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Executive Summary

EUGENOL FOR TOOTHACHE PAIN SHOULD RETAIN CATEGORY I STATUS as an OTC ingredient, Metholatum said in comments on the Tentative Final Monograph for OTC Oral Health Care Products. The monograph, issued on Sept. 24, proposes that eugenol be reclassified to Category III (data are insufficient to classify as safe and effective), reversing a 1978 panel decision classifying eugenol as Category I (safe and effective) ("The Pink Sheet" Sept. 30, 1991, p. 16). The TFM argues that because eugenol has the capacity to "damage viable tooth pulp" and can cause "harmful effects unless used under professional supervision," the ingredient should be classified as Category III. Mentholatum claimed that the evidence of "over 100 years" of usage of eugenol "is adequate to support monograph status [Category I] for the ingredient," adding that "the standard for review of old OTC drugs is more flexible than that for 'new drugs.'" The company has requested a hearing before FDA Commissioner Kessler to discuss the matter. To support its claim, Mentholatum submitted an article "regarding the safety and efficacy of eugenol" by Eugene Pantera, DDS, and Sebastian Ciancio, DDS, from the University of Buffalo. The article counters the TFM claim of possible toxicity and names several factors including "rapid elimination, eposidation of only a small fraction of the dose, and short residence time of the expoxide in the body" to support claims of the low toxicity of eugenol. The TFM also states that the agency has not found the data presented on the efficacy and safety of eugenol sufficient "within the requirements of the OTC drug regulations," and cites "the need for controlled clinical investigations that demonstrate the effectiveness of eugenol used for the relief of toothache." C. S. Dents, maker of Dent's Toothache Gum, Toothache Drops and Lotion-Jel, addressed the Category III status of both eugenol and benzocaine in a Jan. 13 letter. Again referring to the "long history of use of this ingredient," the company claimed that "we do not have the resources to sponsor the studies needed to support the change form Category III to I." Noting the lack of any toothache products given Category I status, Dents said that "if no ingredients achieve Category I status, we may no longer be able to sustain a viable business."

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