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PLAQUE CLAIM "DOES NOT NECESSARILY CREATE DRUG STATUS," NDMA

This article was originally published in The Tan Sheet

Executive Summary

PLAQUE CLAIM "DOES NOT NECESSARILY CREATE DRUG STATUS," NDMA representative Stephen McNamara, of the Washington, D.C. law firm Hyman, Phelps & McNamara, asserted in an Aug. 3 presentation during the inaugural meeting of FDA's Plaque Subcommittee. The Nonprescription Drug Manufacturers Association agrees with FDA that "insofar as plaque claims show that a product is intended to cure, mitigate, treat, or prevent a disease, including gingivitis, caries or periodontal disease, such a product would properly be subject to regulation as a drug," McNamara stated. "Disease prevention, however, is not the only reason why a consumer may want to reduce or remove plaque," he asserted. McNamara explained to the panel that claims to "help the formation of unsightly tartar are . . . generally accepted by FDA to be claims to cleanse, beautify, promote attractiveness, or alter the appearance of the teeth and the mouth, and thus to be cosmetic claims." Likewise, he continued, some anti-plaque products state cosmetic claims such as "helps to prevent the formation of plaque, the precursor of unsightly tartar," and should, therefore, be regarded as cosmetic products. McNamara's comments were echoed by Cosmetic, Toiletry and Fragrance Association Associate General Counsel James Skiles in his presentation to the subcommittee. Skiles elaborated on the drug-versus-cosmetic debate by noting that the "definitions of 'drug' and 'cosmetic' are not mutually exclusive; an article may be both a drug and a cosmetic." He suggested that the distinction between "drug" and "cosmetic" depends on the intended use of the product as represented in labeling claims and advertising. FDA Office of OTC Drug Evaluation staffer Jean Rippere noted that "the agency considers 'plaque' a drug claim." However, she added, "the agency considers 'tartar,' for example, a cosmetic claim." Rippere suggested that "those are things that [the subcommittee] can . . . advise us on." She pointed out to the subcommittee that "a good part of the industry likes to think of plaque as a cosmetic claim -- so, it's still a question." Both NDMA and CTFA asked that the subcommittee allow for combination products. At the end of his presentation, McNamara encouraged the group to "endorse a policy for anti-plaque drug products that will permit appropriate combinations of products and indications for use." Countering the recommendations of CTFA and NDMA, Ira Hill of Whitehill Oral Technologies asserted that FDA's September 1990 call for data on anti-plaque products indicated that the agency intends to evaluate anti-plaque products as drugs. "Until controlled studies demonstrate that plaque is not an etiological agent in gum disease, as current scientific data indicates," Hill maintained, "then plaque and gingivitis claims are really drug claims and worthy of the OTC Review process to determine what standards of performance and safety should apply to each." Hazlet, N.J.-based Whitehill has submitted scientific data and clinical trials to FDA to support marketing approval of two products, Microdent and Stannous Flouride. The subcommittee, in its first meeting, did not formally discuss the drug-versus-cosmetic issue. However, several members of the subcommittee raised questions directly related to the distinction. Jorgan Slots, DDS/PhD, University of Southern California School of Dentistry, pointed out that consumers' perceptions of "cleaning teeth" may assume a drug effect rather than a cosmetic effect. "The consumer cleans his teeth because he wants to mimic what is going on in the dental practice," Slots suggested. "[That perception] is reinforced by the dental hygienist and the dentist," he added. The subcommittee's consumer representative, Jean Frazier, PhD, agreed with Slots that consumers' perceptions are important when considering the claims of oral hygiene products. Frazier asserted that consumers "don't believe that [most oral hygiene products] are for cosmetic purposes."
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