Dataset Information

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

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.

SUBMITTER: Thilakaratne R

PROVIDER: S-EPMC10541320 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

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

Thilakaratne Ruwan R Castorina Rosemary R Gillan Mayela M Han Dorothy D Pattabhiraman Teja T Nirula Anuroop A Miller Mark D MD Marty Melanie M Lehmkuhler Arlie A Mitchell Alyson A Bradman Asa A

Journal of exposure science & environmental epidemiology 20220301 5

<h4>Background</h4>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.<h4>Objective</h4>To estimate exposures to SCAs in children (2-16 years) and pregnant women from intake of common over-the-counter (OTC) medications and vitamins.<h4>Methods</h4>We estim ...[more]

PMID: 35233072

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Dataset Information

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

Background

Objective

Methods

Results

Significance

Impact

Publications

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

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