This table provides recommendations for the declaration of quantitative amounts of vitamins and minerals using only the RDIs that have been established for adults and children 4 years of age and older. FDA regulations, at 21 CFR 101.9(c)(8)(iv), provide RDIs for infants through 12 months, children 1 through 3 years, and pregnant and lactating women. The declaration recommendations can be downloaded in this FDA guidance and can also be applied to the RDIs for these subpopulations.
The Smart Review uses rounding recommendations from the FDA guidance. The value calculated by the app is the amount obtained by applying FDA’s recommended rounding increment to the amount entered.
However, the mathematically nearest rounded value may not always be the most appropriate amount to declare on a finished product label.
Consider formulation, analytical method variability, and expected change over shelf life to ensure the product can meet the declared label amount.
For example, if an analytical or formulation value rounds upward, the manufacturer should consider whether the product can reliably support that declared amount throughout its shelf life. You should base your assumptions on valid stability data and knowledge of the analytical method.