The US normally produces 98% of the infant formula it consumes. However, US shoppers face empty shelves as higher demand and a large-scale recall from one of the country’s biggest manufacturers, Abbott Nutrition, lowered supply of infant formula products.
Acknowledging that ‘many’ US shoppers haven’t been able to buy infant formula and other medical foods, the FDA has been working with US producers to try and improve supplies and has relaxed import rules in the hope that overseas manufacturers will also step into the breach.
“We continue to do everything in our power as part of the all-of-government efforts to ensure there’s adequate infant formula available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert Califf. “Our recent steps will help further bolster supply of infant formula, including through the import of safe and nutritious products from overseas based on our increased flexibilities announced last week. Importantly, we anticipate additional infant formula products may be safely and quickly imported into the US in the near-term based on ongoing discussions with manufacturers and suppliers worldwide.”
Kendal Nutricare to supply two million cans
The FDA has informed Kendal Nutricare that the agency is exercising 'enforcement discretion' for the importation of certain infant formula under the Kendamil brand.
The company initially estimates that about two million cans of infant formula are expected to land on US store shelves beginning in June.
Kendal Nutricare currently has over 40,000 cans in stock for immediate dispatch and the US Department of Health and Human Services has initiated conversations to evaluate options for getting the products to the US ‘as quickly as possible’.
Announcing the news, the FDA said it ‘does not have concerns’ that products can be used safely and provide adequate nutrition. This view was based on information pertaining to nutritional adequacy and safety, including microbiological testing, labeling, and additional information about facility production and inspection history, the FDA said.
Kendal said that its application was ‘fast-tracked’ relative to other European brands thanks to its English language packaging and fully nutritionally-compliant recipe (including iron levels).
Kendal ramping up capacity as global demand surges
Kendal’s production facility is capable of producing around 10 million cans of 900g formula per year. Today it is operating at 50% of its total capacity. Given what the company described as ‘exponential demand’ from the UK, Europe, Asia and now the US, plans are in place to more than double the site's capacity by 2024.
Kendal Nutricare expects to ship 100 trucks to the USA over the next six months. The group said it expects to meet the needs of at least 150,000 US households during the import period. However, management have made clear they will continue to prioritise their core markets and existing customers and so do not expect any impact on its existing markets or supply for UK parents. The company has seen 900% growth in UK sales over the last 12 months and, since its launch in 2016, it has scaled distribution to over 35,000 stores across 40 countries. The UK accounts for half of the company’s total sales currently.
"We have received the call for assistance from the FDA and Kendamil stands ready to act. The urgency of the situation and scale of the US opportunity will justify Kendal Nutricare doubling our capacity for Kendamil by 2024, increasing British dairy exports from Cumbria, creating more local jobs and providing long-term security for British dairy farmers,” Ross McMahon, CEO of Kendal Nutricare, commented.
Abbott to release cans from Michigan on a ‘case-by-case’ basis
The FDA also revealed that Abbott Nutrition will release around 300,000 cans of EleCare amino acid-based infant formula previously produced at its Sturgis, Michigan, facility.
The site was at the centre of the Abbott recall initiated after the deaths of two infants who consumed formula produced at Sturgis.
The FDA said that the release of these cans would support individuals needing ‘urgent, life-sustaining supplies’ of this specialty formula on a case-by-case basis.
“These products will undergo enhanced microbiological testing before release. Although some EleCare product was included in Abbott Nutrition’s infant formula recall, these EleCare products that will be released were in different lots, have never been released and have been maintained in storage under control by Abbott Nutrition,” the FDA said.
“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under insanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility.”
Abbott has confirmed that EleCare will be the first formula produced at the Sturgis facility when it restarts production, and other specialty metabolic formulas will ‘closely follow’.
"All products have been tested and meet all product release requirements. In addition, Abbott has concluded additional, enhanced testing to provide assurance the product is safe to distribute. Abbott plans to restart production at the Sturgis facility on June 4 and will prioritize EleCare production, with initial EleCare product release to consumers beginning on or about June 20," the company said in a statement.