Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA.
California Office of Environmental Health Hazard Assessment, Oakland, CA, USA.
J Expo Sci Environ Epidemiol. 2023 Sep;33(5):787-793. doi: 10.1038/s41370-022-00418-9. Epub 2022 Mar 1.
Food and Drug Administration (FDA) Food Drug and Cosmetic (FD&C) synthetic color additives (SCAs) have been associated with attentional and behavioral problems in children. Efforts to quantify exposure have focused on foods, while the contribution of medications and supplements remains unknown.
To estimate exposures to SCAs in children (2-16 years) and pregnant women from intake of common over-the-counter (OTC) medications and vitamins.
We estimated single-day exposure (mg/kg/day) to FD&C SCAs based on measurements of 25 different products and recommended dosages on product labels. Exposures were compared to SCA exposure estimates from food we previously developed and acceptable daily intakes (ADIs) established by FDA and the World Health Organization.
The highest exposure was found for FD&C Red No. 40 in a children's cold/cough/allergy syrup. A child aged 12-16 years consuming the maximum daily dosage would have an exposure of 0.221 mg/kg/day, which is twice this age group's typical exposure to this additive from food. No estimated exposures exceeded the ADIs.
Some children's OTC medications and vitamins may cause daily SCA exposures comparable to those from foods. OTC medications and vitamins should be considered in efforts to quantify population exposure to FD&C SCAs.
Exposure to synthetic color additives (SCAs) from foods has been associated with behavioral problems in children. Exposures from over-the-counter (OTC) medications and vitamins remain unquantified despite widespread use. We estimated exposures in children and pregnant women for 25 different OTC medication and vitamin products sold in the United States. While exposures were below acceptable daily intakes (ADIs) established by the US Food and Drug Administration and the World Health Organization, some were comparable to typical daily exposures from foods. This work critically informs future SCA exposure assessments and provides valuable information for parents concerned about the health effects of SCAs.
食品和药物管理局（FDA）的食品、药品和化妆品（FD&C）合成色素（SCA）已被证实与儿童的注意力和行为问题有关。为了量化接触量，人们的研究重点主要集中在食品上，而药物和补充剂的贡献则不得而知。
评估儿童（2-16 岁）和孕妇从常见非处方（OTC）药物和维生素中摄入 SCA 的情况。
我们根据 25 种不同产品的测量值和产品标签上的推荐剂量，估计了儿童摄入 SCA 的单日摄入量（mg/kg/天）。我们将这些摄入量与之前从食物中开发的 SCA 暴露量估计值以及 FDA 和世界卫生组织（WHO）制定的每日可接受摄入量（ADI）进行了比较。
在一种儿童感冒/咳嗽/过敏糖浆中，我们发现 FD&C 红色素 40 的暴露量最高。一名 12-16 岁的儿童按最大日剂量服用时，其暴露量为 0.221mg/kg/天，是该年龄段从食物中摄入该添加剂的典型暴露量的两倍。没有估计的暴露量超过 ADI。
一些儿童的 OTC 药物和维生素可能会导致与食物相似的每日 SCA 暴露量。在评估 FD&C SCA 的人群暴露量时，应考虑 OTC 药物和维生素。
从食物中摄入合成色素（SCA）已被证实与儿童的行为问题有关。尽管 OTC 药物和维生素的使用非常广泛，但它们的暴露量仍未得到量化。我们对美国销售的 25 种不同的 OTC 药物和维生素产品进行了儿童和孕妇的暴露量评估。虽然暴露量低于 FDA 和世界卫生组织（WHO）制定的每日可接受摄入量（ADI），但有些与从食物中摄入的典型每日暴露量相当。这项工作为未来的 SCA 暴露评估提供了重要信息，并为关注 SCA 对健康影响的家长提供了有价值的信息。
