Bubs Australia Ltd. Seeks Permanent Access to US Market by FDA


Bubs Australia Ltd., a baby formula producer, is seeking permanent access to the United States market after the US Food and Drug Administration (FDA) revealed how companies that have been filling a temporary shortage can become long-term suppliers of baby formula.

Bubs Australia has lodged a letter of intent with the US FDA for permanent access to the US market until October 2025 and beyond, and the US FDA will also issue a letter of acknowledgement in response.

Global baby formula producers have been importing goods into the United States after the FDA eased its import policy to address a nationwide shortage, which was partly triggered by the manufacturing plant of Abbott Laboratories in Michigan recalling several products in February 2022.

The US FDA said that baby formula producers are currently marketing their products in the United States under enforcement discretion, and they should send a letter to the US FDA, highlighting their intent to pursue completion of all US FDA requirements.

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According to the US FDA, several manufacturers might have most of the information needed to meet all the US FDA requirements and, hence, can achieve compliance quickly, while other manufacturers might need a full time frame.