US formula shortage: Danone NZ, Bellamy’s Organic latest to receive US FDA approval, Meiji makes application

In addition, Japanese firm Meiji has also jumped on the bandwagon with an application made to the US FDA.

Danone NZ will be supplying Aptamil Gold Plus – a stage one infant formula, while Bellamy’s Organic will supply two products, namely Organic Infant Formula Step 1 (0-6 months) and Organic Follow-On Formula Step 2 (6-12 months), the US FDA announced on June 27 and 29.

Danone NZ is estimated to supply 555k cans of infant formula from August, while Bellamy’s Organic is estimated to provide 696k cans across major and speciality retailers starting from this month.

“In May, the Food and Drug Administration (FDA) announced that the agency is exercising enforcement discretion so that Danone can export additional infant formula, including Neocate Infant DHA/ARA and Aptamil First Infant Milk Stage 1. ​

“Danone plans to export approximately 38 million 8-ounce bottle equivalents into the U.S. market, which also includes their Aptamil baby formula from Ireland and New Zealand,” ​the White House said in a statement on June 30.

Danone will also be supplying specialised medical formulas Neocate Junior and Neocate Infant DHA/ARA from Europe to the US on July 8. These products are for babies with severe cow’s milk or multiple food protein allergies and sold via medical distributors.

Meiji made its application ​

Meiji, on the other hand, has applied to the US FDA for the export of two infant formula. 

One of it is a powdered milk for babies allergic to lactose manufactured in its Saitama factory in Japan, while the other one is a cube-shaped powdered milk. 

“Japan was helped by ​by relief supplies at the time of the Great East Japan Earthquake that occurred in 2011. This time we thought it was a turn to help.​

“We also thought it was an opportunity to see who would buy our infant formula in the United States,”​ Tomohisa Kamei from Meiji’s PR department said.

Four APAC firms so far ​ 

Between May 27 and June 29, there have been four companies in the APAC region approved to supply infant formula to the US under the Enforcement Discretion policy.​

The other two companies are 1) Mead Johnson / Reckitt, which will supply base powder to manufacture Enfamil Stage 1 from its facility in Singapore, and 2) Bubs Australia, which is supplying six products.​

The companies were granted discretionary approval after US FDA’s review on their nutritional adequacy and safety, including microbiological testing, labelling, and information on the facility production and inspection history.

By July 3, Operation Fly Formula will have transported more than 37.2 million 8-ounce bottle equivalents to the country, said the White House. ​

Operation Fly Formula allows commercial aircraft to pick up overseas infant formula that meets the country’s health and safety standards and will bypass the regular air freighting routes to speed up importation. ​

Abbott reopened facility flooded ​

Abbott, which reopened its Sturgis production facility last month, had the facility shut down again after parts of it were flooded during a severe storm.

“As a result, Abbott has stopped production of its EleCare specialty formula that was underway to assess damage caused by the storm and clean and re-sanitise the plant. ​

“We have informed FDA and will conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production. ​

“This will likely delay production and distribution of new product for a few weeks,” ​Abbott said on June 15.

The firm added that it would have produced 8.7 million pounds of infant formula in June for the US – which was 95 per cent of what it had produced in January, prior to the recall and does not include production from Sturgis.

Last month, Reuters ​reported that the US FDA was notified of one more infant death in January potentially related to Abbott Laboratories’ baby formula. The FDA has since started an investigation.

The FDA had previously received reports of nine infant deaths, with two associated with Abbott’s Sturgis plant investigation.