presence of Delta-8 THC in hemp products may generate unwanted regulatory oversight and thus slow the exciting pace of growth within the broader hemp dietary supplement industry.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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