Product text labels indicate the presence of other pharmacologically active ingredients in many OTC hemp- and CBD-containing preparations

The 2018 Farm Bill changed the legal status of cannabis plants that meet the definition of industrial hemp and allowed for the rapid expansion of hemp-based products into commercial spaces. With an emphasis on industrial hemp as the source of naturally-occurring cannabinoid compounds, a niche market for cannabidiol (CBD)-containing products was quickly established in pharmacies and grocery stores. Although the U.S. Food and Drug Administration (FDA) has retained oversight of all cannabis-based products, labelling of hemp-derived products for retail markets remains largely unregulated. Under federal law, CBD cannot be added to foods, beverages, sold as a dietary supplement or marketed for a therapeutic benefit, however the perceived health benefits of CBD as an acceptable and safe ingredient contribute to the growing market for these health products. Objective: The objective of this study was to evaluate the range of over-the-counter (OTC) hemp- and CBD-based products available to consumers and determine the prevalence of other pharmacologically active agents identified as ingredients in these products. Labels were scored for the presence of: active and inactive ingredients, percent CBD, full-spectrum hemp, full-spectrum CBD or CBD isolate. Methods: Two large pharmacy chains and one medium-sized grocery store located in the Pacific Northwest were surveyed between May 2020 and February 2021 and OTC hemp-derived products on display were recorded. Identification of pharmacologically active ingredients on the product label was validated using the National Medicines Comprehensive Database. Products that were noted to have CBD or hemp ingredients were included in the study, while any products that did not accurately report the amount of CBD in the product were excluded. Products that did not list the total weight of the product were excluded from the analysis. Results: Thirty-three unique products were recorded from 19 different manufacturers. 39% of product labels indicated the presence of Full-Spectrum Hemp as part of the base product, while 66% of products listed Hemp Extract as the base product. Text labels on CBD-containing products, on average, indicated more than 3 additional pharmacologically active ingredients were contained in each product. Topical CBD products were more likely to have other ingredients such as arnica montana, menthol and camphor, whereas products for oral ingestion were more likely to have only CBD as the primary active ingredient. Text labels on 52% of topical CBD products listed the presence of 10% menthol. Average concentrations of CBD in OTC products was found to be 1.12% ± 1.48 %, based on dry weight. Conclusion: Product text labels on OTC hemp-and CBD-containing preparations is varied and presented in a non-standardized format. Topical CBD products were more likely to contain other pharmacologically active natural products that can be used for the treatment of pain symptoms. Concentrations of arnica montana, menthol and camphor were as much as 10-fold higher than the proportion of CBD contained in these products. The absence of a standard format for labelling of OTC hemp- and CBD-derived products and the frequent presence of other active ingredients has the potential to create confusion and risk for the consumer.