FDA’s Final Rule On OTC Antiseptic Rubs Affects Just 3% Of Market; Alcohol Rulemaking Deferred

The majority of over-the-counter hand sanitizers and wipes on the US market rely on ethyl alcohol, one of three active ingredients for which final rulemaking has been deferred to allow industry to generate additional safety and effectiveness data. FDA's final rule, released April 11, completes a series of related actions pertaining to OTC antiseptic drug products.

The US market for OTC consumer antiseptics – including germ-killing soaps, hand sanitizers and wipes – hangs in the balance as industry works to deliver data to FDA demonstrating general recognition of safety and effectiveness for active ingredients of highest priority.

FDA released a final rule April 11 for consumer antiseptic rubs – i.e., hand sanitizers, wipes and other products intended for use when soap and water are unavailable – concluding that 28 active ingredients are not GRASE, the threshold for inclusion in the agency’s OTC drug monographs.

The jury is still out on three ingredients – benzalkonium chloride, ethyl alcohol, and isopropyl alcohol – with industry studies underway to support GRASE designations.

In a same-day release, FDA says it will address those ingredients’ status once the studies have been completed and evaluated, or sooner if the studies are abandoned.

The agency makes clear that “at this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.”

 

Regarding antiseptic ingredients' safety and effectiveness, "industry has made good progress toward providing data," FDA says in the release.  

There’s much at stake in FDA’s pending rulemaking on deferred ingredients. The agency notes that “millions of Americans use antiseptic rubs daily, sometimes multiple times a day, to help reduce bacteria on their hands.”

Most of those products rely on ethyl alcohol, according to FDA.

The agency is aware of “a very low number” of consumer antiseptic rubs that use benzethonium chloride, which is among active ingredients deemed non-GRASE. Triclosan also falls in that bucket, but industry has voluntarily phased out use of triclosan in recent years, FDA says.

Overall, the final rule is expected to affect just 3% of the US market. Impacted companies have until April 13, 2020, to reformulate away from benzethonium chloride and other non-GRASE ingredients or obtain approvals under new drug applications.

Rubs Rule Follows Final Word On Washes

FDA's final rule for antiseptic rubs follows a December 2017 final rule on antiseptic products used in healthcare settings, which similarly eliminated 24 active ingredients from OTC drug eligibility while deferring decisions on six others. (Also see "More GRASE Time For 6 OTC Antiseptic Ingredients But 24 Flushed In Final Rule" - HBW Insight, 19 Feb, 2018.)

Before that, FDA found 19 ingredients not GRASE for use in OTC consumer antiseptic washes – i.e., antibacterial soaps and body washes used with water – under a September 2016 final rule. (Also see "FDA Rule Marks Consumer Antibacterial Soaps An Endangered Category" - HBW Insight, 2 Sep, 2016.)

Three active ingredients remain in contention in that category, including benzalkonium chloride, as well as benzethonium chloride and chloroxylenol.

Taken together, FDA’s abovementioned final rules address vast segments of a topical antimicrobial drug category that also includes first-aid and food industry antiseptics, which are being treated separately.

The American Cleaning Institute announced in 2016 that it would commit $10m over five years to drive studies on antiseptic ingredient safety and effectiveness in line with FDA data requests. (Also see "ACI Has $10M Plan For Supporting Antibac Ingredients, If FDA Hasn’t Already Closed The Door" - HBW Insight, 27 Oct, 2016.)

FDA notes in its release that “industry has made good progress toward providing data, and we will continue to provide updates to the public about the progress of collecting this data.”

In a same-day statement, ACI’s Richard Sedlak, executive vice president of technical and international affairs, says the trade group is committed to “ensur[ing] the FDA has complete and up-to-date information on ethanol and benzalkonium chloride used in these beneficial products. ACI welcomes the agency’s decision to allow adequate time to complete the new studies.”

In the meantime, consumers can continue to use hand sanitizer products with confidence, the exec says. “We will work to ensure that these products remain available to help people stay clean and healthy in homes, daycare centers, restaurants, and offices across the United States.”

The Centers for Disease Control and Prevention advises hand washing as an important step consumers can take to avoid getting sick or infecting others. If soap and water are not available, it recommends using an alcohol-based hand sanitizer containing at least 60% alcohol.

(Also see "CHPA Consulting With OTC Antiseptic Advocates As Sunscreen GRASE Push Begins " - HBW Insight, 8 Apr, 2019.)