Import Alert 53-18

(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 # 53-18
Published Date: 11/13/2019
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Skin Whitening Creams Containing Mercury"

Reason for Alert:

The toxicity of mercury compounds has been extensively documented. In accordance with 21 CFR 700.13 (FR, Vol. 38 No. 3, January 5, 1973, pgs. 853-854), effective July 5, 1973, except for those cosmetics meeting the conditions of 21 CFR 700.13(d)(2)(i) or (d)(2)(ii), any cosmetic product containing mercury as an ingredient is deemed adulterated and subject to regulatory action.



Analysis performed by CFSAN's Color Technology Branch found a skin cream, Manning Beauty Cream, to contain approximately 8% mercury by weight. In addition, the product is labeled to contain calomel, a form of mercury known as mercurous chloride. Additional creams from other firms have also been labeled as containing mercury compounds.

Guidance:

Districts may detain, without physical sampling and analysis, shipments of products from firms and products identified in the Red List.



For questions or issues concerning science, Science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.



All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:

Skin Whitening Creams

Charge:

"The article is subject to refusal of admission pursuant Section 801(a)(3) in that it appears to contain mercury, a poisonous and deleterious substance, which may render it injurious to users under the conditions of use prescribed in its' labeling or under such conditions of use as are customary or usual [Adulteration, Section 601(a)]."



OASIS charge code - POISONOUS

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


DOMINICAN REPUBLIC


Laboratorios Contifarma, C. Por A.
Date Published : 09/18/2009
Unknown , Santa Domingo, DOMINICAN REPUBLIC
53 L - - -- Skin Care Prep
Date Published: 09/18/2009

Desc: Santa Cream (
Problems: MERCURY;

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 09/18/2009

Desc: Santa Cream (
Problems: MERCURY;

66 V - - -- Patent Medicines, Etc
Date Published: 09/18/2009

Desc: Santa Cream
Problems: MERCURY;

Laboratorios Contifarma, C. Por A.
Date Published : 09/18/2009
Unknown , Santa Domingo, DOMINICAN REPUBLIC
53 L - - -- Skin Care Prep
Date Published: 09/18/2009

Desc: Dermaline Cream; 7/21/03
Problems: MERCURY;

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 09/18/2009

Desc: Dermaline Cream; 7/21/03
Problems: MERCURY;

66 V - - -- Patent Medicines, Etc
Date Published: 09/18/2009

Desc: Dermaline Cream; 7/21/03
Problems: MERCURY;

Laboratorios Key C Por A
Date Published : 09/18/2009
Calle Central No. 3 , Zona Industrial de Herrera , Santo Domingo, DOMINICAN REPUBLIC
53 L - - -- Skin Care Prep
Date Published: 09/18/2009

Desc: Miss Key Whitening Cream
Problems: MERCURY;

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 09/18/2009

Desc: Miss Key Whitening Cream
Problems: MERCURY;

66 V - - -- Patent Medicines, Etc
Date Published: 09/18/2009

Desc: Miss Key Whitening Cream; Crema Bianqueadora Miss Key; 7/21/03
Problems: MERCURY;


LEBANON


Ets Diana De Beaute
Date Published : 11/08/2011
P.o. Box 11-7599 , Riad El Solh , Beirut, LEBANON
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 11/08/2011

Desc: Creme Diana/Eliminates Freckles


MEXICO


Aguaruto Cosmetics/Gloria Maricela Castro
Date Published : 11/01/2011
Josefa Ortiz de Dominguez 126 Oriente , Colonia Tierra Blanca , Culiacan, MEXICO
53 L - - -- Skin Care Prep
Date Published: 11/01/2011

Desc: Crema Aquamary
Notes: Mexico

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 11/01/2011

Desc: Crema Aquamary
Notes: Mexico

66 V - - -- Patent Medicines, Etc
Date Published: 11/01/2011

Desc: Crema Aquamary
Notes: Mexico

Laboratories Vido Natural S.A de C.V.
Date Published : 09/18/2009
Unknown , Tampico, Tamaulipas MEXICO
53 L - - -- Skin Care Prep
Date Published: 08/06/2010

Desc: Manning Beauty Cream/Manning Cream de Belleza
Notes: DWPE date - 7/22/1996
Problems: MERCURY;

Viansilk
Date Published : 05/25/2016
Maria 153, Residencias , Mexicali, Baja, California , Baja, MEXICO
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 05/25/2016

Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Problems: MERCURY;

53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 05/25/2016

Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Problems: MERCURY;

53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/25/2016

Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Problems: MERCURY;

53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 05/25/2016

Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Problems: MERCURY;

53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/25/2016

Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Problems: MERCURY;

53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/25/2016

Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Problems: MERCURY;

53 - - - -- Cosmetics
Date Published: 05/25/2016

Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Problems: MERCURY;

63 V - - 99 Depigmentor N.E.C.
Date Published: 05/25/2016

Desc: Viansilk Skin Cream (Viansilk Crema Piel de Seda)
Problems: MERCURY;


PAKISTAN


Golden Pearl Cosmetics
Date Published : 11/13/2019
115/1 M , Quaid-e-Azam Industrial Estate , Kot Lakhpat, Lahore, Punjab PAKISTAN
53 L - - -- Skin Care Prep
Date Published: 11/13/2019

Desc: Golden Pearl Beauty Cream

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 11/13/2019

Desc: Golden Pearl Beauty Cream

Goree Cosmetics
Date Published : 11/12/2019
222 CCA FF , DHA Phase 4 Sector CCA , Lahore, Punjab PAKISTAN
53 L - - -- Skin Care Prep
Date Published: 11/12/2019

Desc: Goree Beauty Cream

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 11/12/2019

Desc: Goree Beauty Cream

MMC Cosmetics Pakistan
Date Published : 10/02/2019
Main Bazar Rd , Karbirwala, Khanewal PAKISTAN
53 L - - -- Skin Care Prep
Date Published: 10/02/2019

Desc: Sandal Whitening Beauty Cream

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 10/02/2019

Desc: Sandal Whitening Beauty Cream

Shaheen Cosmetics PVT LTD
Date Published : 11/13/2019
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: 11/13/2019

Desc: Face Fresh Beauty Cream

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 11/13/2019

Desc: Face Fresh Beauty Cream


THAILAND


Kim Co, LTD
Date Published : 09/27/2019
888/32 Bang Pree Industrial Estate , Samut Prakan, Samut Prakan THAILAND
53 L - - -- Skin Care Prep
Date Published: 09/27/2019

Desc: Kim Whitening Pearl and Snow Lotus Cream
Problems: MERCURY;

53 Y - - -- Cosmetics and Cosmetic Products,n.e.c.
Date Published: 09/27/2019

Desc: Kim Whitening Pearl and Snow Lotus Cream
Problems: MERCURY;