In recent years, the use of non-Food and Drug Administration (FDA)-approved cannabidiol (CBD) has become a focal point of public discourse, driven by its increasing popularity and widespread marketing for various health conditions.
According to a poll conducted in 2019, 14 percent of American adults aged 18 years and older reported using CBD products. This figure surged in 2020, with one in three adults acknowledging CBD consumption.
However, a critical discrepancy emerges when examining the composition of commercially available, non-FDA-approved CBD products, as they markedly differ from those utilized in clinical studies.
This distinction underscores the imperative for heightened awareness regarding the misconceptions surrounding CBD, accompanied by an understanding of the potential harms and risks associated with its use.
CBD versus Marijuana: Legal Definitions
To understand how CBD is regulated, you need to know how cannabis plants are legally defined. Federal law classifies these plants into two broad categories, namely “hemp” and “marijuana,” contingent on their delta-9 THC content.
The 2018 Farm Bill played a pivotal role in this delineation, legalizing hemp with a delta-9 THC concentration not exceeding 0.3 percent on a dry weight basis. Consequently, hemp cultivation gained approval in all states except Idaho, Mississippi, and the District of Columbia.
While this legislative shift facilitated the legal sale of hemp and hemp-derived products, it did not alter the federal authority to regulate them. Since the enactment of the Farm Bill, all states except Idaho, Mississippi, and the District of Columbia permit some form of hemp cultivation, thereby enhancing access to and the availability of hemp products, including CBD.
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About CBD Products
CBD, derived primarily from hemp due to its low THC concentration, has found its way into a wide variety of products, ranging from lotions, oils, creams, and other topical formulations to food and beverage items such as chocolate, gummies, and tea.
While there is only one FDA-approved CBD product—Epidiolex, a pharmaceutical-grade CBD oral liquid used for treating rare, severe forms of seizure disorders—numerous non-FDA-approved products have flooded the market. This variety in product types has contributed significantly to the soaring popularity of CBD, offering users diverse methods of consumption.
Availability of CBD Products
The accessibility of CBD products, excluding Epidiolex, varies by state due to differing regulations. Over-the-counter CBD products are ubiquitous throughout the United States, with online sales surpassing 60 percent.
Although readily available, it is crucial to note that most of these products lack FDA approval. Even when purchased from reputable retailers, questions regarding their safety, reliability, and effectiveness persist.
CBD products obtained from cannabis dispensaries, while also lacking FDA approval, may contain THC concentrations exceeding 0.3 percent, contingent on the state’s definition of allowable CBD products.
While regulations and oversight mechanisms fluctuate across states, CBD products from dispensaries may be subject to some level of scrutiny and standardization.
Risks and Harms of CBD Use
Potential CBD side effects are wide-ranging and include decreases in alertness (e.g., drowsiness and sedation), changes in mood (e.g., irritability and agitation), decreased appetite, and gastrointestinal symptoms/distress (e.g., diarrhea).
Moreover, CBD use may lead to psychotic effects or cognitive impairment, particularly in individuals concurrently using delta-9 THC products like marijuana.
Adverse events associated with CBD use extend to liver injury, interactions with other drugs, injuries following periods of sedation or drowsiness, and potential harm to male reproductive health.
Several factors influence the likelihood of these hemp side effects, including the product’s strength and purity, the amount used, mode of administration, concurrent substance use, and interactions with prescribed medications.
Unreliable Dosage and Purity
A critical concern surrounding non-FDA-approved CBD products is their unreliable dosage and purity. Given the absence of FDA standards, these products may contain more or less CBD than stated on the label.
More worrisome is the potential presence of biological and chemical contaminants resulting from unsafe manufacturing practices without adequate process controls.
Research indicates that labeled concentrations of CBD products are often unreliable, with a study revealing that among 84 commercial CBD extracts purchased online, only 31 percent accurately reflected the labeled CBD concentration.
The CBD THC capsules side effects include significant health risks, particularly in children, where accurate dosing is paramount. Contaminants, including the intoxicants, further contribute to the questionable purity of commercial CBD.
Unclear or Misleading Labeling
The issue of unclear or misleading labeling compounds the risks associated with CBD use. Products claiming to be THC-free may still contain delta-9 THC, leading to potential positive urine drug tests.
The prevalence of delta-8 or delta-9 THC-contaminated products marketed as pure CBD raises concerns about work-related, legal, and health implications.
Unsuspected delta-9 THC exposure may jeopardize an individual’s employment, lead to inaccurate medical test results, involve law enforcement, and induce unintended drug interactions.
Unknown Health Effects
While evidence suggests that pure, uncontaminated CBD by itself does not induce psychoactive effects, its impact on the body, whether ingested or used topically, may result in observable side effects.
Ambiguities surrounding CBD use include uncertainties about long-term health effects, proper dosing, effects on the developing brain, and potential developmental impacts on fetuses and infants when used by pregnant and breastfeeding individuals.
Due to these uncertainties, the FDA strongly discourages the use of CBD in any form during pregnancy or while breastfeeding.
Safety
The current regulatory framework for CBD products lacks FDA oversight, underscoring the need for heightened consumer awareness. Potential contaminants, such as THC, pesticides, heavy metals, bacteria, or fungi, may be present in some CBD products.
Health experts emphasize the importance of purchasing CBD products from reputable sources and consulting with a healthcare professional before use.
Additionally, it is crucial to note that CBD products containing more than 0.3% THC fall under the legal definition of cannabis, emphasizing the need for awareness and further research while making CBD products.
Alternatives
Even though CBD may present itself as an over-the-counter solution for various health conditions, individuals with safety concerns could also look at other alternative options. One such alternative is palmitoylethanolamide, a naturally occurring substance with potential anti-inflammatory, neuroprotective, and pain-relieving effects. This lipid mediator, derived from egg yolks and the human body, offers a potential avenue for those seeking alternatives to CBD.
Conclusion
While CBD may hold promise in certain therapeutic realms, the lack of FDA approval for many products, coupled with uncertainties surrounding dosages, purity, and long-term effects, necessitates a cautious approach. Individuals considering CBD should first research into it, seek guidance from healthcare professionals, and remain vigilant about the potential risks and legalities associated with its use.
