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This article was originally published in The Tan Sheet

Executive Summary

HENRY THAYER COMPANY LAUNCHING DRY THROAT LOZENGES FOR XEROSTOMIA around Jan. 1 to health food stores and drug chains. Lincoln Center, Mass.-based Thayer said that elm bark-containing Dry Throat Lozenges will be the first consumer product marketed for this use. The active ingredients listed in the product packaging include elm bark, pectin and an electrolyte. Thayer plans to test market the product prior to seeking wider distribution. The company said the product's target audience will be elderly consumers and individuals taking certain dry mouth- producing drugs, such as diuretics, antihistamines, decongestants and antihypertensives, or receiving medical treatments such as radiation therapy. Thayer also plans to promote the products to medical specialists, including ear, nose, and throat specialists, psychiatrists and oncologists. Thayer indicated that its development of the product was prompted, in part, by a request for information published by FDA in a September 1991 Federal Register notice. In the notice, FDA suggested that artificial saliva products could be "potentially useful" for individuals suffering from either temporary or permanent xerostomia. The agency noted, however, that no data submissions had been received regarding these products and invited "specific data and information regarding the use of artificial saliva drug products" for inclusion in the final monograph for OTC oral health care drug products. Companies looking to market elm bark-based OTC products still face one obstacle. FDA informed Thayer on Sept. 3 that "even though elm bark has been proposed as Category I (safe and effective), this ingredient currently is not adequately characterized to permit inclusion in the final monograph" because a USP compendial monograph for elm bark has not yet been established. FDA told Thayer that for "an ingredient such as elm bark" to be included in the final monograph, it would be necessary to develop a USP compendial monograph on that product which would provide "publicly available sufficient chemical information that can be used by all manufacturers to determine that the ingredient is appropriate for use in their products." FDA said it has contacted USP and requested that a compendial monograph for elm bark be established. The agency noted that USP must first "obtain the underlying information necessary to develop a monograph from manufacturers or distributors of the ingredient" and encouraged the company to work with USP in developing the monograph. FDA sent a similar letter on Sept. 3 to Springville, Utah-based Nature's Way Products, which also had asked the agency about the status of elm bark. USP said that development of such a monograph typically takes at least 18 months. A standard for elm bark was listed in the eighth edition of the USP Official Compendium dated 1946 but was deleted about five years later. USP indicated that the old standard would be outdated and that it would be necessary for manufacturers to assist USP in developing a current one.

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