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
|