Abstract
Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements, to avoid the strict rules of medicinal products. Side-effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychoactive Δ 9-tetrahydrocannainol (THC). However, research of pure CBD solutions stored in simulated gastric juice or subjected to various storage conditions such as heat and light with specific liquid chromatographic/tandem mass spectrometric (LC/MS/MS) and ultra-high pressure liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC-QTOF) analyses was unable to confirm THC formation. Another hypothesis for the side-effects of CBD products may be residual THC concentrations in the products as contamination, because most of them are based on crude hemp extracts containing the full spectrum of cannabinoids besides CBD. Analyses of 28 food products of the German market containing hemp extract as an ingredient (mostly CBD oils) confirmed this hypothesis: 10 products (36%) contained THC above the lowest observed adverse effects level (2.5 mg/day). Inversely, CBD was present in the products below the no observed adverse effect level. Hence, it may be assumed that the adverse effects of some commercial CBD products are based on a low-dose effect of THC and not due to effects of CBD itself. The safety, efficacy and purity of commercial CBD products is highly questionable, and all of the products in our sample collection showed various non-conformities to European food law such as unsafe THC levels, full-spectrum hemp extracts as non-approved novel food ingredients, non-approved health claims, and deficits in mandatory food labelling requirements. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety must obviously be challenged.
Highlights
Since hemp has been re-approved for cultivation as an industrial crop in the form of low Δ9-tetrahydrocannabinol (THC) hemp varieties in the European Union, components of the hemp plant are increasingly used for the production of foods and other consumer products such as liquids for electronic cigarettes[1]
Cannabidiol is currently approved in the European Union (EU) in a single medicinal product, namely Epidiolex® for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy
CBD doses in the food supplements on the market are typically much lower than the ones tested in clinical studies
Summary
Cannabidiol (CBD) is currently the compound with highest interest. In contrast to THC, the major drug-constituent of hemp, CBD is a non-psychotropic cannabinoid. It is currently being tested for its possible antispasmodic, anti-inflammatory, anxiolytic and antiemetic effects as a drug, e.g. for the treatment of epilepsy[2,3]. The marketing of CBD products is based on the current “hype” around medicinal hemp products, whereby the CBD products are offered as a supposedly safe alternative, promised as being free of psychotropic components or their side-effects[4]. Cannabidiol is currently approved in the European Union (EU) in a single medicinal product, namely Epidiolex® for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy. Most of the CBD products worldwide are available as food supplements or additives in food
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