Abstract
An interesting and valuable discussion has arisen from our recent article (Lachenmeier et al., 2020) and we are pleased to have the opportunity to expand on the various points we made. Equally important, we wish to correct several important misunderstandings that were made by Kruse and Beitzke (2020) on behalf of the European Industrial Hemp Association (EIHA) that possibly contributed to their concerns about the validity of our data, toxicological assessment and conclusions regarding regulatory status of cannabidiol (CBD) products. First and foremost, our study did only assess the risk of psychotropic Δ 9-tetrahydrocannabinol (THC) without inclusion of non-psychotropic Δ 9-tetrahydrocannabinolic acid (THCA). Secondly, as this article will discuss in more detail, there is ample evidence for adverse effects of CBD products, not only in paediatric patients, but also in adult users of over-the-counter CBD products (including inadvertent "high" effects). Thirdly, the exposure and risk assessment was conducted using up-to-date guidelines according to the European Food Safety Authority (EFSA) and the German Federal Institute for Risk Assessment (BfR). And finally, the current legal situation in the European Union, without approval of any hemp extract-containing product according to the Novel Food regulation, actually allows blanket statements that all such products are illegal on the market, and this indeed would imply a general ban on the use and marketing of such products as food or food ingredients until such an approval has been granted. We hope that this reassures the F1000Research readership regarding the validity of our results and conclusions. We are pleased, though, that the EIHA has acknowledged the fact that there are non-compliant CBD products available, but according to our data these are a substantial fraction of the market.
Highlights
An interesting and valuable discussion has arisen from our recent article (Lachenmeier et al, 2020) and we are pleased to have the opportunity to expand on the various points we made
Any further responses from the reviewers can be found at the end of the article Introduction We agree with a main premise of the European Industrial Hemp Association (EIHA)’s comments; namely, that legal compliance and safety for both producers and consumers of cannabidiol (CBD) products must be ensured[1]
The Food Safety Authority of Ireland (FSAI) reported that from 38 tested CBD products, 37% exceeded the safe limit of THC dosage set by European Food Safety Authority (EFSA) (1 μg/kg body weight/day), 34% were classified as novel food lacking approval, 36% were food supplements lacking the necessary notification of the competent authority, 92% were tested to contain differences between analytical and declared CBD content of more than 10%, and 50% contained misleading claims such as unauthorised health claims or medicinal claims[46]
Summary
Besides the issue about THCA and its potential degradation into Δ9-THC, the uncertainties and limitations of the exposure assessment include a lack of knowledge about the typical consumption amounts of hemp foods, which are not covered by the currently available representative nutritional surveys as a separate food category This problem is less problematic for food supplements, which must be labelled with a recommended daily intake, but may lead to uncertainties with tea, beverages and other derivative products containing CBD or hemp extracts. The novelty does not depend on potential pharmacological effects or health risks of the product In consideration of these consistent reports worldwide, we cannot find a better wording than our original statement: “In our opinion the systematically high Δ9-THC content of CBD products is clearly a “scandal” on the food market. Considering a decision by the Court of Justice of the European Union, the European Commission recently clarified its position to not further consider CBD as narcotic, but to advance the novel food approval procedure[14]
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