IA  #33-15 10/16/02, IMPORT ALERT #33-15, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF GEL CANDIES CONTAINING KONJAC"

          NOTE: This revision updates the product codes.

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
          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).

PRODUCT:  Mini-cup Gel Candies containing Konjac
          (See product characteristics under REASON FOR ALERT)

PRODUCT
CODE:          ***33M[][]01, 33M[][]03, 33M[][]04, 33M[][]05
          33M[][]06, 33M[][]07***

PROBLEM:  Adulterated, unfit for food.
          (The physical characteristics of the small cup-like candies pose a
          serious choking risk)

PAF:      FIL (Filth)

PAC:      03819A

COUNTRY:  All

MANUFACTURER
FEI#:          All

IMPORTER'S
ID#:      N/A

CHARGE:   "The article is subject to refusal of admission pursuant to
          section 801(a)(3) in that it appears to be unfit for food
          [Adulteration 402(a)(3)]."

OASIS CHARGE
CODE:          FOREIGN OB

RECOMMENDING
OFFICE:   CFSAN, OFP, DE, Imports Branch (HFS-606)

REASON FOR
ALERT:    There have been a series of choking deaths as well as near-deaths
          from choking among children and elderly persons who consumed
          candies described as "mini-cup jelly products,"  "mini fruity
          gels," and other similar names. These candies contain the
          ingredient Konjac (also called conjac, konnyaku, yam flour, or
          glucomannan) and are 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 gel
          candies maintain their product characteristics, i.e. shape,
          texture, firmness, without melting when placed in the mouth.

          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.

          Product Size:

          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.

          Product Shape:

          Spherical, ovoid, ellipsoidal, or having circular cross sections
          (round-ended, cylindrical, tapered bullet-shapes, etc.).

          Product Texture:

          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.)

          Consistency:

          Much firmer, and dissolve less readily, than U.S.-type gelatin.
          Sucking does not easily disrupt the integrity of the product.

GUIDANCE: Districts may detain without physical examination all mini-cup gel
          candies containing Konjac from all countries and all
          manufacturers/shippers.

          For questions or issues concerning science, science policy, sample
          collection, analysis, preparation, or analytical methodology,
          contact the Division of Field Science at (301) 827-7605.

PRIORITIZATION
GUIDANCE: I

FOI:      No purging required

KEYWORDS: Konjac, gel, jellies, gelatin, candy, glucomannan


PREPARED
BY:       Ted Poplawski, DIOP, (301) 443-6553

DATE LOADED
INTO FIARS:    October 4, 2001