Figure - available via license: CC BY
Content may be subject to copyright.
Source publication
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 Δ ⁹ -tetrahydrocannabinol (TH...
Contexts in source publication
Context 1
... investigate CBD degradation into THC under acidic conditions, differently concentrated CBD in methanolic solutions was used in a range corresponding to typical amounts consumed with supplements based on commercial CBD (Supelco Cerilliant #C-045, 1.0 mg/mL in methanol) supplied by Merck (Darmstadt, Germany). These solutions were exposed to an artificial gastric juice as well as different incubation times and stress factors such as storage under light and heat (see Table 1 for full experimental design). The solutions were stored either in standard freezer (-18°C) or refrigerator (8°C) or at room temperature (20°C). ...Context 2
... these conditions in contrast to Merrick et al. 12 , no conversion of CBD to THC was observed in any of the samples. Only in case of the positive control (2 week storage in 0.5 mol/L HCl and 50% methanol), a complete degradation of CBD into 27% THC and other not identified products (with fragments similar to the ones found in cannabinol and THC fragmentations but with other retention times) was observed (Table 1, underlying data 11 ). From an analytical viewpoint, the use of less selective and specific analytical methods, especially from the point of chromatographic separation, could result in a situation in which certain CBD degradation products might easily be confused with THC due to structural similarities. ...Context 3
... investigate CBD degradation into THC under acidic conditions, differently concentrated CBD in methanolic solutions was used in a range corresponding to typical amounts consumed with supplements based on commercial CBD (Supelco Cerilliant #C-045, 1.0 mg/mL in methanol) supplied by Merck (Darmstadt, Germany). These solutions were exposed to an artificial gastric juice as well as different incubation times and stress factors such as storage under light and heat (see Table 1 for full experimental design). The solutions were stored either in standard freezer (-18°C) or refrigerator (8°C) or at room temperature (20°C). ...Context 4
... these conditions in contrast to Merrick et al. 12 , no conversion of CBD to THC was observed in any of the samples. Only in case of the positive control (2 week storage in 0.5 mol/L HCl and 50% methanol), a complete degradation of CBD into 27% THC and other not identified products (with fragments similar to the ones found in cannabinol and THC fragmentations but with other retention times) was observed (Table 1, underlying data 11 ). From an analytical viewpoint, the use of less selective and specific analytical methods, especially from the point of chromatographic separation, could result in a situation in which certain CBD degradation products might easily be confused with THC due to structural similarities. ...Context 5
... investigate CBD degradation into THC under acidic conditions, differently concentrated CBD in methanolic solutions was used in a range corresponding to typical amounts consumed with supplements based on commercial CBD (Supelco Cerilliant #C-045, 1.0 mg/mL in methanol) supplied by Merck (Darmstadt, Germany). These solutions were exposed to an artificial gastric juice as well as different incubation times and stress factors such as storage under light and heat (see Table 1 for full experimental design). The solutions were stored either in standard freezer (-18°C) or refrigerator (8°C) or at room temperature (20°C). ...Context 6
... these conditions in contrast to Merrick et al. 12 , no conversion of CBD to THC was observed in any of the samples. Only in case of the positive control (2 week storage in 0.5 mol/L HCl and 50% methanol), a complete degradation of CBD into 27% THC and other not identified products (with fragments similar to the ones found in cannabinol and THC fragmentations but with other retention times) was observed (Table 1, underlying data 11 ). From an analytical viewpoint, the use of less selective and specific analytical methods, especially from the point of chromatographic separation, could result in a situation in which certain CBD degradation products might easily be confused with THC due to structural similarities. ...Context 7
... Dataset for 'Are side effects of cannabidiol (CBD) products caused by delta9-tetrahydrocannabinol (THC) contamination' F1000 Research.xlsx (Version 2) (Excel spreadsheet with data underlying Table 1 and Table 2 Commercial CBD products are usually crude extracts from whole hemp plant material, that are available for purchase in several venues. These extracts have been reported to contain cannabinoid mixtures rather than pure CBD, and are then mixed into edible oils to obtain CBD oil. ...Similar publications
Cannabidiol (CBD)-containing products are widely marketed as over the counter products, mostly as food supplements. Adverse effects reported in anecdotal consumer reports or during clinical studies were first assumed to be due to hydrolytic conversion of CBD to psychotropic Δ ⁹ -tetrahydrocannabinol (Δ ⁹ -THC) in the stomach after oral consumption....
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-T...
Citations
... Cannabidiol (CBD)-based products are proliferating in countries with different legislation regarding the use of cannabis-based products (Walker et al., 2020). Concerns about the safety of CBD-based products have been raised (Lachenmeier et al., 2019). Given the high risk of misleading information and subsequent confusion about CBD's legal status and its effects, there is a need to elucidate motivations and patterns of use among CBD users. ...
Background
Cannabidiol and cannabidiol-based products are proliferating in many countries. This recent and rapid diffusion prompts investigating the reasons for its use.
Methods
We analyzed data from an online survey among cannabidiol users in the French general population ( n = 1166) selected for their interest in such products. We described the reported reasons for using cannabidiol. We performed logistic regressions to identify the correlates of declaring well-being and other specific reasons for using cannabidiol. We also provided descriptive data regarding the cannabidiol patterns of use.
Results
Well-being was the most cited primary reason for use (27% of the sample). Declaring well-being as a primary reason for using cannabidiol was inversely associated with cigarette smoking, cannabis use, and employment. Among cannabidiol users reporting well-being as their primary reason for use, stress and sleep improvements were the most-cited specific reasons. In the whole study sample, the most common modes of use were smoking cannabidiol-rich cannabis (61%) and ingesting cannabidiol oil sublingually (19%).
Conclusions
In a sample of cannabidiol users from France, well-being was the most-cited primary reason for use, and smoking was the first route of administration. Further research is needed to clarify to what extent expected effects are scientifically sound and to understand country-related specificities regarding patterns of use.
... Commercially available CBD products are largely unregulated and are not held to the quality control as FDA-approved medications, which can result in inconsistent dosing, safety, and therapeutic response predictability (Freeman et al., 2019b). Two studies found that a majority of sampled CBD products were mislabeled regarding their CBD content, and approximately a quarter of the products contained detectable amounts of THC (Bonn-Miller et al., 2017;Lachenmeier et al., 2019). ...
Cannabidiol (CBD) has become a fast-growing avenue for research in psychiatry, and clinicians are challenged with understanding the implications of CBD for treating mental health disorders. The goal of this review is to serve as a guide for mental health professionals by providing an overview of CBD and a synthesis the current evidence within major psychiatric disorders. PubMed and PsycINFO were searched for articles containing the terms “cannabidiol” in addition to major psychiatric disorders and symptoms, yielding 2,952 articles. Only randomized controlled trials or within-subject studies investigating CBD as a treatment option for psychiatric disorders (N=16) were included in the review. Studies were reviewed for psychotic disorders (n =6), anxiety disorders (n =3), substance use disorders (tobacco n= 3, cannabis n= 2, opioid n= 1), and insomnia (n= 1). There were no published studies that met inclusion criteria for alcohol or stimulant use disorder, PTSD, ADHD, autism spectrum disorder, or mood disorders. Synthesis of the CBD literature indicates it is generally safe and well tolerated. The most promising preliminary findings are related to the use of CBD in psychotic symptoms and anxiety. There is currently not enough high-quality evidence to suggest the clinical use of CBD for any psychiatric disorder.
... In unklaren Grenzfällen, die der Lebensmittelüberwachung bekannt werden, könnten die Vorgänge zur Prüfung der Betäubungsmitteleinstufung an die dafür zuständige Behörde abgegeben werden. Eine generelle Abgabe aller Fälle erscheint nach dem Urteil des BGH allerdings nicht mehr zweckmäßig.Unsere Untersuchungsergebnisse[27] im Vergleich mit den Modellrechnungen inTabelle 2 zeigen, dass die THC-Gehalte in Hanfprodukten, mit Ausnahme von Einzelfällen, durch die relativ hohen notwendigen Verzehrsmengen in der Regel nicht zum Missbrauch zu Rauschzwecken geeignet sind. Die seit Jahren aus Überwachungskrei-Ob Kalorien, Vitamine oder Aminosäuren, in Austern, Parmesan, Nudeln, Pastinake oder Truthahn -hier steht's. ...
Produkte mit Hanfextrakt sind als neuartige Lebensmittel ohne Zulassung weiter nicht verkehrsfähig. Der Europäische Gerichtshof schließt aber die Einstufung von Cannabidiol als Betäubungsmittel aus. Für Hanfblätter und -blüten muss laut BGH ein Missbrauch zu Rauschzwecken ausgeschlossen werden, jedoch ist dann gegebenenfalls eine Abgabe auch an Endverbraucher möglich.
... The post marketing safety assessment showed gastrointestinal effects as most commonly reported adverse effect 12 . We have included this information and several more studies into the two newer versions (version 3; v3 13 and version 4; v4 14 ) of our article 2 to strengthen our arguments. Besides the mentioned human evidence, experimental research in vivo and in vitro resulted in concerns about hepatotoxicity 15 , teratogenicity 16 , and gut inflammation 17 . ...
... This practice is clearly in favour of the food business operator (FBO) because -as the EIHA correctly states -a major part of total THC may be comprised by THCA 1 . We have updated our article to clarify this issue on several instances and to avoid future misunderstandings 13 . ...
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.
... Il est donc possible d'avoir une présence ou des concentrations supérieures de ce composé par rapport aux spécifications affichées sur le produit [93]. Cela peut mener à une intoxication au 9-THC [94] ou à un contrôle antidopage positif à cette molécule et aux autres cannabinoïdes interdits [95]. La composition du produit est donc un élément important à prendre en compte lors de l'utilisation du CBD et notamment avec les produits dit « full spectrum » (i.e. ...
Résumé
Objectifs
Dans cet article, nous souhaitons faire le point sur les différentes propriétés du cannabidiol (CBD) potentiellement intéressantes pour le sportif.
Actualités
Le CBD est, avec le Δ9-tetrahydrocannabinol, l’un des phytocannabinoïdes les plus abondants du Cannabis Sativa L. Avec la levée de l’interdiction en 2018 du CBD par l’Agence mondiale anti-dopage, il est probable que les sportifs se tournent davantage vers les produits au CBD dérivés du Cannabis Sativa L.
Perspectives et projets
Des études précliniques sur le CBD ont montré des effets anxiolytiques, analgésiques, anti-inflammatoires, neuroprotecteurs mais également sur le sommeil. Ces propriétés pourraient être intéressantes dans la gestion des blessures, des commotions, de l’anxiété et des troubles du sommeil. Si le CBD paraît être une molécule sûre, les effets secondaires indésirables existent bel et bien et notamment pour les produits non réglementés.
Conclusion
Le manque de preuves scientifiques et le trop peu d’études cliniques appliquées aux sportifs ne permettent pas, pour le moment, de recommander l’utilisation du CBD aux athlètes.
... A key reason for choosing to initiate with a CBDpredominant variety was to prioritize safety as CBD is highly tolerable, does not induce euphoria, and has a low risk for adverse effects (Taylor et al. 2018;Larsen and Shahinas 2020). In addition, many CBDpredominant preparations contain a small percentage of THC (Bonn-Miller et al. 2017;Lachenmeier et al. 2020). It was decided that the maximum amount of THC allowed in a CBD-predominant product to be considered for these protocols would be 1:10 THC to CBD. ...
... It was decided that the maximum amount of THC allowed in a CBD-predominant product to be considered for these protocols would be 1:10 THC to CBD. Many global CBD-predominate products contain 0.-2% THC (Bonn-Miller et al. 2017;Corroon et al. 2020;Lachenmeier et al. 2020). ...
... Another deciding factor in choosing CBDpredominant as the initiating product was the fact that many CBD-predominant preparations contain a small percentage of THC (Bonn-Miller et al. 2017;Lachenmeier et al. 2020). If the ratio of THC to CBD is 1:20, a patient taking 40 mg of a CBD-predominant product is also receiving 2 mg of THC. ...
Background
Globally, medical cannabis legalization has increased in recent years and medical cannabis is commonly used to treat chronic pain. However, there are few randomized control trials studying medical cannabis indicating expert guidance on how to dose and administer medical cannabis safely and effectively is needed.
Methods
Using a multistage modified Delphi process, twenty global experts across nine countries developed consensus-based recommendations on how to dose and administer medical cannabis in patients with chronic pain.
Results
There was consensus that medical cannabis may be considered for patients experiencing neuropathic, inflammatory, nociplastic, and mixed pain. Three treatment protocols were developed. A routine protocol where the clinician initiates the patient on a CBD-predominant variety at a dose of 5 mg CBD twice daily and titrates the CBD-predominant dose by 10 mg every 2 to 3 days until the patient reaches their goals, or up to 40 mg/day. At a CBD-predominant dose of 40 mg/day, clinicians may consider adding THC at 2.5 mg and titrate by 2.5 mg every 2 to 7 days until a maximum daily dose of 40 mg/day of THC. A conservative protocol where the clinician initiates the patient on a CBD-predominant variety at a dose of 5 mg once daily and titrates the CBD-predominant dose by 10 mg every 2 to 3 days until the patient reaches their goals, or up to 40 mg/day. At a CBD-predominant dose of 40 mg/day, clinicians may consider adding THC at 1 mg/day and titrate by 1 mg every 7 days until a maximum daily dose of 40 mg/day of THC. A rapid protocol where the clinician initiates the patient on a balanced THC:CBD variety at 2.5–5 mg of each cannabinoid once or twice daily and titrates by 2.5–5 mg of each cannabinoid every 2 to 3 days until the patient reaches his/her goals or to a maximum THC dose of 40 mg/day.
Conclusions
In summary, using a modified Delphi process, expert consensus-based recommendations were developed on how to dose and administer medical cannabis for the treatment of patients with chronic pain.
... On the contrary, persons interested in CBD products marketed as dietary supplements are seeking for specific effects of this substance and make an informed decision to ingest it. As previously showed, these products typically contain much higher THC content (Christinat et al., 2020) and considerably contribute to the exposure to THC (Lachenmeier et al., 2020). ...
The latest report on tetrahydrocannabinol (THC) exposure assessment performed by European Food Safety Authority showed that THC levels in certain food categories are high. However, the performed study included uncertainties regarding occurrence data and hemp-food consumption patterns. The aim of the present study was to quantify the levels of “total” Δ⁹-THC, cannabidiol (CBD) and cannabinol (CBN) in hemp food products available on the market of countries mostly not assessed by the latest EFSA report, as well as to perform cannabinoids health risk assessment. The obtained results allowed us to identify hemp-seed oils as product type which might represent health concern. Furthermore, the analysis of hemp teas showed the possibility of Cannabis drug-type occurrence, but also questioned the justification of cannabinoids maximum transfer principle application for the exposure assessment. It was concluded, that hemp-based food products should not be consumed by population younger than 18 years.
... Survey questions referred to ''CBD-only products with no THC'' and the CBD oil label indicated ''0 mg THC''; yet most CBD products contain some amount of THC. 42 There may have been some uncertainty regarding the definition of a ''CBD-only'' product, and respondents who consume cannabis products with trace amounts of THC, consider CBD to be a cannabis product, and/or live in jurisdictions where cannabis remains illegal may have under-reported their CBD use. Moreover, our interpretation of CBD versus THC-containing cannabis products may be inconsistent with assumptions made by other researchers or the public, influencing interpretation of our results. ...
Objectives: This study aimed to characterize use and perceptions of cannabidiol (CBD) products. Materials and Methods: Participants aged 16-65 years in Canada (n=15,042) and the United States (n=30,288) completed measures on prevalence and patterns of CBD product use and perceptions of CBD oil as part of the 2019 International Cannabis Policy Study online survey. Results: Past 12-month CBD product use was significantly more prevalent among respondents in the United States (26.1%) than in Canada (16.2%). Consumers in the United States and Canada reported using a range of CBD products, including drops (46.3% vs. 47.3%, respectively), topicals (26.0% vs. 16.7%), edibles/foods (23.8% vs. 17.6%), vape oils (18.9% vs. 13.3%), capsules (13.3% vs. 16.7%), and dried flower (10.1% vs. 16.1%). CBD was most commonly reported for management of pain, anxiety, and depression. Over half of CBD consumers in both countries reported that CBD oil was beneficial for health. Conclusions: Use of CBD products is common in both the United States and Canada, primarily to manage self-reported health conditions for which there is little or no evidence of efficacy. Clearer public health messaging regarding the therapeutic effects of CBD is warranted.
... This would suggest that use of nonprescription products produces doses that are well below those identified as effective in clinical trials (Millar, et al., 2019). However, it is also worth noting that the accuracy of the labelling of such products has been called into question by several recent analyses meaning that the actual CBD doses taken by patient may sometimes be larger (or smaller) than intended, and that other cannabinoids, particularly THC, may be present in greater quantities than labelling suggests (Bonn-Miller, et al., 2017;Hazekamp, 2018;Lachenmeier, et al., 2019;Liebling, Clarkson, Gibbs, Yates, & O'Sullivan, 2020;Pavlovic, et al., 2018). ...
... Other potential hazards relate to observations of the inaccuracy of the labelling of non-prescription products. Recent analyses of actual THC and CBD content of available products in the UK (Gibbs, et al., 2019;Liebling, et al., 2020), Germany (Lachenmeier, et al., 2019), other EU countries (Pavlovic, et al., 2018) and USA (Bonn-Miller, et al., 2017) suggest a worrying lack of accuracy in product labelling. Both over-labelling (the product provides lower cannabinoid content than stated on the pack) and under-labelling (the product provides higher cannabinoid content than started on the pack) were detected, with many products in breach of strict THC limits. ...
Background
Recent legislative change has allowed increased access to cannabis products in many jurisdictions. In some locations, this includes over-the-counter (OTC) and/or online access to products containing cannabidiol (CBD), a non-intoxicating cannabinoid with therapeutic properties. Here we compared the availability of CBD products and the associated legislative and regulatory background in nine selected countries.
Methods
Accessibility of CBD products was examined in the USA, Canada, Germany, Ireland, United Kingdom, Switzerland, Japan, Australia, and New Zealand as of May 2020. Regulatory and other relevant documents were obtained from government agency websites and related sources. Relevant commercial websites and some physical retailers were visited to verify access to CBD-containing products and the nature of the products available.
Results
A range of CBD products appeared to be accessible without prescription in seven out of nine countries reviewed. Australia and New Zealand were the exceptions where clinician prescription was required to access any CBD-containing product. CBD products commonly available without prescription included oils, gel capsules, purified crystal and topical products. The daily recommended doses with orally administered non-prescription products were typically well below 150 mg and substantially lower than the doses reported to have therapeutic effects in published clinical trials (e.g., 300-1500 mg). The legal foundations enabling access in several countries were often unclear, with marketed products sometimes failing to meet legal requirements for sale. There was an obvious disparity between federal directives and available products in both the USA and European countries examined.
Conclusions
There are a variety of approaches in how countries manage access to CBD products. Many countries appear to permit OTC and online availability of CBD products but often without legislative clarity. As consumer demand for CBD escalates, improved legislation, guidelines and quality control of CBD products would seem prudent together with clinical trials exploring the therapeutic benefits of lower-dose CBD formulations.
... THC contamination of CBD products is a significant worldwide issue and it is therefore prudent for doctors and patients to request certificates of analysis from the manufacturer. 31 ...
The australian federal government legalised access to medicinal cannabis in 2016:
More than 100 different cannabis products are now available to prescribe most are oral preparations oils or capsules containing delta-9-tetrahydrocannabinol or cannabidiol dried-flower products are also available:
As most products are unregistered drugs prescribing requires approval under the therapeutic goods administration special access scheme-b or authorised prescriber scheme:
Special access scheme category b applications can be made online with approval usually being given within 24–48 hours however supply chain problems may delay dispensing by the pharmacy:
By the end of 2019 over 28000 prescribing approvals had been issued to patients involving more than 1400 doctors mostly gps more than 70000 approvals are projected by the end of 2020:
Most prescriptions are for chronic non-cancer pain anxiety cancer-related symptoms epilepsy and other neurological disorders however the evidence supporting some indications is limited:
Many doctors are cautious about prescribing cannabis while serious adverse events are rare there are legitimate concerns around driving cognitive impairment and drug dependence with products containing delta-9-tetrahydrocannabinol cannabidiol-only products pose fewer risks:
