Bubs wins FDA approval for infant formula

USA – Bubs Australia has secured permanent authorisation from the US Food and Drug Administration (FDA) to supply its infant formula to the local market.

In a statement, Bubs said the FDA has granted permanent regulatory clearance for three of its products: Bubs Goat, Bubs 365 Day Grass Fed and Bubs Essential.

The clearance confirms that the company’s formulations, manufacturing systems and scientific evidence satisfy USA regulatory requirements, the statement added.

Bubs Managing Director and CEO Joe Coote said: “Permanent FDA authorisation is a transformational milestone for Bubs and validates the strength of our farm-to-formula value chain, manufacturing capability and product quality.

“This approval provides the platform to accelerate our US growth strategy, deepen retailer partnerships, strengthen consumer awareness of the Bubs brand and expand consumer reach across a market where we are already represented in more than 10,000 stores nationwide.”

The company first moved to secure permanent authorisation in 2022 amid a nationwide formula shortage sparked by a contamination scare at an Abbott Laboratories plant.

At the time, the US administration granted temporary dispensation to foreign suppliers, including Bubs, to ship products into the country in an effort to plug the shortages.

With the approval now in place, the company said it plans to enter the private-label infant-nutrition segment in the USA.

Coote added: “While any private-label expansion remains subject to further regulatory, technical and commercial milestones, the FDA authorisation represents a significant strategic asset that we consider enhances Bubs’ long-term growth potential.”

The approval comes weeks after Bubs Australia reported group revenue of A$111.9 million (US$80.56 million) for the 12 months to 30 June. The figure marked a 9.2% year-on-year rise, which the company attributed to growth in the US.

Revenue in the USA climbed 24% to A$65.8 million, driven by strong consumer demand in the premium goat segment, expanded store distribution and prioritisation of continuity of supply, the company said in August as it announced the annual results.

However, group gross profit fell 9.4% to A$44.5m, weighed by increased airfreight, regulatory and tariff-related costs, the company said.

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