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Homegrown: The Pot-Dealing Grandmother of Karlsruhe

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Official websites use. Share sensitive information only on official, secure websites. This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Some additional references on adverse effects of cannabidiol and stability studies were included. Cannabidiol CBD -containing products are widely marketed as over the counter products. In view of the growing market for such lifestyle products, the effectiveness of the instrument of food business operators' own responsibility for product safety and regulatory compliance must obviously be challenged, and a strong regulatory framework for hemp products needs to be devised. Keywords: Tetrahydrocannabinol, cannabidiol, Cannabis sativa, hemp, food supplements, risk assessment, drug effects. From all hemp constituents, cannabidiol CBD is currently the compound with the highest interest. It is currently being tested for its possible antispasmodic, anti-inflammatory, anxiolytic and antiemetic effects as a drug, e. The awareness of re-creational CBD use in Germany is high, with approximately half of the population being aware of them and 4. Apart from that, extemporaneous preparations in pharmacies are legally available on prescription in Germany and some other countries. However, most of the CBD products worldwide are available as over the counter products or CBD-containing hemp extracts are used as ingredient in foods and beverages. Commercial CBD products are usually crude extracts from whole hemp plants i. In other ways e. Also, the limited available literature and manufacturer data confirm that CBD products are usually extracted by supercritical CO 2 or with solvents such as ethanol or isopropanol from the entire hemp plant material, which typically has been decarboxylated before the process 7 , 8. No further specific enrichment or purification of CBD is often conducted, so that the commercial extracts are regularly a cannabinoid mixture rather than pure CBD. Otherwise, extracts may be cleaned with different processes such as winterization, or partial fractionation using supercritical CO 2. The most prevalent products are CBD oils in liquid form or hemp extract containing capsules. No significant food consumption of CBD products has been documented before 15 May Up to date as of August , no approved application is documented. Basically, all available CBD products based on hemp extract but also those based on isolated or synthesized CBD, which are intended as food or food supplement within the EU, are therefore illegally sold 2. To circumvent the strict safety requirements for medicinal or food products, some CBD products may be sold as other product categories e. Despite the enforcement efforts of the food and medicinal product control authorities e. Respiratory depression was reported in a case of CBD overdose in a paediatric patient Concerns also include negative effects on the male reproductive system and developmental effects in both sexes 21 , Diarrhoea was an adverse outcome associated with CBD treatment in a meta-analysis of randomized clinical trials, after excluding studies of childhood epilepsy Post marketing safety surveillance of a full spectrum hemp extract reported gastrointestinal symptoms as most common adverse effect, however, they were infrequent 0. The European food safety authority EFSA has recently summarised the state of knowledge on the safety of CBD consumption in the context of the novel food approval procedures. The EFSA determined that the effect of CBD on liver, gastrointestinal tract, endocrine system, nervous system and on psychological function needs to be clarified, and that studies in animals show significant reproductive toxicity In this article, the hypotheses are investigated including new evidence from original data. 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 daylight condition was achieved by storage at a window south side. In deviation of an experimental protocol of Merrick et al. As pure CBD was available only in methanolic solution, the final experimental setups contained 0. The evaluation took place after fragmentation of the mother ion into three mass traces for each compound. In case of QTOF, quantification was conducted over accurate mass and control of fragmentation pattern. The certified reference materials were obtained as solutions in ampoules of 1 mL, all supplied by Merck Darmstadt, Germany. All methods were validated and externally accredited according to ISO standard. This is consistent with more recent research of Solowij et al. Similarly, Zamarripa et al. However, the current scientific evidence does not allow for considering cumulative effects. The BfR has also concluded that the previously suggested German guidance values, which had been considered in versions 1—3 of this article, no longer correspond to current scientific knowledge For further details on interpretation of results and toxicity assessment, see Lachenmeier et al. A detailed rationale for the estimation of the daily dose of products to be applied for the risk assessment has been provided in a correspondence article Similar conclusions were made in a recent systematic review of CBD human trials CBD doses in non-medicinal products on the market are typically much lower than the ones tested in clinical studies. Nevertheless, the EFSA judged in their review of available human and animal studies that a NOAEL could not be identified 28 , and that there might be a possible risk of long-term effects in humans from chronic consumption of CBD as food. Additionally, there are still many uncertainties and contradictions remaining regarding cannabinoid safety studies The metabolism of CBD is very complex. Similar to CBD itself, the toxicological profile of its metabolites has not been systematically investigated The same applies to the interaction with pharmaceuticals However, taking a closer look at these in vitro studies raises some doubts. Due to the contradicting results, a replication of the in vitro study of Merrick et al. Under these conditions in contrast to Merrick et al. Only in case of the positive control 2 week storage in 0. Thus, similar fragmentation patterns and potentially overlapping peaks under certain chromatographic conditions might have led to false positive results in the previous studies. A molecular modelling study 53 provided evidence that the inconsistencies of the study by Merrick et al. The only detectable influence leading to degradation at ambient temperatures is strong acidity, which should be avoided in CBD formulations to ensure stability of products Similar observations were recently provided by Yangsud et al. The acidity appears to be the most important factor, e. Furthermore, all CBD food samples i. In summary, none of the CBD food products in our survey was found as being fully compliant with European food regulations. This might be one of the reasons for the individually very different observed psychotropic effects. In one out of five adults, a single dose of 5 mg already showed corresponding symptoms Some manufacturers even suggest an increase of daily dosage over time. Hence our results provide compelling evidence that THC natively contained in CBD products may be a direct cause for adverse effects of these products. Obviously, there seems to be an involuntary or deliberate lack of quality control of CBD products. In light of the discussion about the three potential causative factors for adverse effects of CBD products, the described acute adverse effects can be explained most probably by the presence of native THC as contaminant in the products rather than by direct action of CBD or its chemical transformation. The conclusions and findings of this study are further supported by several other surveys from the Netherlands and the USA showing inconsistent labelling and THC contents 7 , 76 — In addition, chronic adverse effects of CBD itself are also known, although data gaps remain to be filled for a definitive assessment. Interactions of CBD with pharmaceuticals and degradation products of CBD are unknown and need to be characterized and toxicologically assessed, e. Until then, the safety of the products remains questionable. Furthermore, standardization and purification of the extracts need to be improved and the stability of commercial products during shelf-life should be checked e. Obviously, the manufacturers have — deliberately or in complete ignorance of the legal situation — placed unsafe and unapproved products on the market and thus exposed the consumer to an actually avoidable health risk. It has been claimed by C. Our results have partially corroborated this opinion for a substantial number of products on the German market. Currently we still observe a CBD market in the EU, where obviously considerable numbers of unsafe and misleadingly labelled products are available. Due to consistent deficits in mandatory labelling including a lack of maximum recommended daily dose, dosages up to psychotropic levels for THC or pharmacological levels for CBD cannot be excluded with certainty. Possible long-term risks encompass liver toxicity and reproductive toxicity Obviously, the current regulatory framework is insufficient to adequately regulate products in the grey area between medicines and food supplements. For cannabis-derived products, such as CBD, the problem is aggravated by conflicting regulations in the narcotic, medicinal, and food law areas. For example, hemp extract-based products of similar composition were suggested to be treated as illegal narcotics, prescription-based medicinal products, or novel foods. Only recently, the EU commission clarified its position to not further consider cannabidiol as narcotic, but to advance the novel food approval procedure Clearly for CBD products alongside other cannabis products, a regulated legalization see e. Anderson et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Although the article addresses an important issue and the hypothesis of THC residues being responsible for some of the adverse effects of CBD preparations is plausible and supported by the data, I miss the discussion of two relevant points:. No details are given regarding the extraction of the products. That would be close to the procedure used by most forensic laboratories in Germany. The author's response to reviewer 2 page 4, comments 3 and 8 suggests, however, that THC acid A was determined separately. Solowij et al. Page 8: The German guidance value seems to be several orders of magnitude up to 4 lower than the CBD contents in the products. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Regarding the extraction and measurement of the products, no heat was applied during the whole procedure. This means that the assumption of the reviewer that we might have overestimated the risk by including THCA is unfounded. The reviewer is correct that risk assessment methods of mixtures are currently evolving and have not been applied to mixtures of cannabinoids. Typically, to provide such a risk assessment would be the responsibility of the food business operator and not the responsibility of the authority. Hopefully, such a risk assessment will be provided during the toxicological assessments necessary during the novel food application procedure, which several companies have initiated. For example, Solowij et al. Furthermore, Haney et al. Niemsink and van Laar 4 acknowledge that CBD may counteract the negative effects of THC, but warned that the question remains how laboratory results translate to the real world. We agree with the reviewer that the German guidance value is typically one to several orders of magnitude lower than the THC contents in the products please note that the guideline value is for THC. There is currently no guideline value for CBD available. Deut Lebensm Rundsch. Publisher Full Text. Eur Arch Psychiatry Clin Neurosci. Haney, M. Neuropsychopharmacol 41, — Psychiatry The authors of this manuscript have addressed my questions and concerns in a satisfactory manner. I see no more objection for indexing of this very welcome manuscript. 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. They are marketed as being free of psychoactive component, i. Anecdotal reports of THC-like side effects from these mixtures have been reported. Three hypotheses for these side effects are posed: i direct pharmacological effect of CBD-for which there is little evidence, ii the degradation of CBD to THC due to acidic hydrolysis in the stomach following oral consumption, and iii THC directly contained in the products as a by-product due to co-extraction and enrichment or contamination. The article investigated the latter two of these hypotheses. CBD degradation: Differently concentrated CBD in methanolic solutions was evaluated in a range corresponding to typical amounts consumed in supplements based on commercial CBD supplied by Merck. These solutions were exposed to an artificial gastric juice at different incubation times and under different environmental conditions. Of the 28 samples described in Table 2, none of the products was compliant with European food regulations and most of the samples contained THC, some at a dose that would be expected to lead to intoxication. Although it would have been even more informative to have a clear indication of the CBD content of each of the samples, the data clearly present evidence that the products are mislabeled and that THC-like side effects reported by patients is likely the result of contamination of the product with THC, which was the purpose of the study. This is an important manuscript that will clear up the misconception that CBD is converted to THC in gastric juices of users. The manuscript focuses on the quality of CBD oils, which is a meaningful and contemporary issue. Table 2 is the core of the study, because it compares the claimed composition of CBD oil, with lab results obtained by the authors. The conclusion is that the currently available products in Germany are often not what they claim to be. Unfortunately, the authors did not analyze the actual CBD content of many of the products, and they assume that their own lab analyses are fully accurate, without proving or showing why. The authors use two different methods of analysis without explaining why one method is not sufficient. Also, in many parts of the text, they explain the current situation concerning CBD product without realizing that many readers may not have enough background information to follow their line of reasoning. The manuscript should be rewritten to explain basic concepts better. Also, more data should be added to table 2, particularly about CBD content of the products analyzed. Right now, CBD analysis data is missing for more than half of the samples. It is not clear why so many of the products have not been studied for CBD content, and this undermines the strength of the paper. In general, the idea behind the study is very good, but the execution is relatively poor because it only focuses on the THC content of the product analyzed. Please see my annotated copy of the article here for additional comments. Thank you for your detailed comments and annotations in the copy. As requested, we have revised the background information to clarify the basic concepts. Regarding the criticism of lack of CBD analysis, it must be remarked that the aim of our paper was to investigate the side effects of the products due to THC contamination. Hence, the main purpose of our analytical efforts was to accurately determine the content of THC for health risk assessment. For cost reasons, we have refrained from determining CBD using a second method or dilution it is of note that we had not specific funding for this study and have to generally work economically as tax-payer funded institute. In the legal evaluation of the products, the CBD content is more or less unimportant as long as the content is below the level of pharmacological action for food products. As all products had to be objected for various reasons lack of novel food authorisation, THC contents outside of acceptable levels, mandatory labelling etc. Regarding the question on analytical methods, we actually have confidence in our analytical methods and they are fully validated and our institute is externally accredited according to ISO Nevertheless, as there is no official method for CBD analysis available, we have confirmed our results with a second procedure to even further improve confidence and validity. As of now, we believe that both methods perform similarly and could both be used in instances of laboratories without access to two different instruments. To improve the strength of the paper, as requested by the reviewer, we have added the results of 39 samples measured in the meantime new total 67 samples. In many of these samples it was also possible to quantify CBD. The measurement of these additional samples corroborates our previous results and interpretation, and we hope that the sample collective now appears as sufficient for publication. Regarding the comments in the annotated copy, we have revised the text considering all suggested changes, except for the following comments for which we provide a detailed response comment numbering according to Adobe Acrobat comment numbering in annotated copy of reviewer :. But now it is up to individual EU member states to implement that advise into national legislation. Some countries may decide to not follow the advise. We disagree with this comment. EU regulations such as the novel food regulation are binding in its entirety and directly applicable in all Member States. Therefore there appears to be no leverage for member states to act in infringement of the novel food regulation. In Germany, there are currently at least 7 court rulings that confirmed the status of CBD as novel food and confirmed the actions of the authorities typically removal of products from the market. But in fact this sample may not contain any cannabinoids at all. Some cannabinoids could be qualitatively detected in this sample around the detection limit of the method. Does that mean you do not trust your own methods? In our line of work in providing expert opinions that may be used in court cases, it is often common to use two methods, especially in cases where a reference procedure is not established or when there may be grave consequences in application of the results, such as taking products from the market. We currently cannot see the reason why doing more than perhaps absolutely necessary might hinder publication of such results. Furthermore, as there was a discrepancy between our results and some previous studies regarding in vitro formation of THC from CBD, we found it prudent to confirm our results using a second methodology. Basically, we can accurately quantify all these other cannabinoids using the same method. However, as the results of these are not presented and unnecessary for the current paper, we have deleted all mentions of these compounds in the method section to avoid confusion. The number of replicates depended on several factors, sometimes restricted by the very low sample volume we have received. In certain cases, more replicates were made, for example when several dilutions were within the linearity range. This section collects any data citations, data availability statements, or supplementary materials included in this article. As a library, NLM provides access to scientific literature. Other versions. Find articles by Dirk W Lachenmeier. Find articles by Stephanie Habel. Find articles by Berit Fischer. Find articles by Frauke Herbi. Find articles by Yvonne Zerbe. Find articles by Verena Bock. Find articles by Tabata Rajcic de Rezende. Find articles by Stephan G Walch. Find articles by Constanze Sproll. Accepted Sep 10; Collection date Version Changes Revised. Amendments from Version 6 Some additional references on adverse effects of cannabidiol and stability studies were included. Open in a new tab. Competing interests: No competing interests were disclosed. Find articles by Arno Hazekamp. Arno Hazekamp : Referee. Competing interests: none. PMC Copyright notice. Find articles by Linda A Parker. Linda A Parker : Referee. Associated Data. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel.

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