Cannabidiol (CBD): a strong plea for mandatory pre-marketing approval of food supplements

Lachenmeier, Dirk W.; Walch, Stephan G.

doi:10.1007/s00003-020-01281-2

Cited by 13 publications

(14 citation statements)

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“…Thus, as such a history has not been demonstrated so far, CBD extracts are classified as Novel Food and are therefore not authorized in the EU. In addition to the discrepancy between the excessive product availability and the doubtful compliance with legislation (EU and worldwide) for many of those products [24,25], questions also arise in regard to the safety of these products. Regarding this, a major topic, which is discussed controversially in the recent scientific literature, is the potential conversion of CBD into psychotropic cannabinoids, including Δ 9 -THC.…”

Section: Introductionmentioning

confidence: 99%

Conversion of Cannabidiol (CBD) into Psychotropic Cannabinoids Including Tetrahydrocannabinol (THC): A Controversy in the Scientific Literature

Golombek

Müller

Barthlott

et al. 2020

Toxics

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101

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Cannabidiol (CBD) is a naturally occurring, non-psychotropic cannabinoid of the hemp plant Cannabis sativa L. and has been known to induce several physiological and pharmacological effects. While CBD is approved as a medicinal product subject to prescription, it is also widely sold over the counter (OTC) in the form of food supplements, cosmetics and electronic cigarette liquids. However, regulatory difficulties arise from its origin being a narcotic plant or its status as an unapproved novel food ingredient. Regarding the consumer safety of these OTC products, the question whether or not CBD might be degraded into psychotropic cannabinoids, most prominently tetrahydrocannabinol (THC), under in vivo conditions initiated an ongoing scientific debate. This feature review aims to summarize the current knowledge of CBD degradation processes, specifically the results of in vitro and in vivo studies. Additionally, the literature on psychotropic effects of cannabinoids was carefully studied with a focus on the degradants and metabolites of CBD, but data were found to be sparse. While the literature is contradictory, most studies suggest that CBD is not converted to psychotropic THC under in vivo conditions. Nevertheless, it is certain that CBD degrades to psychotropic products in acidic environments. Hence, the storage stability of commercial formulations requires more attention in the future.

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Section: Introductionmentioning

confidence: 99%

Conversion of Cannabidiol (CBD) into Psychotropic Cannabinoids Including Tetrahydrocannabinol (THC): A Controversy in the Scientific Literature

Golombek

Müller

Barthlott

et al. 2020

Toxics

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101

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“…Clearly for CBD products alongside other medicinal cannabis products, a regulated legalization (see e.g. Anderson et al 47 ) would be preferable, introducing stricter regulations, such as mandatory labelling requirements, safety assessment, testing and pre-marketing approval (also see 29,48).…”

Section: Discussionmentioning

confidence: 99%

Are side effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

et al. 2020

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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 psychotropic Δ9-tetrahydrocannabinol (Δ9-THC) in the stomach after oral consumption. 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 Δ9-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 67 food products of the German market (mostly CBD oils) confirmed this hypothesis: 17 products (25%) contained Δ9-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 Δ9-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 Δ9-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.

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“…Our statement also has been validated by the recent potential suggestion of the European Commission (according to press information 7 ) to consider hemp extracts as narcotic, and hence remove them from the possibility to be marketed as food or food supplement. As detailed elsewhere 3 , 41 , we believe that it would be disproportional to regulate CBD products as narcotic drug according to the principle of "ultima ratio" in criminal law. In closing, we would therefore like to note that we actually have suggested a regulated legalization of CBD products.…”

Section: Proposal Of a Legal Ban On Hemp Extractsmentioning

confidence: 90%

“…We fully stand by this conclusion and have even expanded our judgement of the CBD industry in a recent editorial, which concluded that the illegal market of CBD products may provide a strong rationale for the necessity of a paradigm shift towards pre-marketing approval in regulating food supplements 3 .…”

Section: Judgement About Food Producers Of Cbd Productsmentioning

confidence: 96%

“…We actually 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 . If this can be achieved by their suggestion of a mandatory industry self-regulated approach 1 rather than by our suggestion of strict regulations 2 , 3 is another question. In light of the experience with industry self-regulations in other fields, this suggestion remains highly doubtful 4 , 5 ; it especially appears not well-thought-out how a self-regulation may be mandatory and how this demand can be enforced.…”

Section: Introductionmentioning

confidence: 91%

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Evidence for side effects of cannabidiol (CBD) products and their non-conformity on the European food market – response to the European Industrial Hemp Association

Lachenmeier

Walch

2020

F1000Res

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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 Δ9-tetrahydrocannabinol (THC) without inclusion of non-psychotropic Δ9-tetrahydrocannabinolic acid (THCA). Secondly, as this article will discuss in more detail, there is ample evidence for side 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.

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Cannabidiol (CBD): a strong plea for mandatory pre-marketing approval of food supplements

Cited by 13 publications

References 1 publication

Conversion of Cannabidiol (CBD) into Psychotropic Cannabinoids Including Tetrahydrocannabinol (THC): A Controversy in the Scientific Literature

Conversion of Cannabidiol (CBD) into Psychotropic Cannabinoids Including Tetrahydrocannabinol (THC): A Controversy in the Scientific Literature

Are side effects of cannabidiol (CBD) products caused by tetrahydrocannabinol (THC) contamination?

Evidence for side effects of cannabidiol (CBD) products and their non-conformity on the European food market – response to the European Industrial Hemp Association

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