IA #28-07, REVISED 1/30/98 - IMPORT ALERT #28-07, "DETENTION WITHOUT PHYSICAL EXAMINATION OF COUMARIN IN VANILLA PRODUCTS EXTRACTS - FLAVORINGS - IMITATIONS)", ATTACHMENT REVISED 10/19/04 Note: this import alert is being revised to reflect current alert format and add an attachment for firm(s)/product(s) identified for detention without physical examination. TYPE OF ALERT: Detention without physical examination (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or product 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.) PRODUCT : Vanilla Product(s) (Extracts - Flavorings - Imitations) PRODUCT CODE : As identified on the attachment to the alert PROBLEM : Coumarin contamination - poisonous or deleterious substance - (OASIS charge code = coumarin) PAC FOR COLLECTION : 09006 PAF : FAD COUNTRY : All MANUFACTURER/ SHIPPER : As identified on the attachment to the alert CHARGE : "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain (Coumarin), a poisonous or deleterious substance, which may render it injurious to health [Adulteration, Section 402(a)(1)]." (OASIS charge code = Coumarin) RECOMMENDING OFFICE : DIOP, HFC-172 REASON FOR ALERT : Coumarin in Mexican Vanilla has been a recurring problem for quite sometime. Coumarin has been prohibited in food in the U.S. since 1940 (See CFR Part 189.130), (189.130(b) Food containing any added coumarin as such or as a constituent of tonka beans or tonka extract is deemed to be adulterated under the act). A talk paper T84-17, 3/8/84, and October, 1993, article "Mexican Coumarin No Bargain" in the FDA Consumer have been written regarding this problem. These products are often labeled in Spanish "Extracto de vanilla" or "Vainilla". An attachment to this alert will be updated, as needed, listing manufacturer(s) and product(s) which are found to contain coumarin. GUIDANCE : Districts may detain without physical examination all vanilla product(s) from the identified manufacturer(s) on the attachment to this import alert. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 443-3320 or 3007. PRIORITIZATION GUIDANCE : I FOI : No purging required. KEYWORDS : Coumarin, Vanilla, Tonka Beans, Tonka Extract PREPARED BY : George N. Butler, HFC-172, DIOP, 301-443-6553 DATE LOADED INTO FIARS : January 30, 1998 Attachment to Import Alert 28-07 - 10/19/04 Manufacturers subject to "DETENTION WITHOUT PHYSICAL EXAMINATION OF COUMARIN IN VANILLA PRODUCTS (EXTRACT - FLAVORINGS - IMITATIONS)" FIRM: PRODUCT/CODE Centro Dominicano de Promocion Vanilla Extract/28C--51 Plaza de la Independcia Santo Domingo, Dominican Republic FEI# 1000290693 Industrias Alimenticias - Vanilla flavoring Dona Tina 28C[][]51 Las Brisas Casa No. H-149 01/12/00 Managua, Nicaragua FEI# 3002901227 Jean Raphael Lamarque Vanilla Extract/28C--51 Rue Macajou 3 10/19/04 Port Au Prince Haiti FEI# 3003942570 Juan Miguel Anazaldula Vanilla Extract - Danncy Pure Gutierrez Vanilla Brand/28C[][]51 Juarez No. 1101-A 7/14/98 Nuevo Laredo, Tamaulipas Mexico FEI #3001655129 Julio A. Nunez - Vanilla extract ESI/Almacaribe, Inc. 28C[][]51 Calle Proyecto No. 10 5/16/00 Urb. Moises Santo Domingo, Dominican Republic FEI# 3002691881 P.A. Benjamin Manufacturing Co.,Ltd. Artificial Vanilla 95-97 East Street Flavoring Kingston, Jamaica 45L[][]99 FEI #7917 9/15/98 Serrana Agroindustrial Vanilla Extract Juan de Morfa # 93 28C- - 51 Santo Domingo, DO 5/14/02 FEI # 3003154904 Xiame S.A. de C.V. Vanilla Extract Agustin Olachea No. 151 28C- - 51 Col. Adolfo Lopez Mateos 8/8/02 Deleg. Venustiano Carranza Mexico, D.F., Mexico CP 15670 FEI #3003687015