21 Jul 2022

Fonterra to prioritise NZ, other markets over US as FDA approval process stalls

1:48 pm on 21 July 2022

Fonterra has informed the US Food and Drug Administration that it intends to reallocate infant formula stock it had earmarked for the US.

Spoon with infant formula

Photo: 123rf

In May, Fonterra submitted an application to the FDA to be able to supply finished infant formula to parents in the country amid severe shortages.

Fonterra trade strategy, sustainability, and stakeholder affairs Americas manager James McVitty said approval was yet to be granted.

"We understand the FDA has limited resources and has been prioritising submissions from companies with larger volumes and with existing distribution networks for infant formula in the US.

"Many companies have been waiting for a response from the FDA, and the lack of a response from the FDA does not reflect the quality of our technical submissions."

McVitty said the product which would have been sent to the US would now be sold in New Zealand and other markets as it had a limited lifespan.

"In the future, if we gain enforcement discretion we will reassess infant formula volumes available to send to the US. In addition, we will continue to support other infant formula manufacturers approved for sale in the US with base infant formula powder ingredients."

He said the company had earmarked a relatively small volume of surplus stock in New Zealand to send to the US as Fonterra needed to prioritise supply to parents in New Zealand and other existing markets.

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