Danone will send a formula to the United States for babies with allergies

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The French food giant said around half a million boxes of specialist medical formulas made by its company Nutricia will be flown to the United States in the coming weeks. Danone said the formula would come from its factory in Liverpool, England, which makes the Neocate line of amino acid products used for babies with cow’s milk and other protein allergies.

Infant formula has been in short supply for months, in part due to supply chain issues caused by the Covid-19 pandemic. Product recalls and the shutdown of production by Abbott Laboratories then exacerbated the shortages. A Food and Drug Administration spokeswoman said while more formula is becoming available for infants in general, she understands that the availability of specialty formula continues to be a concern.

Cow’s milk allergy is the most common type of food allergy in infants, affecting between 2% and 5% of babies and young children worldwide, according to Danone. Symptoms include vomiting, diarrhea, wheezing and rashes.

Abbott sells the EleCare line under its Similac brand for babies with cow’s milk allergy, but supplies have been cut since its Sturgis, Michigan, plant closed in February after the FDA discovered the presence of a germ that can be deadly in infants.

The FDA is working to increase the supply of specialty infant formula by accelerating reviews of manufacturing changes aimed at increasing production, the spokeswoman said. The agency said its goal was to ensure stores, hospitals and pharmacies “start to see adequate supplies again in the coming weeks.”

Danone’s formula shipments are expected to land by the end of June, a company spokeswoman said, adding that it would go through medical distributors to release the products in the first half of July.

Nestlé SA has also prioritized increasing the availability of specialist formulas, saying earlier this month it would fly its Gerber Good Start Extensive HA and Alfamino ranges, which are aimed at babies with milk protein allergies. of cow, in the United States. The Swiss company said the first batches of the product arrived Wednesday at its U.S. distribution center near Allentown, Pennsylvania, and it would ship it to retailers, hospitals and state programs starting May 28.

The FDA has said separately that it would not object to the release of approximately 300,000 boxes of Abbott’s EleCare amino acid formula, previously manufactured at the Sturgis facility, to babies in need of an urgent and vital supply of the product on a case-by-case basis. – case by case. He said the formula will undergo additional microbiological testing before release.

The cans Danone plans to airlift to the United States total more than five million 8-ounce bottles. Some are already manufactured in Europe for the US market while others must be labeled to comply with US requirements.

Magdalena Broseta, who leads the global legal, compliance and regulatory teams for Danone’s nutrition business, said the company is still working with the FDA to figure out the details, but that one way for Danone to quickly get more formula in the United States is to use sleeves. for cans or self-adhesive labels to ensure they are compliant.

Danone has been working with the FDA for months to increase supplies since it was contacted by the regulator shortly after Abbott closed its plant, Ms Broseta said. She added that the FDA has promised to help Danone with logistics, such as getting imports cleared and making sure it has enough air cargo capacity to get its formula.

Although Danone only has 1% of the US market, making it a much smaller player than rivals such as Reckitt Benckiser Group PLC, owner of Enfamil, and Nestlé, owner of Gerber, specialty formulas company currently give it disproportionate importance.

Danone had increased production of its more common organic Happy Family formula, running the facility that manufactures the brand at maximum capacity and prioritizing production of the best-selling variants. But the company had previously warned that it takes time to scale up production of medical formulas because its manufacture is more complex, requiring specialist ingredients and extensive quality and food safety procedures. The FDA spokeswoman said not all factories are designed to produce specialty formulas.

Ms Broseta said Danone had increased shifts at the Liverpool plant and hired more people, which helped boost production at Neocate.

Danone says 80% of its Neocate formula is allocated to medical distributors who work with insurance companies while the rest is allocated for sale through its website and Amazon reseller.

Neocate’s U.S. website posted a message on Monday that Neocate Infant DHA/ARA formula, designed for infants with cow’s milk allergy and multiple food allergies, was out of stock online due to the increased demand, but “should be back in stock shortly”. “

This story was published from a news agency feed with no text edits

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