IA# 53-18, 7/21/03, IMPORT ALERT #53-18 ***"DETENTION WITHOUT PHYSICAL
EXAMINATION OF SKIN WHITENING CREAMS CONTAINING MERCURY"***


     This revision creates an attachment to identify affected products.
     Revised information is indicated by asterisks (***).

TYPE OF ALERT: Detention without physical examination

               (Note: This import alert contains guidance to FDA field
               personnel only. It does not establish any requirements, or
               create any rights for, or obligations on, FDA or regulated
               entities.)

PRODUCT:       *** Skin Whitening Creams ***

PRODUCT CODE(s):    *** See Attachment ***

PROBLEM:       *** Contains mercury (Mercury Compounds) ***

PAC FOR
COLLECTION:         *** 29001 ***

COUNTRY:       *** See Attachment ***

MANUFACTURER:  *** See Attachment ***

MANUFACTURER/
SHIPPER I.D.#: *** See Attachment ***

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)]."

RECOMMENDING
OFFICE:        CFSAN, OCAC, Division of Programs and Enforcement Policy
               (HFS-105)

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
               listed in the attachment. ***

               *** For questions or issues concerning science, Science
               policy, sample collection, analysis, preparation, or
               analytical methodology, contact the Division of Field
               Science at (301) 827-7605. ***

PRIORITIZATION
GUIDANCE:      I

FOI:           No purging required.

KEYWORDS:      ***mercury, calomel, cosmetic, beauty cream, skin
               whitening***

PREPARED  BY:  George N. Butler, DIOP, (301) 443-6553

DATE LOADED
INTO FIARS:         July 21, 2003


                                          ATTACHMENT TO IMPORT ALERT 53-18   07/21/03

MANUFACTURER AND PRODUCTS SUBJECT TO DETENTION WITHOUT PHYSICAL EXAMINATION



                     DOMINICAN REPUBLIC (DO)

FIRM(S)                  PRODUCT(S)/PRODUCT CODE(S)

Leivon Cosmetics, Inc.        Dermaline Cream/
Division Laboratories         53L[][][][]
Contifarma, C. por A.         53Y[][][][]
Santa Domingo            66V[][]99
Domincan Republic             7/21/03
FEI #3002735682

Laboratorios Keys             Miss Key Whitening Cream
C. por A.                ("Crema Bianqueadora
Santo Domingo            Miss Key")
Dominican Republic       53L[][][][]
FEI #12393                    53Y[][][][]
                         66V[][]99
                         7/21/03

Laboratorios Contifarma       Santa Cream ("Crema Santa
C. por A.                Limpiadora/Germicida")/
Santo Domingo            53L[][][][]
Dominican Republic       53Y[][][][]
FEI #3003102473               66V[][]99
                         7/21/03



                          Mexico (MX)

FIRM(S)                  PRODUCT(S)/PRODUCT CODE(S)

Laboratoies Vido              Mannig Beauty Cream
Natural S.A. de C.V.          ("Manning Cream De Belleza")/
Tampico, Tamaulipas      53L[][][]
Mexico                   07/22/96
FEI #1000570921