Attorney General Bonta Announces Settlement with Perrigo to Improve Safety of Infant and Toddler Formula Products

Settlement sets lowest enforceable lead levels in the country for infant and toddler formula.  

OAKLAND – California Attorney General Rob Bonta today, along with 10 district attorneys, announced 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 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.

“Today’s settlement sets the lowest enforceable lead levels in the country for infant and toddler formula. This is a win for our children and for their parents, who shouldn't have to worry that the formula they feed their kids might harm their health and development down the line," said Attorney General Bonta. "By agreeing to put ingredient sourcing and quality control processes in place, Perrigo will be able to reduce its lead levels to more than ten times below current federal guidance levels. I hope other companies will take this settlement as evidence that it is possible to reduce the levels of lead in their products — and that if these levels exceed the Prop 65 warning threshold and the companies fail to either reduce the levels or provide a warning, my office won't stand idly by.”

“We take the presence of lead in any product very seriously,” said Alameda County District Attorney Nancy O’Malley. “My office is especially committed to reducing the presence of heavy metals in consumer products, particularly products consumed by infants and children. Ensuring that Perrigo, and other manufacturing business’ products are safe for consumption is our ultimate goal.” 

“My Office is proud to have participated in this settlement because it helps ensure that manufacturers of baby formula and other foods do what is necessary to avoid high levels of lead in their products – particularly when these products feed our children,” said Monterey County District Attorney Jeannine M. Pacioni.

“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,” said Sonoma County District Attorney Jill Ravitch.

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.

On July 12, 2018, the Attorney General and 10 district attorneys filed a lawsuit alleging that Perrigo violated Proposition 65 and California’s Unfair Competition Law by manufacturing products with lead levels that exceeded the Proposition 65 warning threshold. 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.

Attorney General Bonta is committed to reducing levels of toxic heavy metals in consumer products, particularly products consumed by infants and children. In October, Attorney General Bonta joined a multistate coalition in petitioning the U.S. Food and Drug Administration to take swift action to reduce the concentrations of lead, inorganic arsenic, cadmium, and mercury in baby foods. 

Attorney General Bonta is joined in this settlement by the district attorneys of Alameda, Marin, Monterey, Napa, Santa Clara, Santa Cruz, Shasta, Solano, Sonoma, and Orange counties. 

A copy of the settlement can be found here.