US FDA combatting infant formula shortage sparked by Abbott recall: 'We recognize that many consumers have been unable to access infant formula'

Abbott Nutrition initiated a voluntary recall in February after four consumer complaints of infant illness related to products from the company’s Sturgis, MI facility​. All cases are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants.

Since that time, the FDA has been working with Abbott and other manufacturers to ‘bring safe products’ to the US market. FDA Commissioner Robert Califf acknowledged that the recall – as well as an increase in demand for formula products – has meant that ‘many’ US shoppers haven’t been able to buy infant formula and other medical foods.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it,”​ Califf stressed.

‘Our teams have been working tirelessly’

While the Abbott recall certainly hasn’t helped the situation, it is clear that US infant and medical nutrition supplies were already under some pressure. Prior to the recall, FDA said it had already been working to address supply chain issues associated with the COVID-19 pandemic, including those impacting the infant formula industry.

It also comes as demand for formula products is seemingly increasing in the country. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall,”​ FDA noted.

FDA is taking ‘several significant actions’ to help increase the current supply of infant formula in the US, the agency stated.

The FDA is meeting ‘regularly’ with all major infant formula manufacturers to ‘better understand’ their capacity to increase production of various infant formula and medical nutrition 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,”​ FDA stated.

The enforcement body is also cutting red tape to make it easier for manufacturers to push through plans to maximise capacity. FDA said it is ‘expediting review of notifications of manufacturing changes that will help increase supply’, particularly in the case of the specialized formulas for medical needs.

The results of this effort can be seen in other infant formula makers ‘meeting or exceeding’ capacity levels to plug the demand gap.

Elsewhere, the US authorities are making it easier to import product from oversees. These efforts include expediting the necessary certificates to allow for ‘flexibility in the movement of already permitted products’ from abroad; offering a ‘streamlined import entry review process’ for products coming from foreign facilities with favourable inspection records; and ‘exercising enforcement discretion’ on ‘minor labelling issues’ for both domestic and imported products.

The FDA has also taken an active role in gathering data on nationwide availability. It is leveraging its 21 Forward supply chain continuity system, developed during COVID, to understand how the supply chain is operating. Compiling data on trends for in-stock rates on a national and regional level, the FDA hopes this will help the industry understand whether the right amount of formula is available in the right places.

“Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA. Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products,”​ Califf commented.

The organization is also reaching out to retailer organisations, asking their members consider placing purchase limits on some products in order to combat panic buying.