Bubs Australia seeks permanent market access from U.S. FDA

Australia: Baby formula maker Bubs Australia Ltd said on Monday it is seeking permanent access to the U.S. market after the Food and Drug Administration (FDA) spelt out how companies that have been filling a temporary shortage can become long-term suppliers.

Bubs said it had lodged a letter of intent with the U.S. FDA for permanent market access to October 2025 and beyond, adding that the FDA will issue a letter of acknowledgement in response.

Global infant formula manufacturers have been importing goods into the United States after the country's health regulator relaxed its import policy to address a nationwide shortage partly triggered by Abbott Laboratories' manufacturing plant in Michigan recalling some products in February.

The U.S. health regulator on Friday published guidance to help provide a pathway for infant formula manufacturers operating under enforcement discretion in the United States to remain in the market.

The FDA said manufacturers currently marketing their products in the country under enforcement discretion should send a letter to the FDA by Dec. 5, 2022, outlining their intent to pursue completion of all regulatory requirements.

"Some manufacturers may have most of the information needed to meet all U.S. requirements, and therefore, could achieve compliance fairly quickly, while others may need the full time frame being provided," the U.S. health regulator said.