Enfamil Lawsuit Alleges Infant Formulas Contain Undisclosed Heavy Metals

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The maker of Enfamil faces a proposed class action lawsuit that alleges the infant formulas contain undisclosed heavy metals due to a lack of quality controls at the company’s manufacturing facility.

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The 88-page infant formula lawsuit against Mead Johnson Nutrition Company, which only last year voluntarily recalled hundreds of thousands of Enfamil infant formula products due to a risk of bacterial contamination, claims the manufacturer’s products also contain heavy metals, dangerous toxins known to have serious adverse health effects, especially for infants. These toxic heavy metals include arsenic, cadmium and lead, all of which pose known health risks to humans, the suit specifies.

The Enfamil infant formulas mentioned in the lawsuit include Enfamil A.R., Enfamil Gentlease, Enfamil Enspire Gentlease, Enfamil NeuroPro, Enfamil NeuroPro Sensitive, Enfamil Nutramigen and Enfamil ProSobee. Per the suit, testing commissioned by the plaintiffs’ counsel confirmed the presence of heavy metals in each of the aforementioned products, while independent testing detected heavy metals in two additional products, Enfamil ProSobee Soy Infant Formula and Enfamil Infant Formula Milk-Based with Iron. 

The product packaging of the Enfamil formulas at issue includes no disclaimer about the presence or potential presence of heavy metals, the case stresses.

Months after Mead Johnson voluntarily recalled two batches of infant formulas in February 2023 due to bacterial contamination, the Food and Drug Administration (FDA) in August found that the company had “ignored its duties” to ensure proper quality control measures were in place at its manufacturing facilities, the complaint relays. Upon inspection, the FDA found such poor quality control measures at the facility that it issued a formal warning letter to Mead Johnson over violations of the federal Food, Drug, and Cosmetic Act, the case shares.

According to the lawsuit, the FDA has cited Mead Johnson for inadequate or nonexistent quality controls four times since December 2017, three of which were over the company’s failure to establish a system of controls to ensure that infant formula does not become adulterated from microorganisms in the formula or processing environment. The fourth FDA citation, in July 2022, stemmed from a failure to “maintain a building used in manufacture, processing, packing, or holding of infant formula in a clean and sanitary condition,” the filing reads.

Despite the FDA inspections and warning letter, Mead Johnson, in December 2023, issued another voluntary recall of hundreds of thousands of infant formula products similarly at risk of bacterial infection, “yet again due to its failure to implement adequate quality control measures,” the suit states.

The proposed class action says that Mead Johnson, despite the foregoing, has represented itself to new parents as “a trusted company” while failing to disclose the lack of quality controls at its manufacturing facilities or that Enfamil infant formulas had a material risk of containing heavy metals.

“Nowhere on the Infant Formulas’ packaging (or the Defendant’s website or advertisements) is the lack of proper manufacturing controls or the material risk of contamination from failing to ensure safe manufacturing processes disclosed,” the case summarizes, accusing Mead Johnson of deceptively hiding “the true quality of the Products.”

According to the complaint, the Enfamil packaging is designed to induce consumers to believe the infant formulas are of high quality and safe, though there is no disclosure concerning the presence (or potential presence) of heavy metals and Mead Johnson’s “utter failure to use quality control measures in its manufacturing.”

The Enfamil lawsuit looks to cover all persons who, from January 25, 2018 to the present, bought any of the Enfamil infant formulas listed on this page for household use and not for resale.

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