The revision to this import alert dated 05/22/2025 updates the name of the import alert, subtype to firm alert, reason for alert, guidance section, agency contacts, product description, and charge section. Changes are bracketed by asterisks (***). ***In 2001 FDA issued a warning about the danger of choking caused by konjac candy, following several choking deaths as well as near-deaths from choking among children and elderly people who consumed candies described as "mini-cup gel and jelly products," "mini fruity gels," and other similar names. These candies contain the ingredient konjac (also called conjac, konnyaku, yam flour, or glucomannan) and were typically packaged in cups as individual, mouth-sized servings, often featuring an embedded piece of preserved fruit. Although the contents look like gelatin products commonly found in the U.S., e.g. "jello," these small cup-like products maintain their characteristics (i.e., shape, texture, firmness) and do not melt when placed in the mouth. An FDA Health Hazard Evaluation Board and physiologists with the Consumer Products Safety Commission (CPSC) assessed the products and concluded that the physical characteristics of the small cup-like candies (particularly, the packaging, shape, slipperiness, and consistency) pose a serious choking risk, particularly in young children. A 2017 an Australian surveillance study found that banned mini jelly cups containing konjac continue to be imported, showing that there has been recent trade and commerce involving the products. (https://www.productsafety.gov.au/news/accc-s-surveillance-on-mini-jelly-cups-containing-konjac). Between 2020-2025, multiple shipments of mini-cup jelly products that did not contain konjac but were considered a potential choking hazard based on the characteristics of the products, including their size and consistency, were offered for importation into the United States. These mini-cup jelly cups contained other gel-forming ingredients, such as carrageenan. FDA has determined that these products pose a similar choking risk as konjac candies. In October 2020, there were two recalls involving such products. See Eishindo Mini Cup Jelly recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hadson-toko-trading-co-inc-recalls-eishindo-mini-cup-jelly-50pcs-because-potential-choking-hazard) and Tropique Assorted Fruit Jelly Bag recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/comercial-mexicana-international-inc-recalls-tropique-assorted-fruit-jelly-bag-309pcs1006oz-and).***
***Mini-cup Gel and Jelly Candies of Firm Consistency that Present Risk of Choking Product Codes for reference: 33M�-01, 33M�02, 33M�-03,33M�04, 33M�-05, 33M�-06, 33M�07, 35A�01 (See product characteristics under GUIDANCE section)***
***The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food. [Adulteration, Section 402(a)(3)] OASIS charge code � UNFIT4FOOD***
***Divisions may detain without physical examination shipments of the identified product(s) from the manufacturers included on the Red List of this import alert. Products subject to this import alert are packaged candies that may contain konjac or gelling agents other than konjac that may pose a choking hazard, such as carrageenan or agar-agar (not all inclusive), which appear to be adulterated because the products are unfit for food. Divisions should submit recommendations for additions to the Red List to the Human Foods Program Office of Enforcement. HFP/OE will evaluate regulatory packages on a case-by-case basis. The characteristics that an FDA Health Hazard Evaluation Board and CPSC's physiologists identified as contributing to the hazard are related to the packaging, size, shape, consistency and texture of the product. These characteristics may include the following: (1) Packaging that may require a sucking action on the part of the consumer to dislodge the product from the package. (2) Size that is less than or equal to 1.75" in diameter of a cross section of a spherical or near-spherical product or less than or equal to 1.25" in diameter of a cross section of a non-spherical product (3) Shape that is spherical, ovoid, ellipsoidal, or having circular cross sections (round-ended, cylindrical, tapered bullet-shapes, etc.) (4) Much firmer consistency, and ability to dissolve less readily, than U.S.-type gelatin, which means that sucking will not easily disrupt the integrity of the product (5) Smooth slippery surface In the past, laboratories have tested for slipperiness by placing the material in the mouth, as this can provide information on whether the material can slide along the tongue toward the back of the mouth. Recently, laboratories have found that this is not necessary and testing in this way may pose a choking hazard to laboratory employees. NOTE: For more information about validated methods, please contact: FDAPRIVATELABIMPORTALERTS@fda.hhs.gov. Release of Articles Subject to Detention Without Physical Examination under This Import Alert: In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee, and/or another responsible party to the shipment should provide information to the Agency, such as a private laboratory analytical package, to adequately demonstrate that the product does not present the safety concerns described in the import alert that render the product unfit for food. Private laboratory analytical packages containing relevant sampling and analytical records should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, Volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final admissibility decision on the article. Removal from Detention Without Physical Examination (Removal from Red List): In order to remove a firm�s product from the Red List of this import alert, 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. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from DWPE, refer to FDA�s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." If a firm and/or a representative thereof would like to petition for removal from DWPE, 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 FDAImportsInquiry@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 with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained (or live) entry, should be addressed to Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov. ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: The revision to this import alert dated 05/22/2025 updates the name of the import alert, subtype to firm alert, reason for alert, guidance section, agency contacts, product description, and charge section. Changes are bracketed by asterisks (***). ***In 2001 FDA issued a warning about the danger of choking caused by konjac candy, following several choking deaths as well as near-deaths from choking among children and elderly people who consumed candies described as "mini-cup gel and jelly products," "mini fruity gels," and other similar names. These candies contain the ingredient konjac (also called conjac, konnyaku, yam flour, or glucomannan) and were typically packaged in cups as individual, mouth-sized servings, often featuring an embedded piece of preserved fruit. Although the contents look like gelatin products commonly found in the U.S., e.g. "jello," these small cup-like products maintain their characteristics (i.e., shape, texture, firmness) and do not melt when placed in the mouth. An FDA Health Hazard Evaluation Board and physiologists with the Consumer Products Safety Commission (CPSC) assessed the products and concluded that the physical characteristics of the small cup-like candies (particularly, the packaging, shape, slipperiness, and consistency) pose a serious choking risk, particularly in young children. A 2017 an Australian surveillance study found that banned mini jelly cups containing konjac continue to be imported, showing that there has been recent trade and commerce involving the products. (https://www.productsafety.gov.au/news/accc-s-surveillance-on-mini-jelly-cups-containing-konjac). Between 2020-2025, multiple shipments of mini-cup jelly products that did not contain konjac but were considered a potential choking hazard based on the characteristics of the products, including their size and consistency, were offered for importation into the United States. These mini-cup jelly cups contained other gel-forming ingredients, such as carrageenan. FDA has determined that these products pose a similar choking risk as konjac candies. In October 2020, there were two recalls involving such products. See Eishindo Mini Cup Jelly recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hadson-toko-trading-co-inc-recalls-eishindo-mini-cup-jelly-50pcs-because-potential-choking-hazard) and Tropique Assorted Fruit Jelly Bag recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/comercial-mexicana-international-inc-recalls-tropique-assorted-fruit-jelly-bag-309pcs1006oz-and).***
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