Note: The revision of this Import Alert (IA) dated 05/30/2025 updates the IA name, reason for alert, guidance including the agency contacts, charge code language and PAF. Changes to the import alert are bracketed by asterisks (***). ***Since an infant formula shortage in early 2022, the U.S. Food and Drug Administration (FDA or the Agency) and U.S. government partners have been working to expand consumer access to infant formula products, while also ensuring that these products are safe and nutritionally adequate. As we emerged from the acute crisis, the agency has participated in numerous reviews, including an evaluation of the agency�s infant formula response. FDA has taken many steps to improve the resiliency of the infant formula supply, including by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula products in the U.S. marketplace. The agency has also taken steps to enhance the safety of powdered infant formula through the development of a Cronobacter prevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate. The revision of this import alert aligns with the Agency�s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible. This import alert addresses infant formulas that appear to be adulterated and/or misbranded. A detention recommendation case should be forwarded to Human Food Program � Division of Produce and Imports Enforcement, Imports Enforcement Branch.***
Infant formula
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be adulterated in that it does not provide the nutrients required by 21 CFR 107.100 [Adulteration, Section 412(a)(1)]. OASIS charge code: NUTR DEF And/or ***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be adulterated in that it does not meet the quality factor requirements prescribed by the Secretary under Section 412(b)(1). [Adulteration, Section 412(a)(2)]. OASIS charge code: NUTR DEF And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be adulterated in that the processing of such infant formula is not in compliance with the good manufacturing practices and the quality control procedures prescribed by the Secretary under Section 412(b)(2). [Adulteration, Section 412(a)(3)]. OASIS charge code: INSANITARY And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be adulterated in that it contains a poisonous and deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)]. OASIS charge code: POISONOUS And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated within the meaning of section 402(a)(4) because the food was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]. OASIS charge code: INSANITARY And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10 [Misbranded, Section 403(f) and (j)]. OASIS charge code: NUTR UNIT And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the label or labeling is false or misleading in any particular [Misbranded, Section 403(a)(1)]. OASIS charge code: FALSE And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. [Misbranded, Section 403(e)(1)]. OASIS charge code: LACKS FIRM And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act. [Misbranded, Section 403(e)(2)]. OASIS charge code: LACKS N/C And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be. [Misbranded, Section 403(i)(1)]. OASIS charge code: USUAL NAME And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient [Misbranded, Section 403(i)(2)]. OASIS charge code: LIST INGRE And/or The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears the label fails to declare all major food allergens present in the product, as required by Section 403(w)(1). [Misbranded, Section 403(w)].*** OASIS charge code: Allergen
***Divisions may detain without physical examination shipments of identified products from firms on the Red List of this Import Alert.*** Refer to the Infant Formula Compliance Program (7321.006) for guidance on product coverage, sample collection, sample preparation, and sample analysis. ***Recommendations for DWPE, additions to the Red List of this import alert, require documentation of FDA�s Human Food Program � Division of Produce and Import Enforcement, Imports Enforcement Branch, for concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE addition to the Red List should be forwarded to the Division of Import Operations (DIO)*** ***Release of Articles Subject to Detention Without Physical Examination (DWPE) Under this Import Alert: ***In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product meets applicable requirements. Such evidence could include: 1. Private laboratory analysis of samples. And/or 2. Documentation supplied in English which shows the product meets the labeling requirements for infant formula. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's Laboratory Procedure-Private Laboratory Analytical Packages. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.*** ***Removal from DWPE (REMOVE FROM RED LIST): In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from DWPE, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)." If a firm and/or a representative thereof would like to request removal from DWPE under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov*** ***Questions or issues involving import operations should be addressed to OII/DIO at (301) 796-0356 or Imports@fda.hhs.gov Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to fdaprivatelabimportalerts@fda.hhs.gov Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 05/30/2025 updates the IA name, reason for alert, guidance including the agency contacts, charge code language and PAF. Changes to the import alert are bracketed by asterisks (***). ***Since an infant formula shortage in early 2022, the U.S. Food and Drug Administration (FDA or the Agency) and U.S. government partners have been working to expand consumer access to infant formula products, while also ensuring that these products are safe and nutritionally adequate. As we emerged from the acute crisis, the agency has participated in numerous reviews, including an evaluation of the agency�s infant formula response. FDA has taken many steps to improve the resiliency of the infant formula supply, including by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula products in the U.S. marketplace. The agency has also taken steps to enhance the safety of powdered infant formula through the development of a Cronobacter prevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate. The revision of this import alert aligns with the Agency�s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible. This import alert addresses infant formulas that appear to be adulterated and/or misbranded. A detention recommendation case should be forwarded to Human Food Program � Division of Produce and Imports Enforcement, Imports Enforcement Branch.***
Country-specific information is available in the full alert detail on the FDA website.
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