Prop 65 Settlement on Lead in Infant Formula

  • California’s Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65 (Prop 65), prohibits knowingly exposing any individual to a listed chemical without first providing a “clear and reasonable warning” to such individual.  Lead is listed as causing cancer and reproductive toxicity with a current Prop 65 No Significant Risk Level (NSRL) of 15 μg/day for oral exposure and a Maximum Allowable Dose Level (MADL) of 0.5 μg/day.  By comparison, the US Food and Drug Administration (FDA) has a provisional total tolerable intake level (PTTIL) for lead by small children of 6 μg/day.
  • In a February 2, 2022 Press Release, California Attorney General (AG) Rob Bonta, along with 10 district attorneys, announced a settlement with Perrigo Company and two of its subsidiaries (Perrigo) of a 2018 Prop 65 lawsuit that sets a target lead level for all Perrigo infant and toddler formula products sold in California of 4 parts per billion (ppb), with a maximum lead level of 7 ppb for soy-based formulas and 5 ppb for all other covered products.  Perrigo, a manufacturer for store brands of infant and toddler formula, also agreed to civil penalties of $72,500 and additional fees for costs.  The California AG characterized the lead limits under the settlement as “more than ten times below current federal guidance levels” and indicated his office may target other companies that fail to either reduce the lead levels in their infant and toddler products or provide a warning.
  • California’s AG is among a coalition of 23 Attorneys General, which as discussed here, petitioned FDA on October 21, 2021 to expedite setting heavy metal standards for baby foods. 


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