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 9/3/08
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 - 9/3/08
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
Pharmacie Vital-Herne Vanilla
104,rue Pavee 28C[][]51
Port-au-Prince 4/19/07
Haiti
FEI# 3001124108
Procesadora Vizcaya C. Por A. Vanilla Extract
Calle Hatillo Sampana 28C[][]51
#364 Barrio San Miguel 9/3/08
Manoguayabo, Santo Domingo
Dominican Republic
FEI# 2000003379
Serrana Agroindustrial Vanilla Extract
Juan de Morfa # 93 28C- - 51
Santo Domingo, DO 5/14/02
FEI # 3003154904
Twins Manufacturing Chemists Vanilla essence
30 Industrial Estate, Ruimveldt 28C[][]51
Georgetown, Guyana 3/19/08
FEI# 3004381780
Vanilla Mex (Jose Fco. Mendoza Ordonez) Artificial
Calle Sierra Morena No. 1001-C Vanilla flavored
Colonia Las Puentes 8 Sector concentrate
Codigo Postal 66460 28C[][]51
San Nicolas de Los Garza, Mexico 28M[][]04
FEI # 3004796827 02/16/05
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
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