The notice was a requirement for Synlait's NZ-produced lactoferrin to be used in a new 'grass-fed' infant formula that its US partner Munchkin Inc is planning to launch this year. While lactoferrin is already in use in the US, Synlait needed to satisfy the FDA that its product was safe.
The Rakaia-based company is coy about its sales of the high-value, low volume lactoferrin, which is an iron-binding glycoprotein consisting of a single polypeptide chain isolated from raw milk as defined by the FDA. The naturally occurring ingredient of milk reportedly has antibacterial and anti-inflammatory properties. Synlait produced 10 tonnes of lactoferrin in 2016 but hasn't disclosed the value of sales or given much detail of end uses by its customers, which include a2 Milk.
Synlait communications manager Dan Walraven said the company had worked for two years with Munchkin of the new 'grass-fed' formula that was expected to be launched this year in a market where much of the milk comes from intensive, factory-style dairy farms. Synlait believed its own production could be ramped up "with little additional investment" and it was a case of developing customer demand, he said.
Synlait is the second company to gain to gain a GRAS notice to export lactoferrin to the US. Japan's Morinaga Milk gained a notice in 2014, according to FDA records.
Synlait has previously said that significant manufactured volumes for the US market, the second-largest infant formula market after China, aren't expected until the 2018 financial year.
Synlait's shares rose 0.6% to $3.52 and have edged up 0.9% in the past 12 months, lagging behind the S&P/NZX 50 Index's 8.6% gain.
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