Certified food dyes in over the counter medicines and supplements marketed for children and pregnant women.

Abstract

Food, Drug, & Cosmetic (FD&C) dyes are synthetic color additives used in food, prescription drugs and over-the-counter medicines (OTCs). Consumption of FD&C dyes has been associated with neurobehavioral behavior in some children. The amount of dye used in commercial products is proprietary, making it difficult to assess dietary intake and determine exposure in children. To date, no studies have examined FD&C dyes in OTCs or vitamins in the United States. To address this, FD&C Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, and Blue No. 2 levels were measured in prenatal vitamin tablets, children's chewable and gummy vitamins, pain reliever tablets and syrups, and cough/cold/allergy tablets and syrups. Dyes were isolated using solid phase extraction (SPE) and quantified by high performance liquid chromatography (HPLC). Dye levels varied between products with highest levels in pain reliever and cough/cold/allergy syrups. Significant variability was observed within some brands. Degradation of Red No. 40, Blue No. 1, and Yellow No. 6 was observed in the vitamin gummies. Intake of FD&C Red No. 40 is two times the US FDA ADI (accepted daily intake) for some children's pain reliever syrups and almost three times the US FDA ADI for some cough/cold/allergy syrups.

• Authors: Arlie L Lehmkuhler, Mark D Miller, Asa Bradman, Rosemary Castroina, Alyson E Mitchell
• Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association (Food Chem Toxicol) Vol. 143 Pg. 111499 (Sep 2020) ISSN: 1873-6351 [Electronic] England
• PMID: 32599104 (Publication Type: Journal Article)
• Copyright: Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Analgesics
• Coloring Agents
• Food Additives
• Histamine Antagonists
• Nonprescription Drugs
• Vitamins

Topics

• Analgesics (chemistry)
• Child
• Chromatography, High Pressure Liquid
• Coloring Agents (chemistry)
• Dietary Supplements (analysis)
• Female
• Food Additives (chemistry)
• Histamine Antagonists (chemistry)
• Humans
• Molecular Structure
• No-Observed-Adverse-Effect Level
• Nonprescription Drugs (chemistry)
• Pregnancy
• Pregnant Women
• United States
• United States Food and Drug Administration (legislation & jurisprudence)
• Vitamins (chemistry)