Import Alert 53-21
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 53-21
Published Date: 02/21/2025
Type: DWPE
Import Alert Name:
DETENTION WITHOUT PHYSICAL EXAMINATION OF ADULTERATED COSMETIC PRODUCTS AND INGREDIENTS
Reason for Alert:
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).
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).
Guidance:
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 (CFSAN) 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 may be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: 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 any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
***
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 (CFSAN) 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 may be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: 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 any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
***
Product Description:
Cosmetics
Charge:
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
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
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
DOMINICAN REPUBLIC (THE)
Laboratorios Contifarma, C. Por A.
Date Published : 01/23/2025
Unknown
, Santa Domingo,
DOMINICAN REPUBLIC (THE)
53 L - - -- Skin Care Prep
Date Published: 01/23/2025
Desc: Dermaline Cream
Notes: DWPE date: 07/21/2003. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 L - - -- Skin Care Prep
Date Published: 01/23/2025
Desc: Santa Cream
Notes: DWPE date: 07/21/2003. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 01/23/2025
Desc: Santa Cream
Notes: DWPE date: 07/21/2003. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 01/23/2025
Desc: Dermaline Cream
Notes: DWPE date: 07/21/2003. Firm/products previously listed on Import Alert 53-18 for containing mercury.
66 V - - -- Patent Medicines, Etc
Date Published: 01/23/2025
Desc: Santa Cream
Notes: DWPE date: 07/21/2003. Firm/products previously listed on Import Alert 53-18 for containing mercury.
66 V - - -- Patent Medicines, Etc
Date Published: 01/23/2025
Desc: Dermaline Cream
Notes: DWPE date: 07/21/2003. Firm/products previously listed on Import Alert 53-18 for containing mercury.
ITALY
ADVIHAIR SpA
Date Published : 12/02/2024
Via Benini 11
, Zola Predosa,
Bologna ITALY
53 E - - 02 Hair Sprays (Aerosol Fixatives) (Hair Preparations, Non-coloring)
Date Published: 12/02/2024
Desc: CRLAB HAIR SPRAY
Notes: Label shows ingredient ‘dichloromethane’ (methylene chloride)
LEBANON
Ets Diana De Beaute
Date Published : 01/23/2025
Rue Riad El Solh
, Beirut,
Beirut LEBANON
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 01/23/2025
Desc: Creme Diana/Eliminates Freckles
Notes: DWPE date: 11/08/2011. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/23/2025
Desc: Creme Diana/Eliminates Freckles
Notes: DWPE date: 11/08/2011. Firm/products previously listed on Import Alert 53-18 for containing mercury.
MEXICO
Aguaruto Cosmetics/Gloria Maricela Castro
Date Published : 01/23/2025
Josefa Ortiz De Dominguez 126 Oriente , Colonia Tierra Blanca
, Culiacan,
MEXICO
53 L - - -- Skin Care Prep
Date Published: 01/23/2025
Desc: Crema Aquamary
Notes: DWPE date: 11/01/2011. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 01/23/2025
Desc: Crema Aquamary
Notes: DWPE date: 11/01/2011. Firm/products previously listed on Import Alert 53-18 for containing mercury.
66 V - - -- Patent Medicines, Etc
Date Published: 01/23/2025
Desc: Crema Aquamary
Notes: DWPE date: 11/01/2011. Firm/products previously listed on Import Alert 53-18 for containing mercury.
Laboratories Vido Natural S.A de C.V.
Date Published : 01/23/2025
Unknown
, Tampico,
Tamaulipas MEXICO
53 L - - -- Skin Care Prep
Date Published: 01/23/2025
Desc: Manning Beauty Cream/Manning Cream de Belleza
Notes: DWPE date; 07/22/1996. Firm/products previously listed on Import Alert 53-18 for containing mercury.
Viansilk
Date Published : 01/23/2025
Maria 153, Residencias , Baja, California; Col. Mexicali, Mexicali
, Mexicali,
Baja California MEXICO
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 01/23/2025
Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Notes: DWPE date; 05/25/2016. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 01/23/2025
Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Notes: DWPE date; 05/25/2016. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/23/2025
Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Notes: DWPE date; 05/25/2016. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 01/23/2025
Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Notes: DWPE date; 05/25/2016. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/23/2025
Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Notes: DWPE date; 05/25/2016. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 01/23/2025
Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Notes: DWPE date; 05/25/2016. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 - - - -- Cosmetics
Date Published: 01/23/2025
Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Notes: DWPE date; 05/25/2016. Firm/products previously listed on Import Alert 53-18 for containing mercury.
63 V - - 99 Depigmentor N.E.C.
Date Published: 01/23/2025
Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Notes: DWPE date; 05/25/2016. Firm/products previously listed on Import Alert 53-18 for containing mercury.
PAKISTAN
Golden Pearl Cosmetics
Date Published : 01/23/2025
115/1 M , Quaid-e-Azam Industrial Estate
, Kot Lakhpat, Lahore,
Punjab PAKISTAN
53 L - - -- Skin Care Prep
Date Published: 01/23/2025
Desc: Golden Pearl Beauty Cream
Notes: DWPE date: 11/13/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 01/23/2025
Desc: Golden Pearl Beauty Cream
Notes: DWPE date: 11/13/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.
Goree Cosmetics
Date Published : 01/23/2025
222 CCA FF , DHA Phase 4 Sector CCA
, Lahore,
Punjab PAKISTAN
53 L - - -- Skin Care Prep
Date Published: 01/23/2025
Desc: Goree Beauty Cream
Notes: DWPE date: 11/12/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 01/23/2025
Desc: Goree Beauty Cream
Notes: DWPE date: 11/12/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.
MMC Cosmetics Pakistan
Date Published : 01/23/2025
Main Bazar Rd
, Karbirwala,
Khanewal PAKISTAN
53 L - - -- Skin Care Prep
Date Published: 01/23/2025
Desc: Sandal Whitening Beauty Cream
Notes: DWPE date: 10/02/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 01/23/2025
Desc: Sandal Whitening Beauty Cream
Notes: DWPE date: 10/02/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.
Shaheen Cosmetics PVT LTD
Date Published : 01/23/2025
House #8, Block-A4 , P.G.E.C.M.S Punjab Society
, Lahore,
Punjab PAKISTAN
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 01/23/2025
Desc: Fresh Face Beauty Cream
Notes: DWPE date: 11/13/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 01/23/2025
Desc: Fresh Face Beauty Cream
Notes: DWPE date: 11/13/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.
THAILAND
Kim Co, LTD
Date Published : 01/23/2025
888/32 Bang Pree Industrial Estate
, Samut Prakan,
Samut Prakan THAILAND
53 L - - -- Skin Care Prep
Date Published: 01/23/2025
Desc: Kim Whitening Pearl and Snow Lotus Cream
Notes: DWPE date: 09/07/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.
53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 01/23/2025
Desc: Kim Whitening Pearl and Snow Lotus Cream
Notes: DWPE date: 09/07/2019. Firm/products previously listed on Import Alert 53-18 for containing mercury.