Fluoride dental floss
FDA should amend OTC Anticaries Drug Products TFM to disallow "the OTC marketing of sodium fluoride treated dental floss in the absence of clinical data showing superiority over comparable floss" without the cavity-fighting ingredient, Squibb unit Princeton Pharmaceuticals argues in a Nov. 14 petition. Firm maintains GRAS/E status of fluoride cannot be extended to a medical device (floss) on bioequivalency grounds as proposed by Johnson & Johnson in a July 1986 petition. J&J argued that dental floss can deliver fluoride with efficacy comparable to other methods of application ....
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