NOTE: The revision of this Import Alert (IA) dated 03/13/2024 updates the reason for alert, guidance section, product description and charge code section. Changes to the import alert are bracketed by asterisks(***). REASON FOR ALERT: 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 confectionery products may pose a public health risk as the consumer may unknowingly choke on the object. ***Recently, the Agency was made aware of additional confectionery products containing non-nutritive objects offered for sale in the United States. The non-nutritive objects in these products are not imbedded within the confectionery but are an integral part of the confectionery. The non-imbedded, non-nutritive objects may pose a public health risk as they have the potential to detach and cause the consumer to 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. Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act provides that a food shall be deemed adulterated if it is unfit for food. Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act provides that a food shall be deemed adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health. This import alert has been developed for specific firms that have offered adulterated, confectionery products containing non-nutritive objects for entry, and for when detention without physical examination is appropriate.***
Confectionery products containing non-nutritive components, such as small toys or objects, which may be partially or completely imbedded in the food product. Confectionery products that are injurious to health due to a non-nutritive component of the food.
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a confectionery that has partially or completely imbedded therein any nonnutritive object. [Adulteration, Section 402(d)(1)] OASIS charge code: IMBED OBJT *** The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food in that it contains foreign object(s). [Adulteration, Section 402(a)(3)] OASIS charge code: FOREIGN OB The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains: [Adulteration, Section 402(a)(1)] ***OASIS charge code: POISONOUS***
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 in a confectionery product that causes the confectionery to appear adulterated: � 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). Recommendations for DWPE addition to Red List require documentation of Center/Program concurrence, when the action is not covered by direct reference authority (DRA). DWPE may be indicated when CFSAN has determined that a confectionery product appears adulterated due to a non-nutritive object. Final recommendations for DWPE additions to Red List should be forwarded to the Division of Import Operations (DIO). Refer to Compliance Policy Guides (CPG) Sec. 515.100 & 515.350 for guidance related to non-nutritive substances imbedded in confectionery 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 non-nutritive components that cause the product to be adulterated. 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 sent via email to: Importalerts2@fda.hhs.gov Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov Questions or issues on policy, sample collection recommendations, or any other additional questions, not directly related to a detained entry, should be addressed to Human Foods Program Division of Enforcement at hfp-oce-officeofenforcement@fda.hhs.gov. ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: NOTE: The revision of this Import Alert (IA) dated 03/13/2024 updates the reason for alert, guidance section, product description and charge code section. Changes to the import alert are bracketed by asterisks(***). REASON FOR ALERT: 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 confectionery products may pose a public health risk as the consumer may unknowingly choke on the object. ***Recently, the Agency was made aware of additional confectionery products containing non-nutritive objects offered for sale in the United States. The non-nutritive objects in these products are not imbedded within the confectionery but are an integral part of the confectionery. The non-imbedded, non-nutritive objects may pose a public health risk as they have the potential to detach and cause the consumer to 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. Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act provides that a food shall be deemed adulterated if it is unfit for food. Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act provides that a food shall be deemed adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health. This import alert has been developed for specific firms that have offered adulterated, confectionery products containing non-nutritive objects for entry, and for when detention without physical examination is appropriate.***
Country-specific information is available in the full alert detail on the FDA website.
Get alerted when FDA issues new detention orders or modifies existing import alerts affecting your product categories.
Join the Waitlist →