Borgelt Laura M, Armstrong Michael, Brindley Stephen, Brown Jared M, Reisdorph Nichole, Stamm Carol A
Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, Unites States.
Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, Unites States.
Am J Clin Nutr. 2025 Jun;121(6):1395-1402. doi: 10.1016/j.ajcnut.2025.04.013. Epub 2025 Apr 17.
BACKGROUND: Increasing consumer reliance on prenatal multivitamins and minerals (PMVMs) underscores the importance of ensuring their quality and safety. Adequate choline and iodine intakes during pregnancy are crucial for fetal development, yet discrepancies between labeled and actual content in PMVM products pose significant health risks. Additionally, the potential presence of toxic heavy metals, such as arsenic, lead, and cadmium, raises concerns about potential adverse health effects. OBJECTIVES: This study aimed to evaluate nonprescription and prescription PMVMs regarding choline and iodine content as well as arsenic, lead, and cadmium. METHODS: This observational study evaluated a convenience sample of nonprescription and prescription PMVM products from online retailers and local retail pharmacies. Products were analyzed using liquid chromatograph mass spectrometry for choline and inductively coupled plasma mass spectrometry for iodine, arsenic, lead, and cadmium. Choline and iodine actual amounts were compared with reported label amounts and heavy metal amounts were compared with United States Pharmacopeia standards. RESULTS: In total, 32 nonprescription and 15 prescription PMVM products were analyzed. Choline amounts were reported on 12 of the 47 (25.6%) products including 5 (41.7%) within 20% of the claimed amount, 2 (16.7%) over the claimed amount by >20%, and 5 (41.7%) under the claimed amount by >20%. Iodine amounts were reported on 25 of the 47 (53.2%) products including 4 (16.0%) within 20% of the claimed amount, 20 (80.0%) under the claimed amount by >20%, and 1 (4.0%) over the claimed amount by >20%. Measurable amounts of arsenic, lead, and cadmium were found in 7 (14.9%), 32 (68.1%) and 29 (61.7%) PMVMs, respectively; however, no PMVMs exceeded United States Pharmacopeia standard limits. CONCLUSIONS: Current PMVM products are misleading through omission or inaccurate content of essential nutrients. Federal regulation of dietary supplements in the United States is needed to ensure accurate content of essential nutrients in PMVM formulations.
背景：消费者对产前多种维生素和矿物质（PMVMs）的依赖日益增加，这凸显了确保其质量和安全性的重要性。孕期充足的胆碱和碘摄入对胎儿发育至关重要，但PMVM产品的标签含量与实际含量之间的差异带来了重大健康风险。此外，有毒重金属如砷、铅和镉的潜在存在引发了对潜在健康不良影响的担忧。 目的：本研究旨在评估非处方和处方PMVMs的胆碱和碘含量以及砷、铅和镉含量。 方法：本观察性研究评估了从在线零售商和当地零售药店获取的非处方和处方PMVM产品的便利样本。使用液相色谱质谱法分析产品中的胆碱，使用电感耦合等离子体质谱法分析碘、砷、铅和镉。将胆碱和碘的实际含量与报告的标签含量进行比较，将重金属含量与美国药典标准进行比较。 结果：总共分析了32种非处方和15种处方PMVM产品。47种产品中有12种（25.6%）报告了胆碱含量，其中5种（41.7%）在声称含量的20%以内，2种（16.7%）超过声称含量20%以上，5种（41.7%）低于声称含量20%以上。47种产品中有25种（53.2%）报告了碘含量，其中4种（16.0%）在声称含量的20%以内，20种（80.0%）低于声称含量20%以上，1种（4.0%）超过声称含量20%以上。分别在7种（14.9%）、32种（68.1%）和29种（61.7%）PMVMs中检测到可测量量的砷、铅和镉；然而，没有PMVMs超过美国药典标准限值。 结论：当前的PMVM产品通过遗漏或基本营养素含量不准确而具有误导性。美国需要对膳食补充剂进行联邦监管，以确保PMVM配方中基本营养素的准确含量。
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