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Executive Summary

SHUSTER's PHENYLPROPANOLAMINE/BENZOCAINE COMBO PROTOCOL FOR WEIGHT CONTROL should include a separate study showing the product "produced a significant weight reduction and that each component contributed to the claimed effect," OTC Drug Evaluation Div. Director William Gilbertson, PharmD, told Herbert Shuster, Inc. in a Sept. 27 feedback letter. Discussing Shuster's July 1983 protocol submission for the weight control chewing gum, Gilbertson said that "while this study may be useful in demonstrating the effect of the combination on oral sensitivity, it cannot be used on its own to demonstrate effectiveness as an OTC weight control product." According to the feedback letter, Shuster's protocol was "designed to determine whether the combination of phenylpropanolamine and benzocaine in a chewing gum dosage form is superior to the singel ingredients in reducing oral sensitivity for ultimate use in weight control." Gilbertson also noted that the proposed study for oral sensitivity "should include a placebo gum in addition to the combination and single-ingredient gums."

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