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