FDA Issues Warning Letters to Three Infant Formula Manufacturers

Brooke Phillips, CWCMS
Editor | Shield HealthCare
08/31/23  10:00 AM PST
FDA Warning to Baby Formula Manufacturers August 2023

On August 31, 2023, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers to help ensure infant formula is being produced under the safest conditions possible. These warning letters are not associated with any current recalls, and the FDA does not anticipate any impact to the availability of infant formula on the market.

These warning letters were issued to ByHeart Inc.Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. They reflect findings from FDA inspections of these facilities over the last several months. At the time of each inspection, the FDA issued inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace.

The FDA is issuing these letters as part of its normal regulatory process to ensure compliance with the FDA’s laws and regulations, and to reinforce to these manufacturers the importance of instituting and maintaining appropriate corrective actions when they detect pathogens. These warning letters reinforce the manufacturers’ responsibility to properly evaluate their cleaning and sanitation practices, schedules, and procedures before releasing product. Each company will have 15 working days to respond to the FDA to explain what corrective actions they are taking. 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.

“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns. The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage,” said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition.

“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.”

Please note: the FDA does not advise parents and caregivers to discard or avoid purchasing any particular infant formula at this time. The agency is not aware of any distributed product where contamination was confirmed, and it believes that the recalls were effective in removing the potentially contaminated batches of product from the market.

FDA Strategy to Prevent Infant Illness from Cronobacter sakazakii

These letters are the latest in the FDA’s ongoing effort to strengthen the safety and resiliency of the infant formula supply in the U.S. In November 2022, the agency released an outline of a prevention strategy to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. As part of that strategy, the FDA has been working to strengthen regulatory tools, increase funding to oversee the infant formula industry, and to add invasive Cronobacter infections among infants under one year of age to the Nationally Notifiable Conditions List.

Safe Home Use of  Powdered Infant Formula

Parents and caregivers are directed follow manufacturer instructions for preparing powdered infant formula. For babies less than 2 months old, those born prematurely, or those with weakened immune systems, the CDC recommends (if possible) using ready-to-feed liquid infant formula. Liquid infant formula is manufactured to be sterile (without germs) and is the safest option for infants not receiving breast milk. If ready-to-feed liquid formula isn’t an option, parents and caregivers are encouraged to prepare powdered formula for these infants by:

  1. Heating water to at least 158°F/70°C to help protect against Cronobacter;
  2. Adding the powdered infant formula and mixing;
  3. Cooling the formula to body temperature (98.6°F) before feeding.

Is your powdered formula a metabolic or specialty formula? Some metabolic and specialty products include statements on their packaging warning consumers against heating because heating that particular product above 100°F could result in a loss of vitamins and nutrients. When heating those formulas, caregivers should carefully review the manufacturer’s instructions.

Source: US Food and Drug Administration

FDA Media Contact: Janell Goodwin, 240-393-3067
Consumer Inquiries: 888-INFO-FDA

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