Attention

• Industries—Industry bodies – Dairy Australia – Infant Nutrition Council, Dairy Export Industry Consultative Committee, Australian Food and Grocery Council
• Dairy Export establishments
• Department of Agriculture, Water and the Environment — Central and Regional offices

Purpose

To notify Australian manufacturers and exporters that the United States of America (USA) has implemented temporary measures to streamline the approval process for the export of infant formula to the USA.

Establishments must provide a submission to the US Food and Drug Administration (FDA) as outlined in the guidance document.

Summary of key points

• A recent recall of powdered infant formula from the largest infant formula manufacturing plants in the US, coupled with COVID-19 disruptions has caused a significant shortage of infant formula in the USA.
• The US FDA has published a guidance document that aims to temporarily facilitate infant formula export to the USA.
• Fully hydrolysed protein infant formulas are a priority. However, other types of infant formula are also eligible.
• The US FDA will host an industry webinar on 20th May (1:00 am AEST) to provide an overview and answer questions on the released guidance document. To participate, please register here. The webinar will be recorded and posted to the FDA website.
• The temporary discretionary measure by the US FDA will be in effect until 14 November 2022.
• Manufacturers and exporters are encouraged to review the guidance document for specific advice on what information needs to be provided to the FDA to export infant formula to the US, and to work closely with their importer to confirm any specific import requirements.
• All technical questions and/or submissions should be sent direct to the FDA via email - Infant_formula_flexibility@fda.hhs.gov.
• The US FDA will prioritise manufacturers experienced in, and already making essentially complete nutrition products and those that have the largest volume of product available and/or those that can get product onto US shelves the quickest.
• The Manual of Importing Country Requirements (Micor) for the USA will be updated to reflect this market access advice.

Further information

Contact ExportStandards@agriculture.gov.au if you have any queries.

The information provided in this advice is current at the time of writing and is intended for use as guidance only and should not be taken as definitive or exhaustive. The Commonwealth endeavours to keep information current and accurate, however, it may be subject to change without notice. Exporters are encouraged to verify these details with their importers prior to undertaking production/exports. The Commonwealth will not accept liability for any loss resulting from reliance on information contained in this notice.