‘Vast Majority’ Of Antibac Soaps Need Reformulation Under FDA Final Rule

FDA says the “vast majority” of roughly 2,100 consumer antibacterial soaps on the market contain at least one of 19 antimicrobial ingredients banned from OTC use under new final rule. Industry, which suggests the agency is overstating the rule’s impact, is focused on delivering supporting data for three active ingredients still pending before FDA for GRASE use in the category.

Triclosan, long targeted by advocacy groups for alleged health risks, is one of 19 ingredients that must be removed from consumer antibacterial soaps within a year under an FDA final rule released Sept. 2.

The rule, slated for publication in the Sept. 6 Federal Register, impacts a broad swath of the market for consumer hand soaps and body washes, according to FDA.

Teresa Michele, director of the Center for Drug Evaluation and Research’s Division of Nonprescription Drug Products, said in a media briefing that the "vast majority" of marketed products in the category contain at least one of the 19 ingredients that have been determined not GRASE [generally recognized as safe and effective] and therefore ineligible for OTC drug monograph listing.

FDA estimates that there are around 2,100 antibacterial soaps on the market, and that approximately 40% of all consumer hand soaps are positioned as antibacterial or antimicrobial.

“We’re a little concerned that FDA’s rhetoric could give consumers pause. We want to reassure them that these products are safe and effective and have been used safely in many different settings for decades.” – ACI’s Brian Sansoni

The agency’s final rule follows a proposal issued in late 2013, which called for data supporting the safe and effective use of antimicrobial ingredients listed in the agency’s tentative final monograph established in 1978. (Also see "FDA Says Antiseptics Need Testing Or Face Reformulation, Relabeling" - HBW Insight, 23 Dec, 2013.)

FDA cited emerging concerns that ingredients such as triclosan or triclocarbon could pose health risks, including bacterial resistance and hormonal effects, primarily of the thyroid.

Michele said industry failed to provide sufficient evidence to support GRASE determinations for the substances.

Efficacy has been a key piece of that equation and a major point of dispute between FDA and industry stakeholders. Michele noted that the agency was looking for clinical trial data showing antibacterial consumer washes to be more efficacious than regular soap and water.

On the safety end, FDA requested pharmacokinetic data in particular to assess absorption properties and related risks, as well as animal studies exploring the long-term safety of repeated ingredient exposure.

Brian Sansoni, VP of communication and membership at the American Cleaning Institute, suggested in a same-day interview that FDA “muddied the issue somewhat” with its release and statements to media.

“We’re a little concerned that FDA’s rhetoric could give consumers pause,” he said. “We want to reassure them that these products are safe and effective and have been used safely in many different settings for decades.”

According to the exec, many manufacturers anticipated the direction that FDA was headed with its rulemaking and already have reformulated relevant products.

At this point, he said, most consumer antibacterial soaps on the market feature one of three ingredients that are still under consideration at FDA – namely, benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX). (Also see "FDA Rule Marks Consumer Antibac Soaps A Possible Endangered Species" - Pink Sheet, 2 Sep, 2016.)

Sansoni said that aside from triclosan and triclocarban, the ingredients wrapped into FDA’s final rule are outdated substances with minimal use in today’s marketplace.

Industry stands by the safety and efficacy of triclosan and triclocarban, but now is focused on providing FDA with evidence supporting the GRASE status of the remaining three ingredients for which rulemaking has been deferred. Data is due to the agency by next September.

Delivering the required proof of efficacy is no small task, Sansoni said. He suggested that FDA has “moved the goalposts” in recent years, imposing a higher burden of evidence on manufacturers – specifically, that consumer soaps formulated with antibacterial ingredients not only are better germ-killers, but also prevent illness and the transmission of infections more effectively than plain soap and water.

It’s clear that convincing FDA of the remaining ingredients’ virtues is not going to be easy.

In FDA’s release on the final rule, CDER Director Janet Woodcock is pointed in her remarks. “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water.”

“In fact,” she adds, “some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The final rule does not impact consumer antiseptic rubs, such as hand sanitizers and wipes, or healthcare antiseptics, which are being addressed via separate rulemaking initiatives.