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FDA-2015-N-0101; and FDA-2016-N-0124 DE PARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 November 18, 2020 Docket Nos. FDA-1975-N-0012; FDA-2015-N-0101; and FDA-2016-N-0124 The American Cleaning Institute Attention: James Kim, PhD Vice President, Science and Regulatory Affairs 1401 H Street, N.W. Suite 700 Washington, D.C. 20005 Re: Benzalkonium Chloride, Benzethonium Chloride, Chloroxylenol, Ethanol, and Povidone-Iodine Dear Dr. Kim: This letter responds to The American Cleaning Institute’s (ACI’s) July 14, 2020 communication regarding the deferral from final rulemaking under the over-the-counter (OTC) Drug Review on benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, and povidone-iodine for use in nonprescription (often referred to as over-the-counter or OTC) consumer antiseptic wash, health care antiseptic, and consumer antiseptic rub drug products. In March 2016, FDA issued letters granting requests to defer three active ingredients— benzalkonium chloride, benzethonium chloride, and chloroxylenol—from inclusion in the final rulemaking for the December 2013 proposed rule for OTC consumer antiseptic washes (78 FR 76444). Similarly, in January 2017, FDA issued letters granting requests to defer six active ingredients—benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, povidone- iodine, and isopropyl alcohol—from inclusion in the final rulemaking for the May 2015 proposed rule for OTC health care antiseptics (80 FR 25166). In October 2017, FDA issued letters granting requests to defer three active ingredients—benzalkonium chloride, ethanol, and isopropyl alcohol—from inclusion in the final rulemaking for the June 2016 proposed rule for OTC consumer rub antiseptics (81 FR 42912). In April 2018, FDA granted an extension to defer final rulemaking on five active ingredients— benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, and povidone-iodine— under the antiseptic rulemakings, and granted ACI’s request to harmonize into a single document and reporting cycle the timing for deferrals of these five active ingredients among the various antiseptic rulemakings for which it has requested deferrals. On August 14, 2019, FDA granted another one-year deferral extension, subject to renewal, for these five active ingredients. As explained in each of the deferral letters, FDA deferred inclusion of these active ingredients in the respective rulemakings for one year, subject to renewal, to allow more time for completion of the studies necessary to demonstrate safety and effectiveness. FDA also stated, however, that “if no such studies have been commenced, or if the studies in progress do not appear, in FDA’s judgment, to be productive, the agency expects that it will proceed to rulemaking for [the] ingredient[s] after [the] initial deferral[s].” In March 2020, Section 505G of the Federal Food, Drug & Cosmetic Act (FD&C Act or Act) was enacted as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Section 505G addresses nonprescription drugs marketed without an approved application. The CARES Act replaces the rulemaking process that was previously used in determining the conditions under which certain nonprescription drugs are generally recognized as safe and effective (GRASE) with a streamlined administrative order process. Under section 505G(a)(3) of the FD&C Act, as added by the CARES Act, drugs that were classified as Category III in a tentative final monograph (TFM) that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 of the Act in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.1 In the Consumer Antiseptic Wash Proposed Rule, which is the most recently applicable proposal or determination issued under 21 CFR Part 330 for consumer antiseptic wash products, benzalkonium chloride, benzethonium chloride, and chloroxylenol were classified in 1 Topical antiseptics were addressed in the TFM entitled “Topical Antimicrobial Drug Products for Over-the- Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” Proposed Rule, 78 FR 76444 (December 17, 2013) (the Consumer Antiseptic Wash Proposed Rule), “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; and Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 80 FR 25166 (May 1, 2015) (the Health Care Antiseptics Proposed Rule), and “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016) (the Consumer Antiseptic Rub Proposed Rule). 2 Category III for use as an active ingredient in such products. In the Health Care Antiseptics Proposed Rule, which is the most recently applicable proposal or determination issued under 21 CFR Part 330 for health care antiseptic products, benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, isopropyl alcohol, and povidone-iodine were classified as Category III for use as an active ingredient in different indications for such products. In the Consumer Antiseptic Rub Proposed Rule, which was the most recently applicable proposal or determination for consumer antiseptic rub products issued under 21 CFR Part 330, benzalkonium chloride, ethanol (also referred to as ethyl alcohol), and isopropyl alcohol were classified as Category III for use as an active ingredient in such products. Accordingly, a nonprescription topical antiseptic product can be legally marketed for a use for which its active ingredient was classified as Category III if (1) the product is in conformity with the conditions of use in the TFM, as amended by the Consumer Antiseptic Wash Proposed Rule, the Health Care Antiseptics Proposed Rule, and the Consumer Antiseptic Rub Proposed Rule, and (2) the product complies with all other applicable requirements. While, as a result of the CARES Act, certain nonprescription topical antiseptic products have legal marketing status as described above, FDA continues to believe that completion of the studies necessary to demonstrate the safety and effectiveness of the active ingredients discussed above for the proposed indications is important for the public health. We are committed to working with you to fill the remaining data gaps. As we explain in detail below, FDA has reviewed the information that ACI has submitted thus far in support of its progress to demonstrate the safety and effectiveness of drug products containing benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, and povidone-iodine for certain topical antiseptic uses, and we believe that ACI continues to demonstrate its ongoing commitment to and progress in conducting the necessary safety and efficacy studies. We, therefore, do not intend to issue a proposed administrative order regarding the safety and effectiveness of these products for one year, ending on October 31, 2021, subject to renewal. Submit an updated report that includes a description of ACI’s specific progress for these active ingredients to FDA by October 1, 2021.2 ACI submitted its statements of intent to fill the safety and effectiveness data gaps for benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, and povidone-iodine under the antiseptic rulemaking proceedings for use in OTC consumer antiseptic washes, consumer antiseptic rubs, and health care antiseptic products, for certain specified indications. To date, ACI has submitted multiple reports demonstrating its ongoing progress in conducting the necessary safety and efficacy studies (see August 14, 2019 FDA Extension Deferral Letter). On July 14, 2020, ACI submitted its most recent progress report and provided reference to the following updated information in support of its progress in fulfilling the data gaps: 2 Although in FDA’s Meeting Minutes to ACI dated September 29, 2020, we stated that an updated progress report for benzalkonium chloride should be submitted in August 2021, with this letter we are harmonizing the submission date so that the updated progress report should be submitted by October 1, 2021, for all five ingredients, including benzalkonium chloride. Accordingly, the August 2021 report no longer needs to be submitted. 3 (1) ACI’s February 15, 2019 final report (#150941-202) for the active ingredients benzalkonium chloride, benzethonium chloride, chloroxylenol, povidone-iodine, and ethanol entitled “Determination of the Minimum Inhibitory Concentrations (MIC) and Minimum Bacterial Concentrations (MBC) of Five Test Materials.” FDA confirmed in its Advice Letter dated August 29, 2019 that this study is satisfactory, and the milestone is complete; (2) ACI’s February 26, 2019 response to comments and questions contained in FDA’s Advice letter dated July 5, 2018 regarding the time-kill study final report (#150940-201) for the active ingredients benzalkonium
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