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This CSMS message provides instructions regarding the ACE Transmission Requirements for the importation of foreign sourced infant formula, and contact information related to FDA’s recently published infant formula enforcement discretion guidance.
On May 16, 2022, the U.S. Food & Drug Administration (FDA) issued “Guidance for Industry: Infant Formula Enforcement Discretion Policy,” to manufacturers of infant formula, designed to increase the availability of infant formula in the United States. FDA intends to temporarily exercise enforcement discretion with respect to certain requirements for infant formula. The guidance is expected to remain in effect until November 14, 2022.
To increase availability of infant formula in the U.S., FDA has outlined a process by which the agency would not object to the importation of certain infant formula products covered under this guidance. A list of firm/products that FDA has found amenable for enforcement discretion is published at: Increase Infant Formula Supplies.
ACE Transmission Requirements
Program Code: FOO
Processing Code: PRO
Intended Use Code: None for standard import
Product Code: Use Product Code Builder. Industry code “40” is for
Baby Food Products
Products including Infant Formula.
A complete list of required data elements can be found in the FDA Supplemental Guide.
Submission of Prior Notice information is required for infant formula shipments.
For Personal Shipments FDA strongly encourages transmitting the food facility registration (PFR) and the FSVP Importer information. If you are unable to obtain this information, use the following:
FSVP Importer Exemption: Use the exemption code FSX in the affirmation of compliance field
Food Facility Registration Exemption: FME with exemption code K in affirmation of compliance field
Contacts and Additional Information:
Foreign infant formula manufacturers who would like to make a request for enforcement discretion: submit as much product information as you have available to Infant_Formula_Flexibility@fda.hhs.gov, addressing the parameters outlined in the guidance document found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy.
Please find a recording of the recent FDA webinar on the guidance here: https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/fda-webinar-guidance-industry-infant-formula-enforcement-discretion-policy-05202022
Questions regarding the importation of infant formula or including entry filing requirements should be sent to: InfantFormulaImports@fda.hhs.gov
Contact ACE_Support@fda.hhs.gov for ACE rejects and processing questions
Questions about specific entries should be sent to the local FDA Import Office that covers the port where the products entered the United States. Contact information can be found at the following link: Import Offices and Ports of Entry | FDA
You can check the real-time status of your entry, submit entry documents, submit locations for exam, and obtain Notices of FDA Action via ITACS at https://itacs.fda.gov.
For questions on personal importation of infant formula, please review FDA’s Personal Importation webpage.
Questions regarding the United States Department of Agriculture (USDA) certificates should be sent to: APIE@usda.gov (Note Infant Formula in subject line)
Additional Resources
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