On July 6, the Food and Drug Administration announced plans to develop a new framework for continued and expanded US market access for infant formula manufacturers.
After the closure of the Abott factory, which had aggravated the shortage situation in the United States, the American administration realized that it had to diversify and strengthen its supply of infant milk powder.
In order to remedy the temporary shortage, the FDA then expanded the possibilities of imports into the United States in May, facilitating access to certain manufacturers. The agency had then given priority to reviewing applications from companies that can: 1) produce documents to demonstrate the safety and nutritional adequacy of the product; 2) make the greatest volume of product available; and/or 3) get the product quickly on US shelves.
This flexibility made it possible to increase imports. According to the FDA, as of July 6, this has resulted in an estimated total supply of more than 400 million 8-ounce bottles (approximately 236.59 Ml) of infant formula from nine countries for children in the United States. This discretion, stemming from an FDA directive in May, is expected to remain in effect until Nov. 14. “Many companies supplying these formula products have expressed interest in continuing to serve the US market on a permanent basis,” the FDA explains.
Ongoing protocol for a continuous and expanded market
For these reasons, the US administration plans to:
- provide technical support contact unique to the FDA for any company wishing to enter the US infant formula market, making it easier for potential new entrants to navigate the FDA regulatory review process.
- organize meetings this summer with companies that importsell and/or distribute preparations under the FDA’s discretionary temporary application policy to determine what additional steps would be required to pave the way for long-term, uninterrupted commercialization.
- open up the possibility for businesses which have received authorization to import infant formula on a temporary basis, to supply the American market on a permanent basis.
Abott’s infant milk powder factory has reopened
The Abbott factory reopened on July 1. The factory in Sturgis, Michigan (north), had closed for several months after a recall of products suspected of having caused the death of two infants. Production resumed in early June, then was halted again in mid-June due to flooding, again delaying deliveries of its hypoallergenic milk brand EleCare.