IA #63-01, 5/1/97 - REVISED 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 revision places Colgate fluoride toothpaste
               products from Canada and Mexico on detention
               without physical examination. This revision also
               updates the title, format, product code and text.
               Changes are identified by asterisks (***).

TYPE OF
ALERT     :*** Detention without physical examination - for all
               Colgate fluoride toothpaste products from Canada
               and Mexico.

               Guidance - for all other fluoride toothpaste
               products.

              (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   :*** Detention without physical examination - Colgate
               fluoride toothpaste products from Canada and
               Mexico.

               Guidance - All other fluoride toothpaste products,
               all other countries,various brands including Crest
               and Colgate. ***

PRODUCT
CODE      :*** 63R ***


PROBLEM   :    New drug without an approved new drug application
               (DRND)

COUNTRY   :    Detention without physical examination -
               Canada (CA, 260), Mexico (MX, 595)

               Guidance - All (999)

MANUFACTURER/
SHIPPER   :    All



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)."


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 fluoride
               toothpaste products from Canada and Mexico.
               ***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)443-3320 or 3007. ***

FOI:          No purging required.

KEYWORDS:     Toothpaste, double fluoride, Crest, Colgate

PREPARED BY:  Doug Randes, DIOP (301)-443-6553.

DATE LOADED
INTO FIARS :  May 1, 1997