Doctor of Pharmacy Candidate University of Wisconsin School of Pharmacy Madison, Wisconsin
Rationale: CBD products remain largely unregulated in the U.S. Unlike the Rx formulation of CBD, little information is available regarding labeling accuracy, nor lot-to-lot variability. Understanding these properties are fundamental if these products are to be used by patients with epilepsy, where product variability of traditional ASM’s has been suspected to result in inadequate seizure control, or adverse effects Early reports suggested issues with products available via on-line purchase. Since that time, retail purchase of CBD products has become much more common. Therefore, we analyzed commercial CBD products, including not only traditional oils, but aqueous products (i.e., "enriched" beverages) as well, for cannabinoid content vs label claims using United States Pharmacopeia (USP) standards. Methods: Products were purchased directly from a variety of non-dispensary retail vendors. Oil-based oral and aqueous products were obtained. Products were stored in cool, dry dark cabinets, and analyzed upon opening original containers, and analyzed by HPLC for CBD, THC, and CBN concentrations. Products with < 90% of label claim CBD were denoted over-labeled, 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 Results: Among commercial CBD Oils (n=11), mean CBD conc. 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 the oil products, maximum of 0.2%.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. Aqueous product CBD concentrations vs label claim varied widely, from undetectable to 115.38% of label claim. THC was detected in 23.81% (n=5) of the aqueous products tested, maximum THC concentration of 0.0005%.“Other” products (n=7) tested ranged from chocolate bars to transdermal patches. Some “Other” products (n=3) gave specific CBD label claims, with mean CBD concentration vs label claim of 67.01% [95% CI, 0.87%-133.14%]. Among these “Other” products with specific label claims, 33% (n=1) were appropriately labeled, and 66.67% (n=2) were over-labeled, with CBD concentrations vs label claim ranging from a minimum of 39.30% to a maximum of 101.99%. The remaining 57.14% (n=5) of “Other” products tested made nonspecific CBD label claims, denoting CBD content in terms of “full spectrum hemp extract” or “activated cannabinoids”. One such product was labeled with a “40 – 50 mg CBD” range instead of a single, specific value. Finally, THC was detected in 71.43% (n=5) of all “Other” products tested, though none exceeded a THC concentration of 0.0047%. It is notable that less than half of our sampled oil-based products fell within +/- 10% of label, and almost none of our aqueous or topical products doing so. (Figures 1 & 2) Conclusions: Many no-Rx CBD products continue to have substantial inconsistencies in CBD content and vary largely from their label claims and demonstrate lot-to-lot variability making dosing unpredictable. Consistent with the known chemistry of CBD, observed variances from labeled content are even more likely in aqueous products. Funding: Please list any funding that was received in support of this abstract.: None Click here to view image/table
