Date of issue: 10 October 2022
Date of effect: Immediate
Reference Number: MAA2022-32
Related MAAs: MAA2022-15
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, Fisheries and Forestry — Central and Regional offices
Purpose
To notify Australian manufacturers and exporters that the US Food and Drug Administration (FDA) has provided further guidance for those manufacturers currently exporting product under the enforcement discretion released in May 2022 and wishing to continue exporting infant formula to the USA.
The new FDA guidance document, ‘Infant Formula Transition Plan for Exercise of Enforcement Discretion’ provides a recommended timetable for actions manufactures will need to take to achieve full compliance with all FDA requirements that apply to their products. The department encourages all manufacturers that have been issued with an FDA letter of enforcement discretion to follow the new guidance.
Summary of key points
- On 30 September 2022, the FDA published a new guidance document to manufacturers which the FDA has previously granted access to temporarily facilitate infant formula exports to the USA.
- Under the new guidance, approved manufacturers and exporters, that are not currently complying with specific FDA requirements, will be allowed to continue exporting infant formula product beyond the current expiration date of 14 November 2022, while they work towards meeting all FDA requirements.
- These manufacturers and exporters will need to submit a letter of intent to pursue compliance with all regulatory requirements by 5 December 2022. All submissions should be sent directly to the FDA via email - Infant_formula_flexibility@fda.hhs.gov.
- The FDA will review all letters of intent and where appropriate, issue a new letter of enforcement discretion by 6 January 2023.
- The guidance also allows manufacturers of new infant formula product, including manufacturers not currently marketing under the previous enforcement discretion policy, to submit a new infant formula submission.
- The new guidance will remain in effect until 18 October 2025. The FDA will provide notice if they deem an extension necessary.
- The US FDA will host an industry webinar to provide an overview and answer questions on the recently released guidance. More information on the webinars will be released shortly.
- Manufacturers and exporters are encouraged to review the new guidance document for specific advice on what information needs to be provided to the FDA to continue exporting infant formula to the US, and to work closely with their importer to confirm any specific import requirements.
- The Manual of Importing Country Requirements (Micor) for the USA will be updated to reflect this market access advice.
Further information
Contact ExportStandards@aff.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.