Origin of Δ<sup>9</sup>-Tetrahydrocannabinol Impurity in Synthetic Cannabidiol

Citti, Cinzia; Russo, Fabiana; Linciano, Pasquale; Strallhofer, Sarah Sylvana; Tolomeo, Francesco; Forni, Flavio; Vandelli, Maria Angela; Gigli, Giuseppe; Cannazza, Giuseppe

doi:10.1089/can.2020.0021

Cited by 22 publications

(37 citation statements)

References 25 publications

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“…However, samples stored in the dark at room temperature only suffered 4% degradation, suggesting light is a significant contributing factor in degradation at room temperature [ 30 ]. Another recent analysis found that CBD samples stored in the dark at room temperature for three months showed the presence of Δ 9 -THC and Δ 8 -THC impurities [ 31 ]. Whether the stability of CBD products is altered by different formulations is not known [ 32 ].…”

Section: The Problems With Cbdmentioning

confidence: 99%

Towards Better Delivery of Cannabidiol (CBD)

Millar¹,

Maguire

Yates³

et al. 2020

Pharmaceuticals

153

118

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Cannabidiol (CBD) has substantial therapeutic potential, but its development as an effective drug by the pharmaceutical industry is hindered by intrinsic characteristics such as low bioavailability, low water solubility, and variable pharmacokinetic profiles. Importantly, lack of patentability of the drug substance also limits the likelihood of an expensive, full development programme in anything other than orphan indications. Potential avenues to overcome these issues with CBD include self-emulsifying drug delivery systems, improved crystal formulations and other solid-state delivery formulations, which are mostly in the pre-clinical or early clinical stages of development. This review identifies issues compromising current delivery of solid-state CBD, and how advanced pharmaceutical development strategies can enable CBD to realise the full potential as a successful therapeutic agent.

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Section: The Problems With Cbdmentioning

confidence: 99%

Towards Better Delivery of Cannabidiol (CBD)

Millar¹,

Maguire

Yates³

et al. 2020

Pharmaceuticals

153

118

View full text Add to dashboard Cite

show abstract

“…• As a degradation of CBD is expected even in material from synthetic origin 62 , the degradation products must be identified and toxicologically assessed.…”

Section: Discussionmentioning

confidence: 99%

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

Lachenmeier

Walch

2021

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 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.

show abstract

“…• As a degradation of CBD is expected even in material from synthetic origin 61 , the degradation products must be identified and toxicologically assessed.…”

Section: Discussionmentioning

confidence: 99%

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

View full text Add to dashboard Cite

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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Origin of Δ⁹-Tetrahydrocannabinol Impurity in Synthetic Cannabidiol

Cited by 22 publications

References 25 publications

Towards Better Delivery of Cannabidiol (CBD)

Towards Better Delivery of Cannabidiol (CBD)

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

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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Origin of Δ9-Tetrahydrocannabinol Impurity in Synthetic Cannabidiol

Cited by 22 publications

References 25 publications

Towards Better Delivery of Cannabidiol (CBD)

Towards Better Delivery of Cannabidiol (CBD)

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

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

Contact Info

Product

Resources

About

Origin of Δ⁹-Tetrahydrocannabinol Impurity in Synthetic Cannabidiol