Note: The revision of this Import Alert (IA) dated 03/18/2025 updates the guidance section including agency contacts and charge code language. Changes to the import alert are bracketed by asterisks (***). This import alert has been developed for specific firms that have offered cosmetics with microbiological contamination and have met the criteria for detention without physical examination (DWPE) as established in FDA's Regulatory Procedures Manual (RPM) Chapter 9. Cosmetic products must be safe for the consumer when used according to direction on the label or in the customary or expected way. They must also not be prepared, packed, or stored in a way in which they may become contaminated or harmful to health. This includes, for example, making sure cosmetics are free of harmful microorganisms. Cosmetic products must be completely free of high-virulence microbial pathogens, and the total number of aerobic microorganisms per gram must be low.
Cosmetics
*** The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use as are customary or usual, except that this charge does not apply to coal-tar hair dye, the label of which conspicuously bears the legend described in Section 601(a) ***[Adulteration, Section 601(a)] OASIS charge code: POISONOUS AND/OR The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be an ingredient in a cosmetic product and may have been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. [Adulteration, Section 601(c)] OASIS charge code: COSMETIC
Divisions may detain, without physical examination, shipments of specified products from firms identified in the Red List of this import alert. In accordance with Chapter 9 of the Regulatory Procedures Manual, recommendations for addition to DWPE for specific product(s) from an individual firm may be made after one violative entry and all other appropriate criteria are satisfied. *** Recommendations for addition to the Red List of the alert, require documentation of the Office of the Chief Scientist (OCS) concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO) for processing. *** Release of Articles Subject to DWPE under This Import Alert: In order to secure release of an individual shipment subject to detention without physical examination under this alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain microbiological contamination that would render the product violative. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article. A representative sample should consist of a minimum of 5 sub-samples (e.g., 5 retail units, or collections of retail units, if the net weight of a single retail unit is insufficient for analysis). 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 ORA Lab Manual, Volume III, Section 7. 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 including satisfactory microbiological testing results from a third-party laboratory analysis of a representative sample of the detained product in each of the five consecutive shipments should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation and microbial contamination that would render the product violative. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)" *** If a firm and/or a representative thereof would like to petition for 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 or the submission of petitions for removal from DWPE should be addressed to OII/DIO (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 cosmetics policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to Imports@fda.hhs.gov to consult the Office of the Chief Scientist.***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 03/18/2025 updates the guidance section including agency contacts and charge code language. Changes to the import alert are bracketed by asterisks (***). This import alert has been developed for specific firms that have offered cosmetics with microbiological contamination and have met the criteria for detention without physical examination (DWPE) as established in FDA's Regulatory Procedures Manual (RPM) Chapter 9. Cosmetic products must be safe for the consumer when used according to direction on the label or in the customary or expected way. They must also not be prepared, packed, or stored in a way in which they may become contaminated or harmful to health. This includes, for example, making sure cosmetics are free of harmful microorganisms. Cosmetic products must be completely free of high-virulence microbial pathogens, and the total number of aerobic microorganisms per gram must be low.
Country-specific information is available in the full alert detail on the FDA website.
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