Occurrence of fluoride in various infant and toddler formulas in Saudi Arabia: probabilistic dental fluorosis risk assessment by the Monte Carlo simulation method.

The main objective of the present study was to determine fluorine (F) in different types of infant and toddler formulas (ITFs) and to assess the dental fluorosis risk (DFR) using the Monte Carlo simulation method and Crystal Ball software. Three types of ITFs-including SFL, FOFL, and TFL-from ten well-known and widely consumed brands of each type (a total of 30 brands) were selected. For each brand, three samples were collected (90 samples in total), and the F content was measured using the fluoride ion-selective electrode (ISE) method. DFR assessment was performed both for raw ITFs and for the scenario of simultaneous consumption with reconstitution water (RW). The findings indicated that, regardless of F levels in RW, the estimated daily intake (EDI) of F for all brands and all three types of ITFs was below the permissible levels established by the U.S. Environmental Protection Agency (EPA), the European Food Safety Authority (EFSA), and the American Dental Association (ADA), set at 60, 100, and 120 µg/kg bw/day, respectively. Based on EPA guidelines, the hazard quotient for dental fluorosis risk (HQ-DFR) for all brands and ITF types was lower than the threshold level (HQ = 1). When RW containing 0-1.5 mg/L F was assumed for formula preparation, HQ-DFR values increased significantly with higher F concentrations in RW, exceeding the permissible level in some scenarios. However, considering the higher EDI values recommended by EFSA and ADA, and acknowledging that the acceptable standard range for F concentration in drinking water used as RW is 0.5-1.5 mg/L, it can be concluded that the consumption of ITFs available in the Saudi market, together with drinking water within the standard F range, results in an acceptable DFR level for the health of infants and young children.