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IA #52-10, REVISED 2/3/97 - IMPORT ALERT #52-10, "***DETENTION WITHOUT
           PHYSICAL EXAMINATION*** OF LEADED CRYSTAL BABY BOTTLES"

NOTE:     This revision updates the alert into the current format
          and PAC code.  Additional changes are bracketed by
          asterisks (***).

TYPE OF ALERT: ***Detention without physical examination

               NOTE: This import alert contains guidance to FDA
               field personnel only.  It does not establish any
               requirements, or create any rights or obligations
               on FDA or on regulated entities.***

PRODUCT:       Leaded crystal baby bottles

PRODUCT CODE:  52AY-11

PROBLEM:       Product leaches lead

PAC FOR
COLLECTION:    ***04019B***

***PAF FOR
COLLECTION:    MET (Metals in products)***

COUNTRY:       All

MANUFACTURER/
SHIPPER:       All

CHARGE:        "The article is subject to refusal of admission
               pursuant to Section 801(a)(3) in that it appears to
               contain excessive lead, an unsafe food additive
               within the meaning of Section 409 [Adulteration,
               Section 402(a)(2)(C)]."

RECOMMENDING
OFFICE:        CFSAN

REASON FOR
ALERT:         Preliminary studies conducted by researchers at
               Columbia University and within FDA have indicated
               that foods stored in leaded crystalware may leach
               lead.  CFSAN has advised that leaded crystal baby
               bottles, christening cups, or glassware not be used
               for infants and children.

               Several laboratory analyses of crystal baby bottles
               have revealed leachable lead at levels which CFSAN
               deems to be unsafe.

***GUIDANCE:   Districts may detain, without physical
               examination,*** all shipments of leaded crystal
               baby bottles, christening cups, and glassware
               identified for infant and child use.

               Use ***AOAC 973.32, Cadmium and Lead in Earthenware
               (AOAC-ASTM Method), AOAC 16th Edition 9.1.04*** for
               analysis.

               ***For questions or issues concerning science,
               science policy, sample collection, analysis,
               preparation, or analytical methodology, contact the
               Division of Field Science (DFS) at (301) 443-
               3320.***

PRIORITIZATION
GUIDANCE:      I

FOI:           No purging required

KEYWORDS:      Baby bottle, baby cup, christening cup, crystal
               nursers, leaded crystal

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

DATE LOADED
INTO FIARS:    FEBRUARY 3, 1997