US FDA halts UK group’s baby formula imports over ‘modified’ paperwork

The US food safety watchdog has suspended emergency imports of baby formula from a Luton-based group to help with shortages after accusing the UK company of submitting altered paperwork to authorities in its home country.

The suspension of Global Kosher’s plans to export millions of cans of formula to the US is the latest setback in attempts to address problems caused by the shutdown of a US plant and recall of products made by a major manufacturer.

The Food and Drug Administration said it had halted a waiver allowing Global Kosher to ship infant formula to the US after the company “submitted to UK authorities an official letter issued by the FDA that had been significantly modified”.

Global Kosher had applied to export more than 4.8mn cans of formula under a waiver scheme aiming to help deal with the US shortages.

Global Kosher had planned to send formula manufactured by Kendal Nutricare, a UK producer that makes the Kendamil brand and is also exporting directly to the country under the waiver scheme. Global Kosher had not so far sent any shipments, the FDA said.

There is no suggestion that Kendal Nutricare was involved in the altered paperwork.

Global Kosher did not respond to a request for comment.

Dylan McMahon, growth director at Kendal Nutricare, said: “The volumes forecasted by GK [Global Kosher] were made without them being aware that we had already committed to the FDA to offer all of our available capacity to the USA. In light of this, GK won’t be supplying any product to the USA.”

The FDA’s agreement with Global Kosher, enabling the import to the US of an initial 150,000 cans of formula followed by monthly shipments of 1.2mn cans, was one of the largest under the Operation Fly Formula programme.

The programme aims to help address a crisis that began when a Michigan plant run by US-based Abbott Laboratories was closed in February on contamination fears.

It has now reopened but is only producing speciality formulas and has not resumed manufacturing Abbott’s top-selling baby formula brand Similac, which is prolonging a months-long supply shortage across the US.

The US market is highly dependent on domestic production from three companies — Abbott, Reckitt Benckiser and Nestlé — with imports to the country making up just 2 per cent of supplies, a market structure that experts say leaves the US vulnerable to shocks.

Supply chain disruptions caused by Covid-19, the war in Ukraine and panic-buying by worried parents struggling to source products have contributed to the shortages, forcing retailers to ration sales and leading to empty supermarket shelves.

The monthly average availability of baby formula among major retailers such as Amazon Fresh, Kroger and Costco fell to 50.8 per cent in June, down from 74 per cent in January, according to DataWeave, an analytics provider to retailers. It has since increased to 56.9 per cent, in part because of increased imports.

The shortages have sparked a political crisis for the Biden administration, which has temporarily eased regulations and scrapped tariffs on baby formula imports in an attempt to boost supplies from overseas.

The FDA has so far lifted restrictions for almost a dozen importers to enable 18.4mn cans of baby formula to be flown into the US.

Steven Abrams, a University of Texas professor who specialises in care of newborn children, said it is critical US authorities continue to support imports in the short term to address the supply crisis and boost supply chain resilience over the long term.

“Back in March store shelves were completely empty — you couldn’t find any formula. I don’t think we are seeing so much of that now. But we are still very short of formula for special needs, which represents about 5-10 per cent of formula,” he said.

“The [import] policy is a good one but it’s going slowly. Shelves are not empty, but choices are limited and families are still frustrated when they’re looking to find one particular formula.”

The FDA said in a statement the suspension of imports from Global Kosher is not expected to affect the overall supply of ‘routine formula’ but the watchdog recognises more work is needed to “ensure parents and caregivers have access to safe and nutritious infant formula where and when they need it”.