IA #66-30 - 10/28/02, REVISION OF IMPORT ALERT #66-30, "DETENTION
WITHOUT PHYSICAL EXAMINATION OF ILLEGAL SHIPMENTS OF
DIAL SOAP MANUFACTURED IN FOREIGN COUNTRIES"
NOTE: This revision exempts Dial Soap manufactured in one
plant in Guatemala from detention without physical
examination. It also puts the alert into the current
format. Changes appear between 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 : Dial Soap from foreign countries
PRODUCT CODE : 66V--99
PROBLEM : Imitation of a drug (****)
Unsafe Color Additive (USNC)
Lacks complete ingredient statement (MLLM)
PAC FOR
COLLECTION : 56008H
COUNTRY : All (999)
MANUFACTURER/
SHIPPER : All ** except the following firm:
ISC International S.A.
Lote 145 Granjas Gerona
San Miguel Petapa, Guatemala, C.A.
FEI #3002679827
Les Emballages Knowlton, Inc
315 Knowlton Road, Lac Brome Knowlton
(P.O. Box 190)
Knowlton, Quebec, Canada J0E1V0
FEI #3001628809
MANUFACTURER/
SHIPPER I.D.#: FEI# 3002679827
MID# GTINDCOR719SAN**
IMPORTER'S
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to be an imitation of a drug [Misbranding, Section
502(i)(2)]"
AND/OR
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to lack a complete ingredients statement
[Misbranding, Section 502(e)];"
AND/OR
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to contain an unsafe color additive [Adulterated,
Section 501(a)(4)(A) and 601(e)]."
RECOMMENDING
OFFICE : Division of Import Operations & Policy, HFC-170
REASON FOR
ALERT : Antibacterial soap marketed under the brand name
"Dial", which has been manufactured in Cyprus,
Korea, Canada, the Philippines, Mexico and other
foreign countries and is intended solely for use
outside the U.S., continues to be diverted into
the U.S.
In FY 91, 2 shipments of Dial soap from Mexico
were detained. The manufacturers/shippers were
Madik Ltd., and Sanco Exim S.A. One detention of
Dial Soap made in FY 90, was made from
manufacturer/shipper Distribudora, Dominican
Republic.
Although the soap is produced by licensees of
Armour International Company, the maker of Dial,
the license does not authorize shipment into the
U.S. As manufactured by the foreign licensees,
the Dial Soap does not comply with the United
States food, drug and cosmetic laws and
regulations.
All Dial Soap is a drug under Section 201(g) of
the FD&C Act based upon therapeutic claims
contained in its professional labeling e.g.,
reduce nosocomial infections. Foreign Dial Soap
often does not contain the same quantitative or
qualitative formulation of American Dial Soap. In
addition, foreign Dial Soap is offered in the U.S.
under the Dial trade name and thus represents
itself as American Dial Soap when it is not. For
these reasons, it is an imitation drug.
Dial Soap is also regulated as a cosmetic under
Section 201(i) of the Act because of labeling
claims as a deodorant soap. According to
information previously received from Armour
International, some of the foreign Dial Soap
contains illegal color additives (i.e., gold bars
contain Ext. D&C Yellow #1; pink bars contain HI-
VIZ red #3534; aqua bars contain Pigment Blue #15
and Pigment Green #7; and sky blue bars contain
Pigment Blue #15) and lacks the required full
ingredient disclosure statement in accordance with
the requirements of 21 CFR 701.3.
** Recent information received from ^
^ indicates that
Industrias Corporativas Diversificadas, Guatemala
is now a wholly-owned subsidiary of ^
^ and the Dial Soap manufactured there is
labeled and intended for sale in the United
States ***
GUIDANCE : ** Districts may detain, without physical sampling
and analysis, shipments of Dial Soap from any
foreign source other than the manufacturer listed
above. **
PRIORITIZATION
GUIDANCE : N/A
FOI : Information between ^ ^ requires purging.
KEYWORDS : Dial, Soap, Unsafe Color
DATE LOADED
INTO FIARS : September 12, 1996
PREPARED BY : Doug Randes, DIOP, 301-443-6553.
|
