In an attempt to crack down on manufacturing errors and potential bacterial contamination, the Food and Drug Administration issued letters to three baby formula manufacturers on Wednesday. The letters were issued to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC based on FDA inspections at the facilities in the last several months. These inspections occurred during a time when the firms initiated recalls due to potential contamination of Cronobacter sakazakii.
Over the past few years, baby formula recalls have led to significant shortages in the United States, which has become a big issue for parents who rely on formula to feed their babies and toddlers. According to the FDA, parents and caregivers should continue using formula as there is no recall or reason to throw away formula at this time.
More from CafeMom: Pediatrician Shares Expert Advice on Ways Moms Can Handle Formula Shortages
The FDA reported that previous recalls were successful.
According to the news release, the FDA reported that the letters were unrelated to any current recall and that it did not expect any imminent shortages.
“The agency is not aware of any distributed product where contamination was confirmed and believes that the recalls were effective in removing the potentially contaminated batches of product from the market," the release reads.
The letters are meant to reinforce FDA policy and to ensure safety.
The FDA explained in the release that letters are now part of its regulatory process. They help firms reinforce quality standards and ensure their facilities maintain essential cleaning and sanitation protocols. Firms properly evaluate these protocols before releasing new products.
"Each company will have 15 working days to respond to the FDA to explain what corrective actions they are taking," the release notes. "The FDA will assess the adequacy of the companies’ corrective actions in the agency’s review of the responses and during the FDA’s next inspection of each facility. During these inspections the agency will verify proper implementation of appropriate corrective actions taken by each company.”
It is up to the manufacturers to make sure their productions are safe.
Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, explained in the release that the agency wants to prevent further massive formula recalls and implementing these strategies will help.
“Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities. These letters are a reflection of this enhanced oversight and are intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious," he noted.
The FDA suggested strategies to prevent bacterial infections back in November 2022.
Less than a year ago, the FDA sent a message to manufacturers outlining the threat of Cronobacter sakazakii, a bacteria often found in manufacturing plants, and ways to help prevent it. The FDA reported that the bacteria thrive in dry environments such as formula, powdered milk, and tea. Although it is usually harmless, it can be life-threatening for infants 2 months and younger.
The list included keeping up to date with the Infant Formula Compliance Program as necessary to review any new information about Cronobacter and to provide additional education and training to regulatory staff who inspect formula manufacturing facilities.
More from CafeMom: TikToker Shares Video Showing Store Employee Escorting Them To Buy Baby Formula
Formula production is up in the United States.
The FDA reported that since the beginning of 2023, formula in-stock rates are back to 85% or more. The agency believes that stronger regulations and inspections have helped to prevent further contamination and shortages.
“In addition to around-the-clock regulatory work, the FDA remains steadfast in upholding the commitment to unify and strengthen the FDA Human Foods Program. This new vision comes as a result of the agency’s review of findings and recommendations from an external evaluation conducted by the Reagan-Udall Foundation, at the request of the FDA Commissioner, following the agency’s infant formula supply chain response,” the release reads.
