The US Food and Drug Administration issues warning letters to three infant formula manufacturers

For immediate release:

Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to strengthening regulatory oversight to help ensure the industry produces infant formula under the safest conditions possible.

These warning letters regarding violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA infant formula regulations were issued to ByHeart Inc. Mead Johnson Nutrition (Reckitt) and Perrigo Wisconsin, LLC. They reflect findings from FDA inspections of these facilities over the past few months. At the time of each inspection, FDA issued inspection notes and exercised oversight over each company as it initiated recalls (in December 2022, February 2023, and March 2023) to remove the product potentially contaminated with Cronobacter sakazakii from the market.

More importantly, the FDA does not advise parents and caregivers to eliminate or avoid purchasing any particular type of infant formula at this time. The agency is not aware of any distributed product where contamination has been confirmed and believes the recalls were effective in removing potentially contaminated product batches from the market. In addition, these warning letters are not related to any current recalls, and therefore the FDA does not expect any impact on the availability of infant formula on the market.

The FDA is now issuing these letters as part of its regular regulatory process and to reinforce to these companies the importance of establishing and maintaining appropriate corrective actions when they discover pathogens to ensure compliance with FDA laws and regulations. As part of this, companies must, among other things, conduct thorough investigations into root causes and carry out subsequent cleaning and sanitation activities. Notably, companies also need to properly evaluate cleaning and sanitation practices, schedules, and procedures prior to product launch. Each company will have 15 business days to respond to the FDA to explain what corrective actions it is taking. The FDA will assess the adequacy of the corrective actions taken by the companies 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 the proper implementation of the appropriate corrective actions taken by each company.

“Infant formula manufacturers have a responsibility to ensure that safe products are produced, and the agency has been in ongoing discussions with the infant formula industry to address the agency’s concerns. The FDA is committed to identifying issues and taking action,” said Donald Prater, acting director of the FDA’s Center for Food. “Registered early to prevent any company from reaching the level of concern that led to widespread dairy product recalls last year and contributed to infant formula shortages. Safety and Nutrition Applied. “Over the past year, the FDA has continued to increase our oversight of infant formula facilities. These letters are a reflection of this enhanced oversight and are intended to help the industry continually 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.

Today’s actions are the latest in FDA’s ongoing efforts to strengthen the safety and resiliency of the U.S. infant formula supply. In November 2022, the Agency released an outline of a prevention strategy for the prevention of Cronobacter sakazakii diseases associated with the consumption of infant formula. As part of this strategy, the FDA is working with Congress to strengthen our regulatory tools and increase funding for oversight of the infant formula industry, and it has worked closely with the US Centers for Disease Control and Prevention (CDC) to support state and regional epidemiologists’ decision to add invasive Cronobacter infection among Infants under one year of age are included in the list of conditions that must be notified at the national level. The agency has already begun hiring staff as part of our work to create a dedicated cadre of infant formula researchers and an Office of Critical Foods, both of which will strengthen regulatory oversight of infant formula.

A healthy supply of infant formula is available in the US market

Consumers should know that the US infant formula supply is healthy with inventory rates of 85% or higher since the beginning of 2023. The current strength of this market can be attributed in large part to the many actions taken by the US Food and Drug Administration and other US government partners. Until 2022 and 2023, which are identified in the FDA’s National Strategy to Increase the Resilience of the Infant Formula Market.

Ensure the safety of powdered infant formula at home

Parents and caregivers should follow the manufacturer’s instructions for preparing infant formula. For babies younger than 2 months old, born prematurely, or who have a weakened immune system, the CDC recommends that, if possible, use of ready-to-feed liquid infant formula. Liquid infant formula is made to be sterile (without germs) and is the safest option for infants who are not receiving breast milk. However, parents and caregivers can also take additional steps to prepare infant formula for these infant groups by heating water to a minimum temperature of 158°F/70°C to help protect against Cronobacter bacteria, adding and mixing infant formula, and then cooling it . to body temperature (98.6°F) prior to feeding.

However, some metabolic and specialty products include statements on their packaging warning consumers not to heat because heating that particular product above 100 degrees Fahrenheit may result in loss of vitamins and nutrients. Therefore, caregivers should be especially familiar with the manufacturer’s instructions included on the package for metabolic and specialty formulations.

FDA will continue its regulatory oversight and engagement with industry to promote the safety of infant formula, including continuing to conduct annual inspections of infant formula facilities, maintaining dialogue with infant formula manufacturers on these issues, and promoting prevention-based research and activities.

In addition to around-the-clock regulatory work, FDA remains steadfast in supporting the commitment to standardize and strengthen FDA’s human foods program. This new insight comes as a result of the agency’s review of the findings and recommendations of 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.

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The Food and Drug Administration (FDA), an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of food supplies, cosmetics, nutritional supplements, and products that emit electronic radiation in our country, and is responsible for regulating tobacco products.

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