More infant formula set to enter US market to battle shortage, FDA announces

13 Jun 2022 --- Abbott Nutrition will be increasing infant formula supply across the US market with 686,530 cans, accessible to consumers in June. The cans are being produced in Spain and are estimated to fill 16.5 million full-size, 8-ounce bottles, weighing 1.1 million pounds.

The formulas soon to reach the market are Similac Total Comfort Stage (for ages 0-12 months), Similac Total Comfort General (ages up to 24 months) and NeuSure (for premature and low birth weight infants).

Currently, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services are evaluating how to get the products to the market as rapidly as possible. The FDA is also engaging in discussions with suppliers and manufacturers on the supply strategy, aiming to ensure enough infant formulas are available in the US market for all caregivers and parents.

Thousands of infant formula bottles from Abbott are set to enter the market soon.Availability of products

Last week, Abbott received the “green light” to restart their baby formula production. The company halted production after FDA investigations concerning four sick infants that led to hospitalization, whereas two cases were fatal.

The company announced that they are to sell some of the products online, taking WIC participants into account and backing up with emergency samples. WIC is a supplemental nutrition program for women, infants and children, often from low-income households. 

The FDA aims to ensure the products contain the proper nutritional values, are safe to use and include microbiological testing. The agency is also considering labeling and additional information about production and inspection history.

Striving for equilibrium
The Biden-Harris administration has recently unveiled a number of measures to tackle the infant formula shortage, such as increased import from Europe called “Operation Fly Formula” and special attention has been set to WIC participants. The newly announced steps provide more infant formulas in the US through additional flexibilities.

Flexibilities refer to loosening the rules and procedures when it comes to infant formula, for import and export purposes. This is to rapidly be able to provide products to the market.

The flexibilities aim to “bolster the supply” of the products yet ensure nutritional value, as infant formulas are the sole nutrition source for many infants. The agency also mentioned that they will not object to foreign imports initially intended for the foreign market, which was the case prior to the shortage crisis. 

More flexibilities were announced for domestic distribution in the US, where products initially were planned to be exported to foreign markets but will also be sold in the US. Therefore the flexibilities create ease for the whole supply chain, the FDA notes. 

Meanwhile, the agency continues to stress its advice against making homemade formulas and encourages parents and caretakers to reach out to their health care provider for support if needed. 

Additionally, they will continue to monitor fraudulent practices by collaborating with significant marketplaces, a precaution taken as the formula shortage led the way for predatory market behavior through frauds and arbitrage as the formula shortage is creating stress, anxiety and uncertainty across the US.

Edited by Beatrice Wihlander

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