Analysis of cannabidiol (CBD) and THC in nonprescription consumer products: Implications for patients and practitioners

• Published in: Epilepsy & behavior 2022-02, Vol.127, p.108514-108514, Article 108514
• Main Authors: Miller, Owen S., Elder, Edmund J., Jones, Karen J., Gidal, Barry E.
• Format: Article
• Language: English
• Subjects: Cannabidiol; Cannabinoids; Cannabinol; Cannabis; CBD Oil; Dronabinol; Epilepsy; Humans; THC
• ISSN: 1525-5050; 1525-5069
• DOI: 10.1016/j.yebeh.2021.108514

•Consumer CBD products vary greatly in formulation, purity, and label accuracy.•Beverages and other aqueous CBD products are especially inconsistent.•Many of these consumer products contain non-negligible amounts of THC.•Patients and consumers risk side effects, interactions, and failed drug screenings. Cannabidiol products remains largely unregulated in the US. Unlike the Rx formulation of CBD [EpidiolexR], little information is available regarding labeling accuracy (does the product contain what the label says it does), lot to lot variability, nor long-term product stability. Understanding these properties are fundamental if these products are to be used in patients with epilepsy, where product variability of traditional AEDs has been suspected to result in inadequate seizure control. Therefore, we analyzed commercial CBD products, including oils, aqueous products (i.e., beverages), and various Other products for cannabinoid content vs label claims and stability under United States Pharmacopeia (USP) standards. Samples were diluted and analyzed by HPLC for CBD, THC, and CBN concentrations in order to assess product label accuracy. Products with 110% of label claim CBD were denoted under-labeled, and products between 90% and 110% of label claim CBD were denoted appropriately labeled, per USP standards. Among commercial CBD Oils (n = 11), mean CBD concentration vs label claim was 91.56% [95% CI, 66.02–117.10%], although 18.18% of oils (n = 2) made nonspecific label claims of “hemp extract” in lieu of CBD. Among all oils, 36.36% (n = 4) were appropriately labeled, another 36.4% (n = 4) of all oils were under-labeled, maximum 128.3% label claim, and finally, 9.09% (n = 1) of oils were over-labeled. The remaining 18.18% (n = 2) of oils lacked specific CBD label claims, minimum of 0.3 mg CBD per 1-ml “dose”. THC was detected in 54.55% (n = 6) of oils with a maximum concentration of 0.2% w/v and a minimum concentration of 0.036% w/v. Cannabinol was detectable in only 9.1% (n = 1) of products at a concentration of 0.00465% w/v. Among aqueous products (n = 21) tested, only 66.67% (n = 14) gave specific CBD label claims, with mean CBD concentration vs label claim of 59.93% [95% CI, 38.24–81.63%]. Only 7.14% (n = 1) of aqueous products with a label claim were appropriately labeled, 14.29% (n = 2) were found to be under-labeled, and 78.57% (n = 11) over-labeled. THC was detected in 23.81% (n = 5) of a