This import alert has been developed for cosmetic products and cosmetic ingredients that have been imported or offered for import into the United States that appear to be adulterated for reasons other than microbiological contamination or color additive violations. Cosmetic products that appear to violate the Federal Food, Drug, and Cosmetic Act (the FD&C Act) under sections 601(a), 601(b), 601(c), or 601(d) of the FD&C Act [21 U.S.C. � 361(a), (b), (c), or (d)] may be subject to this import alert. Cosmetic products that appear to be adulterated due to microbiological contamination or color additive violations may be subject to other applicable import alerts, including import alerts #53-06 or #53-17. This import alert incorporates firms and products previously covered under Import Alert #53-18, " Detention Without Physical Examination of Skin Whitening Creams Containing Mercury." Import Alert #53-18 will be deactivated. Examples of violations that may be subject to this import alert include, but are not limited to, heavy metal contamination detected through sampling (601(a) � POISONOUS) and insanitary conditions observed during an inspection (601(c) - HELD INSAN).
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 it appears to consist in whole or in part of a filthy, putrid, or decomposed substance. [Adulteration, Section 601(b)] OASIS Charge Code � FILTH AND/OR The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared,packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 601(c)] OASIS Charge Code � HELD INSAN AND/OR The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health. [Adulteration, Section 601(d)] OASIS Charge Code � CONTAINER
Divisions may detain without physical examination, shipments of the indicated cosmetic products from the firms identified in the Red List of this Import Alert. Recommendations for addition to Detention Without Physical Examination (DWPE) under the Red List of this alert, may be forwarded to the Division of Import Operations (DIO). DIO and FDA's Center for Food Safety and Applied Nutrition (Human Foods Program (HFP) may evaluate regulatory evidence on a case-by-case basis. Firm listings on the Red List of this Alert should indicate the charge(s) that resulted in the firm�s addition to the Red List in the Notes section. Release of Articles Subject to Detention Without Physical Examination 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 shipment may provide evidence to FDA that the shipment is not adulterated. Such evidence may include analytical results, as applicable. There may be situations where the violation cannot be shown to be addressed through analytical means, such as some insanitary conditions. In such situations, other supplemental information, such as revised SOPs, may provide sufficient evidence to secure release of the shipment. The acceptability of evidence should be evaluated on a case-by-case basis. 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 Detention without Physical Examination (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 detention without physical examination, 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 petition for removal from DWPE under this import alert, all relevant information supporting the request should be forwarded to the following email address: Importalerts2@fda.hhs.gov *** Questions or issues involving import operations should be addressed to OII Division of Import Operations (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 other any additional questions not directly related to a detained entry, should be addressed to HFP/Dietary Supplement and Labeling Assessment Branch at hfp-oce-officeofenforcement@fda.hhs.gov***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: This import alert has been developed for cosmetic products and cosmetic ingredients that have been imported or offered for import into the United States that appear to be adulterated for reasons other than microbiological contamination or color additive violations. Cosmetic products that appear to violate the Federal Food, Drug, and Cosmetic Act (the FD&C Act) under sections 601(a), 601(b), 601(c), or 601(d) of the FD&C Act [21 U.S.C. � 361(a), (b), (c), or (d)] may be subject to this import alert. Cosmetic products that appear to be adulterated due to microbiological contamination or color additive violations may be subject to other applicable import alerts, including import alerts #53-06 or #53-17. This import alert incorporates firms and products previously covered under Import Alert #53-18, " Detention Without Physical Examination of Skin Whitening Creams Containing Mercury." Import Alert #53-18 will be deactivated. Examples of violations that may be subject to this import alert include, but are not limited to, heavy metal contamination detected through sampling (601(a) � POISONOUS) and insanitary conditions observed during an inspection (601(c) - HELD INSAN).
Country-specific information is available in the full alert detail on the FDA website.
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