OTC weight control ingredients

FDA issues a final rule to prohibit OTC use of 111 ingredients that have not been proven effective. The final rule, published in the Aug. 8 Federal Register, will become effective in six months. Originally proposed on Oct. 30, 1990, the ban includes guar gum, caffeine, phenacetin and ascorbic acid. Not included in the final rule are phenylpropanolamine (PPA) and benzocaine, for which FDA is still reviewing data. The two ingredients will be the focus of a future tentative final monograph on OTC weight control products.