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

Ruwan Thilakaratne; Rosemary Castorina; Mayela Gillan; Dorothy Han; Teja Pattabhiraman; Anuroop Nirula; Mark D Miller; Melanie Marty; Arlie Lehmkuhler; Alyson Mitchell; Asa Bradman

doi:10.1038/s41370-022-00418-9

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

J Expo Sci Environ Epidemiol. 2023 Sep;33(5):787-793. doi: 10.1038/s41370-022-00418-9. Epub 2022 Mar 1.

Authors

Affiliations

¹ Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA.
² Center for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA. rcastori@berkeley.edu.
³ California Office of Environmental Health Hazard Assessment, Oakland, CA, USA.
⁴ Department of Food Science and Technology, University of California at Davis, Davis, CA, USA.
⁵ Department of Public Health, School of Social Sciences, Humanities, and Art, University of California at Merced, Merced, CA, USA.

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.

Keywords: Acceptable daily intake; Artificial food colors; Children; Human exposure; Hyperactivity; Pregnant women.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Child
Dietary Supplements / adverse effects
Female
Food Additives
Humans
Pharmaceutical Preparations
Pregnancy
Pregnant Women*
United States
Vitamin A
Vitamin K
Vitamins* / analysis

Substances

Vitamins
Pharmaceutical Preparations
Food Additives
Vitamin A
Vitamin K