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This article was originally published in The Tan Sheet

Executive Summary

OTC DENTIFRICE LABEL DISCLOSURE OF FLUORIDE LEVELS would lead to consumer "misconceptions" given that a significant number of consumers believe that higher fluoride levels mean a more effective product, a joint industry task force asserted in March 26 comments to FDA. The Oral Health Care Task Group of the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association based its position on fluoride labeling on consumer research that indicated that "fluoride disclosure leads consumers to misconceptions about use of fluoride-containing products and would, therefore, not be helpful." FDA had asked for input on including fluoride-level information in product labeling in a November 1992 Federal Register notice that reopened the OTC dental caries product monograph. In the notice, the agency asked whether there is "consumer benefit in having OTC fluoride-containing drug products labeled to state their fluoride levels" and what the best way is to undertake such labeling. FDA originally sought comments on the notice by Jan. 25. However, the agency pushed back the deadline to March 26 at the request of NDMA and CTFA. FDA said in the November notice that it "plans to discuss identification of fluoride levels" in labeling in the OTC dental caries final monograph. In an NDMA/CTFA-sponsored study, 41% of respondents stated a preference for a toothpaste with more fluoride. NDMA/CTFA concluded that "this is evidence that a substantial number of consumers believe 'more is better' when choosing a dentrifrice." Conducted by DataSource for NDMA/CTFA, the consumer research consisted of "mall intercept interviews" on Feb. 1-8 in eight "geographically dispersed locations." A representative sample of 200 females between 18 and 49 years of age was interviewed. The survey found that when consumers were shown possible labels indicating two different toothpaste options and asked to indicate which product they preferred, 62% chose a label with 1150 parts per million (ppm) of fluoride while 21% chose the 850 ppm fluoride label. When fluoride was expressed in milligrams per inch of toothpaste, 71% of consumers chose 2.3 mg/inch fluoride over 1.1 mg/inch ribbon (18%). In weight per unit volume, 79% of respondents chose labels with .20% fluoride over .09% fluoride (15% of respondents). In its 1988 tentative final monograph for OTC dental caries products, FDA classified total theoretical fluorine levels of 850- 1150 ppm as Category I (safe and effective). However, "there are no comparative safety or efficacy distinctions for different fluoride levels within the Category I range" of 850 ppm to 1150 ppm. "These data indicate that any of the tested labeling proposals would lead to confusion among consumers and lead them to think that there are comparative differences in effectiveness between dentifrices when labeled with net fluoride." Moreover, the group asserted that "this misconception would be fueled by the fact that consumers currently believe a comparative effectiveness of fluoride exists between dentifrices." FDA has "specified no fluoride amount to be superior to another," NDMA/CTFA underscored. As a result of the research findings, the NDMA/CTFA coalition maintained that "additional labeling would leave the consumer responsible for making a choice between products with no sound basis." Therefore, the task group concluded, current dentifrice labeling "is adequate in meeting the needs of consumers for an informative label that allows safe and effective product use with a minimum potential for misleading the public." While opposing labeling changes, the industry task group did make a suggestion on how best to inform consumers about "rational fluoride intake." Based on the task group's data, NDMA/CTFA suggested "that a quantitative scheme (e.g., don't exceed 'x' number of ppms per day) would be less useful and more confusing than general recommendations and precautions (i.e., it is not the specific amount of fluoride in a product that is meaningful to a consumer, but rather how often or how much of that product (or source of fluoride) should or should not be used." NDMA/CTFA further argued that expressing the precise quantity of fluoride in dentifrice product labeling is unnecessary because OTC fluoride-containing dentifrices "are not implicated in fluorosis." At a January meeting of the National Institutes of Health's National Institute of Dental Research, for example, dentifrice use was not implicated in dental fluorosis, the industry task group pointed out.

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