Skip to Content

For Immediate Release

<p>Sonoma County District Attorney's Office & Joint Task Force Reach a Settlement with Perrigo Companies</p>

Santa Rosa,CA | February 03, 2022

Sonoma County District Attorney Jill Ravitch announced today that her office, as part of the California Food Drug and Medical Device Task Force and in conjunction with the California Attorney General’s office, reached a settlement with Perrigo Company and two of its subsidiaries (Perrigo) to improve the safety of the company's infant and toddler formula products by putting in place ingredient sourcing and quality control processes to significantly reduce levels of lead. In 2018, the Attorney General and the 10 counties that form the task force filed a lawsuit against Perrigo after testing showed that its infant and toddler formula products contained levels of lead that exceeded the Proposition 65 warning threshold. Today’s settlement sets maximum lead levels of 5-7 parts per billion (ppb) for most of these products, levels much lower than applicable guidance levels established for this type of product by any U.S. regulatory authority. 

The negative health impacts of heavy metal exposure are well-documented. Lead exposure is particularly dangerous for children, whose developing brains and nervous systems are more sensitive to its damaging effects. Impacts of lead exposure in children include behavioral issues, reduced IQ, slowed body growth, hearing problems, and kidney damage. There is widespread scientific consensus that there is no safe level of lead exposure.

Today’s settlement requires Perrigo to significantly reduce the levels of lead in its products, with substantial injunctive terms, including:

  • The settlement sets a target lead level for all Perrigo infant and toddler formula products sold in California of 4 ppb, with a maximum lead level of 5-7 ppb, depending on the product;
  • To attain the target level, Perrigo must put ingredient sourcing and control processes in place. Perrigo must also consult with an independent food processing auditor, set internal food quality auditing practices, and conduct compliance testing to ensure that its products do not exceed the maximum lead levels; and
  • If a product lot exceeds the maximum lead levels and is not found to be an outlier, Perrigo may not sell that lot in California. It must also investigate the cause of the exceedance, and work with the auditor to keep the level under the maximum.

District Attorney Ravitch stated “This settlement acknowledges the great harm posed to infants and toddlers through lead exposure during their formative years, and will provide greater protection going forward. Sonoma County is proud to be part of this important task force which protects consumers in Proposition 65 cases in addition to false and misleading advertising in the sale of food, drugs and medical devices.” The task force includes the counties of Alameda, Marin, Monterey, Napa, Orange, Santa Clara, Santa Cruz, Shasta, and Solano in addition to Sonoma County.

Perrigo and its counsel worked cooperatively to implement changes to its testing process and sourcing of ingredients and stipulated to the judgment without admitting liability.  The case was prosecuted by Deputy District Caroline Fowler and Chief Deputy Matthew Cheever on behalf of Sonoma County.