Chemisches und Veterinäruntersuchungsamt (CVUA) Karlsruhe, Karlsruhe, 76187, Germany.
F1000Res. 2020 Aug 26;9:1051. doi: 10.12688/f1000research.26045.2. eCollection 2020.
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 -tetrahydrocannabinol (THC) without inclusion of non-psychotropic Δ -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.
我们最近的一篇文章（Lachenmeier 等人，2020）引发了一场有趣且有价值的讨论，我们很高兴有机会进一步阐述我们提出的各种观点。同样重要的是，我们希望纠正克劳斯和贝茨克（2020）代表欧洲工业大麻协会（EIHA）提出的几个重要误解，这些误解可能导致他们对我们数据的有效性、大麻二酚（CBD）产品的毒理学评估和监管地位结论产生质疑。首先，我们的研究仅评估了精神活性Δ-四氢大麻酚（THC）的风险，而不包括非精神活性Δ-四氢大麻酸（THCA）。其次，正如本文将更详细地讨论的那样，有充分的证据表明 CBD 产品存在不良反应，不仅在儿科患者中，而且在非处方 CBD 产品的成年使用者中（包括意外的“高”效应）。第三，暴露和风险评估是根据欧洲食品安全局（EFSA）和德国联邦风险评估研究所（BfR）的最新指南进行的。最后，根据新颖食品法规，未经批准任何含大麻提取物的产品，欧盟目前的法律状况实际上允许对所有此类产品在市场上非法的一概而论的说法，这确实意味着在获得批准之前，此类产品作为食品或食品成分的使用和营销将被普遍禁止。我们希望这能让 F1000Research 的读者对我们的研究结果和结论的有效性放心。不过，我们很高兴 EIHA 已经承认存在不合规的 CBD 产品，但根据我们的数据，这些产品在市场上占有相当大的份额。
