(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 Name:
Reason for Alert:
On August 17, 2001, CFSAN's Health Hazard Evaluation Board concluded that the packaging, shape, slipperiness, and consistency endow the mini-gel products with a potential to cause choking. CFSAN immediately issued a press release warning consumers of this potential choking hazard.
On August 27, 2001,CFSAN staff met with physiologists from the Consumer Products Safety Commission (CPSC) and requested their assistance in evaluating the potential choking hazard associated with these gel candies. CPSC's physiologists are familiar with the physiology and anatomy of the airway, the medical literature on choking risks, and the characteristics of objects involved in fatal choking incidents in young children. In a memo dated September 6, 2001, CPSC physiologists concluded that the physical characteristics of the small cup-like candies pose a serious choking risk, particularly in young children.
Since both CFSAN's Health Hazard Evaluation Board and CPSC's physiologists conclude that the physical characteristics of the gel candies result in a serious choking risk, the characteristics that contribute to the hazard are identified below.
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.
Spherical, ovoid, ellipsoidal, or having circular cross sections (round-ended, cylindrical, tapered bullet-shapes, etc.).
Smooth slippery surfaces when placed in the mouth. The gel is slippery and slides along the tongue toward the back of the mouth, affording the consumer poor control over its direction, positioning, and timing/coordination with swallowing, and thus effectively bypassing the teeth.)
Much firmer, and dissolve less readily, than U.S.-type gelatin. Sucking does not easily disrupt the integrity of the product.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
(See product characteristics under REASON FOR ALERT)
OASIS charge code - FOREIGN OB
MULTIPLE COUNTRIES (PODS ONLY)
(33 M - - 01) Gel Cups, Fruit Flavored
(33 M - - 03) Gel Cups, Fruit Flavored w/Fruit Candy
(33 M - - 04) Gel Cups, Nut Flavored w/Nuts Candy
(33 M - - 05) Gel Cups Candy
(33 M - - 06) Jelly Fruit Poppers Candy
(33 M - - 07) Gel Candy on a Stick Candy
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)