Publishing tomorrow, the FDA will announce that 28 ingredients that were considered in the June 30, 2016 proposed rule were given the boot while further consideration of three ingredients (benzalkonium chloride, alcohol (also referred to as ethanol or ethyl alcohol), and isopropyl alcohol) were deferred until the firms had more time to conduct appropriate studies and the Agency has time to review the additional information to be submitted. The final action on the ineligible ingredients was taken because no additional information was submitted to the FDA after the proposed rule to support a finding of being generally recognized as safe and effective (GRAS/GRAE).
The FDA notes that this final rule applies only to products that are to be used without water (rub on/leave on products like hand sanitizers or wipes) and not to “consumer antiseptic washes (78 FR 76444, 81 FR 61106); healthcare antiseptics (80 FR 25166, 82 FR 60474); antiseptics identified as “first aid antiseptics” in the 1991 First Aid tentative final monograph (TFM) (56 FR 33644); or antiseptics used by the food industry.”
The 62-page final rule in its prepublication form can be found here. The final rule’s effective date is April 13, 2020. ‘On or after that date, any OTC consumer antiseptic rub drug products containing an ingredient that we have found in this document to be ineligible for consideration under the OTC Drug Review for the OTC consumer antiseptic rub monograph cannot be introduced or delivered for introduction into interstate commerce unless it is the subject of an approved NDA or ANDA.”
The document provides a complete history of the entire rule-making process for this OTC category and is quite interesting. There is also a section describing how FDA would apply an efficacy standard. The FDA received 47 comments from the industry, animal rights groups health professionals, trade groups and the general public. The Agency’s responses to these comments are included in the document.
Thus, it looks like it will be at least one year before we find out whether any ingredients survive the GRAS/GRAE analysis for consideration as an eligible ingredient in this class of OTC product.