OTC Weight Control Drug Products for Human Use
May 19  2000- vol93 University yale stroke CONTROL DIET OTC STIMULANT WEIGHT PPA HAZARD AMPHETAMINE ADVERSE REPORTS 1991-2000
2011-04-04
FDA-1981-N-0012-0051
04:00:00
https://api.regulations.gov/v4/comments/FDA-1981-N-0012-0051
Anonymous
Anonymous
Having read the proposed rule for Docket No. FDA-1981-N-0012, I agree whole heartedly with for benzocaine to have a non-mongraph status versus the proposed monograph status (category I) for over-the-counter (OTC) weight control use. In researching the docket proposal, there has not been sufficient data provided by the petitioners.  The data provided was not substantial and from the documentation was not well controlled.  Without adequate data, it would not be prudent to make a determination regarding benzocaines suitability for over-the-counter use for weight loss. Additionally, the manufacturer has not replied to the commissions response to their 1992 petition; the commission responded in 1993. Without any further correspondence from the manufacturer the commission could only assume that the manufacturer agrees with the unsuitability of benzocaine as an over-the-counter weight-loss product.  In reviewing, other consumer advocacy groups we found no references for or against this proposed rule.  However, I firmly advocate the proposed rule for benzocaine to have a non-monograph status. Very Respectfully,Brad Cecil 