US formula shortage: FDA refutes claims of postponing all applications under discretion policy

It clarified that it has sent letters to some – not all – firms to notify them that the agency would be deferring further review of their application under the enforcement discretion policy.

The enforcement discretion policy was introduced to speed up the supplies of infant formulas in the US, in the wake of product shortages earlier this year.

Under the arrangement, applications to export to the US are expedited and the arrangement will be put in place until November 14.

By deferring the review of certain requests, the agency said it would be prioritising other requests for review.

One of the companies that has received deferment notice from the US FDA is New Zealand headquartered The a2 Milk Company.

The a2 Milk Company, which is listed on both New Zealand Exchange (NZX) and Australian Securities Exchange (ASX), made a market update announcement that it had received the deferment notification from the USFDA.

“At this time, the FDA is deferring further consideration of the Company’s request for enforcement discretion to import infant milk formula (IMF) products into the US,” ​the firm said in its ASX announcement.​

In fact, it said it has been advised by the International Dairy Foods Association (IDFA) that such notification has been sent to all pending applicants.

“The company has also subsequently been advised by the International Dairy Foods Association (IDFA) that equivalent letters have been sent to all pending enforcement discretion applicants, indicating that the FDA is deferring any further review at this time of all pending applications.”​

Some of the Asia-Pacific firms that were allowed exportation under the expedited scheme include Bubs Australia,​ Care A2+, and Bellamy’s Organic. 

Responding to queries from NutraIngredients-Asia ​on the deferment notice, ​the US FDA clarified that only some and not all firms have been notified, adding that it would continue to review requests from manufacturers for enforcement discretion.

“The FDA continues to work around the clock to address current supply challenges, including reviewing a number of requests from manufacturers for enforcement discretion, as quickly as possible.​

“The agency, however, has sent letters to some – not all – firms notifying them that the agency is deferring further review of their enforcement discretion request at this time.​

“The letters include a general list of issues the agency has identified with these requests that have let the FDA to defer further consideration of these specific requests,” ​a USFDA spokesperson said.

NutraIngredients-Asia ​has reached out to IDFA for comments.

Why certain applications deferred?  ​

The spokesperson explained that the deferment letters were sent out not because the products involved were unsafe, but because the USFDA has found issues that “would unlikely to be resolved quickly.”​

In this case, firms could seek to enter the US market through the FDA’s routine infant formula submission process.

Having sent out the deferment letters to some companies, the USFDA would then prioritise the other applications for review.

“Given the nature of the infant formula supply challenges and the need to quickly address the shortage, the FDA is deferring consideration of these specific requests at this time and prioritizing others for review,” ​said the spokesperson.

The review process includes assessing the products’ nutritional adequacy and safety, including microbiological testing, labeling, and additional information about facility production and inspection history.

Until November​

The USFDA said earlier that it intended to exercise enforcement discretion until November 14.

Products that were approved and exported to the US on or before November 14 can remain on the US market after that date.

“The FDA does not intend to require product on the market to be removed after that date,” ​the agency said.