Import Alert 34-02

(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 # 34-02
Published Date: 08/28/2017
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Confectionery Products Containing Non-Nutritive Components"

Reason for Alert:

NOTE: Revision to this Import Alert dated 3/1/2012 updates the import alert format/language, modifies the reason for alert and guidance sections, and provides more specific product coding. Changes are noted and bracketed by three asterisks (***).



*** Import Alert 34-02 was created as the Agency was made aware of a product called "Kinder Surprise Eggs", and similar articles containing imbedded, non-nutritive objects, being offered for sale in the United States. The imbedded non-nutritive objects in these confectionary products may pose a public health risk as the consumer may unknowingly choke on the object. ***



Section 402(d)(1) of the Federal Food, Drug, and Cosmetic Act provides that confectionery having partially, or completely imbedded therein, any non-nutritive object is adulterated unless FDA has issued a regulation recognizing that the non-nutritive object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health.



*** This import alert has been developed for specific manufacturers and shippers that have offered adulterated, confectionary products containing non-nutritive objects for entry and have met the criteria for detention without physical examination as established in FDA-s Regulatory Procedures Manual (RPM). ***

Guidance:

*** Districts may detain, without physical examination, the indicated products from the firms identified on the Red List of this Alert. ***



Districts should also notify the following federal government agencies of FDAs findings of a non-nutritive object imbedded in a confectionary product:

Consumer Product Safety Commission (CPSC), Office of Compliance and Field Operations (301-504-7520). CPSC will address any choking hazard associated with the non-nutritive object, e.g., a toy, under their regulations. FDA and CPSC have cooperated in this manner regarding Kinder Surprise type products in the past; and,

Local U.S. Customs and Border Protection (CBP).



*** Refer to Compliance Policy Guides (CPG) Sec. 515.100 & 515.350 for guidance related to non-nutritive substances in confectionary products.



In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.



For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."



If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:



Food and Drug Administration

Division of Import Operations and Policy (HFC-170)

12420 Parklawn Drive, ELEM-3109

Rockville, MD 20857



Or be sent via email: Importalerts2@fda.hhs.gov



For questions or issues involving import operations, contact the Division of Import Operations & Policy at (301) 796-0356.



For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-6600.



For questions on policy or sample collection recommendations contact the Office of Compliance, Division of Enforcement, CFSAN, at (240) 402-1750. ***

Product Description:

Confectionery products containing non-nutritive components, such as small toys or objects, which may be partially or completely imbedded in the food product.

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a confectionery that has a partially or completely imbedded non-nutritive object [Adulteration, Section 402(d)(1)].



OASIS Charge Code - IMBED OBJT

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


ARGENTINA


Ferrero Argentina
Date Published : 03/29/2012
Ruta 6 Km 19 , Los Cardales, ARGENTINA
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 03/29/2012

Desc:Milk Chocolate Eggs aka Kinder Sorpresa (chocolate egg containing capsule with puzzle pieces)

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 03/29/2012

Desc:Milk Chocolate Eggs aka Kinder Sorpresa (chocolate egg containing capsule with puzzle pieces)

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 03/29/2012

Desc:Milk Chocolate Eggs aka Kinder Sorpresa (chocolate egg containing capsule with puzzle pieces)


BRAZIL


Dist. Int'L De Prod. Brasileiro Eir
Date Published : 11/01/2016
Cdd Vila Da Penha , Rio De Janeiro, Rj BRAZIL
34 C - - 01 Chocolate Candy Bar, with Nuts or Nut Products (not Coconut)
Date Published: 11/01/2016

Desc:CHOCALATE EGGS


CANADA


The Candy Tree Company
Date Published : 10/01/2009
109 10 Ave Ne , Calgary, Alberta CANADA
33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 10/01/2009

Notes:Hard candy lollipop heads DWPE date - 9/15/2009


ITALY


CISA S.R.L.
Date Published : 10/01/2009
Via Dell'Artigiano 81 , Rovereto, ITALY
33 L - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, without Nuts and Fruit (without Chocolate)
Date Published: 10/01/2009

Notes:Milk chocolate eggs chocolate egg containing toys DWPE date - 9/15/2009

Dolciaria Luigia Snc Di Baiocchi Natale & C.
Date Published : 03/10/2016
Via Ravenna 231 , Bellaria Igea Marina, RN ITALY
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 03/10/2016

Desc:Milk Chocolate Easter Egg (30g; 150g;

34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 03/10/2016

Desc:Dark Chocolate Easter Egg (350g; 500g; 1000g;

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 03/10/2016

Desc:Dark Chocolate Easter Egg (350g; 500g; 1000g;

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 03/10/2016

Desc:Milk Chocolate Easter Egg (30g; 150g;

34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 03/10/2016

Desc:Dark Chocolate Easter Egg (350g; 500g; 1000g; & 3000g)

34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 03/10/2016

Desc:Milk Chocolate Easter Egg (30g; 150g;

Luigi Zaini S.p.A
Date Published : 10/23/2015
Via Carlo Imbonati, 59 , Milano, Mi ITALY
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 10/23/2015

Desc:Milk Chocolate Egg (egg contains Frozen toy character)

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 10/23/2015

Desc:Milk Chocolate Egg (egg contains Frozen toy character)

34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 10/23/2015

Desc:Milk Chocolate Egg (egg contains Frozen toy character)

Luigi Zaini S.p.A.
Date Published : 10/23/2015
Via Europa 2 , Senago, Mi ITALY
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 10/23/2015

Desc:Milk Chocolate Egg (egg contains Frozen toy character)

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 10/23/2015

Desc:Milk Chocolate Egg (egg contains Frozen toy character)

34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 10/23/2015

Desc:Milk Chocolate Egg (egg contains Frozen toy character)


JAPAN


Baytrade
Date Published : 08/11/2016
Shochiku Bldg. 4f , Hachimandori; Chuo-Ku , Kobe-Shi, Hyogo JAPAN
34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 08/11/2016

Desc:A720 CHOCO EGG POKE MON CRACKER

FURUTA CONFECTIONERY CO., LTD. MIHARA FACTORY
Date Published : 08/11/2016
663 KUROYAMA, MIHARA-KU, , Sakai-shi, Osaka-fu JAPAN
34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 08/11/2016

Desc:A720 CHOCO EGG POKE MON CRACKER

FURUTA SEIKA CO.,LTD. MIHARA FACTORY
Date Published : 08/11/2016
663 Kuroyama Mihara , Minami Kawachi-gun, OSAKA JAPAN
34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 08/11/2016

Desc:A720 CHOCO EGG POKE MON CRACKER


MEXICO


DISTRIBUIDORA SAA / MAYOREO Y MENUDEO
Date Published : 03/29/2012
MARGARITA MAZA DE JUAREZ #4020 , Tijuana, BC MEXICO
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 03/29/2012

Desc:Milk Chocolate Eggs aka Kinder Sorpresa (chocolate egg containing capsule with puzzle pieces)

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 03/29/2012

Desc:Milk Chocolate Eggs aka Kinder Sorpresa (chocolate egg containing capsule with puzzle pieces)

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 03/29/2012

Desc:Milk Chocolate Eggs aka Kinder Sorpresa (chocolate egg containing capsule with puzzle pieces)


POLAND


ARSENAL PL Sp. Z o. o
Date Published : 08/28/2017
Ul. Przedzalniana 6H , Bialystok, Podlaskie POLAND
34 F - - 01 Chocolate Candy Bar, without Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Surprise

34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Surprise

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Surprise

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Surprise

34 K - - 04 Chocolate Bars
Date Published: 08/28/2017

Desc:Kinder Surprise

FERRERO POLSK SP Z.O.O.
Date Published : 08/28/2017
Ul. Wiertnicza 126 , Warsaw, Mazowieckie POLAND
34 C - - 01 Chocolate Candy Bar, with Nuts or Nut Products (not Coconut)
Date Published: 08/28/2017

Desc:Kinder Egg

34 C - - 04 Chocolate Covered Candy Pieces, with Nuts or Nut Products (not Coconut)
Date Published: 08/28/2017

Desc:Kinder Egg

34 F - - 01 Chocolate Candy Bar, without Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Egg

34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Egg

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Egg

34 F - - 07 Mixed or Assorted Chocolate Candies (Bars, Boxes, Loose Form), without Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Egg

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Egg

34 G - - 07 Mixed or Assorted Chocolate Candies (Bars, Boxes, Loose Form), with Nuts and Fruit
Date Published: 08/28/2017

Desc:Kinder Egg

34 K - - 04 Chocolate Bars
Date Published: 08/28/2017

Desc:Kinder Egg


RUSSIA


Shokoladniy dom Ekaterinburg
Date Published : 01/13/2015
1A, Stroiteley st., pos.Kluchevsk , Berezovskiy, Sverdlovskaya Obl. RUSSIA
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 01/13/2015

Desc:Chocolate Figure Happy New Year with Surprise

34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 01/13/2015

Desc:Chocolate Figure New Year Mix with Surprise

34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 01/13/2015

Desc:Chocolate Figure Ewe Lamb

ZAO "RUSSKIY CHOCOLATE"
Date Published : 06/02/2016
ul. Vereyskaya 29 , Moscow, Moscow g RUSSIA
34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 06/02/2016

Desc:Doll Shaped Chocolate with Surprise Inside
Notes:Problems; Imbedded Non-Nutritive Object


SLOVAKIA


I.D.C. Holding
Date Published : 04/23/2013
Drienova 3 , Bratislava - Ruzinov, Bratislavsky SLOVAKIA
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 04/23/2013

Desc:Kinder Egg Milk Chocolate Egg with Toy inside

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 04/23/2013

Desc:Kinder Egg Milk Chocolate Egg with Toy inside

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 04/23/2013

Desc:Kinder Egg Milk Chocolate Egg with Toy inside


TURKEY


Simsek Biskuvi ve gida sanayii A.s.
Date Published : 10/01/2009
Organize Sanayii Bolgesi , Karaman, Tr-70 TURKEY
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 10/01/2009

Notes:Simsek Milky Kid Surprise egg Chocolate egg containing plastic toys. DWPE date - 6/29/2009

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 10/01/2009

Notes:Simsek Milky Kid Surprise egg Chocolate egg containing plastic toys. DWPE date - 6/29/2009

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 10/01/2009

Notes:Simsek Milky Kid Surprise egg Chocolate egg containing plastic toys. DWPE date - 6/29/2009

34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 10/01/2009

Notes:Simsek Milky Kid Surprise egg Chocolate egg containing plastic toys. DWPE date - 6/29/2009


UNITED KINGDOM


Cadbury Trebor Bassett
Date Published : 04/16/2012
P.O. Box , 12 Bournville Lane , Birmingham, Birmingham UNITED KINGDOM
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 04/16/2012

Desc:Milk Chocolate Eggs Aka Dairy Milk Buttons Chocolate egg containing milk chocolate pieces in plastic bag

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 04/16/2012

Desc:Milk Chocolate Eggs Aka Dairy Milk Buttons Chocolate egg containing milk chocolate pieces in plastic bag

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 04/16/2012

Desc:Milk Chocolate Eggs Aka Dairy Milk Buttons Chocolate egg containing milk chocolate pieces in plastic bag