Synlait said the process, known as New Infant Formula Notification (NIFN), could take an additional four to 12 months.
The procedure involves trials, audits and a range of documentation.
No impact on financials
John Penno, Synlait’s managing director and CEO, said the company is confident Munchkin Grass Fed formula will be launched, however, the timing would be later than had been anticipated.
Penno added the adjusted timing would not impact Synlait’s forecast FY18 volumes.
Synlait said when Grass Fed is launched in the US, it will become only the second imported formula brand with US FDA registration.
Munchkin Grass Fed infant formula is produced from milk fed only grass, and is GMO free, rBGH free, and grain free.