Dataset of FD&C Certified Food Dyes in Foods Commonly Consumed by Children.

This is dataset describing the levels of Food, Drug, & Cosmetic (FD&C) dye in juice drinks, breakfast cereals, frozen desserts, ice cream cones, fruit flavored soft drinks, frostings & icings, fruit snacks/candy, decoration chips for baking, water enhancers, and flavored fruit drink powder. Data values are organized by absolute values, averages, SDs and % RSD. High performance liquid chromatography with a photometric diode array detector (HPLC-PDA) was used to measure dye levels and generate the data. These values can be used to calculate levels of dyes consumed within various populations, such as children, and compare them to accepted daily intake (ADIs) values established by the United States Food & Drug Administration (US FDA). The data are interpreted in "Survey of Certified Food Dye Levels in Food Samples Consumed by Children for Updated Exposure Levels" in the Journal of Food Additives and Contaminants: Part B.1.

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

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.

Evaluation of Saccharin and Resveratrol as Extrinsic Markers of Small-Quantity Lipid-Based Nutrient Supplement Consumption in Healthy Women.

BACKGROUND: Dietary supplements, like small-quantity lipid-based nutrient supplements (SQ-LNS), are used in intervention programs to prevent undernutrition among women and young children in low-income countries. An objective marker is needed to track consumption of supplements to evaluate the effectiveness of these programs. OBJECTIVE: The aim of this study was to evaluate saccharin and resveratrol as potential adherence markers for tracking recent consumption of a single serving of SQ-LNS in women. METHODS: Forty-seven healthy nonpregnant women 18-45 y of age were assigned to consume a single dose of SQ-LNS (20 g) containing either 10 mg sodium saccharin or 5 mg trans-resveratrol, under supervision. On the day before and for 2 d following SQ-LNS consumption, urine samples were collected each day for 24 h as 3 consecutive 4-h collections and one 12-h overnight collection. Urinary concentrations of saccharin and trans-resveratrol-3-O-sulfate, a resveratrol metabolite, were measured by ultra-high-performance liquid chromatography interfaced to a mass spectrometer with electrospray ionization [UHPLC-(ESI-)MS/MS]. Urinary concentrations (µmol/L urine) of saccharin and trans-resveratrol-3-O-sulfate were plotted against time, and receiver operating characteristic (ROC) curves were used to determine the discriminative capacity of each compound, at each post-consumption time point compared with baseline, to detect recent consumption of SQ-LNS. Cutoff values to differentiate supplement consumption from nonconsumption of each marker were developed using the closest-to-(0,1)-corner cut-point approach. RESULTS: Forty-five participants were included in the analysis. Urinary concentrations of saccharin and trans-resveratrol-3-O-sulfate increased within 4 h of SQ-LNS consumption. Urinary concentration cutoff values for saccharin (13.4 µmol/L) and trans-resveratrol-3-O-sulfate (0.7 µmol/L) allowed for 78% and 89% sensitivity, respectively, and 100% specificity in detecting consumption of SQ-LNS within the first 12 h after consumption. CONCLUSIONS: Urinary concentrations of saccharin and trans-resveratrol-3-O-sulfate reflect consumption of SQ-LNS containing those compounds during the first 12 h post-consumption with high sensitivity and specificity in healthy women and may be useful objective adherence markers for tracking consumption of SQ-LNS.

Measurement of Saccharin and trans-Resveratrol Metabolites in Urine as Adherence Markers for Small Quantity Lipid-Based Nutrient Supplement Consumption.

Saccharin and trans-resveratrol were incorporated into small quantity lipid-based nutritional supplements (SQ-LNS) to be evaluated as the markers of consumption for nutritional intervention studies. Forty-seven healthy women consumed a single supplement with either 8.6 mg of saccharin or 5 mg of trans-resveratrol, and urine was collected for 4 h. A rapid 11 min method employing multiple reaction monitoring and ultrahigh performance liquid chromatography coupled to a triple quadrupole mass spectrometer was developed to measure saccharin and resveratrol metabolites in urine simultaneously. The linear dynamic range of the method was from 3 to 1000 ng mL-1, with the correlation coefficient of 0.999 and limits of quantification from 15.28 to 53.03 ng mL-1. Sample preparation was simple dilution with an average recovery of 97.8%. Ion suppression was observed with urine concentrations >10%. Mean levels of saccharin and resveratrol-3-O-sulfate in urine were 5.481 ± 4.359 and 3.440 ± 4.160 nmol L-1, respectively. We developed and validated a method to measure saccharin and trans-resveratrol metabolites in urine to objectively corroborate the consumption of SQ-LNS for the first time in nutrition intervention studies.

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].

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

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.

Factors influencing the cytotoxicity of α-methylene-γ-hydroxy esters against pancreatic cancer.

A systematic study to identify the factors influencing the cytotoxicity of α-methylene-γ-hydroxy esters against three pancreatic cancer cell lines (Panc-1, MIA-PaCa-2, and BxPC-3) has established that, in addition to Michael acceptor abilities, the possibility to lactonize to α-methylene-γ-butyrolactones is as important. The substitution pattern and the number of carbons between the hydroxy and ester moieties also influence the bio-activity.