FDA draws up steps to tackle infant formula shortage

13 May 2022 --- The US Food and Drug Administration (FDA) is trying to ensure the availability of infant formula, as the country faces a nationwide shortage with parents scrambling to find supply.

“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,” says FDA Commissioner Dr. Robert Califf.

“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.”

Parents are reporting challenges in finding infant formula. Escalating problem
The problem has been brewing over the past few months as a result of compounding issues ranging from the supply chain crisis and Russia’s invasion in Ukraine. The situation was further escalated after Abbott Nutrition voluntarily recalled a number of its products after an FDA investigation was launched in connection with four children being hospitalized, whereas two died.

An inspection of the Abbott nutrition facility in Sturgis, Michigan found five environmental subsamples were positive for Cronobacter sakazakii. Nonetheless, the FDA has since allowed the release of the recalled products in “urgent cases”.

“Other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand. Notably, more infant formula was purchased in the month of April than in the month prior to the recall,” the FDA explains.

In a bid to try and combat the shortages, the agency will also support Abbott Nutrition in improving its formula. 

Leveraging available tools
Currently, efforts are already underway by several infant formula manufacturers to optimize processes and production schedules to increase product output, the FDA notes. 

Product lines in greater need, such as specialty formulas are being prioritized, the agency notes. 

The FDA is also meeting with several infant formula manufacturers to understand the volume of products they can supply. The production process has increased due to the shortage, and the FDA is helping the manufacturers to make sure that safe products reach the market.The FDA is battling the issue from different angles to rapidly fill this supply shortage.

The agency is also expediting the necessary certificates to allow for flexibility in the movement of already permitted products from abroad into the US. It is also offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records. 

Additionally, the FDA is exercising enforcement discretion on minor labeling issues for both domestic and imported products to help increase the volume of infant formula available as quickly as possible.

The FDA has also reached out to retailers to implement a purchase stop on the quantity bought per individual. To ensure that all consumers can get their hands on the product, and discourage third-party price gouging. They still strongly advise against making infant formula at home.

There is a high need for specialty formula products aimed at infants with allergies or other health conditions who require a particular product. The FDA also mentions that they aim to increase the availability and supply of basic and special formulas to make sure all infants get the product they need.

Edited by Beatrice Wihlander