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: 02/28/2022
Type: DWPE

Import Alert Name:

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

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 2/28 /2022 updates the IA Subtype, guidance section, agency contacts, charge code language, and removes the Countries section. Changes to the import alert are bracketed by 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:

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

Divisions 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 ***(301-504-7912)***. 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).

***DWPE will be indicated when CFSAN has determined that a product is adulterated due to a non-nutritive object imbedded in a confectionary product. DIO will coordinate with CFSAN for concurrence.***

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

***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:

In order to secure the release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide evidence that the product does not contain partially or completely imbedded non-nutritive components. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention.***

***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

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 "Import Operations and Actions", Section 9-8 "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:***

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email to: Importalerts2@fda.hhs.gov

***Questions or issues involving import operations should be addressed to The Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov

Questions or issues on human food policy, sample collection recommendations, should be addressed to CFSAN, Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov

                                                                                                                                                                        ***

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 confectionary that has partially or completely imbedded therein any nonnutritive 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' Artigianato 81 , Rovereto, Trento 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, Rimini 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 , Milan, Milan 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
Viale Europa 2 , Senago, Milan 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
4f Shochiku Bldg. , Hachimandori; Chuo , Kobe, 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 , Sakai, 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

FURUTA SEIKA CO., LTD MIHARA FAC
Date Published : 08/11/2016
663 Kuroyama , Mihara; Kuroyama; Mihara , Sakai, 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


LITHUANIA


UAB "DAISENA"
Date Published : 11/09/2017
Taikos pr. 161 , Kovno, Kauno LITHUANIA
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 11/09/2017

Desc: CHOCOLATE EGGS AHA ZOO

34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit
Date Published: 11/09/2017

Desc: CHOCOLATE EGGS AHA ZOO

34 F - - 08 Chocolate Suckers and Novelties, without Nuts and Fruit
Date Published: 11/09/2017

Desc: CHOCOLATE EGGS AHA ZOO

34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C.
Date Published: 11/09/2017

Desc: CHOCOLATE EGGS AHA ZOO


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
Pos.Kluchevsk 1a , Ul. Stroiteley , 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


Britsuperstore
Date Published : 11/14/2017
122 Elms Vale Road , Dover, UNITED KINGDOM
34 F - - 02 Chocolate Candy Pieces, without Nuts and Fruit
Date Published: 11/14/2017

Desc: Kinder Surprise
Notes:                                                                                                                                                                                                                                                                                                                                                           

Cadbury Trebor Bassett
Date Published : 04/16/2012
12 Bournville Lane; Bir , Birmingham, BIR 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