Amid nationwide reports of infant formula shortages, FDA says sales are up and it is working to make sure appropriate formulas are available to the public.

An outbreak of cronobacter infections that has hospitalized at least four babies with two deaths has led to the closure of a major manufacturing plant operated by Abbott Nutrition in Sturgis, MI. The outbreak spurred the company to recall a number of infant formulas sold under the brands of Similac, Alimentum and EleCare.

Among the recalled products are infant formulas for babies and older children with special dietary needs because of medical conditions. Last week the Food and Drug Administration announced it was allowing Abbott Nutrition to begin releasing several of those products on a case-by-case basis in conjunction with health care providers’ recommendations.

Almost immediately after the recalls were put in place on Feb. 17, news media across the country started reporting on parents who said they were having problems finding powdered infant formula.

Datasembly, a retail software company, said that about 31 percent of formula products were out of stock across the country as of April. In seven states — Connecticut, Delaware, Montana, New Jersey, Rhode Island, Texas and Washington — the rate for the week of April 3 was even worse, at 40 percent.

However, the FDA reported on May 10 that sales data paints a different picture.

“The FDA continues to take several significant actions to help increase the current supply of infant formula in the U.S. In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” according to the agency update.

“Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

In its update, the FDA cited a list of efforts to ensure adequate supplies of infant formula, including:

• Meeting regularly with major infant formula manufacturers to better understand their capacity to increase production of various types of infant formulas and medical foods. The infant formula industry is already working to maximize their production to meet new demands. Efforts already underway by several infant formula manufacturers include optimizing processes and production schedules to increase product output, as well as prioritizing product lines that are of greatest need, particularly the specialty formulas.
• Helping manufacturers bring safe product to the market by expediting review of notifications of manufacturing changes that will help increase supply, particularly in the case of the specialized formulas for medical needs.
• Monitoring the status of the infant formula supply by using the agency’s 21 Forward food supply chain continuity system, combined with external data. 21 Forward was developed during the pandemic to provide a comprehensive, data-backed understanding of how COVID-19 is currently impacting food supply chains.
• Compiling data on trends for in-stock rates at both national and regional levels to help understand whether the right amount of infant formula is available in the right locations, and if not, where it should go.
• Expediting the necessary certificates to allow for flexibility in the movement of already permitted products from abroad into the U.S
• Offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records.
• Exercising enforcement discretion on minor labeling issues for both domestic and imported products to help increase volume of product available as quickly as possible.
• Reaching out to retailer stakeholder groups to request that their members consider placing purchase limits on some products in order to protect infant formula inventories for all consumers.
• Not objecting to Abbott Nutrition releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold at its Sturgis facility. In these circumstances, the benefit of allowing caregivers, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection. The FDA is working to ensure health care provider associations and stakeholders understand information about the risks and benefits of pursuing this product.

“It’s important to understand that only facilities experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risks to consumers,” according to the agency.

“The FDA established an Incident Management Group to continue coordinating longer-term activities, which is focused on working with other major infant formula manufacturers to increase supply and helping to ensure that production of infant formula products can safely resume at Abbott Nutrition’s Sturgis facility, among other activities.”

The agency continues to advise against making infant formulas at home and encourages caregivers to work with their child’s health care provider for recommendations on changing feeding practices.

Related Information

• FDA Investigation of Cronobacter Infections: Powdered Infant Formula plus Recall Information (February 2022)
• Jan. 31-March 18, 2022 FDA Inspection Form 483 on Abbott production plant
• Powdered Infant Formula Recall: What to Know | FDA