IA #33-10, REVISED 6/22/05 - IMPORT ALERT, #33-10, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF CANDY DUE TO LEAD"
ATTACHMENT, REVISED - 12/17/08
NOTE: This import alert is being reissued to accommodate additional candy
products subject to detention without physical examination. Asterisks
bracket changes (***).
TYPE OF ALERT: Detention Without Physical Examination (DWPE)
NOTE: This import alert contains guidance to FDA field personnel only. It
does not establish any requirements, or create any rights for, or obligations
on, FDA or regulated entities.
PRODUCT : *** See Attachment ***
PRODUCT CODE: See attachment
PROBLEM: Excessive levels of lead (HMPB)
PAC FOR
COLLECTION : 04019A
COUNTRY : See attachment
MANUFACTURER/
SHIPPER : See attachment
MANUFACTURER/
SHIPPER I.D.#: See attachment
CHARGE : The article is subject to refusal of admission pursuant to
Section 801(a)(3), in that the article appears to bear or
contain a poisonous or deleterious substance, lead which
may render it injurious to health [Adulteration, Section
402(a)(1)];
and
Its container (paper wrapper) is composed in part of a
poisonous or deleterious substance, lead, which may render
the contents injurious to health [Adulteration,Section
402(a)(6)];
and/or
It appears to bear or contain a food additive, lead, that
is unsafe within the meaning of Section 409 [Adulteration
402(a)(2)(C)]."
RECOMMENDING
OFFICE: LOS-DO (HFR-PA256)
SAN-DO (HFR-PA152)
REASON FOR
ALERT: From August through October 1994, lollipops from Mexico were
detained because of high lead levels. Lead was also found in
some of the wrappers. In 1995, FDA initially provided guidance
in this import alert that it would consider action against candy
products that exceeded 0.5 ppm lead. This guidance allowed for a
lead intake from these candies of no more than approximately 10
micrograms of lead per day, based upon an estimated daily candy
consumption of 21 grams. More recently, FDA has learned that
some candy products have serving sizes substantially larger than
21 grams and FDA believes that children are likely to consume the
entire product on one eating occasion. In order to continue to
provide the comparable level of protection to children when they
eat these larger products, i.e., no more than approximately 10
micrograms per serving, FDA has revised the import alert to
indicate that it may also consider action against candy products
containing 0.5 ppm or less lead, when the amount of lead per
serving is 10 micrograms or more.
In January 1995, SAN-DO analyzed a sample of tamarind candy
packaged in green ceramic containers and found approximately 25
parts per million lead.
In July 1996, FDA learned of an investigation conducted by the
Orange County, California, Environmental Health Division
concerning a child with elevated blood lead levels. The child
had consumed Storck brand Eucalyptus Menthol Candy.
A sample of the Storck candy was collected and analyzed by SAN-
DO. The wrapper was found to leach 33,000 ppm lead and the candy
was found to contain 0.880 ppm lead. There is evidence that ink
from the wrapper is the source of the lead and the amount of lead
in the candy was shown to be related to the amount of pigmented
ink that transferred to the candy.
The Storck candy was manufactured by Storck Products, Inc.,
Philippines under license of August Storck KG, 100 Berlin 27,
F.R. Germany.
GUIDANCE: Districts may detain without physical sampling and analysis, all
products identified on the attachment to this alert.
For the individually wrapped candies, both the candy and wrapper
should be analyzed for lead in order to overcome the appearance
of a violation. Additionally, adequate documentation should be
provided showing that the manufacturer has addressed the problem
and that the packaging materials (i.e., wrappers including inks)
that may contact the food comply with the agency's requirements
for contact materials.
In order to consider regulatory action, one of the following
conditions must be met:
Analysis of the candy shows potentially harmful levels of lead:
Greater than 0.5 ppm lead, or 0.5 ppm or less lead, and a serving
size that would result in a lead intake of 10 micrograms or more
per serving. To calculate the amount of lead per serving in
micrograms, multiply the lead level in the candy expressed as
ppm, by the serving size of the candy expressed in grams. For
example, if the lead level in the candy is 0.3 ppm and the
serving size is 37 g. 0.3 x 37 = 11.1 micrograms per serving.
Evidence exists that lead has migrated from the wrapper/container
to the Candy.
In some cases, there are visual indications of components of the
wrapper (ink) migrating to the candy. SAN-DO has documented
cases where the lead level is higher in the portion of the candy
with a visual indication of migration.
Wrappers should be analyzed using a 24 hour leach at room
temperature in a 1N HCL solution. Recommended lead methods of
analysis are listed in Compliance Program 7304.019.
Districts should consider that each candy may present a different
situation with regard to the potential for regulatory action.
For example, the following considerations may be relevant:
is there both an inner and outer wrapper? If there is an inner
wrapper, does it act as a barrier to lead migration?
is there ink on any surface that may come in contact with
the candy? Is the ink on the inner or outer surface of the
wrapper?
The Quick Color Test may be helpful as an indication of whether a packaging
surface contains lead. Districts should contact CFSAN/DOE/Imports Branch,
Doriliz Mestey, at (301) 436-2772 for questions concerning compliance or
criteria for the release of lots.
For questions on 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 : Lead, Candy, Lollipop, Powder Candy, Storck
eucalyptus-menthol candy.
PREPARED BY : Stella Notzon, DIOP (301) 443-6553
DATE LOADED
INTO FIARS : June 22, 2005
ATTACHMENT TO IMPORT ALERT #33-10 - 12/17/08
FIRM PRODUCT/ MANUFACTURER/
PRODUCT CODE SHIPPER
MEXICO
Candy Pop S.A. De C.V. Tamarind candy/lollipops M
Calle 26 No. 1815 Z. Industrial 33S[][]06
Guadalajara, Jalisco, Mexico 8/27/03
FEI# 3002809020
Carmen Patricia Guzman Lollipop (Sucker) M
Armenta Av. Plan de Iguala 33C[][]99/33S[][]06
1339 Col. Lazaro Cardenas 11/8/94
Mexicali, Baja California,
Mexico
FEI #1000256653
MID #MXCARPAT1339MEX
Dulces Vero S.A. de C.V. Lollipop, strawberry M
aka Vero Dulces flavored with chili
aka Vero Candies coating [Vero Elotes]
Calle 26, #2395 Zona Industrial 33S[][]06
Guadalajara, Jalisco, MX 33E[][]99
FEI# 2000007136 9/18/08
*Dulces Vero
aka Vero Dulces
aka Vero Distribuciones
Calle 26, #2395 Zona Industrial
Guadalajara, Jalisco, MX
FEI# 3004077681
*Parent company/Re-labeler/declared as Manufacturer
Fabrica de Dulces Ravi, Pancho's Hot Orange Manufacturer
S.A. de C.V. Jellies
Bustamante #801 33L--07
Colonia Los Nogales
Monterrey, Nuevo Leon
Mexico 64260
FEI #1000439056
Industria Dulcera S.A. de C.V. Chaca Candy M
Ave Miguel Hidalgo No 13 33J[][]99
Morelia, Michoacan 33S[][]99
Mexico 33L[][]05
FEI #3000214092 04/8 /04
Margarita Guiltron Tamarind candy M
Ramirez in ceramic jars
Av. Rio Nilo #2038 33Y[][]99
Col Lomas 6/5/95
Guadalajara, Jalisco, Mexico
FEI #1000333180
MID #MXMARRAM2GUA
***PHILIPPINES***
Storck Products, Inc. Eucalyptus-Menthol Candy M
West Capitol Drive 33E[][]06
Pasig, Metro Manila 8/21/96
Philippines
FEI #1000469384
MID #PHSTOPROMAN
The firms below are reported to be shippers for this product:
CPMulti-Commodities Corporation
S
17 Clemente St., Bgy. San Agustin
Novaliches, Metro Manila
Philippines
FEI: 146
MID: PHCPMCOM17MET
Pacific Isles International Trading, Inc. S
62-9th Street, New Manila
Quezon City, Philippines
EFEI: #1000168008
MID: PHPACISL62QU
Productos Karla SA de CV Vasito Tamarind & Guava M
Carretera Guadalajara- flavored Soft Candy
Saltillo, Km 187 33L[][]99, 33L[][]06,
Zacatecas, Tabasco, Mexico 33Y[][]99, 33S[][]99
FEI # 1000475421 11/1/06
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