Abstract

Food, Drug, & Cosmetic (FD&C) dyes can be found in various products outside of food that are consumed by children. The amount of FD&C dyes used in commercial products is proprietary. Determining the contribution of dye intake from commercial products requires direct assessment of FD&C dyes in the products. This dataset contains the raw data of HPLC peak areas, absolute values, averages, SDs and % RSD for FD&C dyes in children's gummy vitamins, children's tablet vitamins, prenatal vitamins, children's cough/cold/allergy tablets & syrups, and children's pain reliever tablets & syrups obtained using high performance liquid chromatography with a photometric diode array detector (HPLC-PDA). The data can be used for further interpretations of dye intake in children, based upon dose levels suggested for distinct age groups, to evaluate the consumption of the FD&C dyes and accepted daily intake (ADIs) suggested for each FD&C dye by the United States Food & Drug Administration (US FDA). The variability associated within each category is critical for understanding how products on the market can differ between lot especially with large gaps between expiration dates. The interpretation of the data is described in “Certified Food Dyes in Over the Counter Medicines and Supplements Marketed for Children and Pregnant Women” in the Journal of Food and Chemical Toxicology [1].

Highlights

  • Dataset of certified food dye levels in over the counter medicines and vitamins intended for consumption by children and pregnant women

  • Determining the contribution of dye intake from commercial products requires direct assessment of FD&C dyes in the products. This dataset contains the raw data of HPLC peak areas, absolute values, averages, SDs and % RSD for FD&C dyes in children’s gummy vitamins, children’s tablet vitamins, prenatal vitamins, children’s cough/cold/allergy tablets & syrups, and children’s pain reliever tablets & syrups obtained using high performance liquid chromatography with a photometric diode array detector (HPLC-photodiode array (PDA))

  • The data can be used for further interpretations of dye intake in children, based upon dose levels suggested for distinct age groups, to evaluate the consumption of the FD&C dyes and accepted daily intake (ADIs) suggested for each FD&C dye by the United States Food & Drug Administration (US FDA)

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Summary

Data description

FD&C dyes were evaluated in seven common commercial over-the-counter medicines (OTCs) and vitamins including: children’s gummy vitamins, children’s tablet vitamins, prenatal vitamins, children’s cough/cold/allergy tablets & syrups, and children’s pain reliever tablets & syrups and the seven data files are individually organized in the same manner. The average dye content in milligrams per kilogram can found in Table 1 plus/minus the standard deviation for each value. The summary of average dye content per tablet, gummy, or milliliter can be found in Table 3 with its corresponding standard deviation and % RSD (to evaluate variability within the brand). Each individual table contains data organized by color, since these two categories had three colors within each lot for each brand.

Materials for analysis
Samples for analysis
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