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