Import Alert 52-10

(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 # 52-10
Published Date: 12/10/2020
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Leaded Crystal Baby Bottles"

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 Office of Regulatory Science (DFS) at 310 796-6600.***



All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:

Leaded crystal baby bottles

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)]."



OASIS charge code - UNSAFE ADD

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (52 A Y - 11) Lead Crystal Housewares (Kitchen and Tableware, Cups, Mugs, Plates, Platters, Bowls, Etc.), Not Elsewhere Classified (NEC)
    Desc: leaded crystal baby bottles
    Problems:LEAD;