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 nonnutritive 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
