Author ORCID Identifier

https://orcid.org/0000-0003-0313-6221

Date Available

4-14-2024

Year of Publication

2022

Document Type

Doctoral Dissertation

Degree Name

Doctor of Philosophy (PhD)

College

Medicine

Department/School/Program

Pharmacology and Nutritional Sciences

Advisor

Dr. Michael Kilgore

Abstract

Human interactions with cannabis have a history spanning millennia as a source of fiber, food, and medicine. The plant came across Asia, Europe, and Africa with the movements of people and travelers eventually coming to the Americas with European explorers. In colonizing North America, cannabis fiber was key to the production of canvas and ropes for ships. Although fiber was the driver for cannabis production in the United States, medicinal uses were prevalent and propelled the eventual regulations. The Pure Food and Drug Act of 1906 mandated accurate labeling on drugs such as cannabis followed by the Marihuana Tax Act of 1937 that essentially made cannabis illegal. The legal status of cannabis was not changed on the federal level until the Agricultural Act of 2014 which opened the door to varieties of cannabis, labeled as hemp, with Δ9-tetrahydrocannabinol (Δ9-THC) content less than 0.3 % per dry weight of plant material. The Agricultural Improvement Act of 2018 removed hemp from scheduling originally implemented in the Controlled Substance Act of 1970. As the doors opened to hemp, the market was flooded with hemp-derived products minimally regulated as the language of the Agricultural Improvement Act of 2018 was primarily directed at the agricultural commodity leaving individual states to develop and manage the rules for the agricultural commodity and finished products. As such, the industry has outpaced the regulations leaving consumers to rely on the product manufactures and anecdotal stories from family, friends, and the internet to guide their usage. Today, hemp-derived products can be found on seemingly every corner from the gas stations to grocery stores to pharmacies to boutique CBD stores. Consumers are turning to these products in addition to, and as an alternative to, standard medications. With little to no regulations regarding the finished products, and the quality concerns shown by other studies demonstrate the need for methodology to better understand what these hemp-derived products contain.

For these studies, 80 unregulated hemp-derived oil products representing 51 brands were purchased from 9 local (brick and mortar) and 21 online retailers between April 2 to May 9, 2021. The samples were selected to represent a cross section of local and national brands produced inside and outside of Kentucky. Additionally, Epidiolex® (the FDA-approved CBD product) was obtained (UK Investigational Drug Service Pharmacy) to serve as regulated control. These samples were extracted and quantified by liquid-chromatography tandem mass-spectrometry (LC-MS/MS).

In these studies, the hemp-derived oil products were evaluated quantitatively for 17 cannabinoids comprising a range of metabolic products in the plant as well as potential degradants. The cannabidiol (CBD) content detected was compared to the label claim amount. Of the products tested, 31% contained more than 110% of the label claimed content and 15% contained less than 90% of the label claimed content. With regards to Δ9-THC, 52 products contained Δ9-THC ranging from 0.008 mg/mL to 2.071 mg/mL including 5 of 21 products labeled as “THC Free”. Δ9-THC was not detected in any products tested. Excluding CBD and Δ9-THC, the minor cannabinoids most frequently detected in the samples were cannabidivarin (100% of samples tested), cannabigerol (77%), cannabichromene (72%), cannabinol (67%), cannabicyclol (67%), and cannabidiolic acid (51%). The concentrations of these minor cannabinoids varied widely from trace levels to several milligrams per milliliter (e.g., CBDA: 0.006 – 12.258 mg/mL).

Consumers are taking these products, often to treat a medical condition, without knowing the true contents. The inaccuracy of the label claim content with regards to CBD, the marketed cannabinoid in these products, could lead to unknown dosing. Additionally, consumers are taking these products without understanding the risks of unintentional consumption of Δ9-THC. This accidental use of Δ9-THC could have adverse effects on health and safety as well as potentially legal consequences in child custody and impaired driving or could impact employment, military, and sport eligibility status. Furthermore, many of the other 15 phytocannabinoids quantified in this study have been shown to have pharmacological activity in pre-clinical studies. Overall, these studies clearly demonstrate that consumers are not being provided with an accurate and comprehensive unawareness of the contents of the products they are consuming.

Digital Object Identifier (DOI)

https://doi.org/10.13023/etd.2022.148

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