3 baby formula companies receive FDA warning letter for failing to ensure safe manufacturing

The U.S. Food and Drug Administration has issued a warning to three baby formula manufacturers after finding they violated quality-control practices.

On Wednesday, Aug. 30, the FDA sent warning letters to ByHeart Inc., Reckitt Benckiser Group's Mead Johnson Nutrition and Perrigo’s Wisconsin facility, after finding the companies failed to ensure their infant formula is not contaminated during the manufacturing process.

The three manufacturers produce the brands Enfamil, ByHeart, Parent’s Choice and store brand formulas, including Walmart, Sam’s Club, Costco and Target.

"You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment," the letters read.

The letters were a result of FDA inspections following infant formula recalls by all three companies last year and will not result in a recall at this time, the agency added in the letters issued.

A spokesperson for Perrigo told TODAY.com in a written statement that the company has "been committed to meeting the needs of consumers, parents and caregivers — and the quality and safety of our products is our highest priority," adding that the letter Perrigo received "pertained only to its infant formula manufacturing facility located in Wisconsin, which Perrigo acquired from Nestle on November 1, 2022."

"As noted in the FDA’s press release, we want to assure the public that all of Perrigo’s infant formula products available to parents and caregivers are safe for infant feeding, and FDA does not advise discarding or avoiding purchase of any particular infant formula," the spokesperson added.

A spokesperson for Reckitt and Mead Johnson Nutrition said in a written statement to TODAY.com that "the safety of babies is of the utmost importance to us and we can confirm that all of our infant formula products continue to meet the highest FDA standards for safety and quality.

"The FDA’s communication is part of its enhanced regulatory oversight and does not relate to any new concerns or issues, as they reflect findings from previous inspections," the spokesperson continued, adding that to date there "are no safety or quality concerns with any Reckitt/Mead Johnson formula" and that "parents and caregivers can rest assured, our products can be used with confidence, and they don’t need to do anything differently when shopping or feeding their infants."

ByHeart, Inc. shared a statement with TODAY.com, saying that they "commend" the FDA and support the "enhanced oversight."

"Providing safe and high-quality infant formula continues to be our top priority and we can assure our customers that no distributed ByHeart product has tested positive for contaminants," the statement reads. "There is no disruption to ByHeart’s manufacturing and we currently have three production plants across the US that are operating to meet the demand for our formula."

In 2022, the country experienced a severe baby formula shortage due to supply chain issues and after the FDA investigated Similac, Alimentum and EleCare for contaminated formula made at the Abbot Nutrition facility in Sturgis, Michigan, that allegedly left four infants hospitalized and two dead.

As a result, Abbott closed its Sturgis facility, crippling infant formula production and leaving retailers like CVS, Walgreens and Target to put limits on how much formula customers could obtain during a single purchase.

“Due to increased demand and various supplier challenges, infant and toddler formulas are seeing constraints across the country," a spokesperson for Walgreens told TODAY.com at the time. "Similar to other retailers, we put into effect purchase limits of three per transaction on all infant and toddler formulas to help improve inventory. We continue to work diligently with our supplier partners to best meet customer demands.”

In January 2022, parents and caregivers faced a 23% shortage in baby formula — in April, it rose to 31%, according to to Datasembly, a retail data analysis company.

The FDA concluded in part that Abbot “did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.”

"After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses," a spokesperson for Abbott said in a written statement on May 11, 2022.

The Sturgis facility eventually reopened in late August 2022.

The FDA has not issued any recall in association with the warning letters issued to ByHeart, Inc., Reckitt Benckiser Group’s Mead Johnson Nutrition and Perrigo on Wednesday, and does not expect any impact on baby formula supply.

The companies have 15 working days upon receipt of the letters to notify the FDA of "the specific steps" the companies have "taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur," according to the letters.

This article was originally published on TODAY.com