Table 4.
Children’s estimated exposures to FD&C Red No. 40, FD&C Blue No. 1, FD&C Yellow No. 5, and FD&C Yellow No. 6 synthetic color additives from recommended daily dosages of three brands of gummy vitamins.
| FD&C Red No. 40 average exposure estimate (mg/kg/day)a | FD&C Blue No. 1 average exposure estimate (mg/kg/day)a | FD&C Yellow No. 5 average exposure estimate (mg/kg/day)a | FD&C Yellow No. 6 average exposure estimate (mg/kg/day)a | |||||
|---|---|---|---|---|---|---|---|---|
| 1 gummy /day | 2 gummies /day | 1 gummy /day | 2 gummies /day | 1 gummy /day | 2 gummies /day | 1 gummy /day | 2 gummies /day | |
| Brand 1 (Red, Orange and Purple) | ||||||||
| 2–<3 years | 0.04 | NC | 0.002 | NC | ND | ND | ND | ND |
| 3–<6 years | 0.03 | 0.05 | 0.002 | 0.003 | ND | ND | ND | ND |
| 6–<11 years | 0.02 | 0.03 | 0.001 | 0.002 | ND | ND | ND | ND |
| 11–<16 years | 0.01 | 0.02 | 0.001 | 0.001 | ND | ND | ND | ND |
| Brand 2 (Red, Orange and Purple) | ||||||||
| 2–<3 years | 0.03 | NC | 0.002 | NC | ND | ND | 0.01 | NC |
| 3–<6 years | 0.02 | 0.04 | 0.001 | 0.002 | ND | ND | 0.007 | 0.01 |
| 6–<11 years | 0.01 | 0.02 | 0.001 | 0.001 | ND | ND | 0.004 | 0.008 |
| 11–<16 years | 0.007 | 0.01 | 0.001 | 0.001 | ND | ND | 0.003 | 0.005 |
| Brand 3 (Red, Yellow and Green) | ||||||||
| 2–<3 years | 0.07 | NC | 0.004 | NC | 0.02 | NC | ND | ND |
| 3–<6 years | 0.06 | 0.11 | 0.003 | 0.005 | 0.01 | 0.02 | ND | ND |
| 6–<11 years | 0.03 | 0.06 | 0.002 | 0.003 | 0.01 | 0.01 | ND | ND |
| 11–<16 years | 0.02 | 0.04 | 0.001 | 0.002 | 0.004 | 0.008 | ND | ND |
FD&C Food, Drug, and Cosmetic, ND non-detect, meaning the color additive is neither listed nor found in the product, NC not calculated as 2 gummies per day is not recommended for children under 3 years of age.
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.