Safety of CBD and other cannabinoids remains a hotly debated topic. Data derived from clinical trials as well as experimental data (Devinsky et al. 2018 ; Ewing et al. 2019a ) demonstrate that at high doses, CBD and CBD-rich cannabis extract pose significant risk for hepatotoxicity. Furthermore, accumulating evidence indicates CBD has a significant drug interaction potential that can further exacerbate hepatotoxicity (Ewing et al. 2019b ; Anciones and Gil-Nagel 2020 ).
Cannabidiol (CBD) is a non-psychotropic constituent of Cannabis sativa that has grown in popularity during the last decade. CBD is the active component of EPIDIOLEX®, a U.S. Food and Drug Administration (FDA)-approved drug designed for the treatment of drug-resistant pediatric epileptic seizures associated with several rare syndromes. Furthermore, CBD has been proposed as a treatment for a number of other diseases for which clinical trials are now ongoing.
Labeling and safety considerations
In the opening article for this Special Issue, Walker and colleagues provide their opinion on the perspectives on science, safety, and potential regulatory approaches for CBD in the United States (Walker et al. 2020 ). The authors note that the observed rapid expansion of marketed consumer CBD products, paralleled by the wide-ranging disease treatment claims, and the prevalence of substandard or even adulterated products, pose a serious public health and regulatory dilemma. Although the federal controlled substance status of hemp-derived CBD was relaxed as per the Agricultural Improvement Act of 2018 (a.k.a., “2018 Farm Bill”), the question of its regulatory status in DS was brought into sharp focus.
Accumulating evidence indicates that the number of “CBD-containing” products, available mostly online, is growing exponentially. However, the U.S. FDA currently prohibits sales of CBD as a dietary supplement (DS) or ingredient in conventional food. Further, clear federal regulatory and quality oversight does not exist, which has led to an uncontrolled CBD market that, in turn, threatens to result in negative health effects experienced by a trusting public.
This Special Issue, the first of its kind on CBD and other phytocannabinoids, is devoted to answering those and other questions by publishing articles in the fields of pharmacology, toxicology, and regulation.
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The control over the amount of psychoactive THC (Δ-9-tetrahydrocannabinol) in commercial cannabidiol (CBD) products has to be strict. A fast and simple semiquantitative Ag(I)-impregnated paper spray mass spectrometric method for differentiating between THC and CBD, which show no difference in standard single-stage or tandem MS, was established. Because of a different binding affinity to Ag(I) ions, quasi-molecular Ag(I) adducts [THC + Ag] + and [CBD + Ag] + at m/z 421 and 423 give different fragmentation patterns. The product ions at m/z 313 for THC and m/z 353 and 355 for CBD can be used to distinguish THC and CBD and to determine their ratio. Quantification of THC/CBD ratios in commercial CBD oils was accomplished with a low matrix effect (−2.2 ± 0.4% for THC and −2.0 ± 0.3% for CBD). After simple methanol extraction (recovery of 87.3 ± 1.2% for THC and 92.3 ± 1.4% for CBD), Ag(I)-impregnated paper spray analysis was employed to determine this ratio. A single run can be completed in a few minutes. This method was benchmarked against the UHPLC-UV method. Ag(I)-impregnated paper spray MS had the same working range (THC/CBD = 0.001–1) as UHPLC-UV analysis (R 2 = 0.9896 and R 2 = 0.9998, respectively), as well as comparable accuracy (−2.7 to 14%) and precision (RSD 1.7–11%). The method was further validated by the analysis of 10 commercial oils by Ag(I)-impregnated paper spray MS and UHPLC-UV analysis. Based on the determined relative concentration ratios of THC/CBD and the declared CBD concentration, 6 out of 10 CBD oils appear to contain more THC than the Dutch legal limit of 0.05%.