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

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].

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 ].
© 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license.
( http://creativecommons.org/licenses/by/4.0/ ) Value of the Data • Those working in public health and allied fields can benefit from this data to understand that variable can be dependent on lot differences (processing), brand, and product expiration date due to dye degradation. • These data can further be applied to average heights, average weights, and dosing to determine the contribution of OTCs and vitamins to certified food dye intake in children. • This data can be utilized in further investigations of dye degradation in correlation with expiration date in children's vitamin gummies. The toxicity of degradation products of FD&C dyes in these products has not been investigated.

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 FD&C dyes measured in the products include FD&C Yellow 5, Yellow 6, Red 40, Blue 2, and Blue 1. For each file, the average dye content in milligrams per kilogram can found in Table 1 plus/minus the standard deviation for each value. Table 2 shows the average mass of each tablet/gummy or average density for the syrup categories, along with the conversion to kilogram, or kilogram per milliliter when appropriate. 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). Tables table in Tables 4-8. Each individual table contains data organized by color, since these two categories had three colors within each lot for each brand. Tables 4-8 associate the expiration date with each corresponding lot for every category.

Materials for analysis
Analytical standards for each of the following food dyes:

Samples for analysis
Seven categories were identified to sample the OTC and vitamin market, 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. Each category was identified on the market to determined number of brands that could be sampled. Three to five brands were identified for each category and products with multiple colors were evaluated based on each color rather than a composite of all colors. Three lots were identified to better evaluate each brand and potential variability over different preparations of the same product. Each lot, and color if necessary, was prepared and evaluated in duplicate.

Sample Preparation
Sample preparation was completed based on Yang et al (2014) and Yang et al (2011) [ 2 , 3 ]. Syrups and gummies were weighed out at 3 grams per sample into a 50mL conical tube. The vitamin tablets were crushed using mortar and pestle and only 1 gram was used for evaluation. The syrups and gummies were brought up to 30mL total volume using MilliQ water. The vitamin tablets were brought up to 10mL total volume using MilliQ water. Sonication and heat was used to homogenize the samples for 30 min at 55 ± 5 °C; each sample was vortexed every 10 min to ensure homogeneity. Samples must be completely dissolved in order for sonication to be complete. These samples were centrifuged at 50 0 0RPM for 10 min and set aside. An SPE manifold was used with Oasis WAX SPE Cartridges (3cc, 60 mg x 60 μm) to clean up samples.
The cartridges were conditioned with 1mL of methanol and followed by 1mL of water. Three mL of each sample was loaded onto the column and pulled through the cartridge by gravity. The cartridge was washed with 1mL of 2% formic acid in water and 1mL of methanol to follow. The samples were collected in glass tubes with 2 mL of 5% ammonia in methanol solution. The glass tubes were dried using a SpeedVac (Savant SpeedVac, ThermoFisher, Massachusetts, USA). The internal standard was added after drying (10μL of 250μg/mL amaranth in water) and brought up in 500μL of MilliQ water. The sample was put into a vial for HPLC analysis.
Tablet samples from children's cough/cold/allergy and children's pain reliever categories containing FD&C Blue No. 2 were evaluated by measuring the crushed composite out to 0.1g sample and added to a 2mL centrifuge tube with 0.01g EDTA. Sodium hydroxide solution at 0.25M was added for a final volume of 2mL. The samples were vortexed and sonicated for 30 min at 40 ± 5 °C. Each tube was centrifuged for 10 min at 120 0 0RPM and the supernatant was transferred to a new 2mL tube to adjust the pH back to 6-7 with 5% formic acid solution in water. The SPE procedure described above is the continuation of sample preparation for these samples, only using 1mL of sample rather than 3mL as described for syrups, gummies, and other tablets.

Declaration of Competing Interest
The authors declare that they have no known competing financial interests or personal relationships which have, or could be perceived to have, influenced the work reported in this article. and Mayela Gillian for assisting in evaluation of the market upon choosing samples and obtaining samples.

Supplementary materials
Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.dib.2020.106073 .