Import Alert 28-07

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) 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).

Import Alert # 28-07
Published Date: 12/10/2020
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Coumarin in Vanilla Products Extracts Flavorings Imitations"

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."

Guidance:

Districts may detain without physical examination all vanilla product(s) from the identified manufacturer(s) on the attachment for this import alert.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301 796-6000.

Product Description:

Vanilla Product(s) (Extracts - Flavorings - Imitations)

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)

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


DOMINICAN REPUBLIC


Centro Dominicano De Promocion De
Date Published : 09/18/2009
Plaza De La Independenciaapartado 199-2 , Santo Domingo, DOMINICAN REPUBLIC
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Problems: COUMARIN CFR-189.130 (FLA/ILL);

Julio A. Nunez - ESI/Almacaribe, Inc.
Date Published : 09/18/2009
Calle Proyecto No. 10, Urb. Moises , Santo Domingo, DOMINICAN REPUBLIC
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Notes: 5/16/00
Problems: COUMARIN CFR-189.130 (FLA/ILL);

Procesadora Vizcaya, C por A
Date Published : 09/18/2009
Barrio San Miguel , Calle Hatillo Sampana No. 364 , Santo Domingo, Distrito Nacional (Santo Domin DOMINICAN REPUBLIC
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Notes: 4/19/07
Problems: COUMARIN CFR-189.130 (FLA/ILL);

Serrana Agroindustrial S.R.L
Date Published : 09/18/2009
Juan de Morfa No. 93 , Santo Domingo, D.N., Distrito Nacional DOMINICAN REPUBLIC
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Desc: vanilla extract
Notes: 5/14/02
Problems: COUMARIN CFR-189.130 (FLA/ILL);


EL SALVADOR


exportaciones san miguell
Date Published : 10/01/2009
av. las camelias n2 col. san francisco , av. las camelias n2 col. san francisco , san salvador, SV-SS EL SALVADOR
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 10/01/2009


GUYANA


Twins Manufacturing Chemists
Date Published : 09/18/2009
31 Industrial Estate , Ruimveldt, GY-NOTA GUYANA
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Desc: vanilla essence
Notes: 3/19/08
Problems: COUMARIN CFR-189.130 (FLA/ILL);


HAITI


Jean Raphael Lamarque
Date Published : 09/18/2009
Rue Macajou 3 , Port Au Prince, HAITI
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Notes: 10/19/04
Problems: COUMARIN CFR-189.130 (FLA/ILL);

Pharmacie Vital - Herne
Date Published : 09/18/2009
Rue Pavee No 104 , Port-Au-Prince, ouest HAITI
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Notes: 9/3/08
Problems: COUMARIN CFR-189.130 (FLA/ILL);

SONAPROD
Date Published : 12/02/2012
Unknown , Port-Au-Prince, ouest HAITI
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 12/02/2012

Desc: Vanilla Essence


MEXICO


Juan Miguel Anazaldua Gutierrez
Date Published : 09/18/2009
Juarez No. 1101-A , Nuevo Laredo, Tamps., MEXICO
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Desc: Danncy Pure Vanilla Brand
Notes: 7/14/98
Problems: COUMARIN CFR-189.130 (FLA/ILL);

VANILLA MEX (Jose Fco. Mendoza Ordonez)
Date Published : 09/18/2009
Calle Sierra Morena 1001 C , Col. Las Puentes 8 Sector, San Nicolas De Los Garza , San Nicolas De Los Garza, Nuevo Leon MEXICO
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Desc: artificial vanilla flavored concentrate
Notes: 2/16/05
Problems: COUMARIN CFR-189.130 (FLA/ILL);

28 M - - 04 Vanilla (Vanillin) Imitation Flavor
Date Published: 09/18/2009

Desc: artificial vanilla flavored concentrate
Notes: 2/16/05
Problems: COUMARIN CFR-189.130 (FLA/ILL);

Xiame S.A. De C.V.
Date Published : 09/18/2009
Calle Agustin Olachea Aviles No. 151 , Col. Adolfo Lopez Mateos, Venustiano Carranza , Ciudad De Mexico, Ciudad de Mexico MEXICO
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Desc: vanilla extract
Notes: 8/8/02
Problems: COUMARIN CFR-189.130 (FLA/ILL);


NICARAGUA


Industrias Alimenticias "Dona Tina"
Date Published : 09/18/2009
Las Brisas Casa No. H149 , Minsa No. 1321 , Managua, NICARAGUA
28 C - - 51 Vanilla, Natural Extract or Flavor (Spice)
Date Published: 09/18/2009

Notes: 1/12/00
Problems: COUMARIN CFR-189.130 (FLA/ILL);