IA #34-02, 5/6/08, IMPORT ALERT #34-02, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF KINDER SURPRISE EGGS"
TYPE OF ALERT: Detention without Physical Examination (DWPE)
(Note: This Import Alert represents the Agency's current
guidance to FDA field personnel regarding the
manufacturer(s) and/or product(s) at issue. It does create
or confer any rights for or on any person, and does not
operate to bind FDA or the public.)
PRODUCT: Kinder Surprise Eggs, the product is made by the Ferrero
Group and its subsidiaries, and consists of a hollow candy
egg composed of an outer layer of dark chocolate and inner
layer of white chocolate. Enclosed inside the chocolate egg
is a plastic capsule that contains a small toy. The non-
nutritive components (plastic capsule and toy) are
completely surrounded by the chocolate egg.
PRODUCT CODE: 34F[][]04
34F[][]08
34F[][]99
34F[][]02
PROBLEM: Confectionery that has a non-nutritive product therein.
PAF: FIL
PAC CODE: 03819A
COUNTRY: All
MANUFACTURER/
SHIPPER: All
MANUFACTURER
FEI: All
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: Foreign OB
RECOMMENDING
OFFICE: CFSAN, HFS-606
REASON FOR
ALERT: Section 402(d)(1) of the Federal Food, Drug, and Cosmetic
Act provides that confectionery that has 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. The FDA is aware
that a product called "Kinder Surprise Egg" is available for
sale and shipment to the U.S. via the Internet at various
sites, including the following sites: ^
^. FDA's examination of the websites and samples of the
product establish that the product is a chocolate egg that
contains inside it a plastic capsule that contains a toy.
This appears to be a violation of Section 402(d)(1) of the
Act because the product appears to be a confectionery
product with a non-nutritive object imbedded in it. The
internet vendors all appear to ship the product to the U.S.
from Canada. The product may be manufactured in Argentina
or Germany. Shipments could be entering the U.S. from any
source via the Mail.
GUIDANCE: Districts may detain without physical examination (DWPE) all
Kinder Surprise Eggs from all countries and all
manufacturers/shippers. Inform U.S. Customs and Border
Protection and the U.S. Postal Service that FDA has interest
in this product. Notify the Consumer Product Safety
Commission (CPSC), Office of Compliance and Field Operations
(301-504-7520) about the agency's finding of a small toy
imbedded in a candy product. CPSC will address any choking
hazard associated with the toy under its regulations. FDA
and CPSC have cooperated in this manner regarding Kinder
Surprise in the past.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required.
KEYWORDS: confectionary product, imbedded non-nutritive object, Kinder
Surprise Egg, Chocolate
PREPARED BY: Sal Evola, CFSAN (HFS-606)
Doug Randes, DIOP, HFC-170
DATE LOADED
INTO FIARS: September 7, 2007
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