Table 2.
Children’s estimated exposures to FD&C Red No. 40 and FD&C Blue No. 1 synthetic color additives from recommended daily dosages of five brands of cold/cough/allergy syrups.
| FD&C Red No. 40 average exposure estimate (mg/kg/day)a | FD&C Blue No. 1 average exposure estimate (mg/kg/day)a | |||
|---|---|---|---|---|
| 1 dose/day | 6 doses/day | 1 dose/day | 6 doses/day | |
| Brand 1, Grape | ||||
| 6–11 years | 0.007 | 0.040 | 0.001 | 0.007 |
| 12–16 years | 0.007 | 0.044 | 0.001 | 0.007 |
| Brand 2, Cherry | ||||
| 6–11 years | 0.001 | 0.006 | ND | ND |
| 12–16 years | 0.001 | 0.007 | ND | ND |
| Brand 3, Grape | ||||
| 6–<12 years | 0.010 | 0.062 | 0.002 | 0.011 |
| 12–16 years | 0.012 | 0.070 | 0.002 | 0.012 |
| Brand 4, Very Berry | ||||
| 6–<12 years | 0.015 | 0.088 | 0.00004 | 0.0003 |
| 12–16 years | 0.016 | 0.098 | 0.00005 | 0.0003 |
| Brand 5, Grape | ||||
| 4–6 years | 0.028 | 0.169 | 0.004 | 0.022 |
| 6–<12 years | 0.033 | 0.198 | 0.004 | 0.026 |
| 12–16 years | 0.037 | 0.221 | 0.005 | 0.029 |
FD&C Food, Drug, and Cosmetic, ND non-detect, meaning the color additive is neither listed nor found in the product.
aExposures are calculated as mg of color additive per kg of body weight per day (mg/kg/day). Body weights are age-specific median US Environmental Protection Agency reference body weights. Average exposure estimates are based on the average color additive concentration across three different lot numbers of the product.