IA #33-10, REVISED 4/8/04 - IMPORT ALERT, #33-10, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF CANDY FROM MEXICO AND THE PHILIPPINES
DUE TO LEAD", ATTACHMENT, REVISED - 4/8/04
NOTE: This import alert is being reissued to provide additional guidance for
situations where the analysis of the candy shows a level of lead less than 0.5
ppm, yet the serving size of the food consumed is large enough to result
inconsumption of potentially harmful levels of lead. 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 : Candy lollipops (suckers) and granular powders
Eucalyptus-Menthol candy
PRODUCT CODE: See attachment
PROBLEM: Excessive levels of lead (HMPB)
PAC FOR
COLLECTION : ***04019A***
COUNTRY : Mexico (MX, 595)
Philippines (PH, 725)
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
I ts 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
I t 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.
The product consists of candy contained in a clear inner wrapper and a lime green outer wrapper
with dark green lettering. Storck candies manufactured in Germany have been tested by SAN-
DO and no lead had been detected; only the product manufactured in the Philippines is suspect.
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:
C Greater than 0.5 ppm lead, or
C 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, ***Charles Parfitt
at (301) 827-7605 ***.
PRIORITIZATION
GUIDANCE : I
FOI : No purging required.
KEYWORDS : Lead, Candy, Lollipop, Powder Candy, Storck eucalyptus-menthol
candy.
PREPARED BY : Denise Jones, DIOP (301) 443-6553
DATE LOADED
INTO FIARS : April 8, 2004
ATTACHMENT TO IMPORT ALERT #33-10 - 4/7/04
PRODUCT/ MANUFACTURER/
FIRM PRODUCT CODE SHIPPER
MEXICO
Candy Pop S.A. De C.V. Tamarind 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
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/ /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***