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Safety and risks of CBD oils purchased online: unveiling uncertain quality and vague health claims
Buying weed Szombathely
Official websites use. Share sensitive information only on official, secure websites. Reviewed by: Nadezhda A. The use, distribution or reproduction in other forums is permitted, provided the original author s and the copyright owner s are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Introduction: The unmet need for highly effective, naturally derived products with minimal side effects results in the over-popularity of ever-newer medicinal plants. In the middle of , products containing cannabidiol CBD , one of the special metabolites of Cannabis sativa , started to gain popularity. For consumers and healthcare providers alike, the legal context surrounding the marketing of CBD products is not entirely clear, and the safety of using some products is in doubt. Companies in the online medicinal product market profit from the confusion around CBD oils. Methods: In our study, we employed a complex method known as risk-based safety mapping of the online pharmaceutical market, which included health claim content analysis of online stores, test purchases, and labeling and quantitative analysis of the CBD content. A total of 12 CBD oil products were test-purchased from online retailers in December The measured CBD concentrations of the products ranged from One 8. Discussion: Further research and quality control are necessary to establish the regulatory context of the usage and classification of CBD and other cannabinoids in nonmedicinal products e. Keywords: cannabidiol oil, cannabidiol, consumer product safety, online medicinal products, product labeling, quality, test purchase. Phytocannabinoids are characteristic metabolites of Cannabis sativa L. Cannabinoids are insoluble in water but soluble in alcohols, non-polar organic solvents e. That is why the first products encountered in were mostly oil-based Messina et al. The revival of plant-based products and the steady shift in attitude surrounding Cannabis sativa L. The opioid epidemic, which raised demand for non-opioid analgesic alternatives, also contributed to the emergence of the Cannabis and CBD product markets Olfson et al. The rise of CBD products began in —, with the introduction of numerous food supplements not only in the United States but also in Europe. Since its distribution as food is incompatible with the novel food regulation European Parliament, , it can no longer be sold as a food supplement or conventional food ingredient. As a result, manufacturers resorted to other non-medical health product categories, such as medical devices or cosmetics. This legal ambiguity, along with the increase in demand over the past decade, has spawned a multibillion-dollar global market Sarma et al. Given that these plant-based products were initially marketed as food supplements, it is not surprising that health claims for CBD products have appeared. Regulatory agencies identified several regulatory violations, including the use of medical claims, and such incidents are still frequent among these products Amann et al. The potential long-term adverse health effects, including liver toxicity, possible harm to the male reproductive system, and the increased risk of drug interactions, also call for stricter control of CBD-containing products and emphasize the dangers of their uncontrolled use as food supplements Huestis et al. The Summary of Product Characteristics SmPC of these products may help identify the potential adverse health consequences of unregulated CBD oil and specific patient populations that will not benefit from their use Kalant and Porath-Waller, ; Bajtel et al. National regulatory agencies are responding differently to the unresolved issue of CBD products because the current regulatory frameworks are incapable of mitigating these risks, and new approaches are required. The Hungarian National Institute of Pharmacy and Nutrition—similarly to other national authorities—has chosen a restrictive approach Food and Drug Administration, ; Hughes et al. In the European Union, foods containing CBD extracts and CBD-enriched foods are considered novel foods, and their distribution is, therefore, prohibited, regardless of their THC content, as cannabinoids are not permitted as novel foods. Only hemp seed and products derived from hemp seed processing e. Similarly, THC content, regarded as an impurity, needs to be evaluated case by case, taking into account the overall characteristics of the product. Globally, hemp and CBD products may be subject to varying regulations, which may lead to confusion. According to current European legislation, the generally accepted cannabinoid profile of hemp is 1. For native and produced hemp seeds, the maximum THC content is 0. There is public pressure on pharmaceutical authorities to establish clear and concise regulatory frameworks for CBD products, as information regarding product content is frequently restricted or unknown, and lot-to-lot variation and long-term stability are debatable. International organizations involved in the regulation of controlled substances, such as the International Narcotics Control Board INCB , likewise struggle with the questions and problems associated with these products. Due to the ongoing issues and debates around CBD oils, it is of public health significance to call the attention of consumers and policymakers to prevent misperceptions about CBD products and reduce the potential harms and health risks associated with their use. Our study consisted of three sections. First, we conducted an online market analysis, focusing on the content analysis of web stores selling CBD oils for consumers in an effort to identify potentially misleading health claims. Second, selected CBD oils were test-purchased online, and the packaging and labeling of products were evaluated to assess the reliability of the information provided on the delivered products. Finally, product quality was assessed using a quantitative analysis of the CBD content. The online availability of CBD oil products was evaluated using a consumer purchase simulation method based on our previously published methodology for risk-based safety mapping of the online pharmaceutical market. This complex risk-based algorithm simulates what consumers can easily find and what websites they are most likely to visit when searching the internet for CBD oils Vida et al. An online search was conducted on Google. During searches, researchers were not logged into any accounts, and their browsers were configured with default security settings. The websites offering CBD oils to consumers were further evaluated. Content available on social media sites was not evaluated in this study. During the search, the authors documented the category of the website web shop, sites with online information on CBD products, redirect page, social networking site, and others ; the language of operation; distributor name; and contact information. Additionally, we evaluated whether a website sold products from a single firm or several brands. The payment choices listed were PayPal, money transfer, and cash on delivery. To estimate the security of an internet connection, the implementation of the Secure Sockets Layer SSL protocol was documented, and the safety and dependability of websites were anticipated based on a manual assessment of language and content that emphasized spelling and grammatical problems. Following a review of the website content, we determined that the majority of websites offered a variety of CBD oils for retail sale. Due to budgetary constraints, 12 products were selected for test purchase. All steps of the purchasing procedure were photographed for further evaluation. The brand name, distributor, purchase identification number, price and shipping cost, method of payment, invoice, and date of arrival were recorded. The inner and outer packaging and any accompanying documentation of the products were photographed upon arrival. The products were stored according to the recommendations on the label or at room temperature in a dry environment, and the oils were tested immediately after opening. The extracts were diluted fold and subsequently filtrated using a 0. For CBD quantification, external calibration was applied. The seven-point calibration curve had an LOD of From the first twenty search engine results, 18 links were considered relevant, while one informational website about Cannabis and one redirecting page, both without purchase options, were excluded from content analysis. After removing duplicates, 16 online stores were identified and included in the analysis. Notably, one online store sold 27 distinct types of CBD oils. The prices of these products ranged between 15 and 45 EUR; the average unit price for the test purchase products was 1. Through additional online research, we determined that 12 products were available from web shops outside of Hungary and are, therefore, regarded as worldwide available, whereas just four products were offered only in Hungary. In 12 online stores, we were able to pay via PayPal, wire transfer, or cash on delivery, whereas three accepted only cash on delivery. One of these www. Critical evaluation of health claims—including potential benefits and adverse effects—is of utmost importance, as potential consumer harm and adverse effects may be associated with the improper application of these products or the application for health conditions without medical supervision, in addition to or in lieu of medicinal therapy. Consequently, the information provided to consumers during the purchasing process is a vital element of consumer safety. We assessed health claim information available in online stores by searching for medical conditions and then ranked these claims based on their frequency. Additional indications, such as epilepsy, which is an authorized indication for a cannabidiol-based medicine, were also commonly mentioned, possibly as a direct-to-consumer marketing technique to raise demand for these products among certain patient groups. Occurrence of direct or indirect health claims and indications on 16 web shops offering CBD oils for sale. In December , 12 CBD oil products identified by a previous market analysis were obtained from online retailers for testing purposes. The majority of products All test purchases were attached to an invoice; seven electronic, three paper-based and, in the case of two products, in both formats. Shipping information was unavailable for two products Only four products The collected information regarding the CBD oils purchased for testing is shown in Table 2. CBD concentration ranged from Based on a quantitative examination of CBD concentration, 8. With a concentration of The labeling accuracy of CBD oils purchased for testing is shown in Table 3. In , Bonn-Miller et al. In general, the concentration of unlabeled cannabinoids was modest; nonetheless, THC was detected in The officers of the Mississippi Bureau of Narcotics in purchased CBD-containing products from offline retailers in the state of Mississippi, according to a separate study. The authors highlighted the misleading therapeutic or cosmetic claims Spindle et al. However, these findings are not country-specific and reflect a worldwide trend since other European studies have shown the same discrepancies in labeling accuracy as the International Cannabis and Cannabinoids Institute reported in Cannabis and Cannabinoids Institute, The CBD content varied between 0. Additional investigation indicated that 12 of 14 contained THC Pavlovic et al. In a study from the UK, Liebling et al. Some products contained residual solvents like n-pentane, ethanol, ethyl acetate, isopropanol, heptane, and cyclohexane; in addition, small quantities of lead 0. All values were below the ICH guidelines for medicinal products but above safety levels of the food limit Liebling et al. The provenance of the products ranged from the Netherlands to Switzerland to Barcelona. Unique to the experiment were the use of authorized CBD medicinal products as a positive control Epidiolex and the inclusion of only oil products. The CBD concentration varied between 9. In a study led by a pharmacy student in the southwest Wisconsin area in , 39 cannabidiol products were purchased from local retail shops, and of the 11 oils, only THC was detected in As part of an international study conducted in —, 24 samples were purchased online from Austria, France, Germany, Great Britain, Luxembourg, the Netherlands, and Spain. One sample had a THC concentration above 0. In this product category, reporting the potential for adverse health effects and practicing pharmacovigilance are crucial Bonn-Miller et al. Similar results were found and published by Johnson et al. Bonn-Miller et al. Chronic pain and spasticity, multiple sclerosis, treatment-resistant epilepsy, nausea and vomiting due to chemotherapy, weight gain in HIV infection, sleep disorders, Tourette syndrome, anxiety, post-traumatic stress disorder, and schizophrenia are among the approved indications or applications of authorized CBD medicinal products. Whiting et al. Although some cannabinoids have beneficial effects, CBD products that are not medications are prohibited from using therapeutic indications and health claims in their marketing. Similar to our findings, other studies have indicated that regulation violations occur often on the food supplement markets in the United States and Europe Evans, ; Zenone et al. Similarly, a study by Soleymanpour et al. CBD oils usually have a lower concentration of CBD than medicinal products in clinical trials; therefore, claims on efficacy should be handled with precautions. When evaluating the potency of CBD oils and their potential for health risk, a dose regimen and content analysis comparable to ours, as well as a comparison with approved medications containing the same substance, might be helpful Table 4. Suggested dosing and maximum CBD content of the ordered products compared to authorized medicine. Admittedly, we could not identify toxic levels of the CBD content or recommended dose, and the preclinical and clinical data from medicine trials cannot be generally applied to other health products. However, the uncontrolled product quality in this market and unsupervised application or combination with other cannabis or addictive substances e. Uncontrolled consumption especially when the product lacks application and dosage information of a new ingredient regulated as a drug for which there is no EFSA novel food recommendation should not be promoted and regarded as a safe phenomenon. From a legal perspective, these products are regarded as counterfeit medicines: food supplements containing active pharmaceutical ingredients Freeman et al. The use of CBD products should be advised with caution for several patient or consumer groups, including young adults 18—25 years old due to the unknown effects of CBD on developing brains; people with coexisting psychiatric conditions; elderly people taking multiple medications, as CBD may increase the risk of falls; people with decreased liver function or liver disease; women who are pregnant or nursing; and people who have allergies to cannabis or components in CBD products Health Canada, Given that CBD products are probably used under unsupervised circumstances, it is imperative to provide accurate product information about how to use and dose these items. Nevertheless, our study also demonstrated that consumers are more likely to take the wrong dosage, which is consistent with prior label accuracy studies from the US, Europe, or other nations. Therefore, these products can have serious negative effects on health when used by sensitive patient groups such as those who have epilepsy Health Canada, It is also recommended that companies include warnings regarding special patient groups like pregnant and breastfeeding women, allergies, patients taking multiple prescribed medications, and the potential for drug interactions. Additionally, it is advised to include in the packaging of health products containing CBD clear dosing instructions and warnings of potential side effects, as they are dose-dependent. The committee recommends that since there are no conclusive studies that have validated its use for such indications, health products containing cannabis should bear a warning stating that they are not designed to help reduce consumption of opioids or alcohol. Along with the regulatory overview and change, the education of the public through awareness campaigns should also be carried out Australian Government Department of Health and Aged Care Therapeutic Goods Administration, Labels on these products should encourage consumers to report adverse reactions on a defined platform or to the pharmacist. Finally, it is advisable to restrict the availability of these products; for example, health products containing CBD should only be available in pharmacies National Mental Health and Substance Use Policy Laboratory, These recommendations might also be helpful to other countries that are having trouble regulating CBD products. Since there was no significant history of consumption in the EU prior to May , CBD and other cannabinoids were confirmed to fall under the novel food legislation in As a result, CBD oils must first undergo evaluation and authorization before they can be utilized as an ingredient in food or dietary supplements. Furthermore, while evaluating CBD as a novel food, interactions should be taken into account due to the intricacy and importance of CBD receptors and pathways. Although there is a general increase in awareness and scrutiny from a regulatory perspective, distributors and companies have found other ways to sell the products, such as cosmetics. Although numerous studies have evaluated CBD products sold over the internet in previous years, this is the first Central European study. Additionally, we focused on the evaluation of health claims while assessing the correctness of the labeling on the purchased products. Last, the purpose of this study is to provide an up-to-date, complete overview and discussion of the international relevance of marketing and regulatory concerns pertaining to CBD oils. Admittedly, there are a few limitations to our study that we must acknowledge. First, we only considered oils and excluded all other CBD products; however, at the time of purchase, oils were the most popular and readily available. Second, reporting additional cannabinoids would have provided more comprehensive results. In recent years, CBD products have gained global attention due to their inconsistent labeling and unregulated marketing, which pose a significant threat to consumer and patient safety since their diverse compositions might result in toxicities and drug interactions. The likelihood of serious adverse effects, such as liver failure, should highlight the dangers associated with the use of illegally marketed CBD oils. The improvement of pharmacovigilance, such as customers reporting adverse reactions to non-medicinal items including dietary supplements , can be a valuable method for reducing risks. To build the regulatory framework for CBD containing products, additional research, including phytochemical investigations using validated methodologies, clinical and real world safety studies, is required. RV: methodology and writing—original draft. LS: data curation, investigation, and writing—review and editing. TK: investigation, methodology, and writing—review and editing. DC: investigation, methodology, and writing—original draft. AF: conceptualization, data curation, funding acquisition, methodology, supervision, and writing—review and editing. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that they were editorial board members of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision. All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors, and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. 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. Front Pharmacol. Find articles by Lilien Victoria Strauss. Find articles by Tivadar Kiss. Received Aug 6; Accepted Nov 27; Collection date Open in a new tab. Main characteristics of CBD products purchased from selected web shops. Labeling accuracy and number of health claims of CBD oils test-purchased over the internet. The Farm Bill defined hemp as Cannabis sativa L. Foods and dietary supplements cannot contain CBD! Less than 0. Click here for additional data file. 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. United States Medical Kft. Hempstore Kft. Gnath Hunt Kft. Biofora Herbal kft. Against neurodegenerative diseases, e. All products, made from industrial hemp and CBD-containing products are legal. Hemp seed products that contain less than 0. All hemp products must contain less than 0.
Buying weed Szombathely
Safety and risks of CBD oils purchased online: unveiling uncertain quality and vague health claims
Buying weed Szombathely
Buying weed Szombathely
Safety and risks of CBD oils purchased online: unveiling uncertain quality and vague health claims
Buying weed Szombathely
Buying weed Szombathely
Buying weed Szombathely
Buying hash online in Cagayan de Oro
Buying weed Szombathely