US formula crisis: ANZ firms encouraged by Bubs’ success, Fonterra, a2mc submit applications
According to an industry expert, Fonterra and The a2 Milk Company have also submitted applications to the US FDA to export to their products to the US.
Infant Nutrition Council (INC), which represents the Australian and New Zealand companies, has noticed that between six and eight of their Australian members have intentions to enter the US which has been plagued by the ongoing infant formula shortage. The six to eight of them include Bubs and Sprout Organic.
Last week, Bubs Australia announced that all six of its infant formula products were approved for immediate import, sale, and distribution into the US. The company sells both goat milk and cow’s milk infant formulas.
The volume involved is at least 1.25 million tins, equivalent to at least 27.5 million bottles in the coming weeks and months.
The latest update is that the US government will be flying first two deliveries of Bubs infant formula products to the US, departing from Melbourne Tullamarine Airport on 9 and 11 June 2022.
The initial shipment will arrive in Bubs’ nominated distribution centres based in Pennsylvania and then directly dispatched to major national retailers.
Bubs has been selling toddler formulas in the US since last June.
In a recent interview with NutraIngredients-Asia, plant-based infant formula firm Sprout Organic also said that it expected to participate in the US market within the next 90 days.
These examples have encouraged INC members to consider entering the US – a market marked by high entry barriers, including the need to present human clinical trial findings when registering the products with the US FDA.
“My best guess of the Australian members that we have, probably six to eight [including Bubs Australia and Sprout Organic] will be looking seriously at this, although I am not sure if they have put up an application with the US FDA as this is commercial and confidential.
“A number have looked at the Bubs example and thought we can perhaps do this as well, so we are expecting a good response, but we will see how many of those applications are successful,” Simon Woolmer, trade and market access manager at INC told us.
He said that the council has been connecting companies with Austrade and the Department of Agriculture in helping companies enter the US.
The council is also working with its US counterpart.
“We are trying to facilitate that process and make it as easy as possible [for Australian companies] to enter the US.”
Minimum volume required
At the same time, CEO of INC, Jan Carey noted that companies would have to meet a minimum volume of exports and some smaller companies might not be able to fulfil it.
“The US FDA requires streamlining the process until November, but companies have to meet a minimum volume of product and it's quite a large volume of product.
“Now for small companies, they may not be able to gear up to that in a short period of time. And so, the opportunity may not be worth it. And then we don't know if this is going to be a short-term solution, or whether the US FDA is going to allow these companies’ products to remain after November.
“If they do allow them to remain in the market, that will be extremely a great opportunity for the ANZ industries,” she said.
The US FDA said earlier that the guidance to help manufacturers navigate the US infant formula import requirements will be in effect until November 14.
“The guidance is related to both the importation into the U.S. of infant formula produced in other countries and infant formula that is produced domestically.
“It describes the information that infant formula manufacturers should provide to the FDA if they want to introduce into U.S. commerce infant formula that is safe and nutritionally adequate but may not comply with all FDA requirements,” the US FDA said.
Other companies that have submitted application to the US FDA include The a2 Milk Company and Fonterra, both firms have confirmed with us.
“We do not currently have a finished infant formula supply chain in the US for a number of reasons, including traditionally onerous FDA registration requirements.
“In light of the current situation and revised FDA guidance, we have submitted an application to the FDA for approval to supply finished infant formula to parents in the US,” said Simon Tucker, Director Global Sustainability, Stakeholder Affairs & Trade at New Zealand headquartered Fonterra.
He added that Fonterra has been supporting its existing ingredient customers by prioritising manufacturing and expediting supply via air freight.
The a2 Milk Company, on the other hand, has submitted an application to the US FDA on the week of May 23.
The company currently sells a2 Milk fluid milk, a2 Milk Half and Half, and Hershey’s a2 Milk to about 27,000 stores in the US.
An Austrade spokeswoman told us that the Australian government would continue to confirm regulatory arrangements and facilitate exports of infant formula.
“With world class baby formula products and a strong trading relationship under Australia-US Free Trade Agreement, Australia is well placed to supply US demand for baby formula.
“Australia is a global leader in quality baby formula products with world class safety and biosecurity standards. In the infant nutrition dairy sub-sector, Australia has more than forty companies covering bulk ingredients, branded formulation manufacturing to trading and export business.
“Austrade will work with exporters to help agribusinesses take advantage of short- and long-term opportunities,” she said.
The other agencies involved in the export processes are the Department of Agriculture, Water and the Environment, and the Department of Foreign Affairs and Trade.
Bubs the only Aussie firm for now
At the moment, Bubs is the only company from Australia to receive the Enforcement Discretion for Regular Infant Formula, according to the US FDA.
The infant formulas that have been approved by the US were: Bubs Organic Grass Fed Infant Formula Stage 1 and Follow-On Stage 2, Bubs Supreme A2 Beta-Casein Protein Formula Stage 1 and Follow-On Stage 2, and Bubs Easy-digest Goat Milk Formula Stage 1 and Follow-On Stage 2.
The other company which has received the status is Kendamil Nutricare from the UK. The firm has three products approved by the US FDA.
Behind the scenes
Bubs said that it had reached out to the US FDA before the latter announced it would be taking applications from international brands.
“We have a US label, Aussie Bubs, and have been selling our Aussie Bubs toddler formulas at major US retailers since last year. So, we were closely watching what was unfolding with the infant formula shortage.
“Just before the FDA announced it would be taking applications from international brands, we submitted a letter to see how we could help,” Kristy Carr, founder CEO said.
“From that point, things progressed very quickly. The FDA and The White House Task Force completed very thorough checks on our products, manufacturing processes and supply. There were many late nights, but as a publicly traded company in business for 17 years, we were prepared to answer all of their questions.
“On May 27 US time, we got word that Bubs Australia has been recognised by the FDA as a safe, clean and nutritionally sound product for American babies,” she said.
She added that the product labels were US FDA-compliant, but they might look slightly different because they were expressed in millilitre (ml). There will be a diagram on its website to help make the conversion into oz.
There are over 1,000 brick and mortar stores selling Bubs’ toddler formulas in the US. Some of them include DPI Specialty Foods, KeHe, UNFI, Smart & Final, Ralphs, and Food4Less.
The products are also available at major e-commerce platforms Vitacost, Walmart, Amazon, Thrive market, Buy Buy Baby, and Aussie Bubs’ direct to consumer website.