IA 63-01, REVISION - 3/22/01, IMPORT ALERT #63-01, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF COLGATE FLUORIDE TOOTHPASTE FROM
CANADA AND MEXICO AND GUIDANCE FOR ALL OTHER FLUORIDE
TOOTHPASTE PRODUCTS"
NOTE: This alert is being updated to revise the format.
Attachments have been created clarify the products at issue.
Other changes are bracketed by asterisks.
TYPE OF
ALERT: Detention without physical examination - for all Colgate fluoride
toothpaste products from Canada, Mexico, and Turkey.
Guidance - for all other fluoride toothpaste products.
(Note: This import alert represents the Agency's current guidance
to FDA field personnel regarding the manufacturer(s) and/or
product(s) at issue. It does not create or confer rights for or
on any person, and does not operate to bind FDA or the public.)
PRODUCT: Fluoride toothpaste (Colgate brand)
PRODUCT
CODE: 63R[][][][]
PROBLEM: New drug without an approved new drug application (DRND)
***PAF: AAP (approvals) ***
***PAC: 56008H ***
COUNTRY: Detention without physical examination - see Attachment A
Guidance - All (ZZ)
MANUFACTURER/
SHIPPER: See Attachments
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a new drug without an
approved new drug application (NDA) as required by Section
505(a)."
***OASIS
CHARGE CODE: UNAPPROVED ***
RECOMMENDING
OFFICE: DIOP (HFC-170) and CDER (HFD-310)
REASON FOR
ALERT: There is a continuing problem of imported toothpaste products with
more than one fluoride ingredient or containing fluoride at a
level higher than that allowed in OTC anticaries toothpastes, or
containing other non permitted ingredients. These products are
considered new drugs without approved new drug applications.
In the past shipments of toothpaste products from England,
Portugal, Italy, India, China, Brazil, Chile, Mexico, and Canada
have been detained because of double fluoride or excessive
fluoride levels.
Recently representatives of the Colgate-Palmolive Company have
presented information indicating that Colgate fluoride toothpaste
manufactured in Canada and Mexico, for sale in those countries, is
being diverted into the United States. Based on information
provided by the firm, the Canadian toothpaste contains cyclamates
and the Mexican toothpaste contains two fluoride ingredients.
Neither formulation is acceptable - cyclamates are not permitted
as sweeteners and the final monograph on fluoride dentifrices
(21CFR355) does not permit combination of two fluoride
ingredients. These products cannot be brought into compliance by
relabeling. In FY96 there were 10 detentions of Colgate toothpaste
from Canada, and 12 detentions of Colgate toothpaste from Mexico.
For FY97 (as of 3/25/97) there have been 4 detentions of Colgate
toothpaste from Canada, and 6 detentions of Colgate toothpaste
from Mexico.
GUIDANCE: Districts may detain without physical examination all shipments of
Colgate brand fluoride toothpaste products from Canada, Mexico,
and Turkey.
Districts may perform label reviews on entries of other anticaries
toothpaste products. Products found labeled as containing double
fluoride ingredients or other non-permitted ingredients should be
detained. Districts may sample other products for fluoride
content, color additives, and sweeteners. Questions concerning
analytical findings should be referred to Robert Eshelman, HFD-
312, 301-594-1065.
Use the following methodology for determination of fluoride and
monofluorophosphate in toothpastes containing both types of
fluorides: Journal of Chromatography, Vol. 546, pgs. 351-361,
Murawski 1991.
"Ion Chromatography for Analysis of Household Consumer Products"
Journal of Chromatography, Vol. 367, pgs. 423-427, Potter et, al.
1986 "Determination of Fluoride and Monofluorophosphates in
toothpastes by Ion Chromatography."
For determination of fluoride in toothpastes containing sodium
fluoride or stannous fluoride:
Laboratory Information Bulletin (LIB) #2742, pgs. 1-6, Tobias 1983
"Ion Selective Determination of Free Fluoride in Toothpaste."
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301) 827-7650.
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging required.
KEYWORDS: Toothpaste, double fluoride, Crest, Colgate
PREPARED BY: Fredda Shere-Valenti, DIOP (301)-443-6553.
DATE LOADED
INTO FIARS: March 22, 2001
Attachment A for Import Alert #63-01
Countries and/or manufacturers recommended for Detention Without Physical
Examination
CANADA (CA)
FIRM PRODUCT/PRODUCT CODE
All Toothpaste, Colgate brand
INDIA (IN)
Balsara Hygiene Products Ltd. Toothpaste
43, N. Master Road 63RAJ04
Fort, Mambai 400 001, India (Unapproved new drug
FEI #3001413302 Due to nonperitted color addition
Ponceau 4R)
9/16/03
-
MEXICO (MX)
FIRM PRODUCT/PRODUCT CODE
All Toothpaste, Colgate brand
TURKEY (TR)
FIRM PRODUCT/PRODUCT CODE
Colgate-Palmolive Temizlik Colgate Total Toothpaste
Urunleri Sanayi ve Ticaret A.S. 63R[][][][]
Ayayna Knyly Monzo (Note: Product may also be
Istanbul, Turkey listed under product code
FEI# 3002831722 53I[][]01 - Cosmetic Oral
Hygiene Products)
ALSO WHEN SHIPPED BY:
Yahya Gulf Trading FZE
P.O. Box Dubai, United Emirates
FEI# 3001851129
Attachment B for Import Alert #63-01
Manufacturers exempt from Detention Without Physical Examination
None at this time.