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“Topical Benefits” IMPORT ALERTS According to the U.S. FDA, there is a continuing problem with imported toothpaste products containing more than one fluoride ingredient, or containing fluoride at a level higher than that allowed in over-the-counter (OTC) 'anticaries' toothpastes, or containing other non-permitted ingredients. The FDA considers these items "new drugs without approved new drug applications." (FDA Import Alert #63-01 - 1997 -2001) 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 (FDA Import Alert #63-01 - 1997 - 2001). The Canadian toothpaste also contained cyclamates which are not permitted as sweeteners, and the toothpaste from Mexico contained two fluoride ingredients, also an illegal measure, as the final monograph on fluoride dentifrices (21CFR355) does not permit combination of two fluoride ingredients. In 1996 alone there were 10 detentions of Colgate toothpaste from Canada, and 12 detentions of Colgate toothpaste from Mexico. In the first three months of 1997 there were 4 detentions of Colgate toothpaste from Canada, and 6 detentions of Colgate toothpaste from Mexico (FDA Import Alert #63-01 - 1997; 1999, 2001). =================================== FDA Import Alert #63-01 - 1997,1999, 2001
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