French food group Danone has won US FDA approval to export infant formula to the US. Photo / File
French food group Danone has won US FDA approval to export infant formula to the US. Photo / File
Danone NZ has won Food and Drug Administration (FDA) approval to export New Zealand-made infant formula to help offset severe shortages in the United States.
The French food group, which has substantial formula making facilities in New Zealand, said it expects to be exporting formula to the US later thismonth.
Danone said that in response to the shortages in the United States, and in collaboration with the US authorities, that it had continued to explore ways to increase production to meet the need.
"The US FDA approval is also a great endorsement for the broader dairy industry in New Zealand, which has a stellar global reputation as one of the world's finest producers," Danone NZ operations director Steve Donnelly said.
The FDA last week approved the import of a batch of Danone's "Aptamil" formula into the US from its manufacturing facility in New Zealand.
The company - one of the world's biggest food groups - will make available an additional 500,000 cans of "Neocate" - specialised for babies with allergies - through its Nutricia business.
These cans will be flown to the US from facilities in Europe as part of the White House's "Operation Fly Formula" programme.
Danone Nutricia's manufacturing facility at Balclutha. Photo / Supplied
Australian formula company Bubs was quick out of the blocks to meet the call for formula. It qualified, under the FDA's discretion policy, in May.
Under Operation Fly Formula, Bubs today said it had entered into supply agreements with two new retailer banner groups in the United States, including H-E-B Grocery, a supermarket chain based in Texas with 340 stores, and Meijer - an American supercentre chain with 259 stores mostly in the Midwest.
The remainder of the goods in the air shipment will be distributed to replenish existing stockists including Walmart, Kroger and ABSCO.
The total gross revenue generated from its fourth planeload was about A$3.0 million ($3.3m), Bubs said.
Bubs has substantially upgraded its earnings forecasts in response to unanticipated demand out of the US.
"It has been an extraordinary journey for Bubs to have had over 12 months of in-market experience to provide the first response to USA's infant formula shortage, which is likely to change the industry landscape in the USA," Bubs said.
The shortage had significantly accelerated its entry to one of the largest infant formula markets in the world, Bubs said.
Fonterra produces finished infant formula for sale in New Zealand and in a range of export markets, but not for the United States market.
James McVitty, Fonterra's trade strategy, compliance and stakeholder affairs manager said the FDA had confirmed receipt of its submissions and had asked some follow-up questions.
The FDA had given no timeframes as to when its review would be completed.
"We hope our submissions are approved in the near future by FDA providing a 'no objections' letter which will allow imports into the US," he said in a statement supplied to the Herald.
"We understand the FDA are working through a significant number of submissions from manufacturers around the world including New Zealand," McVitty said.
In May, NZX-listed a2 Milk applied to the FDA to supply formula.
A spokesman for a2 Milk said there had been no progress since then.
The US shortage has been exacerbated by the closure of formula maker Abbott Nutrition's plant in February after the plant failed several inspections from the FDA.
American TV news channel CNN said the shortage had left many mothers and families desperately scrambling to feed their infants.
CNN said the shortage had been made more acute by the low rate of breastfeeding in the country compared with most industrialised nations, which has made the US especially vulnerable to shocks in the highly concentrated market for formula.
A big part of the problem was baby formula manufacturers' aggressive marketing and promotional practices, which undermined breastfeeding practices for new mothers and influenced their decisions to use formula, CNN said.
The United States takes a lax approach to formula marketing, unlike many other countries, it said.
