Label accuracy of unregulated cannabidiol (CBD) products: measured concentration vs. label claim.
Label accuracy of unregulated cannabidiol (CBD) products: measured concentration vs. label claim.
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DOI：
10.1186/s42238-022-00140-1
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发表时间：
2022-06-06
影响因子：
3.7
通讯作者：
Babalonis, Shanna
中科院分区：
文献类型：
--
作者：
Johnson, Erin;Kilgore, Michael;Babalonis, Shanna
大麻在美国的合法化导致了大麻衍生产品的巨大增长，特别是大麻二酚（CBD）产品。该行业缺乏监管，导致CBD产品的成分和质量存在问题。当前研究的目的是检查从网上和当地零售商购买的80种市售大麻衍生CBD产品中的CBD含量。Epidiolex®也作为阳性对照纳入研究。大麻衍生的CBD产品被选中代表肯塔基中部居民随时可用的产品。这些样品包括在肯塔基州内外不同地点生产的本地和国家品牌。采用液相色谱-串联质谱（LC-MS /MS）对产品进行分析，并将分析结果与CBD含量的标签声明进行比较。描述性统计和基于正态的置信区间使用Microsoft Excel计算。标签声称CBD含量范围为7.5至60 mg/mL，而LC-MS /MS分析检测到的范围为2.9至61.3 mg/mL。在评估的80种产品中，37种产品的CBD浓度与标签上列出的浓度相差至少±10%（范围为0.9至30.6 mg/mL） - 12种产品的含量< 90%，而25种产品的含量为bbb10 - 110%。使用标签声明±10%公差测试的样品的一致性度为54%。这些数据表明，需要额外的监管来确保标签的准确性，因为本研究中近一半的产品没有正确标记（即，不在±10%的误差范围内）。消费者和从业者应该对不受监管和经常贴错标签的CBD产品保持谨慎，因为服用过多CBD的风险（例如，药物-药物相互作用，肝酶升高，副作用增加）和服用太少的后果（例如，由于剂量不足而没有临床益处）。这项研究的结果支持了对CBD产品的良好生产规范和测试标准的持续需求。
The legalization of hemp in the USA has led to tremendous growth in the availability of hemp-derived products, particularly cannabidiol (CBD) products. The lack of regulatory oversight in this industry has resulted in the marketing and sale of CBD products with questionable ingredients and quality. The aim of the current study was to examine the CBD content in 80 commercially available hemp-derived CBD products purchased from online and local retailers. Epidiolex® was also included in the study as a positive control. Hemp-derived CBD products were selected to represent products readily available to residents of Central Kentucky. The samples were comprised of local and national brands produced in a variety of locations inside and outside of Kentucky. The products were analyzed by liquid chromatography-tandem mass spectrometry (LC–MS/MS), and the analytical findings were compared to the label claims for CBD content. Descriptive statistics and normal-based confidence intervals were calculated using Microsoft Excel. The label claims for CBD content ranged from 7.5 to 60 mg/mL, while LC–MS/MS analysis detected a range of 2.9 to 61.3 mg/mL. Of the 80 products evaluated, 37 contained CBD concentrations that were at least ± 10% different than the concentration listed on the label (range of 0.9 to 30.6 mg/mL from label claim) — 12 products contained < 90%, while 25 products contained > 110%. The degree of concordance for the samples tested using ± 10% tolerance from label claim was 54%. These data suggest that additional regulation is required to ensure label accuracy as nearly half of the products in this study were not properly labelled (i.e., not within a ± 10% margin of error). Consumers and practitioners should remain cautious of unregulated and often-mislabeled CBD products due to the risks of taking too much CBD (e.g., drug-drug interactions, liver enzyme elevations, increased side effects) and the consequences of taking too little (e.g., no clinical benefits due to underdosing). The results of this study support the continued need for good manufacturing practices and testing standards for CBD products.
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