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This article was originally published in The Tan Sheet

Executive Summary

NEW LIFE HEALTH PRODUCTS SILVER ACETATE SMOKING CESSATION TRIAL is expected to be completed by the fall, the Morris Plains, N.J. firm said. The 500-patient clinical trial is currently in progress at the University of Medicine and Dentistry of New Jersey. The trial represents the second such study funded by New Life Health Products; the first study was completed in 1991. New Life Health Products markets the Stop Smoking Aid and Quit Aid lozenges, which both contain silver acetate. In FDA's June 1 final monograph for over-the-counter smoking deterrent drug products, silver acetate was not considered a Category I (safe and effective) ingredient ("The Tan Sheet" June 7, p. 15). Three previously submitted silver acetate studies mentioned in the monograph were not deemed by FDA to be sufficient to support the reclassification of silver acetate from Category III (data insufficient to permit classification) to Category I. The monograph did not recognize any other OTC smoking deterrent ingredients as safe and effective. In the final rule, FDA prohibited new shipments of OTC smoking deterrent products after Dec. 1 if the active ingredient is not demonstrated as effective in helping consumers quit or reduce their smoking. Laguna Hills, Calif.-based Advantage Life Products, which markets the CigArrest Stop Smoking System, said that it is scheduled to meet with FDA the week of June 21 to discuss the continued marketing of its product. CigArrest contains lobeline sulfate, which also was not deemed Category I in the final monograph. Advantage maintained that CigArrest -- which presently contains a workbook, an audio cassette, 15 lobeline sulfate tablets (.3 mg each) and seven vitamins -- is a behavior modification program whose efficacy is difficult to document. Advantage said that it plans to clarify to FDA the purpose of its product as an OTC smoking deterrent. In addition, Advantage noted that it is in the process of revamping the CigArrest product and may eliminate lobeline sulfate altogether from the package. The firm said it may replace the lobeline sulfate tablets with nutritional supplement lozenges or gum. The modified CigArrest product will feature a revised workbook and audio cassette, as well as updated packaging, according to Advantage. The modified product is expected to begin arriving on-shelf before Dec. 1, the company stated. Depending upon the outcome of the firm's meeting with FDA, however, Advantage said it would consider conducting studies on lobeline sulfate as a smoking deterrent. Advantage recently licensed rights to CigArrest to Regal Communications, an infomercial producer that will handle some of the advertising for the product ("The Tan Sheet" April 26, p. 8). A round of national TV, print and radio advertising spots for CigArrest began in May.

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