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This article was originally published in The Tan Sheet

Executive Summary

SMITHKLINE BEECHAM's REQUEST FOR TOOTH DESENSITIZER "FEEDBACK" MEETING DENIED by FDA in a June 2 letter. SmithKline Beecham asked to meet with FDA in an April 13 letter in order to "discuss observed consumer confusion" caused by the agency's proposed four- week limit on the use of OTC potassium nitrate tooth desensitizing agents -- especially products also containing fluoride -- and to suggest alternative wording in product labeling for potassium nitrate/fluoride dentifrices until the final rule is published ("The Tan Sheet" May 3, p. 11). FDA told the company that "a meeting at this time would not be useful." The agency pointed out that the company's request for a "feedback" meeting was received after the deadline for the May 1992 Federal Register notice addressing the marketing of potassium nitrate/fluoride dentifrices. However, the agency said it was in the process of reviewing SmithKline's April 13 letter along with previously submitted comments. SmithKline markets Aquafresh Sensitive, a 5% potassium nitrate and fluoride toothpaste. FDA emphasized that SmithKline cannot use its proposed new warning label until the agency "affirmatively states in the Federal Register that the warning may be used. Product labeling must be in accord with the labeling in the amended TFM for oral health care drug products . . . and the TFM and amended TFM for OTC anticaries drug products." SmithKline proposed that the warning read: "If relief is not apparent after four weeks of regular use or if the intensity of the pain increases (or problem worsens) see your dentist promptly, as this may indicate a serious dental problem." The company asserted that its warning accomplished FDA's goal of directing users with serious conditions to seek professional consultation, "yet does not penalize those who are clearly benefiting from their therapy" with the tooth desensitizing agent. In support of its alternative label warning, SmithKline cited the results of a market research survey finding that 57% of those reading the current label did not think that the tooth desensitizing agents had "a limitation of use" and 33% said that they would use such a product continuously. The company concluded that "apparently the correct message was not getting through." FDA told SmithKline that in order for the results of the marketing survey "to be evaluated along with other data and information" prior to publication of the final rule for oral health care products, the company must submit "copies of the survey, the methods used, and the raw data" to FDA. SmithKline maintained that FDA's proposed warning for potassium nitrate products penalizes consumers with dental hypersensitivity who benefit from continued use of a tooth desensitizing agent. Under the May 1992 notice, products containing tooth desensitizing agents must state: "Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than four weeks unless recommended by a dentist or doctor."

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