Danone to Fly Formula to the U.S. for Babies With Allergies
Danone SA
DANOY 0.60%
is to send the equivalent of about five million bottles of specialist infant formula to the U.S. as part of a broader push to alleviate shortages faced by babies with allergies.
The French food giant said about half a million cans of specialized medical formula made by its Nutricia business will be flown into the U.S. in the coming weeks. Danone said the formula will come from its factory in Liverpool, England, which makes the Neocate line of amino acid-based products used for babies allergic to cow’s milk and other proteins.
Baby formula has been in short supply for months partly because of supply-chain issues caused by the Covid-19 pandemic. Product recalls and a production halt by
Abbott Laboratories
ABT 1.58%
then exacerbated the shortages. A spokeswoman for the Food and Drug Administration said that while more formula is becoming available to infants generally, it understands that the availability of specialty formula continues to be of 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 globally, according to Danone. Symptoms include vomiting, diarrhea, wheezing and skin rashes.
Abbott sells the EleCare line under its Similac brand for babies with allergies to cow’s milk but supplies have been interrupted since its Sturgis, Mich., facility closed in February after the FDA found the presence of a germ that can be deadly in infants.
The FDA is working to increase the supply of specialist baby formula by expediting reviews of manufacturing changes aimed at increasing production, the spokeswoman said. The agency has said its goal is to ensure that stores, hospitals and pharmacies “begin seeing adequate supplies again in the coming weeks.”
Danone’s formula shipments should land by the end of June, a spokeswoman for the company said, adding that it would work through medical distributors to get the products out in the first half of July.
Nestle SA
has also given priority to boosting the availability of specialist formula, saying earlier this month that it would fly its Gerber Good Start Extensive HA and Alfamino lines, which are for babies with allergies to cow’s milk protein, to the U.S. The Swiss company said the first batches of the product had arrived at its U.S. distribution center near Allentown, Pa., on Wednesday and it would send this out to retailers, hospitals and state programs starting May 28.
The FDA has separately said it wouldn’t object to the release of about 300,000 cans of Abbott’s EleCare amino acid-based formula, previously made at the Sturgis facility, to babies needing urgent, life-sustaining supplies of the product on a case-by-case basis. It said the formula would undergo extra microbiological testing before release.
More on the Baby-Formula Shortage
The cans that Danone plans to fly to the U.S. amount to more than five million 8oz bottles. Some are already made in Europe for the U.S. market while others need to be labeled so they comply with U.S. 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 specifics, but that one way Danone could quickly get more formula into the U.S. is by using sleeves for cans or stick-on labels to ensure they comply.
Danone has been working with the FDA for months on boosting supplies since it was contacted by the regulator soon after Abbott closed its factory, Ms. Broseta said. She added that the FDA has promised to help Danone with logistics such as getting clearance for imports and ensuring it has enough airfreight capacity to get its formula over.
Although Danone has just 1% of the U.S. market, making it a much smaller player than rivals such as Enfamil owner
Reckitt Benckiser Group
PLC and Gerber owner Nestlé, the company’s specialty formula products currently give it an outsize importance.
Danone had increased production of its more mainstream organic Happy Family formula, running the facility that makes the brand at maximum capacity and giving priority to production of bestselling variants. But the company had previously warned that it takes time to increase production of medical formula because its manufacture is more complex, requiring specialized ingredients and extensive quality and food safety procedures. The FDA spokeswoman said not every factory is set up to produce specialty formula.
Ms. Broseta said Danone has increased shifts at the Liverpool factory and hired more people, which has helped to increase production of Neocate.
Danone says 80% of its Neocate formula is allocated to medical distributors who work with insurance carriers while the remainder is allocated for sale via its website and its
Amazon
reseller.
The Neocate U.S. website on Monday showed a message saying the Neocate Infant DHA/ARA formula, made for infants with cow milk allergy and multiple food allergies, was out of stock online because of the surge in demand but “should be back in stock shortly.”
Write to Saabira Chaudhuri at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Danone SA
DANOY 0.60%
is to send the equivalent of about five million bottles of specialist infant formula to the U.S. as part of a broader push to alleviate shortages faced by babies with allergies.
The French food giant said about half a million cans of specialized medical formula made by its Nutricia business will be flown into the U.S. in the coming weeks. Danone said the formula will come from its factory in Liverpool, England, which makes the Neocate line of amino acid-based products used for babies allergic to cow’s milk and other proteins.
Baby formula has been in short supply for months partly because of supply-chain issues caused by the Covid-19 pandemic. Product recalls and a production halt by
Abbott Laboratories
ABT 1.58%
then exacerbated the shortages. A spokeswoman for the Food and Drug Administration said that while more formula is becoming available to infants generally, it understands that the availability of specialty formula continues to be of 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 globally, according to Danone. Symptoms include vomiting, diarrhea, wheezing and skin rashes.
Abbott sells the EleCare line under its Similac brand for babies with allergies to cow’s milk but supplies have been interrupted since its Sturgis, Mich., facility closed in February after the FDA found the presence of a germ that can be deadly in infants.
The FDA is working to increase the supply of specialist baby formula by expediting reviews of manufacturing changes aimed at increasing production, the spokeswoman said. The agency has said its goal is to ensure that stores, hospitals and pharmacies “begin seeing adequate supplies again in the coming weeks.”
Danone’s formula shipments should land by the end of June, a spokeswoman for the company said, adding that it would work through medical distributors to get the products out in the first half of July.
Nestle SA
has also given priority to boosting the availability of specialist formula, saying earlier this month that it would fly its Gerber Good Start Extensive HA and Alfamino lines, which are for babies with allergies to cow’s milk protein, to the U.S. The Swiss company said the first batches of the product had arrived at its U.S. distribution center near Allentown, Pa., on Wednesday and it would send this out to retailers, hospitals and state programs starting May 28.
The FDA has separately said it wouldn’t object to the release of about 300,000 cans of Abbott’s EleCare amino acid-based formula, previously made at the Sturgis facility, to babies needing urgent, life-sustaining supplies of the product on a case-by-case basis. It said the formula would undergo extra microbiological testing before release.
More on the Baby-Formula Shortage
The cans that Danone plans to fly to the U.S. amount to more than five million 8oz bottles. Some are already made in Europe for the U.S. market while others need to be labeled so they comply with U.S. 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 specifics, but that one way Danone could quickly get more formula into the U.S. is by using sleeves for cans or stick-on labels to ensure they comply.
Danone has been working with the FDA for months on boosting supplies since it was contacted by the regulator soon after Abbott closed its factory, Ms. Broseta said. She added that the FDA has promised to help Danone with logistics such as getting clearance for imports and ensuring it has enough airfreight capacity to get its formula over.
Although Danone has just 1% of the U.S. market, making it a much smaller player than rivals such as Enfamil owner
Reckitt Benckiser Group
PLC and Gerber owner Nestlé, the company’s specialty formula products currently give it an outsize importance.
Danone had increased production of its more mainstream organic Happy Family formula, running the facility that makes the brand at maximum capacity and giving priority to production of bestselling variants. But the company had previously warned that it takes time to increase production of medical formula because its manufacture is more complex, requiring specialized ingredients and extensive quality and food safety procedures. The FDA spokeswoman said not every factory is set up to produce specialty formula.
Ms. Broseta said Danone has increased shifts at the Liverpool factory and hired more people, which has helped to increase production of Neocate.
Danone says 80% of its Neocate formula is allocated to medical distributors who work with insurance carriers while the remainder is allocated for sale via its website and its
Amazon
reseller.
The Neocate U.S. website on Monday showed a message saying the Neocate Infant DHA/ARA formula, made for infants with cow milk allergy and multiple food allergies, was out of stock online because of the surge in demand but “should be back in stock shortly.”
Write to Saabira Chaudhuri at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
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