FDA to develop a new framework to prevent future shortage of infant formula

US – Food and Drug Administration (FDA) is developing a new framework to give foreign baby formula manufacturers long-term access to the US market as a strategy for alleviating any future shortages.

Among other things, the framework will work on a pathway of giving long-term access to overseas producers that have already sent supplies.

It will also work on making it easier for new importers to navigate the FDA’s regulatory review process.

In addition, the FDA will provide technical support for companies seeking to enter the baby formula market.

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Before the shortage of infant formula in the US, the federal regulations on baby formula imports had been so strict that few shipments made it to the country.

“The FDA expects that our continued efforts will help infant formula manufacturers who are new entrants to the U.S. market to better continue producing and supplying formula to the US,” the agency said.

FDA Commissioner Dr. Robert Califf added that the recent shutdown of a major infant formula plant of Abbott laboratories, compounded by unforeseen natural weather events, has shown just how vulnerable the supply chain has become.

Califf and Mayne hinted that the agency’s flexibility during the shortage period has enabled some foreign companies to use a greater breadth of their existing, global manufacturing footprint.

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This, according to Califf, has created more resiliency in the US market supply chain and reduced the risk of reliance on too few production facilities supporting the United States.

The government of the US hopes new entrants will reduce the concentration in the baby formula market, where Abbott and Reckitt Benckiser hold a combined 80% share.

One of the new entrants seeking to continue supplying its products to the U.S. permanently is Bubs Australia.

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According to the manufacturer, since the FDA issued its May guidance, Bubs has worked to supply 1.25 million cans of six of its formula products to the United States.

Bubs founder and CEO Kristy Carr said in a statement that the company plans to work with the FDA to continue to distribute and market its products in the US “without interruption beyond November and over the longer term.”

Other foreign companies also shipping infant formula to the US include Nestlé, Bellamy’s Organic, New Zealand’s Fonterra, and A2 Milk  

Canada runs short in supply of baby formula

Elsewhere, Canada is also experiencing a shortage of baby formula for infants with food allergies and certain medical conditions.

Health Canada says the shortage is limited to only hydrolyzed formulas and amino acid-based formulas.

These types of formulas are created specifically for infants at risk of serious allergic anaphylactic reactions.

The state department has responded that new shipments are expected to arrive next week, however, the agency warns supplies are likely to remain scarce throughout the summer.

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