OTC MARKET WITHDRAWAL OF 258 CATEGORY II AND III INGREDIENTS

Executive Summary

OTC MARKET WITHDRAWAL OF 258 CATEGORY II AND III INGREDIENTS is proposed by FDA in a May 16 Federal Register notice. The proposed rulemaking would designate as "not generally recognized as safe and effective all ingredients that were Category II or III in the tentative final rulemaking stage and for which "no significant comments or new data to upgrade the status of these ingredients have been submitted." The proposal covers 21 different OTC rulemakings that have passed the closing date for comments on the tentative final monograph (see chart for affected TFMs). "Based on the absence of substantive comments in opposition to the agency's proposed nonmonograph status for these ingredients as well as the failure of interested parties to submit new data or information to FDA," the notice states, "FDA has determined that the presence of these ingredients in an OTC drug product would result in that drug product not being generally recognized as safe and effective or would result in misbranding." To date, Category II and III ingredients have been permitted to stay on the market, barring any significant safety issues, until publication of the applicable final monograph. FDA is explaining its proposal to bar marketing prior to the final monographs as an effort "to expedite completion of the OTC drug review." Under the proposal, manufacturers would have six months from publication of the final rule to remove the ingredients from their OTC products, "regardless of whether further testing is undertaken to justify further use, and regardless of whether the relevant OTC monographs have been finalized at that time." The agency, however, said that "manufacturers are encouraged to comply voluntarily at the earliest possible date." The proposal presumably will not affect many major OTC brands since the affected ingredients are ones for which sponsors did not actively seek Category I status. As with final monographs, the proposal will not preclude a manufacturer from further testing of an ingredient. FDA points out that "new, relevant data can be submitted to the agency at a later date as the subject of a new drug application (NDA),...and where there are adequate data establishing general recognition of safety and effectiveness, such data may be submitted in an appropriate citizen petition to amend or establish a monograph, as appropriate." FDA is accepting comments on the proposal for 60 days; the comment period, however, does not open the administrative rulemakings to permit data submissions on individual ingredients.