Background
Antimicrobial ingredients are typically found in antibacterial hand soaps (hand washes) and hand sanitizers (hand rubs). Hand washes and hand rubs are over-the-counter (OTC) topical antiseptic drugs and thus are regulated by the US Food and Drug Administration (FDA). Household antibacterial soaps containing benzalkonium chloride (BAC), benzethonium chloride (BZT), and chloroxylenol (PCMX) remain under FDA’s ongoing review to characterize the safety and effectiveness of topical antiseptic active ingredients.
Historically, these products have been regulated under FDA’s OTC monograph system, which allows continued market access while FDA evaluates whether the ingredients are classified as “Generally Recognized as Safe and Effective” (GRAS/E). Recently, there has been an interest in regulating these products at the state level as well.
| FDA OTC Monograph Categories | Designation |
| I | GRASE/E |
| II | Not GRAS/E |
| III | Insufficient data for final classification |
Why It Matters
Antibacterial hand soaps play a critical role in reducing the spread of bacteria in both consumer and community settings. Removing these tools before FDA completes its thorough scientific review would undermine public health protections and limit consumer access to effective antibacterial options.
Premature state bans also risk creating a fragmented regulatory landscape that conflicts with federal law and disrupts interstate commerce. The Federal Food, Drug and Cosmetic Act (FD&C Act) is the federal law that regulates topical antiseptic drugs, preempting state law. These active ingredients remain in Category III under FDA’s authority and are lawfully marketed while safety and efficacy research progresses.
What's Next?
FDA’s review of BAC, BZT and PCMX remains ongoing, and ACI continues leading the industry’s scientific research to support a final determination on these ingredients. The Topical Antiseptics Program (TAP) continues to make progress on a suite of safety and efficacy studies, with planned touchpoints to update FDA as new data becomes available. Ensuring these ingredients remain lawfully on the market throughout this process is a top priority. The American Cleaning Institute (ACI) will remain engaged with state agencies, providing scientific insights and reinforcing the essential public health benefits of these products.