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United States of America (US)

Temporary changes for infant formula to the USA

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 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. Refer to MAA 2022-32 for specific advice. Note: Exporters will still be required to follow the testing requirements outlined in Section 4 and departmental seals outlined in Section 5.

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1. Preconditions for market access

2. Production of products for human consumption

3. Production of products not for human consumption

4. Operational requirements

5. Documentation requirements

6. Import procedures

7. Packaging, labelling and shipping marks

8. Shipping and air freight requirements

9. Additional documentation available

10. Definitions

Latest updates

04/08/2023 - Updated residue statement to refer to importing country standards (section 4.1).
14/10/2022 - Updated FDA infant formula alert.
06/06/2022 - Temporary changes for infant formula to the USA.
07/03/2022 - Removal and replacement of Dairy by Definition wording (sections 2.1 and 5).
20/02/2022 - Content on this page may have changed location to conform to standard Dairy headings.
03/02/2022 - Updated broken links (section 1.2).
10/06/2021 - References to export legislation have been updated.
Last updated: 4/08/2023 12:33 PMCreated: 20/02/2022 11:53 PM