Evidence map›Paper›PMID 35233072›Full record

ArticleJournal of exposure science & environmental epidemiology2023

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 and 1 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of exposure science & environmental epidemiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 49% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Synthetic Colors in Food: A Warning for Children's Health.International journal of environmental research and public health · 2024
    Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Ruwan ThilakaratneCenter for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA.ORCID 0000-0002-6077-701X
Rosemary CastorinaCenter for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA. rcastori@berkeley.edu.ORCID 0000-0002-0910-4901
Mayela GillanCenter for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA.
Dorothy HanCenter for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA.
Teja PattabhiramanCenter for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA.ORCID 0000-0001-9002-8901
Anuroop NirulaCenter for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA.
Mark D MillerCalifornia Office of Environmental Health Hazard Assessment, Oakland, CA, USA.ORCID 0000-0002-9301-0093
Melanie MartyCalifornia Office of Environmental Health Hazard Assessment, Oakland, CA, USA.
Arlie LehmkuhlerDepartment of Food Science and Technology, University of California at Davis, Davis, CA, USA.
Alyson MitchellDepartment of Food Science and Technology, University of California at Davis, Davis, CA, USA.ORCID 0000-0003-0286-5238
Asa BradmanCenter for Environmental Research and Community Health (CERCH), School of Public Health, University of California at Berkeley, Berkeley, CA, USA.
California Environmental Protection Agency · USUniversity of California, Davis · USBerkeley Public Health Division · USUniversity of California, Merced · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFood 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.

objectiveTo estimate exposures to SCAs in children (2-16 years) and pregnant women from intake of common over-the-counter (OTC) medications and vitamins.

methodsWe 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.

resultsThe 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.

Indexed as

Pregnant PeopleVitaminsChildDietary SupplementsFemaleFood AdditivesHumansPharmaceutical PreparationsPregnancyUnited StatesVitamin AVitamin KFood AdditivesPharmaceutical PreparationsVitamin AVitamin KVitaminsAcceptable daily intakeArtificial food colorsChildrenHuman exposureHyperactivityPregnant women

Identifiers

PMID35233072
PMCPMC10541320
OpenAlexW4214817361

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.