Exposures to FD&C synthetic color additives from over-the-counter medications and vitamins in United States children and pregnant women

Author:

Thilakaratne RuwanORCID,Castorina RosemaryORCID,Gillan Mayela,Han Dorothy,Pattabhiraman TejaORCID,Nirula Anuroop,Miller Mark D.ORCID,Marty Melanie,Lehmkuhler Arlie,Mitchell AlysonORCID,Bradman Asa

Abstract

Abstract Background 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. Objective To estimate exposures to SCAs in children (2–16 years) and pregnant women from intake of common over-the-counter (OTC) medications and vitamins. Methods 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. Results 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. Significance 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. Impact 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.

Publisher

Springer Science and Business Media LLC

Subject

Public Health, Environmental and Occupational Health,Pollution,Toxicology,Epidemiology

Reference23 articles.

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